Mefloquine Lariam

FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report
Date:11/04/97ISR Number: 100000135Report Type:Expedited (15-DaCompany Report #88781 Outcome Other Serious PT Vaginal Haemorrhage Complication Of Pregnancy Premature Baby Cervical Incompetence Uterine Haemorrhage Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age:29 YR Route ORAL
Gender:Female Dose 250.000MG 1.0 X PER WEEK ORAL
I/FU:I Duration
Date:11/04/97ISR Number: 100000137Report Type:Expedited (15-DaCompany Report #88780 Outcome Other Serious PT Vaginal Haematoma Cervical Incompetence Haematoma Antepartum Haemorrhage Premature Baby Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 250 MG 1.0 X PER WEEK
Date:11/04/97ISR Number: 100000155Report Type:Expedited (15-DaCompany Report #80275 Outcome Other Serious PT Drug Hypersensitivity Angioedema Tongue Oedema Skin Test Positive Toxicity To Various Agents Report Source Foreign Health Professional Product Lariam Premarin Role PS C Manufacturer
Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL
I/FU:F Duration
Date:11/04/97ISR Number: 100000155Report Type:Expedited (15-DaCompany Report #85380 Outcome Other Serious PT Deafness Neurosensory Tinnitus Report Source Foreign Health Professional Other Product Lariam Augmentin Role PS C Manufacturer
Gender:Male
I/FU:F
Dose Duration 250.0000 MG 1.0X PER WEEK ORAL
Date:11/06/97ISR Number: 3005648-7Report Type:Direct Outcome Life-Threatening Disability Other Serious PT Thinking Abnormal Crying Decreased Appetite
Company Report #
Age:42 YR
Gender:Female
I/FU:I
Required Intervention to Prevent Permanent Impairment/Damage
Panic Disorder Insomnia Related To Another Mental Condition Anxiety Personality Change Fear Insomnia Paraesthesia Page: 1
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysarthria Confusional State Suicidal Ideation Asthenia Depression Chills Abnormal Dreams
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose Duration TABS; 250 MG TAB PO ONCE WEEKLY;(PT D'CD DRUG)
Date:11/10/97ISR Number: 3000073-7Report Type:Expedited (15-DaCompany Report #86849 Outcome Hospitalization Initial or Prolonged PT Cough Dyspnoea Asthenia Bronchitis Dizziness Red Blood Cell Sedimentation Rate Increased Vomiting Nausea Pyrexia Report Source Foreign Other Product Lariam Dpt Yellow Fever Vaccine Havrix Typhim Mercalm Genhevac B Role PS C C C C C C Manufacturer
Gender:Male Dose 250.000 MG 1.0 X PER WEEK ORAL
I/FU:F Duration
Date:11/10/97ISR Number: 3005888-7Report Type:Direct Outcome Disability PT Restlessness Depression Confusional State Emotional Disorder Memory Impairment Visual Impairment Anxiety
Company Report # Report Source Product Lariam Mefloquine Role PS SS Manufacturer
Age:28 YR Route
Gender:Female Dose
I/FU:I Duration
Date:11/12/97ISR Number: 3000157-3Report Type:Expedited (15-DaCompany Report #89097 Outcome Hospitalization Initial or Prolonged PT Dyspnoea Lung Infiltration Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Female Dose
I/FU:I Duration
Date:11/12/97ISR Number: 3000321-3Report Type:Expedited (15-DaCompany Report #89246 Outcome Required PT Uterine Contractions Report Source Foreign Product Lariam Tablets Role Manufacturer
Age:37 YR Route
Gender:Female Dose
I/FU:I Duration
Intervention to Prevent Permanent Impairment/Damage
Abnormal
Health Professional Other
(Mefloquine Hydrochloride)
PS
ORAL
250MG 1 X PER WEEK ORAL
03-Apr-2012
09:37 AM
Page: 2
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/97ISR Number: 3000325-0Report Type:Expedited (15-DaCompany Report #89247 Outcome Hospitalization Initial or Prolonged PT Blood Amylase Increased Pancreatitis Lipase Increased Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) Imodium (Loperamide Hydrochloride) Flagyl (Metronidazole) Role PS C C Manufacturer Age:25 YR Route ORAL Gender:Female Dose 250MG 1 X PER WEEK, ORAL I/FU:I Duration
Date:11/12/97ISR Number: 3000331-6Report Type:Expedited (15-DaCompany Report #82871 Outcome Other Serious PT Tachycardia Hyperventilation Alkalosis Hypokalaemic Paraesthesia Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquiine Hydrochloride) Cyclo-Menorette (Estradiol Valerate/ Estradiol Succinate/ Levonorgestrel) Role PS Manufacturer
Gender:Female Dose 250MG 1 X PER WEEK ORAL
I/FU:I Duration
Date:11/12/97ISR Number: 3000529-7Report Type:Expedited (15-DaCompany Report #80739 Outcome Hospitalization Initial or Prolonged PT Astrocytoma Convulsion Complex Partial Seizures Grand Mal Convulsion Paresis Hallucination Hemiplegia Aphasia Speech Disorder Blood Glucose Decreased Blood Lactic Acid Decreased Brain Neoplasm Glioma Simple Partial Seizures Paralysis Blood Albumin Abnormal Hemiparesis Report Source Foreign Health Professional Product Lariam Phenhydan Role PS C Manufacturer
I/FU:F Duration
Date:11/17/97ISR Number: 3000972-6Report Type:Expedited (15-DaCompany Report #85820
Age:26 YR
Gender:Male
I/FU:I
Outcome Hospitalization Initial or Prolonged
PT Migraine Headache Gastroenteritis Bacterial Trance Illusion Paraesthesia Page: 3
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Disturbance In Attention Restlessness Psychotic Disorder
Report Source Foreign Health Professional
Product Lariam Ciprobay
Role PS C
Manufacturer
Route ORAL
Dose 250.0000 MG 1.0 X PER WEEK ORAL
Duration
Date:11/17/97ISR Number: 3006058-9Report Type:Direct Outcome Disability PT Amnesia Fatigue Depression Immune System Disorder Weight Decreased Decreased Appetite
Company Report # Report Source Product Mefloquine Prozac Role PS C Manufacturer
Gender:Female
I/FU:I
Dose Duration 1 TABLET PER WEEK
Date:11/17/97ISR Number: 3006086-3Report Type:Direct Outcome Other Serious PT Anxiety Gastrooesophageal Reflux Disease
Company Report # Report Source Product Mefloquine Role PS Manufacturer
Gender:Female Dose Q WEEK PO
I/FU:I Duration
Date:11/19/97ISR Number: 3001851-0Report Type:Expedited (15-DaCompany Report #85820 Outcome Hospitalization Initial or Prolonged PT Restlessness Sleep Disorder Trance Headache Psychotic Disorder Paraesthesia Migraine Illusion Gastroenteritis Bacterial Suicidal Ideation Disturbance In Attention Diarrhoea Report Source Foreign Health Professional Product Lariam Ciprobay Role PS C Manufacturer
I/FU:F Duration
Date:11/21/97ISR Number: 3002261-2Report Type:Expedited (15-DaCompany Report #88615 Outcome Other Serious PT Dyspnoea Report Source Foreign Product Lariam Role PS Manufacturer
Gender:Male Dose 250.0000 MG
I/FU:I Duration
Tachycardia Arrhythmia Anxiety
Health Professional
1.0 X PER WEEK ORAL
03-Apr-2012
09:37 AM
Page: 4
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/97ISR Number: 3002889-XReport Type:Expedited (15-DaCompany Report #89882 Outcome Hospitalization Initial or Prolonged PT Paralysis Sensory Disturbance Gait Disturbance Hypoaesthesia Coordination Abnormal Feeling Drunk Sciatica Report Source Foreign Health Professional Product Lariam Insuline Role PS C Manufacturer Age:82 YR Route ORAL Gender:Male Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:11/26/97ISR Number: 3002892-XReport Type:Expedited (15-DaCompany Report #89097 Outcome Hospitalization Initial or Prolonged PT Dyspnoea Lung Infiltration Report Source Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:F
Dose Duration 10.0000 MG/KG DAILY ORAL
Date:12/01/97ISR Number: 3003013-XReport Type:Expedited (15-DaCompany Report #86213 Outcome Disability PT Muscle Spasms Medication Error Pain Nausea Tremor Dizziness Agitation Confusional State Anxiety Condition Aggravated Report Source Health Professional Other Product Lariam Tetanus Vaccine Hepatitis Vaccine Birth Control Pills Role PS C C C Manufacturer
Gender:Female Dose 1.2500 GRAM 1.0 X PER ODOS ORAL
I/FU:I Duration
Date:12/01/97ISR Number: 3003015-3Report Type:Expedited (15-DaCompany Report #90214 Outcome Other Serious PT Bradycardia Abdominal Pain Syncope Dizziness Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:12/01/97ISR Number: 3003374-1Report Type:Expedited (15-DaCompany Report #90289 Outcome Other Serious PT Skin Infection Urticaria Erysipeloid Report Source Foreign Consumer Product Lariam Role PS Manufacturer
Gender:Male Dose
I/FU:I Duration
Date:12/01/97ISR Number: 3003432-1Report Type:Expedited (15-DaCompany Report #92090 Outcome Other Serious 03-Apr-2012 09:37 AM PT Skin Infection Urticaria
Age:72 YR
Gender:Female
I/FU:I
Page: 5
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erysipeloid Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Route ORAL Dose Duration
Date:12/01/97ISR Number: 3003541-7Report Type:Expedited (15-DaCompany Report #89097 Outcome Hospitalization Initial or Prolonged PT Dyspnoea Lung Infiltration Report Source Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:F
Dose Duration 10.0000 MG/KG DAILY ORAL
Date:12/01/97ISR Number: 3082443-4Report Type:Expedited (15-DaCompany Report #90612 Outcome Other Serious PT Parkinsonism Extrapyramidal Disorder Report Source Health Professional Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender: Dose ORAL
I/FU:I Duration
Date:12/02/97ISR Number: 3003685-XReport Type:Expedited (15-DaCompany Report #87481 Outcome Disability Other Serious PT Dizziness Hypertension Medication Error Vomiting Fatigue Oedema Visual Impairment Hypoaesthesia Paraesthesia Nausea Dysgeusia Report Source Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Dose Duration 250.0000 MG 1.0 X PER DAY ORAL
Date:12/02/97ISR Number: 3003799-4Report Type:Expedited (15-DaCompany Report #90767 Outcome Hospitalization Initial or Prolonged PT Toxic Skin Eruption Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Female Dose 250.0000MG 1.0 X PER WEEK ORAL
I/FU:I Duration
Age:36 YR
Gender:Male
I/FU:I
Outcome Other Serious
PT Depressed Mood Mood Swings Ear Infection Depression Suicidal Panic Attack Suicidal Ideation 09:37 AM
Report Source Foreign Other
Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Yellow Fever Vaccine
Role
Manufacturer
Route
Dose
Duration
PS C
ORAL
250.000 MG 1.0 X PER WEEK ORAL Page: 6
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rabies Vaccine Havrix C C
Date:12/02/97ISR Number: 3003979-8Report Type:Expedited (15-DaCompany Report #85820 Outcome Hospitalization Initial or Prolonged PT Anxiety Diarrhoea Insomnia Illusion Paraesthesia Gastroenteritis Bacterial Disturbance In Attention Restlessness Headache Psychotic Disorder Hypoaesthesia Trance Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Ciprobay
SS
ORAL
Dose Duration 250.0000 MG 1.0 X PER WEEK ORAL TAB 500.0000 MG 2.0 X PER DAY ORAL
Date:12/02/97ISR Number: 3003982-8Report Type:Expedited (15-DaCompany Report #59906 Outcome Other Serious PT No Adverse Event Report Source Foreign Health Professional Product Lariam Paludrine Typhim Vi Nivaquine Role PS C C C Manufacturer
Gender:Female Dose 250 MG
I/FU:I Duration
Date:12/02/97ISR Number: 3004047-1Report Type:Expedited (15-DaCompany Report #90736 Outcome Hospitalization Initial or Prolonged PT Hostility Delusion Nervousness Psychotic Disorder Agitation Toxicity To Various Agents Hypersensitivity Hallucination, Auditory Trance Aggression Report Source Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:12/02/97ISR Number: 3004049-5Report Type:Expedited (15-DaCompany Report #90607 Outcome PT Report Source Product Role Manufacturer
Age:78 YR Route
Gender:Male Dose
I/FU:I Duration
Other Serious
Dementia
Foreign Health Professional
Lariam
PS
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 7
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/97ISR Number: 3004114-2Report Type:Expedited (15-DaCompany Report #89618 Outcome Other Serious PT Decreased Appetite Abnormal Dreams Crying Palpitations Hyperreflexia Hypoaesthesia Insomnia Abnormal Behaviour Muscle Contractions Involuntary Motor Dysfunction Panic Reaction Drug Hypersensitivity Paraesthesia Report Source Consumer Product Lariam Role PS Manufacturer Age:42 YR Route ORAL Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:12/03/97ISR Number: 3003946-4Report Type:Expedited (15-DaCompany Report #88694 Outcome Hospitalization Initial or Prolonged PT Paraesthesia Dizziness Asthenia Blood Calcium Increased Alopecia Arthralgia Headache Hypoaesthesia Hypoparathyroidism Hyperhidrosis Visual Impairment Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer
I/FU:I Duration 56 DAY
Date:12/03/97ISR Number: 3007297-3Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Panic Attack Insomnia Anxiety Agoraphobia Dyspnoea
Company Report # Report Source Product Lariam Role PS Manufacturer
Age:42 YR Route
Gender:Female Dose 1 PER WEEK
I/FU:I Duration
Date:12/08/97ISR Number: 3004513-9Report Type:Expedited (15-DaCompany Report #90887 Outcome Hospitalization Initial or Prolonged PT Muscle Rigidity Muscle Twitching Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male Dose 250.000 MG 1.0 X PER
I/FU:I Duration
Blood Glucose Decreased
WEEK ORAL
03-Apr-2012
09:37 AM
Page: 8
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/97ISR Number: 3004514-0Report Type:Expedited (15-DaCompany Report #90886 Outcome Other Serious PT Photosensitivity Reaction Rash Pustular Skin Infection Report Source Foreign Other Product Lariam Sakmonella Vaccine Immunoglobulins Poliomyelitis Vaccine Role PS C C C Manufacturer Age:45 YR Route ORAL Gender:Male Dose 250.000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:12/08/97ISR Number: 3004766-7Report Type:Expedited (15-DaCompany Report #90692 Outcome Disability PT Cough Deafness Neurosensory Tinnitus Report Source Consumer Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:12/08/97ISR Number: 3004769-2Report Type:Expedited (15-DaCompany Report #89328 Outcome Other Serious PT Abortion Missed Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female
I/FU:I
Dose Duration 250.0000MG 1.0X PER WEEK ORAL
Date:12/09/97ISR Number: 3004654-6Report Type:Expedited (15-DaCompany Report #911054 Outcome Hospitalization Initial or Prolonged PT Electrocardiogram Qrs Complex Abnormal Chest Pain Atrial Flutter Condition Aggravated Atrioventricular Block Palpitations Heart Rate Increased Conduction Disorder Tachycardia Report Source Foreign Literature Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:12/09/97ISR Number: 3004657-1Report Type:Expedited (15-DaCompany Report #90945 Outcome Hospitalization Initial or Prolonged PT Anaemia Jaundice Asthenia Report Source Foreign Literature Product Lariam Role PS Manufacturer
I/FU:I Duration
Pyrexia Malaria Chills Chromaturia Blood Creatinine Increased Haemolysis 03-Apr-2012 09:37 AM Page: 9
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/97ISR Number: 3004686-8Report Type:Expedited (15-DaCompany Report #91054 Outcome Hospitalization Initial or Prolonged PT Chest Pain Palpitations Atrial Flutter Heart Rate Increased Tachycardia Report Source Foreign Literature Product Lariam Role PS Manufacturer Age:63 YR Route ORAL Gender:Male Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:12/11/97ISR Number: 3007641-7Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Coordination Abnormal Photophobia Gait Disturbance Asthenia Headache
Company Report # Report Source Product Mefloquine Role PS Manufacturer Roche
Age:8 YR Route ORAL
Gender:Male
I/FU:I
Dose Duration 125 MG WEEKLY
Date:12/12/97ISR Number: 3006775-0Report Type:Expedited (15-DaCompany Report #91314 Outcome Death PT Abnormal Behaviour Completed Suicide Report Source Foreign Other Product Lariam Chlorquine Role PS SS Manufacturer
Age: Route ORAL
Gender:Male Dose 250.0000MG 1.0 X PER WEEK ORAL UNKNOWN
I/FU:I Duration
Date:12/16/97ISR Number: 3008113-6Report Type:Expedited (15-DaCompany Report #91370 Outcome Hospitalization Initial or Prolonged PT Ulna Fracture Delusional Disorder, Persecutory Type Suicide Attempt Radius Fracture Psychotic Disorder Pelvic Fracture Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male Dose 250.0000MG 1.0 X PER WEEK ORAL
I/FU:I Duration
Date:12/16/97ISR Number: 3008116-1Report Type:Expedited (15-DaCompany Report #89882 Outcome Hospitalization Initial or Prolonged PT Gait Disturbance Paralysis Hypoaesthesia Muscular Weakness Report Source Foreign Health Professional Product Lariam Daonil Insulin Role PS C C Manufacturer
I/FU:F Duration
Date:12/23/97ISR Number: 3010716-XReport Type:Expedited (15-DaCompany Report #91691 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Hallucination, Tactile Hyperhidrosis
Age:50 YR
Gender:Male
I/FU:I
Page: 10
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Hallucination, Visual Report Source Foreign Other Product Lariam Role PS Manufacturer Route ORAL Dose 250.0000MG 1.0 X PER WEEK ORAL Duration
Date:12/30/97ISR Number: 3097260-9Report Type:Direct Outcome Life-Threatening PT Nervousness Feeling Jittery Malaise Insomnia Panic Attack
Age:37 YR Route
Gender:Male
I/FU:I
Dose Duration 250MG /WK X3
Date:01/02/98ISR Number: 3014141-7Report Type:Expedited (15-DaCompany Report #JAFRA-36938 Outcome Hospitalization Initial or Prolonged PT Staphylococcal Infection Arthralgia Pyrexia Aspartate Aminotransferase Increased Arthritis Reactive Diarrhoea Hepatomegaly Conjunctivitis Alanine Aminotransferase Increased Report Source Foreign Product Imodium Ercefuryl Smecta Engerix B Lariam Tiorfan Role PS SS SS SS SS C Manufacturer Janssen
Age:25 YR Route ORAL ORAL INTRAMUSCULAR ORAL ORAL
Gender:Female Dose ORAL ORAL 20 MCG TOTAL INTRAMUSCULAR 1 WEEKLY ORAL 100 MG ORAL
I/FU:I Duration 30 7 30 DAY WK DAY
Date:01/07/98ISR Number: 3015608-8Report Type:Expedited (15-DaCompany Report #90736 Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Delusion Aggression Nervousness Toxicity To Various Agents Agitation Trance Report Source Other Product Lariam Role PS Manufacturer
I/FU:F Duration
Age:
Gender:Female
I/FU:I
PT Depression Suicidal Ideation Anxiety
Report Source Foreign Consumer
Product Lariam
Role PS
Manufacturer
Route
Dose 250.0000MG 1.0 X PER WEEK
Duration
03-Apr-2012
09:37 AM
Page: 11
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/98ISR Number: 3016847-2Report Type:Expedited (15-DaCompany Report #92171 Outcome Hospitalization Initial or Prolonged PT Myalgia Sick Sinus Syndrome Post Viral Fatigue Syndrome Report Source Foreign Other Product Lariam Thyroxine Role PS C Manufacturer Age:58 YR Route ORAL Gender:Female I/FU:I
Dose Duration 250 MG 1.0 X PER WEEK ORAL
Date:01/12/98ISR Number: 3016579-0Report Type:Expedited (15-DaCompany Report #92444 Outcome Hospitalization Initial or Prolonged Congenital Anomaly PT Small For Dates Baby Maternal Drugs Affecting Foetus Premature Baby Foetal Growth Restriction Report Source Foreign Consumer Other Product Lariam Adepal Yellow Fever Vaccine Role PS SS SS Manufacturer
Age:24 YR Route ORAL ORAL SUBCUTANEOUS
Gender:Female
I/FU:I
Hepatitis A Vaccine Hepatitis B Vaccine
SS SS
INTRAMUSCULAR INTRAMUSCULAR
Dose Duration 250.0000 MG 1.0 X PER WEEK ORAL 1.0000 DOSE FORM 1.0 X PER DAY ORAL 1.0000 DOSE FORM 1.0 X PER ODOS SUBCUTANEOUS 1.0 X PER ODOS INTRAMUSCULAR 1.0 X PER ODOS INTRAMUSCULAR
Date:01/15/98ISR Number: 3018437-4Report Type:Direct Outcome Disability PT Fall Gait Disturbance Balance Disorder
Company Report # Report Source Product Lariam Novaldex Role PS C Manufacturer Laroche
Age:80 YR Route
Gender:Female
I/FU:I
Dose Duration 1 WEEKLY FOR 8 WKS
Date:01/15/98ISR Number: 3053811-1Report Type:Periodic Outcome PT Chills Anxiety Fatigue Dizziness Headache Myalgia Nausea Palpitations Asthenia
Company Report #WAES 97041992
Age:44 YR
Gender:Male
I/FU:F
Tinnitus Accommodation Disorder Diarrhoea Decreased Appetite Abdominal Pain Depression Pruritus Drug Interaction 03-Apr-2012 09:37 AM Page: 12
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysgeusia Emotional Disorder Salivary Hypersecretion
Report Source Consumer Health Professional
Product Crixivan Lariam Unk Halicon Triazolam Retin-A Valtrex Zerit Cimetidine Epivir (Beta)-Carotene Nizoral
Role PS SS C C C C C C C C C
Manufacturer Merck Research Laboratories Div Merck Co Inc
Route ORAL ORAL
Dose 800 MG/Q8H/PO PO
Duration
Date:01/21/98ISR Number: 3017831-5Report Type:Expedited (15-DaCompany Report #92564 Outcome Hospitalization Initial or Prolonged PT Bradycardia Gastroenteritis Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:01/22/98ISR Number: 3018708-1Report Type:Direct Outcome Disability PT Balance Disorder Gait Disturbance
Company Report # Report Source Product Lariam Nolvadex Role PS C Manufacturer La Roche Pharmaceutical
Age:80 YR Route Co
Gender:Female Dose 1 PER WEEK FOR 8 WEEKS
I/FU:I Duration
Date:01/27/98ISR Number: 3019299-1Report Type:Expedited (15-DaCompany Report #92891 Outcome Other Serious PT Vertigo Balance Disorder Gait Disturbance Report Source Foreign Health Professional Product Lariam Geluprane Role PS C Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:01/27/98ISR Number: 3019406-0Report Type:Expedited (15-DaCompany Report #91568 Outcome Other Serious PT Viith Nerve Paralysis Report Source Foreign Health Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose 250.0000 MG 1.0 X PER
I/FU:I Duration
Professional Premarin Salazopyrine C C
WEEK ORAL
28
DAY
03-Apr-2012
09:37 AM
Page: 13
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/98ISR Number: 3021867-8Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Palpitations Fatigue Chest Pain Company Report # Report Source Product Mefloquine Role PS Manufacturer Age:53 YR Route ORAL Gender:Male Dose 250 MG PO DOSES 8 I/FU:I Duration
Date:02/02/98ISR Number: 3021875-7Report Type:Expedited (15-DaCompany Report #80873 Outcome Congenital Anomaly PT Thymus Enlargement Trisomy 21 Congenital Anomaly Ventricular Septal Defect Acquired Dysmorphism Maternal Drugs Affecting Foetus Abortion Induced Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/02/98ISR Number: 3021893-9Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Fatigue Chest Discomfort Decreased Appetite Cardiac Disorder Asthenia Heart Rate Increased
Company Report # Report Source Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 250 MG WEEKLY 4 WK
Date:02/02/98ISR Number: 3021894-0Report Type:Expedited (15-DaCompany Report #89618 Outcome Other Serious PT Palpitations Insomnia Crying Decreased Appetite Hyperreflexia Panic Attack Motor Dysfunction Paraesthesia Abnormal Dreams Report Source Consumer Product Lariam Role PS Manufacturer
Gender:Female Dose 250.OOO MG 1.0 X PER WEEK ORAL
I/FU:F Duration
Age:25 YR
Gender:Female
I/FU:I
PT Diarrhoea Pyrexia Embolism Arterial Headache Hemiparesis
Product Lariam Marvelon
Role PS C
Manufacturer
Route ORAL
Dose Duration 250.00 MG 1.0 X PER WEEK ORAL
03-Apr-2012
09:37 AM
Page: 14
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/98ISR Number: 3022672-9Report Type:Expedited (15-DaCompany Report #90763 Outcome Hospitalization Initial or Prolonged PT Leukopenia Hyperhidrosis Myalgia Aspartate Aminotransferase Increased Fatigue Hepatic Enzyme Increased Blood Creatine Phosphokinase Increased Skin Discolouration Myopathy Liver Function Test Abnormal Alanine Aminotransferase Increased Chest Pain Pain In Extremity Diarrhoea Hypogammaglobulinaemia Tongue Coated Cardiovascular Disorder Muscular Weakness Myocarditis Hepatic Steatosis Gamma-Glutamyltransferase Increased Headache Myoglobin Blood Increased Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Age:36 YR Route ORAL Gender:Male Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:02/04/98ISR Number: 3022673-0Report Type:Expedited (15-DaCompany Report #92891 Outcome Other Serious PT Balance Disorder Vertigo Gait Disturbance Dizziness Report Source Foreign Health Professional Product Lariam Geluprane Role PS C Manufacturer
I/FU:F Duration
Date:02/04/98ISR Number: 3023912-2Report Type:Expedited (15-DaCompany Report #87481 Outcome Disability Other Serious PT Amnesia Fatigue Nausea Hypoaesthesia Nervous System Disorder
Age:54 YR
Gender:Male
I/FU:F
Overdose Dysgeusia Hypertension Oedema Disturbance In Attention Visual Field Defect Paraesthesia Vomiting 03-Apr-2012 09:37 AM Page: 15
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Report Source Consumer Health Professional Product Lariam Role PS Manufacturer Route ORAL Dose Duration 250.000 MG 1.0 X PER DAY ORAL
Date:02/09/98ISR Number: 3025971-XReport Type:Expedited (15-DaCompany Report #88651 Outcome Other Serious PT Diplopia Vith Nerve Paralysis Nausea Headache Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL TAB
I/FU:I Duration
Date:02/09/98ISR Number: 3026005-3Report Type:Expedited (15-DaCompany Report #93517 Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Heart Rate Decreased Atrioventricular Block Complete Dizziness Pallor Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/10/98ISR Number: 3027135-2Report Type:Expedited (15-DaCompany Report #87481 Outcome Disability PT Mental Impairment Medication Error Visual Impairment Vomiting Overdose Hypertension Drug Level Above Therapeutic Dysgeusia Dizziness Brain Injury Visual Acuity Reduced Amnesia Fatigue Paraesthesia Nausea Oedema Report Source Health Professional Other Product Lariam Role PS Manufacturer
Gender:Male Dose 250.000 MG 2.0 X WEEK ORAL
I/FU:F Duration
Date:02/12/98ISR Number: 3027269-2Report Type:Expedited (15-DaCompany Report #92564 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Bradycardia Gastroenteritis Asthenia
Age:16 YR
Gender:Female
I/FU:F
Page: 16
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Red Blood Cell Sedimentation Rate Increased
Product Lariam
Role PS
Manufacturer
Route ORAL
Duration
Date:02/12/98ISR Number: 3028339-5Report Type:Expedited (15-DaCompany Report #93802 Outcome Hospitalization Initial or Prolonged PT Depression Anxiety Thinking Abnormal Tremor Personality Disorder Abnormal Behaviour Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration 50.000 MG 1.0 X PER WEEK
Date:02/12/98ISR Number: 3030309-8Report Type:Expedited (15-DaCompany Report #89882 Outcome Hospitalization Initial or Prolonged PT Hypoaesthesia Feeling Drunk Coordination Abnormal Paralysis Balance Disorder Muscular Weakness Monoparesis Report Source Foreign Health Professional Product Lariam Daonil Insuline Role PS C C Manufacturer
I/FU:F Duration
Date:02/12/98ISR Number: 3030313-XReport Type:Expedited (15-DaCompany Report #87481 Outcome Disability Other Serious PT Hypoaesthesia Dysgeusia Hypertension Medication Error Nausea Fatigue Visual Impairment Dizziness Disturbance In Attention Vomiting Memory Impairment Brain Injury Oedema Report Source Consumer Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:02/13/98ISR Number: 3030113-0Report Type:Expedited (15-DaCompany Report #JAFRA-36938 Outcome Hospitalization Initial or Prolonged PT Diarrhoea Hepatic Function Abnormal Hepatomegaly Pyrexia Arthralgia
Age:25 YR
Gender:Female
I/FU:F
03-Apr-2012
09:37 AM
Page: 17
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Conjunctivitis Report Source Foreign Health Professional Product Imodium Ercefuryl Smecta Engerix B Role PS SS SS SS Manufacturer Janssen Route ORAL ORAL INTRAMUSCULAR Dose ORAL ORAL 20 MCG TOTAL, INTRAMUSCULAR SUSPENSION 20 MCG 1 TABLET WEEKLY ORAL 100MG CAPSULES Duration 30 DAY
Lariam Tiorfan
SS C
ORAL ORAL
7 30
WK DAY
Date:02/18/98ISR Number: 3032216-3Report Type:Expedited (15-DaCompany Report #94117 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Polyneuropathy Gait Disturbance Spinal Osteoarthritis Sciatica Back Pain Lumbar Spinal Stenosis Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/18/98ISR Number: 3032221-7Report Type:Expedited (15-DaCompany Report #93891 Outcome Life-Threatening PT Renal Failure Cardiac Arrest Malaria Report Source Foreign Consumer Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose 250 MG ORAL;TAB
I/FU:I Duration
Date:02/18/98ISR Number: 3036413-2Report Type:Direct Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage PT Panic Attack Convulsion Dizziness Tremor Vision Blurred Anxiety
Age:44 YR Route
Gender:Male Dose PRESCRIBED AMOUNTS
I/FU:I Duration
Age:30 YR Route
Gender:Male Dose
I/FU:F Duration
Other Serious
Depression Suicidal Ideation
Foreign Other
Lariam
PS
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 18
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/98ISR Number: 3035857-2Report Type:Expedited (15-DaCompany Report #93243 Outcome Other Serious PT Blood Alkaline Phosphatase Increased Gamma-Glutamyltransferase Increased Platelet Count Decreased White Blood Cell Count Decreased Thrombocytopenia Alanine Aminotransferase Increased Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Age:58 YR Route ORAL Gender:Male I/FU:I
Dose Duration 1500.0000 MG ORAL
Date:02/23/98ISR Number: 3035884-5Report Type:Expedited (15-DaCompany Report #94429 Outcome Death PT Pneumonia Viral Maternal Drugs Affecting Foetus Report Source Literature Product Lariam Role PS Manufacturer
Age:4 MON Route ORAL
Gender:Female
I/FU:I
Dose Duration 250 MG 1 X PER WEEK ORAL
Date:02/23/98ISR Number: 3035887-0Report Type:Expedited (15-DaCompany Report #94430 Outcome Other Serious PT Maternal Drugs Affecting Foetus Benign Hydatidiform Mole Report Source Literature Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Date:02/23/98ISR Number: 3036234-0Report Type:Expedited (15-DaCompany Report #94382 Outcome Other Serious PT Coordination Abnormal Agraphia Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/23/98ISR Number: 3037257-8Report Type:Expedited (15-DaCompany Report #93562 Outcome Hospitalization Initial or Prolonged PT Cardiolipin Antibody Positive Abortion Spontaneous Dna Antibody Positive Systemic Lupus Erythematosus Pre-Eclampsia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Age: Route ORAL
I/FU:F Duration
Maternal Drugs Affecting Foetus
03-Apr-2012
09:37 AM
Page: 19
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/98ISR Number: 3037262-1Report Type:Expedited (15-DaCompany Report #94371 Outcome Death PT Completed Suicide Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Age:33 YR Route ORAL Gender:Male I/FU:I
Date:02/24/98ISR Number: 3035602-0Report Type:Expedited (15-DaCompany Report #94035 Outcome Other Serious PT Disturbance In Attention Dyskinesia Insomnia Dizziness Nausea Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Female Dose 250.000 MG ORAL
I/FU:I Duration
Date:02/24/98ISR Number: 3035604-4Report Type:Expedited (15-DaCompany Report #94037 Outcome Other Serious PT Urticaria Angioedema Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male Dose 250.000 MG ORAL
I/FU:I Duration
Date:02/24/98ISR Number: 3035607-XReport Type:Expedited (15-DaCompany Report #947072 Outcome Other Serious PT Psychotic Disorder Suicidal Ideation Anxiety Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/24/98ISR Number: 3035611-1Report Type:Expedited (15-DaCompany Report #94073 Outcome Other Serious PT Disturbance In Attention Agitation Anxiety Palpitations Atrial Fibrillation Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/24/98ISR Number: 3035613-5Report Type:Expedited (15-DaCompany Report #94074 Outcome Other Serious PT Depression Suicidal Ideation Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/24/98ISR Number: 3035616-0Report Type:Expedited (15-DaCompany Report #94092 Outcome Other Serious 03-Apr-2012 09:37 AM PT Depression Psychotic Disorder
Age:24 YR
Gender:Female
I/FU:I
Page: 20
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Anxiety Report Source Foreign Other Product Lariam Role PS Manufacturer Route ORAL Dose 250.000 MG ORAL Duration
Date:02/24/98ISR Number: 3035620-2Report Type:Expedited (15-DaCompany Report #94093 Outcome Other Serious PT Psychotic Disorder Renal Failure Acute Dermatitis Disorientation Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/24/98ISR Number: 3035623-8Report Type:Expedited (15-DaCompany Report #94101 Outcome Other Serious PT Anxiety Dyskinesia Agitation Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/24/98ISR Number: 3035628-7Report Type:Expedited (15-DaCompany Report #04106 Outcome Other Serious PT Hyperhidrosis Vomiting Palpitations Psychotic Disorder Diarrhoea Hallucination Paralysis Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/24/98ISR Number: 3035644-5Report Type:Expedited (15-DaCompany Report #94124 Outcome Other Serious PT Anaemia Coombs Direct Test Positive Report Source Foreign Other Product Lariam Role PS Manufacturer
Age:5 YR Route ORAL
I/FU:I Duration
Date:02/24/98ISR Number: 3035647-0Report Type:Expedited (15-DaCompany Report #94126 Outcome Other Serious PT Fatigue Report Source Foreign Product Lariam Role PS Manufacturer
I/FU:I Duration
Angina Pectoris
Other
1.0 X PER WEEK ORAL
03-Apr-2012
09:37 AM
Page: 21
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/98ISR Number: 3035650-0Report Type:Expedited (15-DaCompany Report #94128 Outcome Other Serious PT Bronchospasm Report Source Foreign Other Product Lariam Role PS Manufacturer Age:27 YR Route ORAL Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:02/24/98ISR Number: 3035652-4Report Type:Expedited (15-DaCompany Report #94131 Outcome Hospitalization Initial or Prolonged PT Cardiac Failure Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/24/98ISR Number: 3035657-3Report Type:Expedited (15-DaCompany Report #94137 Outcome Other Serious PT Hepatitis Cholestatic Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/24/98ISR Number: 3035660-3Report Type:Expedited (15-DaCompany Report #94146 Outcome Hospitalization Initial or Prolonged PT Hypoglycaemia Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:02/24/98ISR Number: 3103313-9Report Type:Expedited (15-DaCompany Report #94065 Outcome Other Serious PT Angioedema Dermatitis Depressed Mood Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:03/02/98ISR Number: 3050236-XReport Type:Direct Outcome Other Serious PT Nightmare
Gender:Male Dose 250 MG PO
I/FU:I Duration
Age:12 YR
Gender:Male
I/FU:I
PT Obsessive-Compulsive Disorder Emotional Disorder Panic Attack
Report Source Health Professional
Product Lariam
Role PS
Manufacturer
Route ORAL
Dose
Duration
03-Apr-2012
09:37 AM
Page: 22
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/98ISR Number: 3049890-8Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Depressed Level Of Consciousness Hallucination, Visual Myalgia Muscular Weakness Depression Pain In Extremity Hypersensitivity Dizziness Headache Paralysis Bone Pain Injury Pain Pyrexia Dyspnoea Psychotic Disorder Agitation Paraesthesia Tinnitus Educational Problem Heart Rate Irregular Coordination Abnormal Loss Of Consciousness Insomnia Chills Abnormal Behaviour Sleep Disorder Hallucination, Auditory Abnormal Dreams Palpitations Cold Sweat Speech Disorder Visual Impairment Influenza Like Illness Company Report # Report Source Product Lariam Role PS Manufacturer Hoffmann-Laroche Age:15 YR Route Gender:Male Dose 250MG WKLY I/FU:I Duration
Date:03/05/98ISR Number: 3050365-0Report Type:Direct Outcome Other Serious PT Abnormal Dreams Pain In Extremity Scab Insomnia Dermatitis Bullous Rash Papular Urticaria
Company Report # Report Source Consumer Product Lariam Role PS Manufacturer Hoffman La Roche
Age:53 YR Route
Gender:Male Dose 1 TAB/WEEK
I/FU:I Duration
Date:03/05/98ISR Number: 3050366-2Report Type:Direct Outcome Other Serious PT Sleep Disorder Dermatitis Bullous
Company Report # Report Source Consumer Product Lariam Role PS Manufacturer Hoffman Laroche
Age:48 YR Route
Gender:Female Dose 1 TAB/WK
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 23
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/98ISR Number: 3049117-7Report Type:Direct Outcome Disability PT Abnormal Dreams Photosensitivity Reaction Scleral Discolouration Tooth Discolouration Sleep Disorder Company Report # Report Source Product Lariam Vitamins Role PS C Manufacturer Age:24 YR Route ORAL Gender:Male I/FU:I
Dose Duration 1 PILL WEEKLY
Date:03/10/98ISR Number: 3054941-0Report Type:Expedited (15-DaCompany Report #88694 Outcome Hospitalization Initial or Prolonged PT Visual Impairment Asthenia Blood Calcium Decreased Infectious Mononucleosis Paraesthesia Arthralgia Dizziness Hyperhidrosis Mental Disorder Hypoaesthesia Arrhythmia Tension Headache Alopecia Sensory Disturbance Hypoparathyroidism Headache Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer
I/FU:F Duration
Date:03/12/98ISR Number: 3058545-5Report Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Anxiety Panic Attack
Company Report # Report Source Product Lariam Birth Control Pills Role PS C Manufacturer
Age:24 YR Route
Gender:Female
I/FU:I
Dose Duration 1 PER WEEK 5 DOSES
Date:03/12/98ISR Number: 3059187-8Report Type:Direct Outcome Other Serious PT Insomnia Agitation Nervousness
Company Report # Report Source Health Professional Product Sibutamine Mefloquine Role PS SS Manufacturer Knoll Roche
Age:50 YR Route ORAL ORAL
Gender:Female
I/FU:I
Dose Duration 10 MG QD 250 MG Q WEEK
Date:03/16/98ISR Number: 3055731-5Report Type:Expedited (15-DaCompany Report #94329 Outcome Other Serious PT Inappropriate Antidiuretic Hormone Secretion Diabetes Insipidus Polyuria 09:37 AM
Age:2 YR
Gender:Male
I/FU:I
03-Apr-2012
Page: 24
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polydipsia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Route ORAL Dose Duration 250 MG 1.0 X PER WEEK ORAL
Date:03/16/98ISR Number: 3055732-7Report Type:Expedited (15-DaCompany Report #95577 Outcome Hospitalization Initial or Prolonged PT Anxiety Dehydration Abdominal Pain Upper Cholecystitis Vomiting Gastroenteritis Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration 1 DOSE FORM 1 X PER DAY ORAL
Date:03/17/98ISR Number: 3055864-3Report Type:Expedited (15-DaCompany Report #940202190001 Outcome Other Serious PT Foetal Growth Restriction Premature Baby Maternal Drugs Affecting Foetus Report Source Other Product Lariam Iron Orasthin Vitamins Role PS C C C Manufacturer
I/FU:F Duration
Date:03/17/98ISR Number: 3055868-0Report Type:Expedited (15-DaCompany Report #940202190002 Outcome Other Serious PT Premature Labour Polyhydramnios Report Source Literature Other Product Lariam Meningococci Vaccine Cholera Vaccine Plague Vaccine Immunoglobulins Typhoid Vaccine Role PS C C C C C Manufacturer
I/FU:I Duration
Date:03/17/98ISR Number: 3055872-2Report Type:Expedited (15-DaCompany Report #940202190003 Outcome Other Serious PT Jaundice Neonatal Report Source Literature Other Product Lariam Role PS Manufacturer
Age: Route ORAL
I/FU:F Duration
Iron Tuberkulin Tine Test Ppd Yellow Fever Vaccine Influenza Virus Immunoglobulins Vitamins Oral Contraceptive 03-Apr-2012 09:37 AM
C C C C C C C Page: 25
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/98ISR Number: 3055892-8Report Type:Expedited (15-DaCompany Report #92796 Outcome Hospitalization Initial or Prolonged PT Suicidal Ideation Flight Of Ideas Psychotic Disorder Diarrhoea Paranoia Hallucination, Auditory Delusional Disorder, Unspecified Type Dystonia Thinking Abnormal Agitation Mood Swings Report Source Health Professional Product Lariam Birth Control Pills Role PS C Manufacturer Age:23 YR Route ORAL Gender:Female Dose 1.0 X PER WEEK ORAL I/FU:I Duration
Date:03/18/98ISR Number: 3056397-0Report Type:Direct Outcome Disability PT Tooth Discolouration Scleral Discolouration Photosensitivity Reaction Abnormal Dreams Sleep Disorder
Company Report # Report Source Product Lariam Vitamines Role PS C Manufacturer
Age:24 YR Route
Gender:Male
I/FU:I
Dose Duration 1 PILL WEEKLY
Date:03/19/98ISR Number: 3057866-XReport Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Hallucinations, Mixed Hyperventilation Chest Pain Insomnia Abnormal Behaviour Suicidal Ideation Psychomotor Hyperactivity
Age:15 YR Route
Gender:Female Dose 3 TABLETS SINGLE DOSE
I/FU:I Duration
Date:03/24/98ISR Number: 3059313-0Report Type:Expedited (15-DaCompany Report #95970 Outcome Hospitalization Initial or Prolonged PT Pancreatitis Report Source Foreign Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Age:26 YR
Gender:Female
I/FU:I
PT Vision Blurred Nystagmus Bronchospasm Panic Attack
Product Lariam Beecham'S Powders Tyrozets Kalms Herbal
Role PS C C C
Manufacturer
Route ORAL
Duration
03-Apr-2012
09:37 AM
Page: 26
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/98ISR Number: 3059363-4Report Type:Expedited (15-DaCompany Report #96078 Outcome Other Serious PT Epilepsy Bradycardia Loss Of Consciousness Paraesthesia Amnesia Report Source Foreign Health Professional Product Lariam Colitofalk (Mesalamine) Role PS Manufacturer Age:41 YR Route ORAL Gender:Male Dose 250.0000 MG 1.0 X PER WEEK I/FU:I Duration
Date:03/24/98ISR Number: 3059365-8Report Type:Expedited (15-DaCompany Report #95984 Outcome Other Serious PT Malaise Insomnia Balance Disorder Oropharyngeal Pain Pyrexia Coordination Abnormal Anosmia Fatigue Confusional State Anxiety Dysgeusia Report Source Foreign Other Product Lariam Logynon Role PS C Manufacturer
I/FU:I Duration
Date:03/24/98ISR Number: 3060160-4Report Type:Expedited (15-DaCompany Report #96194 Outcome Other Serious PT Fatigue Dizziness Postural Depression Medication Error Gamma-Glutamyltransferase Increased Nausea Aspartate Aminotransferase Increased Diarrhoea Tinnitus Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:03/24/98ISR Number: 3060164-1Report Type:Expedited (15-DaCompany Report #96200 Outcome Other Serious PT Bleeding Time Prolonged Abdominal Pain C-Reactive Protein Increased
Age:23 YR
Gender:Male
I/FU:I
Headache Dizziness Panic Reaction Encephalitis Psychotic Disorder Myalgia Gastrointestinal Disorder Anxiety 03-Apr-2012 09:37 AM Page: 27
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Transferrin Increased Report Source Foreign Other Product Lariam Hepatitis A Vaccination Flagyl Yellow Fever Vaccine Role PS Manufacturer Route ORAL Dose 250.0000 MG 1.O X PER WEEK ORAL Duration
C C C
Date:03/24/98ISR Number: 3060304-4Report Type:Expedited (15-DaCompany Report #91489 Outcome Other Serious PT Cerebral Ischaemia Clonic Convulsion Spinal Disorder Report Source Foreign Health Professional Product Lariam Flu Vaccine (Influenza Virus Vaccine) Flixotide Salbutamol Prozac Tetracyclin Role PS Manufacturer
I/FU:I Duration
C C C C C
Date:03/24/98ISR Number: 3061536-1Report Type:Expedited (15-DaCompany Report #92796 Outcome Hospitalization Initial or Prolonged PT Thinking Abnormal Diarrhoea Dystonia Suicidal Ideation Psychotic Disorder Delusion Hallucination, Auditory Paranoia Agitation Mood Altered Toxicologic Test Abnormal Report Source Health Professional Product Lariam Birth Control Pills Role PS C Manufacturer
Gender:Female Dose 1.0 X PER WEEK ORAL
I/FU:F Duration
Date:03/25/98ISR Number: 3058316-XReport Type:Expedited (15-DaCompany Report #96157 Outcome Disability PT Diplopia Condition Aggravated Report Source Health Professional Product Lariam Estratest Role PS C Manufacturer
I/FU:I Duration
Synthroid
03-Apr-2012
09:37 AM
Page: 28
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/98ISR Number: 3061119-3Report Type:Direct Outcome Other Serious PT Palpitations Dizziness Company Report # Report Source Product Mefloquine Prastitata Natural Vitamin Role PS Manufacturer Hoffman-La Roche Age:57 YR Route ORAL Gender:Male I/FU:I
Dose Duration 250MG ONCE A WEEK PO ONLY ONE DOSE
Date:03/27/98ISR Number: 3065019-4Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Nervous System Disorder Dissociation Abnormal Dreams Ileus Paralytic
Gender:Female
I/FU:I
Dose Duration TAB; 250 MG PO Q 7 DAYS-8 DOSES , LAST 2 MONTHS
Date:03/31/98ISR Number: 3060069-6Report Type:Expedited (15-DaCompany Report #93604 Outcome Hospitalization Initial or Prolonged PT Nausea Fatigue Vomiting Overdose Headache Dysarthria Vision Blurred Somnolence Depression Confusional State Diarrhoea Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 250.0000 MG 1.0 X PER DAY 28 DAY
Date:03/31/98ISR Number: 3063290-6Report Type:Direct Outcome Disability PT Insomnia Urinary Bladder Haemorrhage Haematochezia Ear Haemorrhage Weight Decreased Diarrhoea
Company Report # Report Source Product Larium Primaquine Ogen Synthroid Role PS SS C C Manufacturer Hoffman-La Roche
Age:69 YR Route
Gender:Female
I/FU:I
Dose Duration LARIUM -1 A WEEK PRIMAQUINE 1 X DAY 2 WK
Date:03/31/98ISR Number: 3067124-5Report Type:Direct
Company Report #
Age:
Gender:Male
I/FU:I
PT Depression Mood Swings Hallucination
Report Source
Product Lariam
Role PS
Manufacturer
Route
Dose Duration AS INSTRUCTED-DO NT REMEMBER
03-Apr-2012
09:37 AM
Page: 29
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/98ISR Number: 3059988-6Report Type:Expedited (15-DaCompany Report #96729 Outcome Other Serious PT Clonic Convulsion Report Source Foreign Other Product Lariam Influenza Vaccine Flixotide Salbutamol Prozac Tetracycline Role PS C C C C C Manufacturer Age:57 YR Route ORAL Gender:Female Dose 250.000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:04/02/98ISR Number: 3059990-4Report Type:Expedited (15-DaCompany Report #94329 Outcome Other Serious PT Diabetes Insipidus Polydipsia Polyuria Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Age:2 YR Route ORAL
I/FU:F Duration
Date:04/02/98ISR Number: 3059992-8Report Type:Expedited (15-DaCompany Report #96767 Outcome Disability PT Pyrexia Intraocular Pressure Test Chills Retinal Detachment Eye Pain Report Source Health Professional Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:04/03/98ISR Number: 3063293-1Report Type:Expedited (15-DaCompany Report #96727 Outcome Other Serious PT Platelet Count Decreased Leukopenia Thrombocytopenia Blood Alkaline Phosphatase Increased Gamma-Glutamyltransferase Increased Thrombocytosis White Blood Cell Count Increased Aspartate Aminotransferase Increased Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration 1500.0000 MG DAILY ORAL
Date:04/03/98ISR Number: 3063295-5Report Type:Expedited (15-DaCompany Report #967761 Outcome Other Serious PT Haemangioma Of Liver Nephrolithiasis Report Source Consumer Product Lariam Tetanus Booster Polio Booster 03-Apr-2012 09:37 AM Role PS C C Manufacturer
I/FU:I Duration
Page: 30
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Poliomyelitis Vaccines Hepatitis A Vaccine Hepatitis B Vaccine
C C C
Date:04/07/98ISR Number: 3061744-XReport Type:Expedited (15-DaCompany Report #90692 Outcome Disability PT Cough Influenza Tinnitus Deafness Neurosensory Report Source Consumer Product Lariam Role PS Manufacturer
I/FU:F Duration
Date:04/07/98ISR Number: 3061746-3Report Type:Expedited (15-DaCompany Report #83677 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Atrial Fibrillation Maternal Drugs Affecting Foetus Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:04/07/98ISR Number: 3061749-9Report Type:Expedited (15-DaCompany Report #93562 Outcome Hospitalization Initial or Prolonged PT Systemic Lupus Erythematosus Dna Antibody Positive Abortion Spontaneous Cardiolipin Antibody Positive Pre-Eclampsia Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer
I/FU:F Duration
Date:04/09/98ISR Number: 3062290-XReport Type:Expedited (15-DaCompany Report #96373 Outcome Hospitalization Initial or Prolonged PT Ecchymosis Report Source Health Professional Product Lariam Flonase Ventolin Amoxicillin Ortho-Cept Role PS C C C C Manufacturer
I/FU:I Duration
Date:04/10/98ISR Number: 3061854-7Report Type:Expedited (15-DaCompany Report #97149 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Ileus Paralytic Dehydration Feeling Abnormal
Age:52 YR
Gender:Female
I/FU:I
Page: 31
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Abnormal Dreams Decreased Appetite Nausea Abdominal Pain
Product Lariam
Role PS
Manufacturer
Route ORAL
Duration
Date:04/10/98ISR Number: 3061856-0Report Type:Expedited (15-DaCompany Report #96157 Outcome Disability PT Diplopia Report Source Health Professional Product Lariam Estratest Synthroid Role PS C C Manufacturer
Gender:Female
I/FU:F
Date:04/14/98ISR Number: 3073100-9Report Type:Direct Outcome Disability PT Depression Anxiety Flushing Thinking Abnormal Pyrexia Insomnia Suicidal Ideation Diarrhoea Cold Sweat
Company Report # Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Female Dose ONCE PER WEEEK
I/FU:I Duration
Date:04/15/98ISR Number: 3066252-8Report Type:Expedited (15-DaCompany Report #97094 Outcome Other Serious PT Allergic Granulomatous Angiitis Report Source Other Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose 250.0000 MG 1.0 X PER WEEK PO
I/FU:I Duration
Date:04/15/98ISR Number: 3066253-XReport Type:Expedited (15-DaCompany Report #96103 Outcome Other Serious PT Brain Scan Abnormal Delirium Psychotic Disorder Encephalopathy Mania Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:04/15/98ISR Number: 3071734-9Report Type:Direct Outcome Other Serious PT Fatigue Malaise Night Sweats Depression 09:37 AM
Company Report #
Age:64 YR
Gender:Female
I/FU:I
03-Apr-2012
Page: 32
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance In Attention Confusional State Blood Pressure Fluctuation Asthenia Paraesthesia
Report Source
Product Lariam Mevacor Tenormin Moduretic
Role PS C C C
Manufacturer Roche
Route ORAL
Dose Duration 250MGM ; ORAL ;ONCE A WEEK
Date:04/20/98ISR Number: 3065208-9Report Type:Expedited (15-DaCompany Report #97097 Outcome Other Serious PT Coma Report Source Foreign Literature Health Professional Product Lariam Pyrimethamine Sulfadoxine Role PS C C Manufacturer
Age: Route ORAL
Gender:
I/FU:I
Dose Duration 19.3000 MG/KG 1.O X PER ODOS ORAL
Date:04/20/98ISR Number: 3066091-8Report Type:Expedited (15-DaCompany Report #97118 Outcome Hospitalization Initial or Prolonged PT Rash Morbilliform Neurotoxicity Pyrexia Drug Interaction Status Epilepticus Convulsion Report Source Foreign Literature Health Professional Product Lariam Quinine Role PS SS Manufacturer
Age:5 YR Route ORAL INTRAVENOUS
Gender:
I/FU:I
Dose Duration 50.0000 MG 1.0 X PER WEEK ORAL 21.0000 MG/KG DAILY INTRAVENOUS 7 DAY
Date:04/20/98ISR Number: 3069248-5Report Type:Expedited (15-DaCompany Report #97566 Outcome Other Serious PT Tinnitus Deafness Report Source Health Professional Product Lariam Premarin Role PS C Manufacturer
Gender:Female
I/FU:I
Dose Duration 250 MG (TABLET) 1.0 X PER WEEK
Date:04/20/98ISR Number: 3073073-9Report Type:Direct Outcome Disability Other Serious PT Insomnia Hyperhidrosis Anxiety Disturbance In Attention Restlessness Weight Decreased
Company Report # Report Source Product Lariam Role PS Manufacturer Roche Laboratories
Age:61 YR Route
Gender:Male Dose 1 PER WEEK
I/FU:I Duration
Eating Disorder
03-Apr-2012
09:37 AM
Page: 33
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/98ISR Number: 3073074-0Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Ulcer Blood Pressure Increased Company Report # Report Source Product Lariam Role PS Manufacturer Age:36 YR Route Gender:Male I/FU:I
Dose Duration 1 TABLET A DAY FOR ONE WEEK THEN ONE EVERY WEEK
Date:04/21/98ISR Number: 3074855-XReport Type:Direct Outcome Disability PT Headache Balance Disorder Hearing Impaired Visual Impairment
Company Report # Report Source Product Larium Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration ONE PILL EACH WEEK
Date:04/23/98ISR Number: 3071860-4Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Paranoia Delusion Psychotic Disorder
Company Report # Report Source Health Professional Product Lariam Cipro Role PS C Manufacturer
Gender:Female
I/FU:I
Dose Duration (1) TAB Q/WK ORAL 1 DAY
Date:04/24/98ISR Number: 3068735-3Report Type:Expedited (15-DaCompany Report #97094 Outcome Other Serious PT Allergic Granulomatous Angiitis Report Source Other Product Lariam Unknown Role PS C Manufacturer
Age: Route ORAL
Gender:Female
I/FU:F
Dose Duration 250 MG 1XPER WEEK
Date:04/24/98ISR Number: 3068760-2Report Type:Expedited (15-DaCompany Report #97775 Outcome Hospitalization Initial or Prolonged PT Pneumonia Viral Pneumonitis Alveolitis Allergic Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:04/24/98ISR Number: 3068768-7Report Type:Expedited (15-DaCompany Report #97779 Outcome Other Serious PT Maternal Drugs Affecting Foetus Report Source Foreign Health Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 250 MG 1X PER WEEK ORAL
Pre-Eclampsia
Professional
03-Apr-2012
09:37 AM
Page: 34
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/98ISR Number: 3068811-5Report Type:Expedited (15-DaCompany Report #83939 Outcome Congenital Anomaly PT Pre-Eclampsia Maternal Drugs Affecting Foetus Cleft Palate Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Age:26 YR Route ORAL Gender:Female Dose 250.000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:04/24/98ISR Number: 3072341-4Report Type:Direct Outcome Disability PT Paranoia Depression Thinking Abnormal Dermatitis Feeling Of Body Temperature Change Anxiety Diarrhoea Suicidal Ideation Insomnia Pyrexia
Age: Route
Gender:Female
I/FU:I
Dose Duration ONCE PER WEEK
Date:04/27/98ISR Number: 3069033-4Report Type:Expedited (15-DaCompany Report #83939 Outcome Congenital Anomaly PT Cleft Palate Maternal Drugs Affecting Foetus Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:F
Date:04/27/98ISR Number: 3069037-1Report Type:Expedited (15-DaCompany Report #97885 Outcome Hospitalization Initial or Prolonged PT Dry Mouth Oedema Mouth Pharyngeal Oedema Report Source Foreign Health Professional Product Lariam Levlen Role PS C Manufacturer
Gender:Female
I/FU:I
Date:04/27/98ISR Number: 3070615-4Report Type:Expedited (15-DaCompany Report #96103 Outcome Other Serious PT Psychotic Disorder Delirium Progressive Multifocal Leukoencephalopathy Mania Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:04/27/98ISR Number: 3072501-2Report Type:Direct Outcome Disability Required 03-Apr-2012 09:37 AM
Company Report #
Age:40 YR
Gender:Male
I/FU:I
Page: 35
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Personality Disorder Disorientation Acute Psychosis Paranoia Hallucination, Auditory Visual Impairment Agitation Nausea Disturbance In Attention Headache Report Source Product Mefloquine Role PS Manufacturer Route ORAL Dose Duration 250MG WEEKLY PO
Date:04/29/98ISR Number: 3072953-8Report Type:Direct Outcome Disability Other Serious PT Fear Heat Exhaustion Paranoia Insomnia Nausea Vomiting Decreased Appetite Panic Attack Alopecia Palpitations
Company Report # Report Source Health Professional Product Lariam Role PS Manufacturer La Roche
Gender:Female Dose 1 TABLET WEEKLY
I/FU:I Duration
Date:04/30/98ISR Number: 3074393-4Report Type:Expedited (15-DaCompany Report #98097 Outcome Death PT Skull Fracture Facial Bones Fracture Completed Suicide Aortic Injury Multiple Injuries Fall Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration 250 MG 1X PER WEEK ORAL TAB
Date:04/30/98ISR Number: 3074395-8Report Type:Expedited (15-DaCompany Report #98092 Outcome Other Serious PT Paralysis Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender: Dose ORAL
I/FU:I Duration
Date:05/04/98ISR Number: 3073979-0Report Type:Expedited (15-DaCompany Report #93422 Outcome Hospitalization Initial or Prolonged Disability PT Rash Pruritic Insomnia Hypersensitivity Swelling Spider Naevus
Age:28 YR
Gender:Female
I/FU:I
03-Apr-2012
09:37 AM
Page: 36
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Restlessness Mental Disorder Asthma Nausea Anxiety Vision Blurred Headache
Report Source Other
Product Lariam Hepatitis A Vaccine Albuterol Inhaler Triphasic Birth Control Pill
Role PS C C C
Manufacturer
Route ORAL
Date:05/04/98ISR Number: 3073980-7Report Type:Expedited (15-DaCompany Report #96923 Outcome Other Serious PT Disturbance In Attention Amnesia Brain Neoplasm Mental Disorder Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose ORAL
I/FU:I Duration
Date:05/05/98ISR Number: 3073586-XReport Type:Expedited (15-DaCompany Report #91747 Outcome Other Serious PT Maternal Drugs Affecting Foetus Dysmorphism Report Source Foreign Health Professional Product Lariam Vaccines Nos Role PS C Manufacturer
Gender:Female Dose 250 MG 1 X PER WEEK
I/FU:I Duration
Date:05/05/98ISR Number: 3073768-7Report Type:Expedited (15-DaCompany Report #98430 Outcome Other Serious PT Dyspnoea Pulmonary Fibrosis Report Source Product Lariam Role PS Manufacturer
Gender:Male Dose ORAL
I/FU:I Duration
Date:05/05/98ISR Number: 3073808-5Report Type:Expedited (15-DaCompany Report #97885 Outcome Hospitalization Initial or Prolonged PT Hypoaesthesia Dry Mouth Oedema Mouth Pharyngeal Oedema Liver Function Test Abnormal Report Source Foreign Health Professional Product Lariam Levlen Role PS C Manufacturer
Gender:Female
I/FU:F
Company Report #
Age:21 YR
Gender:Female
I/FU:I
PT Psychotic Disorder Abnormal Behaviour
Report Source
Product Larium
Role PS
Manufacturer Roche
Route
Dose 1 DOSE
Duration
03-Apr-2012
09:37 AM
Page: 37
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/98ISR Number: 3076411-6Report Type:Expedited (15-DaCompany Report #9905511 Outcome Death PT Psychotic Disorder Epilepsy Drug Level Below Therapeutic Drug Interaction Abnormal Behaviour Report Source Foreign Consumer Product Depakene Mefloquine Carbamazepine Role PS SS C Manufacturer Abbott Age:27 YR Route ORAL ORAL Gender:Male Dose PO PO I/FU:I Duration
Date:05/12/98ISR Number: 3077372-6Report Type:Expedited (15-DaCompany Report #98566 Outcome Other Serious PT Thinking Abnormal Mania Report Source Foreign Other Product Lariam Role PS Manufacturer Global Development
Gender:Male
I/FU:I
Dose Duration 250 MG 1 X PER DAY ORAL
Date:05/12/98ISR Number: 3077375-1Report Type:Expedited (15-DaCompany Report #87481 Outcome Disability PT Fatigue Hypertension Oedema Nausea Sleep Apnoea Syndrome Overdose Cough Eye Irritation Visual Acuity Reduced Dizziness Hypoaesthesia Bone Pain Chest Pain Paraesthesia Medication Error Brain Injury Neck Pain Nocturia Dysgeusia Thinking Abnormal Vomiting Upper Respiratory Tract Infection Report Source Health Professional Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:05/12/98ISR Number: 3077579-8Report Type:Expedited (15-DaCompany Report #91489 Outcome Other Serious PT Spinal Cord Injury Report Source Foreign Product Lariam Role PS Manufacturer
Gender:Female
I/FU:F
Dose Duration 250 MG 1X PER
Cervical Cerebral Ischaemia Clonic Convulsion Spinal Cord Injury Thoracic
Study Health Professional Other
WEEK Flu Vaccine (Influenza Virus Vaccine) Flixotide(Fluticason e Propionate) Salbutamol (Albuterol) C C C Page: 38
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prozac (Fluoxetine Hydrochloride) Tetracyclin (Tetracycline)
C C
Date:05/15/98ISR Number: 3079401-2Report Type:Expedited (15-DaCompany Report #96103 Outcome Other Serious PT Mania Encephalopathy Delirium Psychotic Disorder Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Dose Duration 250 MG X PER WEEK ORAL
Date:05/15/98ISR Number: 3079404-8Report Type:Expedited (15-DaCompany Report #98742 Outcome Hospitalization Initial or Prolonged PT Myocardial Infarction Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:05/15/98ISR Number: 3079416-4Report Type:Expedited (15-DaCompany Report #89246 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Premature Labour Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:F
Dose Duration 250 MG 1XPER WEEK ORAL
Date:05/15/98ISR Number: 3079420-6Report Type:Expedited (15-DaCompany Report #96729 Outcome Other Serious PT Clonic Convulsion Report Source Foreign Other Product Lariam Influenza Vaccine Flixotide Salbutamol Prozac Tetracycline Role PS C C C C C Manufacturer
Gender:Female Dose 250MG 1XPER WEEK ORAL
I/FU:F Duration
Date:05/15/98ISR Number: 3079450-4Report Type:Expedited (15-DaCompany Report #93562 Outcome Hospitalization PT Renal Failure Report Source Foreign Product Larium Role PS Manufacturer
Gender:Female
I/FU:F
Dose Duration 250MG X 1 PER
Initial or Prolonged
Systemic Lupus Erythematosus Pre-Eclampsia Abortion Spontaneous
WEEK ORAL
03-Apr-2012
09:37 AM
Page: 39
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/98ISR Number: 3079460-7Report Type:Expedited (15-DaCompany Report #98539 Outcome Hospitalization Initial or Prolonged Congenital Anomaly PT Dysmorphism Oligohydramnios Placental Disorder Maternal Drugs Affecting Foetus Report Source Foreign Other Product Lariam Role PS Manufacturer Age:26 YR Route ORAL Gender:Female I/FU:I
Date:05/15/98ISR Number: 3079461-9Report Type:Expedited (15-DaCompany Report #97094 Outcome Other Serious PT Oedema Peripheral Allergic Granulomatous Angiitis Skin Mass Report Source Other Product Lariam Proventil Inhaler Aminophylline Fosamax Premarin Flovent Vitamin E Fish Oil Calcium Seliran Multivitamins Accolate Vitamin C Role PS C C C C C C C C C C C C Manufacturer
Gender:Female
I/FU:F
Date:05/19/98ISR Number: 3081150-1Report Type:Expedited (15-DaCompany Report #83711 Outcome Other Serious PT Paranoia Visual Impairment Anxiety Schizophrenia Abnormal Dreams Psychotic Disorder Hallucination, Visual Report Source Health Professional Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Male
I/FU:I
Date:05/19/98ISR Number: 3081153-7Report Type:Expedited (15-DaCompany Report #80215 Outcome Other Serious PT Nightmare Nausea Visual Impairment Blindness Report Source Company Representative Product Lariam Role PS Manufacturer
Gender:Female
I/FU:F
Date:05/19/98ISR Number: 3081447-5Report Type:Expedited (15-DaCompany Report #85335 Outcome Hospitalization Initial or Prolonged PT Abnormal Behaviour Aggression Hallucination Schizophrenia Report Source Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration 1 DOSE FROM 1 X PER WEEK ORAL Page: 40
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/98ISR Number: 3080425-XReport Type:Direct Outcome Disability Other Serious PT Visual Impairment Abnormal Dreams Mood Altered Anxiety Panic Attack Company Report # Report Source Product Lariam Role PS Manufacturer Age: Route Gender:Male Dose 250 MG 1 X WEEK I/FU:I Duration
Date:05/20/98ISR Number: 3081830-8Report Type:Expedited (15-DaCompany Report #98794 Outcome Other Serious PT Haemolysis Liver Function Test Abnormal Platelet Count Decreased Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Date:05/22/98ISR Number: 3082507-5Report Type:Expedited (15-DaCompany Report #96767 Outcome Disability PT Retinal Detachment Malaria Intraocular Pressure Increased Pyrexia Eye Pain Chills Hyperhidrosis Report Source Health Professional Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:05/22/98ISR Number: 3082511-7Report Type:Expedited (15-DaCompany Report #88781 Outcome Other Serious PT Premature Baby Uterine Haemorrhage Respiratory Disorder Neonatal Infection Uterine Injury Maternal Drugs Affecting Foetus Cervical Incompetence Haematoma Vaginal Haemorrhage Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:F
Age:29 YR
Gender:Female
I/FU:F
PT Premature Baby Premature Labour Vaginal Haemorrhage Infection Cervical Incompetence Haematoma 09:37 AM
Product Lariam
Role PS
Manufacturer
Route ORAL
03-Apr-2012
Page: 41
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/98ISR Number: 3084316-XReport Type:Direct Outcome Other Serious PT Abnormal Dreams Dizziness Feeling Abnormal Anxiety Company Report # Report Source Health Professional Product Mefloquine Role PS Manufacturer Age:25 YR Route ORAL Gender:Female I/FU:I
Dose Duration 1 TAB Q WK ; 250 MG/WK P.O. 4 WK
Date:05/28/98ISR Number: 3084620-5Report Type:Expedited (15-DaCompany Report #99368 Outcome Other Serious PT Infectious Mononucleosis Mouth Ulceration Post Viral Fatigue Syndrome Lymphopenia Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:06/01/98ISR Number: 3087636-8Report Type:Expedited (15-DaCompany Report #85972 Outcome Other Serious PT Maternal Drugs Affecting Foetus Jaundice Neonatal Report Source Foreign Health Professional Product Lariam Cabergoline Role PS C Manufacturer
Age: Route ORAL
Gender:Female
I/FU:I
Date:06/01/98ISR Number: 3088034-3Report Type:Expedited (15-DaCompany Report #98742 Outcome Hospitalization Initial or Prolonged PT Myocardial Infarction Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:06/01/98ISR Number: 3088035-5Report Type:Expedited (15-DaCompany Report #99181 Outcome Hospitalization Initial or Prolonged PT Dyspnoea Hypersensitivity Asthma Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:06/01/98ISR Number: 3088675-3Report Type:Expedited (15-DaCompany Report #80215 Outcome Other Serious PT Nausea Visual Acuity Reduced Report Source Consumer Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Nightmare
Estrogen
03-Apr-2012
09:37 AM
Page: 42
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/98ISR Number: 3088297-4Report Type:Expedited (15-DaCompany Report #98097 Outcome Death PT Depression Completed Suicide Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer Age:37 YR Route ORAL Gender:Male I/FU:F
Date:06/04/98ISR Number: 3089762-6Report Type:Expedited (15-DaCompany Report #99833 Outcome Other Serious PT Arthralgia Myalgia Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:06/04/98ISR Number: 3090175-1Report Type:Expedited (15-DaCompany Report #68408 Outcome Disability PT Spinal Fracture Hallucination Paraplegia Mental Disorder Panic Attack Fall Report Source Health Professional Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:06/04/98ISR Number: 3090177-5Report Type:Expedited (15-DaCompany Report #99753 Outcome Other Serious PT Hallucination Agitation Suicide Attempt Suicidal Ideation Paranoia Flushing Restlessness Diarrhoea Report Source Other Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Date:06/05/98ISR Number: 3179164-6Report Type:Periodic Outcome Other Serious PT Abnormal Dreams Nausea
Company Report #95701 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Male Dose 250.0000 MG 1.0 X PER WEEK
I/FU:I Duration
21
DAY
Date:06/08/98ISR Number: 3159668-2Report Type:Periodic Outcome Other Serious PT Alopecia
Company Report #81017 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 43
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid C
Date:06/08/98ISR Number: 3159671-2Report Type:Periodic Outcome Other Serious PT Pruritus Dizziness Alopecia Abnormal Dreams Eye Irritation
Company Report #81018 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Dyazide Role Manufacturer
Age:75 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
250.000 MG 1.0 X PER WEEK (ORAL)
Date:06/08/98ISR Number: 3159674-8Report Type:Periodic Outcome Other Serious PT Nausea Thirst Eye Irritation Hypoaesthesia Oral
Company Report #82001 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Zestril Role Manufacturer
Age:51 YR Route
Gender:Male Dose
I/FU:I Duration
PS C
ORAL
250.000 MG 1.0 X PER WEEK ORAL
Date:06/08/98ISR Number: 3159676-1Report Type:Periodic Outcome Other Serious PT Abnormal Dreams Heart Rate Increased Nervousness Paranoia Hallucinations, Mixed Anxiety
Company Report #82176 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Role Manufacturer
Age:29 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3159680-3Report Type:Periodic Outcome Other Serious PT Blood Phosphorus Increased Gamma-Glutamyltransferase Increased
Company Report #82334 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Role Manufacturer
Age:48 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3159682-7Report Type:Periodic Outcome Other Serious PT Tinnitus
Age:54 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
250.000 MG Page: 44
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1.0 X PER WEEK ORAL
Date:06/08/98ISR Number: 3159683-9Report Type:Periodic Outcome Other Serious PT Pain In Extremity Pain Arthralgia
Age:72 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3159684-0Report Type:Periodic Outcome Other Serious PT Disorientation Tremor Anxiety
Company Report #82726 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Role Manufacturer
Age:20 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3159685-2Report Type:Periodic Outcome Other Serious PT Amnesia Judgement Impaired Panic Disorder Confusional State Crying
Age:21 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
1.0000 DOSE FORM 1.0 X PER WEEK ORAL
Date:06/08/98ISR Number: 3159686-4Report Type:Periodic Outcome Other Serious PT Abnormal Dreams Sedation Memory Impairment Vision Blurred Fatigue Dizziness Tachycardia Visual Impairment
Age:38 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3159687-6Report Type:Periodic Outcome Other Serious PT Urinary Incontinence Muscle Spasms
Age:24 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
250.000 MG Page: 45
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1.0 X PER WEEK ORAL Yellow Fever Vaccine Rabies Vaccine C C
Date:06/08/98ISR Number: 3159688-8Report Type:Periodic Outcome Other Serious PT Gynaecomastia
Company Report #83622 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Sporanox (Itraconazole) 250.000 Mg Vitamin E Vitamin D Vitamin B Complex Role Manufacturer
Age:48 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
250.000 MG 1.0 X PER WEEK ORAL 3.0 X PER MON ORAL
SS C C C
ORAL
Date:06/08/98ISR Number: 3159690-6Report Type:Periodic Outcome Other Serious PT Visual Acuity Reduced Alopecia
Company Report #83624 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Premarin Synthroid Role Manufacturer
Age:45 YR Route
Gender:Female Dose
I/FU:I Duration
PS C C
ORAL
Date:06/08/98ISR Number: 3159691-8Report Type:Periodic Outcome Other Serious PT Visual Impairment
Age:64 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
250.000 MG 1.O X PER WEEK ORAL
Date:06/08/98ISR Number: 3159692-XReport Type:Periodic
Company Report #83947
Age:58 YR
Gender:Female
I/FU:I
PT Hyporeflexia Paraesthesia
Report Source Consumer
Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Mevacor (Lovastatin)
Role
Manufacturer
Route
Dose
Duration
PS SS
ORAL ORAL
250.000 MG 1.0 X PER WEEK ORAL 20.0000 MG Page: 46
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY ORAL Premarin Provera C C
Company Report #83953 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Maxidex Role Manufacturer
Age:52 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
250.000 MG 1.O X PER WEEK ORAL
Date:06/08/98ISR Number: 3159695-5Report Type:Periodic Outcome Other Serious PT Depression
Age:52 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3159697-9Report Type:Periodic Outcome Other Serious PT Insomnia Palpitations
Age:44 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
250.000 MG 1.0 PER WEEK ORAL
Date:06/08/98ISR Number: 3159699-2Report Type:Periodic Outcome Other Serious PT Nausea Palpitations Flashback
Company Report #84462 Report Source Health Professional Product Lariam Tablets ( Mefloquine Hydrochloride) 250.000 Mg Role Manufacturer
Age:39 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3159701-8Report Type:Periodic Outcome Other Serious PT Anxiety
Age:22 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
250.000 MG Page: 47
03-Apr-2012
09:37 AM
Date:06/08/98ISR Number: 3159702-XReport Type:Periodic Outcome Other Serious PT Dermatitis Exfoliative
Age:27 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
ORAL
Date:06/08/98ISR Number: 3159703-1Report Type:Periodic Outcome Other Serious PT Nausea Diarrhoea Asthenia
Company Report #84870 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Estrogen (Estrogens Nos) Role PS Manufacturer
I/FU:I Duration
Date:06/08/98ISR Number: 3159705-5Report Type:Periodic Outcome Other Serious PT Paraesthesia
Company Report #84928 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Sectral (Acebutolol) Role PS C Manufacturer
I/FU:I Duration
Date:06/08/98ISR Number: 3159707-9Report Type:Periodic Outcome Other Serious PT Blood Pressure Increased
I/FU:I Duration
Date:06/08/98ISR Number: 3159709-2Report Type:Periodic Outcome PT
Company Report #84991 Report Source Product Role Manufacturer
Age:46 YR Route
Gender:Male Dose
I/FU:I Duration
Other Serious
Dyspnoea
Other
Lariam Tablets (Mefloquine Hydrochloride)
PS
ORAL
03-Apr-2012
09:37 AM
Page: 48
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3159710-9Report Type:Periodic Outcome Other Serious PT Nausea Headache Dizziness Company Report #85215 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:44 YR Route ORAL Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:06/08/98ISR Number: 3159711-0Report Type:Periodic Outcome Other Serious PT Feeling Abnormal
Age:55 YR Route OCCLUSIVE DRESSING
Gender:Male Dose
I/FU:I Duration
Date:06/08/98ISR Number: 3159712-2Report Type:Periodic Outcome Other Serious PT Blood Pressure Systolic Decreased Eye Irritation Nausea Insomnia Conjunctivitis Allergic
Age:57 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3159714-6Report Type:Periodic Outcome Other Serious PT Diarrhoea
Age: Route ORAL
I/FU:I Duration
Date:06/08/98ISR Number: 3159716-XReport Type:Periodic Outcome Other Serious PT Psoriasis Abnormal Dreams Pruritus
Company Report #85494 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Male Dose 250.0000 MG 1.0 X PER
I/FU:I Duration
WEEK ORAL
03-Apr-2012
09:37 AM
Page: 49
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3159719-5Report Type:Periodic Outcome Other Serious PT Metrorrhagia Company Report #85538 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Synthroid (Levothyroxine Sodium) Role PS Manufacturer Age:31 YR Route ORAL Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:06/08/98ISR Number: 3159721-3Report Type:Periodic Outcome Other Serious PT Ecchymosis
Company Report #85602 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Cipro (Ciprofloxacin Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:06/08/98ISR Number: 3159722-5Report Type:Periodic Outcome Other Serious PT Nausea Decreased Appetite
Gender:Male Dose 0.5000 DOSE FORM 1.0 X PER WEEK ORAL
I/FU:I Duration
Date:06/08/98ISR Number: 3159725-0Report Type:Periodic Outcome Other Serious PT Oligomenorrhoea
Company Report #85699 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Hepatitis Vaccine (Hepatitis Vaccine) Typhoid Vaccine (Typhoid Vaccines) Polio Vaccination (Poliomyelitis Vaccines) Role PS Manufacturer
I/FU:I Duration
C C C
Amoxicillin (Amoxicillin) Anaprox (Naproxen Sodium)
C C
03-Apr-2012
09:37 AM
Page: 50
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3159726-2Report Type:Periodic Outcome Other Serious PT Urticaria Company Report #85807 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:3 YR Route ORAL Gender:Male Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:06/08/98ISR Number: 3159727-4Report Type:Periodic Outcome Other Serious PT Dermatitis
Company Report #85892 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Contraceptives (Contraceptives) Role PS Manufacturer
I/FU:I Duration
Date:06/08/98ISR Number: 3159729-8Report Type:Periodic Outcome Other Serious PT Chills Pyrexia Myalgia
I/FU:I Duration
Date:06/08/98ISR Number: 3159730-4Report Type:Periodic Outcome Other Serious PT Emotional Disorder Aggression Abnormal Dreams Crying
I/FU:I Duration
I/FU:I Duration
WEEK ORAL
03-Apr-2012
09:37 AM
Page: 51
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3159732-8Report Type:Periodic Outcome Other Serious PT Pruritus Rash Maculo-Papular Company Report #87231 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Ortho-Novum (Ethinyl Estradiol Or Menstranol/ Norethindrone) Role PS Manufacturer Age:28 YR Route ORAL Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:06/08/98ISR Number: 3159734-1Report Type:Periodic Outcome Other Serious PT Flushing Insomnia
Company Report #87256 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Zantac (Ranitidine) Vivelle Transdermal System (Estradiol) Role PS C C Manufacturer
I/FU:I Duration
49
DAY
Date:06/08/98ISR Number: 3160383-XReport Type:Periodic Outcome Other Serious PT Tinnitus Insomnia Dizziness Nausea Nasal Congestion
Company Report #87379 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Role Manufacturer
Age:68 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3160387-7Report Type:Periodic Outcome Other Serious PT Blood Iron Increased Hepatomegaly
Age:51 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3160390-7Report Type:Periodic Outcome Other Serious PT Dizziness Nausea Hair Disorder
Age:41 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
250.000 MG 1.0 PER WEEK Page: 52
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL
Date:06/08/98ISR Number: 3160394-4Report Type:Periodic Outcome Other Serious PT Blindness Deafness
Age: Route ORAL
Gender: Dose ORAL
I/FU:I Duration
Date:06/08/98ISR Number: 3160396-8Report Type:Periodic Outcome Other Serious PT Dyspepsia
Company Report #87777 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Demulen Role Manufacturer
Age:35 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
250.000 MG 1.0 1.0 PER WEEK ORAL
Date:06/08/98ISR Number: 3160398-1Report Type:Periodic Outcome Other Serious PT Pollakiuria Thirst
Company Report #87993 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250. 000 Mg Role Manufacturer
Age: Route
Gender: Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3160401-9Report Type:Periodic Outcome Other Serious PT Insomnia
Age:62 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3160403-2Report Type:Periodic Outcome Other Serious PT Vertigo
Company Report #88273 Report Source Health Product Lariam Tablets Role Manufacturer
Age:65 YR Route
Gender:Male Dose
I/FU:I Duration
Professional
(Mefloquine Hydrochloride) 250. 000 Mg
PS
ORAL
03-Apr-2012
09:37 AM
Page: 53
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3160405-6Report Type:Periodic Outcome Other Serious PT Tremor Dizziness Lymphadenopathy Irritability Nausea Headache Company Report #88393 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg Cipro Nordette Role Manufacturer Age:33 YR Route Gender:Female Dose I/FU:I Duration
PS C C
ORAL
Date:06/08/98ISR Number: 3160406-8Report Type:Periodic Outcome Other Serious PT Headache
Company Report #89194 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250. 000 Mg Role Manufacturer
Age:34 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3160409-3Report Type:Periodic Outcome Other Serious PT Dyspepsia Nightmare Insomnia Headache
Age:33 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3160410-XReport Type:Periodic Outcome Other Serious PT Nightmare
Age:30 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Age:27 YR Route
Gender:Female Dose
I/FU:I Duration
Other Serious
Vomiting Pyrexia Panic Attack Decreased Appetite Dizziness Disturbance In Attention
Consumer
Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Ortho Novum Hepatitis Vaccine
PS C C
ORAL
03-Apr-2012
09:37 AM
Page: 54
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valium General Anesthesia Lortab Erytromycin C C C C
Company Report #90262 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Estrace Prilosec Role Manufacturer
Age:63 YR Route
Gender:Female Dose
I/FU:I Duration
PS C C
ORAL
Date:06/08/98ISR Number: 3175254-2Report Type:Periodic Outcome Other Serious PT Hallucination Insomnia
Age:15 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3175260-8Report Type:Periodic Outcome Other Serious PT Emotional Disorder Anxiety
Company Report #90406 Report Source Literature Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg Synthroid Role Manufacturer
Age:46 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
250.000 MG 1.0 X PER WEEK, ORAL
Date:06/08/98ISR Number: 3175262-1Report Type:Periodic Outcome Other Serious PT Viral Infection Dyspepsia Tachycardia Tremor
Age:69 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
250.000 MG
Pyrexia Glucophage Glyburide Flu Shot Lotensin C C C C
1.0 X PER WEEK, ORAL
03-Apr-2012
09:37 AM
Page: 55
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3175264-5Report Type:Periodic Outcome Other Serious PT Depression Diarrhoea Crying Dysphoria Company Report #91344 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg Role Manufacturer Age:32 YR Route Gender:Male Dose I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3175267-0Report Type:Periodic Outcome Other Serious PT Insomnia Pressure Of Speech Restlessness Paranoia
Age:40 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3175269-4Report Type:Periodic Outcome Other Serious PT Menstruation Irregular
Company Report #91527 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg Vitamin C Role Manufacturer
Age:22 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
250.0000 MG 1.0 PER WEEK, ORAL
Date:06/08/98ISR Number: 3175271-2Report Type:Periodic Outcome Other Serious PT Nightmare Heart Rate Increased Insomnia Anxiety
Company Report #91582 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Ortho-Novum 7/7/7 Role Manufacturer
Age:33 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
250 MG 1.0 X PER WEEK, ORAL
Age:36 YR Route
Gender:Female Dose
I/FU:I Duration
Other Serious
Restlessness Nausea Diarrhoea Dyspepsia Flatulence Dermatitis Dizziness 09:37 AM
Other
Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg
PS
ORAL
03-Apr-2012
Page: 56
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3175275-XReport Type:Periodic Outcome Other Serious PT Prothrombin Time Prolonged Company Report #92041 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg Coumadin Role Manufacturer Age:56 YR Route Gender:Female Dose I/FU:I Duration
PS C
ORAL
250.00 MG 1.0 PER WEEK, ORAL
Date:06/08/98ISR Number: 3175277-3Report Type:Periodic Outcome Other Serious PT Nausea Diarrhoea
Age:72 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3175279-7Report Type:Periodic Outcome Other Serious PT Diarrhoea Insomnia Visual Acuity Reduced Paraesthesia Thinking Abnormal Hallucination
Age:19 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
250.00 MG 1.0 X PER ODOS, ORAL
Date:06/08/98ISR Number: 3175282-7Report Type:Periodic Outcome Other Serious PT Diarrhoea Nausea Emotional Disorder Amoebic Dysentery
Company Report #92697 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg Flagyl Role Manufacturer
Age:40 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
Age:38 YR Route
Gender:Female Dose
I/FU:I Duration
Other Serious
Anxiety Insomnia
Consumer
Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg
PS
ORAL
03-Apr-2012
09:37 AM
Page: 57
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3175286-4Report Type:Periodic Outcome Other Serious PT Nightmare Company Report #92738 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg Role Manufacturer Age:54 YR Route Gender:Male Dose I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3175288-8Report Type:Periodic Outcome Other Serious PT Vomiting Agitation Dizziness Photosensitivity Reaction Insomnia
Age:13 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3175290-6Report Type:Periodic Outcome Other Serious PT Arthralgia Myalgia
Age:41 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3175291-8Report Type:Periodic Outcome Other Serious PT Chromaturia
Company Report #93511 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg Ortho-Novum 1/35 Role Manufacturer
Age:31 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
Date:06/08/98ISR Number: 3175292-XReport Type:Periodic Outcome Other Serious PT Laryngitis
Company Report #93513 Report Source Consumer Product Lariam Tablets Role Manufacturer
Age:35 YR Route
Gender:Female Dose
I/FU:I Duration
Health Professional
(Mefloquine Hydrochloride) 250.00 Mg Amoxycillin
PS C
ORAL
03-Apr-2012
09:37 AM
Page: 58
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3175294-3Report Type:Periodic Outcome Other Serious PT Syncope Abdominal Pain Dizziness Vomiting Company Report #93921 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250.00 Mg Role Manufacturer Age:20 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
250.00 MG 1.0 X PER ODOS, ORAL
Date:06/08/98ISR Number: 3175296-7Report Type:Periodic Outcome Other Serious PT Depression Anxiety Nervousness
Company Report #93923 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:20 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3179135-XReport Type:Periodic Outcome Other Serious PT Neurogenic Bladder Pollakiuria Micturition Urgency
Age:54 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3179137-3Report Type:Periodic Outcome Other Serious PT Abortion Spontaneous
Company Report #77417 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Typhoid Vaccine (Thphoid Vaccines) Dramamine (Dimenhydrinate) Measles, Mumps, & Rubella Vaccine (Measles Virus Vaccine Live/Mumps Virus Vaccine Role PS C C Manufacturer
I/FU:I Duration
Date:06/08/98ISR Number: 3179139-7Report Type:Periodic Outcome Other Serious PT Dizziness Hypoaesthesia Oral Headache 09:37 AM
Age:34 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
250.0000 MG Page: 59
03-Apr-2012
Date:06/08/98ISR Number: 3179140-3Report Type:Periodic Outcome Other Serious PT Sedation Petit Mal Epilepsy
Age:10 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3179141-5Report Type:Periodic Outcome Other Serious PT Prostatic Specific Antigen Increased
Company Report #80172 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Hytrin (Terazosin Hydrochloride) Role Manufacturer
Age:50 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Company Report #80199 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Accupril (Quinapril Hydrochloride) Prempro (Estrogens, Conjugated/Medroxypr ogesterone Acetate) Role Manufacturer
Age:56 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
C C
Date:06/08/98ISR Number: 3179145-2Report Type:Periodic Outcome Other Serious PT Nausea Abdominal Pain Upper Muscle Spasms
Company Report #80216 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Role Manufacturer
Age:65 YR Route
Gender:Male Dose
I/FU:I Duration
250.000 Mg Klonopin (Clonazepam) Ritalin (Methylphenidate Hydrochloride) 03-Apr-2012 09:37 AM
PS
ORAL
C C Page: 60
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inderal (Propranolol Hydrochloride) Paxil (Paroxetine)
C C
Date:06/08/98ISR Number: 3179146-4Report Type:Periodic Outcome Other Serious PT Alopecia Depression
Company Report #96623 Report Source Consumer Other Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Role Manufacturer
Age:23 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3179147-6Report Type:Periodic Outcome Other Serious PT Abdominal Pain Upper Blood Cholesterol Increased
Company Report #97072 Report Source Consumer Product Lariam Tablets (Mefloquine Hidrochloride) 250. 000 Mg Lipitor (Atorvastatin Calcium) Hepatitis Injection (Hepatitis Injection Nos) Calcium (Calcium Nos) Magnesium (Magnesium Nos) Glucosamine Sulfate (Glucosamine Sulfate) Vitamin E (Vitamin E) Multivitamins (Multivitamin Nos) Vitamin C (Ascorbid Acid) Role Manufacturer
Age:69 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
250.0000 MG 1.0 X PER WEEK ORAL ORAL
42
DAY
SS C C C C C C C
ORAL
Date:06/08/98ISR Number: 3179148-8Report Type:Periodic Outcome Other Serious PT Insomnia
Age:35 YR Route
Gender:Male Dose
I/FU:I Duration
Professional
(Mefloquine Hydrochloride) 250.000 Mg Kaolin (Kaolin)
PS C
ORAL
250.0000 MG 1.0 X PER DAY ORAL
03-Apr-2012
09:37 AM
Page: 61
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3179149-XReport Type:Periodic Outcome Other Serious PT Dermatitis Pruritus Flushing Rhinorrhoea Company Report #97647 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Premarin (Estrogens, Conjugated) Role Manufacturer Age:58 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3179150-6Report Type:Periodic Outcome Other Serious PT Nausea Thinking Abnormal Fatigue
Age:25 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/08/98ISR Number: 3179151-8Report Type:Periodic Outcome Hospitalization Initial or Prolonged Disability PT Insomnia Nausea Vertigo Visual Impairment Depression Decreased Appetite Anxiety
Age: Route ORAL
I/FU:F Duration
Date:06/08/98ISR Number: 3179152-XReport Type:Periodic Outcome Hospitalization Initial or Prolonged PT Hallucinations, Mixed
Age:32 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:06/08/98ISR Number: 3179153-1Report Type:Periodic
Age:51 YR
Gender:Male
I/FU:F
PT Urticaria Abnormal Dreams
Report Source Consumer User Facility
Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Cotrim
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
250.000 MG 1.0 X PER WEEK ORAL Page: 62
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Sulfamethoxazole/Tr imethoprim) C
Date:06/08/98ISR Number: 3179154-3Report Type:Periodic Outcome Other Serious PT Nausea
Age:64 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Company Report #74666 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Estrogens Nos (Estrogens Nos) Role PS Manufacturer
I/FU:F Duration
Date:06/08/98ISR Number: 3179156-7Report Type:Periodic Outcome Other Serious PT Nervousness
Age: Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
Date:06/08/98ISR Number: 3179157-9Report Type:Periodic Outcome Other Serious PT Exfoliative Rash
Company Report #78054 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Metakelfin (Pyrimethamine/Sulfa lene) Role Manufacturer
Age:34 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
250.000 MG 1.0 X PER WEEK ORAL ORAL
SS
ORAL
Date:06/08/98ISR Number: 3179158-0Report Type:Periodic Outcome Other Serious 03-Apr-2012 09:37 AM PT Pruritus
Company Report #81052 Report Source Health Professional Product Lariam Tablets (Mefloquine Role Manufacturer
Age:75 YR Route
Gender:Female Dose
I/FU:F Duration
Page: 63
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) 250.000 Mg PS ORAL 250.0000 MG 1.0 X PER WEEK ORAL
Date:06/08/98ISR Number: 3179159-2Report Type:Periodic Outcome Other Serious PT Insomnia Dermatitis
Age: Route ORAL
Gender:Female Dose 250.0000 MG 1.0 X PER WEEK
I/FU:I Duration
Date:06/08/98ISR Number: 3179160-9Report Type:Periodic Outcome Other Serious PT Vestibular Disorder Dizziness Tinnitus
Age: Route ORAL
Gender:Female Dose 250.0000 MG 1.0 X PER DAY
I/FU:I Duration
I/FU:I Duration
Company Report #95230 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Amlodipine (Amlodipine Besylate) Cozaar (Losartan Potassium) Role PS Manufacturer
Gender:Male Dose 250.0000 M 1.0 X PER WEEK
I/FU:I Duration
C C
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 64
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3179165-8Report Type:Periodic Outcome Other Serious PT Visual Impairment Dizziness Depression Insomnia Gait Disturbance Cough Confusional State Company Report #95731 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:32 YR Route ORAL Gender:Female Dose 250.0000 MG 1.0 X PER WEEK I/FU:I Duration
Date:06/08/98ISR Number: 3179166-XReport Type:Periodic Outcome Other Serious PT Flushing
Company Report #96253 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Synthroid (Levothyroxine Sodium) Role PS Manufacturer
I/FU:I Duration
Date:06/08/98ISR Number: 3179167-1Report Type:Periodic Outcome Other Serious PT Palpitations Dizziness
Gender:Male Dose 250.0000 MG 1.0 X PER WEEK
I/FU:I Duration
Date:06/08/98ISR Number: 3179168-3Report Type:Periodic Outcome Other Serious PT Abnormal Dreams Anxiety Depression Disturbance In Attention Chills Insomnia Confusional State Flushing Dizziness
Company Report #96334 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Paxil (Paroxetine) Role PS C Manufacturer
I/FU:I Duration
Date:06/08/98ISR Number: 3179169-5Report Type:Periodic Outcome Other Serious PT Dizziness
Age: Route ORAL
Gender: Dose
03-Apr-2012
09:37 AM
Page: 65
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3179170-1Report Type:Periodic Outcome Other Serious PT Feeling Cold Flushing Nausea Company Report #96418 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:36 YR Route ORAL Gender:Female Dose 250.0000 MG 1.0 X PER WEEK I/FU:I Duration
Date:06/08/98ISR Number: 3179171-3Report Type:Periodic Outcome Other Serious PT Muscle Spasms
Gender:Female Dose 250.0000 MG 1.0 PER WEEK
I/FU:I Duration
Date:06/08/98ISR Number: 3179172-5Report Type:Periodic Outcome Other Serious PT Muscular Weakness Syncope Pallor
Age:29 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Age:20 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
49
DAY
Date:06/08/98ISR Number: 3179175-0Report Type:Periodic Outcome Other Serious PT Nausea Nightmare Neuropathy Peripheral Confusional State Palpitations
Company Report #80485 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Female Dose 250.0000 MG 1.0 X PER WEEK, ORAL
I/FU:I Duration
Birth Control Pills (Oral Contraceptive Nos)
03-Apr-2012
09:37 AM
Page: 66
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3179968-XReport Type:Periodic Outcome Other Serious PT Hypoaesthesia Malaria Nausea Dysgeusia Sunburn Headache Abdominal Pain Diarrhoea Sensory Disturbance Paraesthesia Company Report #77585 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:33 YR Route ORAL Gender:Male Dose 250.0000 MG 1.O X PER WEEK ORAL I/FU:I Duration
Date:06/08/98ISR Number: 3179969-1Report Type:Periodic Outcome Other Serious PT Encephalopathy
Age: Route ORAL
Gender:Unknown Dose ORAL
I/FU:I Duration
Date:06/08/98ISR Number: 3179970-8Report Type:Periodic Outcome Other Serious PT Epilepsy Diarrhoea Chills Glossodynia Loss Of Consciousness Hepatic Function Abnormal Headache Pyrexia Platelet Count Decreased
Company Report #80968 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Imipramine (Imipramine Hydrochloride) Premarin (Estrogens, Conjugated) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
C C
Date:06/08/98ISR Number: 3179971-XReport Type:Periodic Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Productive Cough Aspartate Aminotransferase Increased Chills Pulmonary Congestion
I/FU:I Duration
Date:06/08/98ISR Number: 3179972-1Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Hallucination
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 67
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report WEEK ORAL Robitussin (Guaifenesin) Premarin (Estrogens, Conjugated) C C
Date:06/08/98ISR Number: 3179973-3Report Type:Periodic Outcome Other Serious PT Nausea
Age: Route ORAL
Gender:Female Dose 250.0000 MG 1.0 X PER DAY ORAL
I/FU:I Duration
Date:06/08/98ISR Number: 3179974-5Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Vomiting Diarrhoea Pyrexia
Company Report #84444 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) Luvox (Fluvoxamine) Role PS SS Manufacturer
I/FU:I Duration
Date:06/08/98ISR Number: 3179975-7Report Type:Periodic Outcome Other Serious PT Dermatitis Erythema Multiforme
Company Report #85156 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Oruvail (Ketoprofen) Fosamax (Alendronate Sodium) Mevacor (Lovastatin) Role PS SS C C Manufacturer
Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL ORAL
I/FU:I Duration
Date:06/08/98ISR Number: 3179976-9Report Type:Periodic Outcome Other Serious PT Neuropathy Peripheral Paraesthesia Pain Tonic Convulsion Hypoaesthesia
I/FU:I Duration
Propulsid (Cisapride) Proscar (Finasteride)
C C
03-Apr-2012
09:37 AM
Page: 68
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3179977-0Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Insomnia Major Depression Mood Altered Company Report #86526 Report Source Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:15 YR Route ORAL Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:06/08/98ISR Number: 3179978-2Report Type:Periodic Outcome Other Serious PT Dizziness Aggression Confusional State Tinnitus Fatigue Depression Nightmare Hallucination
Company Report #90808 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:06/08/98ISR Number: 3179979-4Report Type:Periodic Outcome Other Serious PT Hypoaesthesia
I/FU:I Duration
Company Report #92026 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Ambien (Zolpidem Tartrate) Norvasc (Amlodipine Besylate) Alcohol (Alcohol) Role PS Manufacturer
Gender:Male Dose 250.0000 MG 1.0 X PER DAY ORAL
I/FU:I Duration
C C C
Age:46 YR
Gender:Male
I/FU:I
PT Blood Pressure Increased Visual Impairment Hyperventilation
Product Lariam Tablets (Mefloquine Hydrochloride)
Role PS
Manufacturer
Route ORAL
Duration
03-Apr-2012
09:37 AM
Page: 69
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3179982-4Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Chills Chest Pain Diarrhoea Nausea Malaise Anxiety Palpitations Company Report #94951 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:48 YR Route ORAL Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:06/08/98ISR Number: 3179983-6Report Type:Periodic Outcome Other Serious PT Mania
Age: Route ORAL
I/FU:I Duration
Date:06/08/98ISR Number: 3179984-8Report Type:Periodic Outcome Other Serious PT Visual Acuity Reduced Coordination Abnormal Tremor Muscle Contractions Involuntary
I/FU:I Duration
Date:06/08/98ISR Number: 3179985-XReport Type:Periodic Outcome Other Serious PT Arthralgia Upper Respiratory Tract Infection Dermatitis
Company Report #75973 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Imodium (Loperamide Hydrochloride) Augmentin (Amoxicillin/Clavula nate Potassium) Role PS Manufacturer
Age:9 YR Route ORAL
I/FU:I Duration
C C
Date:06/08/98ISR Number: 3179986-1Report Type:Periodic Outcome Other Serious PT Abortion Spontaneous
Age:37 YR Route
Gender:Female Dose
I/FU:I Duration
(Mefloquine Hydrochloride)
PS
ORAL
03-Apr-2012
09:37 AM
Page: 70
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3179987-3Report Type:Periodic Outcome Other Serious PT Dermatitis Pruritus Company Report #76173 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:45 YR Route ORAL Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL I/FU:I Duration
Date:06/09/98ISR Number: 3091276-4Report Type:Expedited (15-DaCompany Report #99832 Outcome Hospitalization Initial or Prolonged PT Pneumonitis Report Source Foreign Other Product Lariam Havrix (Hepatitis A Vaccine) Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 250 MG 1 X PER ONE DOSE ORAL
Date:06/09/98ISR Number: 3091279-XReport Type:Expedited (15-DaCompany Report #99823 Outcome Other Serious PT Maculopathy Report Source Foreign Other Product Lariam Scopolamine (Scopolamine Hydrobromide) Role PS Manufacturer
Gender:Female
I/FU:I
Date:06/09/98ISR Number: 3091862-1Report Type:Expedited (15-DaCompany Report #99981 Outcome Hospitalization Initial or Prolonged PT Pneumonitis Report Source Health Professional Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Male
I/FU:I
Date:06/09/98ISR Number: 3091863-3Report Type:Expedited (15-DaCompany Report #98430 Outcome Hospitalization Initial or Prolonged PT Pulmonary Fibrosis Dyspnoea Report Source Foreign Health Professional Product Lariam Naproxen Role PS C Manufacturer
Gender:Male
I/FU:F
Age:35 YR Route
Gender:Male Dose
I/FU:I Duration
Hospitalization Initial or Prolonged
Agitation Nightmare Paranoia Influenza Like Illness
Foreign Other
Lariam Cannabis
PS C
ORAL
250 MG 1 X PER WEEK ORAL
03-Apr-2012
09:37 AM
Page: 71
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/98ISR Number: 3092795-7Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Memory Impairment Decompression Sickness Company Report # Report Source Product Larium Role PS Manufacturer Age:39 YR Route Gender:Female I/FU:I
Dose Duration AS PRESCRIBED
Date:06/11/98ISR Number: 3092547-8Report Type:Expedited (15-DaCompany Report #88780 Outcome Other Serious PT Premature Baby Cervical Incompetence Haematoma Vaginal Infection Vaginal Haemorrhage Premature Labour Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:F
Date:06/16/98ISR Number: 3094153-8Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Disorientation Panic Attack Suicidal Ideation Myocardial Infarction Headache Depression
Age:29 YR Route
Gender:Female Dose ONCE A WEEK
I/FU:I Duration 6 WK
Date:06/16/98ISR Number: 3094934-0Report Type:Expedited (15-DaCompany Report #94569 Outcome Other Serious PT Prophylaxis Anxiety Panic Attack Emotional Disorder Obsessive-Compulsive Disorder Report Source Health Professional Product Lariam Role PS Manufacturer
I/FU:F Duration
Date:06/16/98ISR Number: 3094936-4Report Type:Expedited (15-DaCompany Report #65435 Outcome Disability PT Anxiety Report Source Consumer Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose 250MG 1XPER
I/FU:F Duration
Apathy Hallucination Mental Impairment Pain Lethargy
Health Professional
WEEK ORAL
03-Apr-2012
09:37 AM
Page: 72
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/98ISR Number: 3096992-6Report Type:Expedited (15-DaCompany Report #98742 Outcome Hospitalization Initial or Prolonged PT Myocardial Infarction Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Age:39 YR Route ORAL Gender:Male Dose 250 MG 1 X PER WEEK I/FU:F Duration
Date:06/19/98ISR Number: 3097002-7Report Type:Expedited (15-DaCompany Report #100462 Outcome Other Serious PT Carpal Tunnel Syndrome Arthralgia Myalgia Report Source Foreign Consumer Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female
I/FU:I
Date:06/23/98ISR Number: 3097532-8Report Type:Expedited (15-DaCompany Report #98486 Outcome Other Serious PT Hearing Impaired Audiogram Abnormal Vestibular Disorder Dizziness Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male Dose 250 MG 1 X PER WEEK ORAL
I/FU:I Duration
Date:06/29/98ISR Number: 3100448-1Report Type:Expedited (15-DaCompany Report #101184 Outcome Death PT Completed Suicide Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:06/29/98ISR Number: 3102153-4Report Type:Periodic Outcome Other Serious PT Drug Interaction Vision Blurred Dizziness
Company Report #7395898 Report Source Health Professional Company Representative Other Product Norvir Lariam Zovirax Dt4 Ddi Lariam Role PS SS C C C C Manufacturer
Gender:Male
I/FU:I
Dose Duration 300.000 MG PO BID
Age: Route
Gender: Dose
I/FU:I Duration
Other Serious
Viith Nerve Paralysis
Lariam
PS
ORAL
250 MG X 1 PER WEEK ORAL
03-Apr-2012
09:37 AM
Page: 73
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/98ISR Number: 3101373-2Report Type:Expedited (15-DaCompany Report #96761 Outcome Other Serious PT Nephrolithiasis Haemangioma Of Liver Infection Parasitic Report Source Consumer Product Lariam Tetanus Booster (Tetanus Toxoid) Polio Booster (Poliomyelitis Vaccines) Hepatitis A Vaccine Hepatitis B Vaccine Role PS C C C C Manufacturer Age:41 YR Route ORAL Gender:Male I/FU:F
Date:07/02/98ISR Number: 3101779-1Report Type:Expedited (15-DaCompany Report #98097 Outcome Death PT Completed Suicide Depression Abnormal Behaviour Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:07/07/98ISR Number: 3102623-9Report Type:Expedited (15-DaCompany Report #101725 Outcome Other Serious PT Disorientation Dyslexia Headache Aphasia Dizziness Toxicity To Various Agents Report Source Foreign Health Professional Product Lariam Chloroquine (Choroquine) Role PS C Manufacturer
Gender:Female Dose 6 DOSE FORM DAILY ORAL
I/FU:I Duration
Date:07/13/98ISR Number: 3104477-3Report Type:Expedited (15-DaCompany Report #74171 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Paresis Dizziness Ileus Paralytic Guillain-Barre Syndrome Gait Disturbance Abdominal Distension Insomnia Gastrointestinal Disorder Report Source Foreign Health Professional Other Product Lariam Epaxal Arilvax Role PS SS SS Manufacturer
Age:47 YR Route ORAL INTRAMUSCULAR SUBCUTANEOUS
Gender:Female
I/FU:F
Dose Duration 250 MG 1 X PER ONE DOSE ORAL .5 ML 1 X PER ONE DOSE INTRAMUSCULAR .5 ML 1 X PER ONE DOSE SUBCUTANEOUS
Date:07/13/98ISR Number: 3105539-7Report Type:Expedited (15-DaCompany Report #98430 Outcome Hospitalization Initial or Prolonged PT Dyspnoea Pulmonary Fibrosis Report Source Foreign Health Professional Product Lariam Naproxen Role PS C Manufacturer
Gender:Male
I/FU:F
03-Apr-2012
09:37 AM
Page: 74
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/98ISR Number: 3106187-5Report Type:Expedited (15-DaCompany Report #102436 Outcome Disability PT Anxiety Fatigue Chest Pain Pain In Extremity Dyspnoea Report Source Foreign Consumer Product Lariam Role PS Manufacturer Age: Route Gender:Male Dose I/FU:I Duration
Date:07/23/98ISR Number: 3109359-9Report Type:Direct Outcome PT Fatigue Arthralgia Allergic Granulomatous Angiitis Gait Disturbance Myalgia Granuloma
Company Report #4-756-039-6 Report Source Product Accolate Lariam Dyazide Prednisone Role PS SS C C Manufacturer
Age:67 YR Route
Gender:Female Dose
I/FU:I Duration
Date:07/24/98ISR Number: 3109393-9Report Type:Expedited (15-DaCompany Report #96767 Outcome Disability PT Retinal Detachment Eye Pain Hyperhidrosis Malaria Chills Intraocular Pressure Increased Pyrexia Report Source Health Professional Other Product Lariam Role PS Manufacturer
Gender:Male Dose 250 MG 1 X PER WEEK ,ORAL
I/FU:F Duration
Date:07/29/98ISR Number: 3110717-7Report Type:Expedited (15-DaCompany Report #100462 Outcome Other Serious PT Myalgia Arthralgia Paraesthesia Carpal Tunnel Syndrome Report Source Foreign Consumer Product Lariam Role PS Manufacturer
Gender:Female Dose 250 MG 1 X PER WEEK
I/FU:I Duration
Date:07/29/98ISR Number: 3113067-8Report Type:Direct Outcome Required Intervention to PT Rash Vesicular Scar
Gender:Female Dose PO 1/WEEK
Prevent Permanent Impairment/Damage
Insomnia Haemorrhage Erythema Wound Secretion Dermatitis Exfoliative Pruritus Discomfort Page: 75
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/98ISR Number: 3123285-0Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Palpitations Anxiety Restlessness Company Report # Report Source Product Larium Role PS Manufacturer Roche Age:48 YR Route ORAL Gender:Female I/FU:I
Dose Duration 250 MG ORAL ONCE PER WEEK
Date:08/03/98ISR Number: 3112339-0Report Type:Expedited (15-DaCompany Report #103417 Outcome Other Serious PT Paranoia Gastrointestinal Hypermotility Restlessness Muscular Weakness Alopecia Decreased Appetite Periorbital Oedema Anxiety Feeling Abnormal Oedema Psychotic Disorder Abnormal Dreams Memory Impairment Lethargy Report Source Foreign Consumer Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 250 MG DAILY ORAL
Date:08/14/98ISR Number: 3117013-2Report Type:Direct Outcome Other Serious PT Dizziness Diarrhoea Vomiting Vertigo Anxiety
Company Report # Report Source Product Mefloquine Lariam Role PS SS Manufacturer
Gender:Male Dose 250 MG PO Q 1T WEEK
I/FU:I Duration
Date:08/18/98ISR Number: 3118491-5Report Type:Expedited (15-DaCompany Report #101725 Outcome Other Serious PT Dizziness Headache Disorientation Dyslexia Aphasia Toxicity To Various Agents Report Source Foreign Health Professional Product Lariam Chloroquine (Chloroquine) Role PS C Manufacturer
I/FU:F Duration
Date:08/19/98ISR Number: 3118885-8Report Type:Expedited (15-DaCompany Report #90892 Outcome Congenital Anomaly PT Feeding Disorder Neonatal Maternal Drugs Affecting Foetus Congenital Jaw
Age:28 YR
Gender:Female
I/FU:I
03-Apr-2012
09:37 AM
Page: 76
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malformation Dysmorphism Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Route ORAL Dose Duration 250 MG 1 X PER WEEK ORAL
Date:08/19/98ISR Number: 3118889-5Report Type:Expedited (15-DaCompany Report #104255 Outcome Other Serious PT Congenital Musculoskeletal Anomaly Cholestasis Dysmorphism Maternal Drugs Affecting Foetus Premature Labour Liver Function Test Abnormal Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Date:09/02/98ISR Number: 3124912-4Report Type:Expedited (15-DaCompany Report #104882 Outcome Hospitalization Initial or Prolonged PT Confusional State Anxiety Dizziness Tachycardia Arrhythmia Convulsion Cardiovascular Disorder Balance Disorder Restlessness Circulatory Collapse Ventricular Extrasystoles Asthenia Report Source Foreign Consumer Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose 250 MG 1 X PER WEEK ORAL
I/FU:I Duration
Date:09/02/98ISR Number: 3124913-6Report Type:Expedited (15-DaCompany Report #104935 Outcome Congenital Anomaly PT Maternal Drugs Affecting Foetus Cleft Palate Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Age:27 YR
Gender:Female
I/FU:I
PT Tachycardia Panic Attack Nausea Dizziness Bradycardia Insomnia Palpitations Page: 77
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Report Source Foreign Other Product Lariam Role PS Manufacturer Route ORAL Dose 250 MG 1 X PER WEEK; ORAL Duration
Date:09/04/98ISR Number: 3126058-8Report Type:Expedited (15-DaCompany Report #104663 Outcome Other Serious PT Osteoarthritis Disturbance In Attention Joint Swelling Arthralgia Fatigue Serum Sickness Anxiety Report Source Health Professional Product Lariam Typhoid Vaccine (Typhoid Vaccines) Role PS SS Manufacturer
Age:55 YR Route ORAL INTRAMUSCULAR
Gender:Male
I/FU:I
Dose Duration 250 MG 1 X PER WEEK ORAL 1 X PER ONE DOSE INTRAMUSCULAR
Date:09/10/98ISR Number: 3128393-6Report Type:Direct Outcome Other Serious PT Abnormal Dreams Depression Anxiety Hearing Impaired Aggression Fatigue Hallucination
Gender:Female Dose 250MG/WEEK ORAL
I/FU:I Duration
Date:09/14/98ISR Number: 3128291-8Report Type:Expedited (15-DaCompany Report #105284 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Suicide Attempt Depression Restlessness Insomnia Report Source Foreign Health Professional Product Lariam Tranxilium (Colorazepate Dipotassium) Atosil (Promethazine Hydrochloride) Resochin (Chloroquine Phosphate) Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 250 MG, 750 MG 1 X PER ONE DOSE ORAL
C C C
Age:27 YR
Gender:Female
I/FU:I
Outcome Required Intervention to Prevent Permanent Impairment/Damage
PT Arrested Labour Maternal Drugs Affecting Foetus
Product Lariam Clarityne (Loratadine) Engerix B (Hepatitis B Virus Vaccine
Role PS C
Manufacturer
Route ORAL
03-Apr-2012
09:37 AM
Page: 78
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inactivated) Atarax (Hydroxyzine Hydrochloride) Typhim (Typhoif Vaccines) Dpt (Diphteria Toxoid/Pertussis Vaccine/Tetaus Toxoid) C C C
Date:09/30/98ISR Number: 3136796-9Report Type:Expedited (15-DaCompany Report #106188 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Fatigue Haemolytic Anaemia Influenza Like Illness Anxiety Report Source Foreign Other Product Lariam Aspirin (Aspirin) Grippostad C (Acetaminophen/Ascor bic Acid/Caffeine/Chlorp heniramine Maleate) Role PS C Manufacturer
Gender:Male
I/FU:I
Date:10/02/98ISR Number: 3260324-0Report Type:Periodic Outcome Other Serious PT Erythema Multiforme
Company Report #8-97337-022L Report Source Health Professional Product Oruvail Lariam Mevacor Cortisone Injection Fosamax Role PS SS C C C Manufacturer
Gender:Female
I/FU:I
Dose Duration ORAL 250 MG WEEKLY ORAL
Date:10/13/98ISR Number: 3142010-0Report Type:Expedited (15-DaCompany Report #106318 Outcome Hospitalization Initial or Prolonged PT Dystonia Panic Attack Grand Mal Convulsion Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Date:10/13/98ISR Number: 3142011-2Report Type:Expedited (15-DaCompany Report #106675 Outcome Other Serious PT Ovarian Cancer Report Source Health Professional Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female
I/FU:I
Date:10/23/98ISR Number: 3145988-4Report Type:Expedited (15-DaCompany Report #106970 Outcome Death PT Mania Completed Suicide Hypomania Depression 09:37 AM Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
03-Apr-2012
Page: 79
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/98ISR Number: 3145989-6Report Type:Expedited (15-DaCompany Report #107015 Outcome Hospitalization Initial or Prolonged PT Dissociative Identity Disorder Hallucination Panic Attack Report Source Foreign Other Product Lariam Role PS Manufacturer Age:50 YR Route ORAL Gender:Male I/FU:I
Date:11/02/98ISR Number: 3152111-9Report Type:Expedited (15-DaCompany Report #107663 Outcome Other Serious PT Grand Mal Convulsion Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:11/05/98ISR Number: 3152322-2Report Type:Expedited (15-DaCompany Report #92444 Outcome Hospitalization Initial or Prolonged Congenital Anomaly PT Maternal Drugs Affecting Foetus Premature Baby Foetal Growth Restriction Small For Dates Baby Report Source Foreign Health Professional Other Product Lariam Adepal Stamaril Role PS SS SS Manufacturer
Age:24 YR Route ORAL ORAL SUBCUTANEOUS
Gender:Female
I/FU:F
Havrix
SS
INTRAMUSCULAR
Hepatitis
SS
INTRAMUSCULAR
Dose Duration 250 MG 1 X PER WEEK ORAL 1 DOSE FORM 1 X PER DAY ORAL 1 DOSE FORM 1 X PER ONE DOSE SUBCUTANEOUS 1440 UNIT/ML 1 X PER ONE DOSE INTRAMUSCULAR 1 X PER ONE DOSE INTRAMUSCULAR
Date:11/10/98ISR Number: 3155903-5Report Type:Expedited (15-DaCompany Report #107875 Outcome Congenital Anomaly PT Maternal Drugs Affecting Foetus Benign Congenital Hypotonia Congenital Anomaly Microcephaly Thalassaemia Alpha Mental Retardation Dysmorphism Report Source Foreign Other Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female
I/FU:I
Strabismus Developmental Delay
03-Apr-2012
09:37 AM
Page: 80
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/98ISR Number: 3155959-XReport Type:Expedited (15-DaCompany Report #107840 Outcome Hospitalization Initial or Prolonged PT Colitis Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Age: Route ORAL Gender:Female I/FU:I
Dose Duration TABLETS; ORAL
Date:11/12/98ISR Number: 3156945-6Report Type:Expedited (15-DaCompany Report #107872 Outcome Other Serious PT Fall Circulatory Collapse Fatigue Grand Mal Convulsion Loss Of Consciousness Anhedonia Epilepsy Lethargy Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 250MG 1 X PER WEEK ORAL
Date:11/13/98ISR Number: 3157862-8Report Type:Direct Outcome PT Crying Depression Emotional Disorder
Company Report # Report Source Consumer Product Larium Role PS Manufacturer
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:11/17/98ISR Number: 3158657-1Report Type:Expedited (15-DaCompany Report #107663 Outcome Other Serious PT Grand Mal Convulsion Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:11/20/98ISR Number: 3160902-3Report Type:Expedited (15-DaCompany Report #65435 Outcome Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Apathy Pollakiuria Haematuria Anxiety Cholecystitis Syncope Constipation Nausea Cough
Age:33 YR
Gender:Female
I/FU:F
Lethargy Night Sweats Nightmare Chills Back Pain Micturition Urgency Culture Urine Positive Condition Aggravated 03-Apr-2012 09:37 AM Page: 81
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Headache Mental Disorder Hallucinations, Mixed Pain Calculus Urinary
Report Source Consumer Health Professional Other
Product Lariam Lorazepam Anaprox Ds Motrin Toradol Wellbutrin Zovirax
Role PS C C C C C C
Manufacturer
Route ORAL
Dose Duration 250 MG 1 X PER WEEK ORAL 14 DAY
Date:11/24/98ISR Number: 3161905-5Report Type:Direct Outcome Other Serious PT Paraesthesia Hallucination Dermatitis Convulsion Flushing Anxiety Insomnia
Age:55 YR Route
Gender:Female Dose 250MG,1 PER WEEK FOR 5 WEEKS
Date:11/30/98ISR Number: 3164083-1Report Type:Expedited (15-DaCompany Report #108878 Outcome Other Serious PT Cerebral Infarction Hemianopia Report Source Foreign Other Product Lariam Hepatitis A Vaccine Yellow Fever Vaccine Mengivac Typhim Role PS C C C C Manufacturer
Gender:Male
I/FU:I
Date:11/30/98ISR Number: 3164100-9Report Type:Expedited (15-DaCompany Report #108916 Outcome Other Serious PT Grand Mal Convulsion Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:11/30/98ISR Number: 3164195-2Report Type:Expedited (15-DaCompany Report #81879 Outcome Hospitalization Initial or Prolonged PT Chills Tongue Disorder Suicidal Ideation
Age:23 YR
Gender:Male
I/FU:F
Medication Error Blood Cholesterol Increased Bipolar I Disorder Pulmonary Congestion Schizophreniform Disorder Culture Stool Positive Hepatic Enzyme Increased 03-Apr-2012 09:37 AM Page: 82
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspartate Aminotransferase Increased Psychotic Disorder Oral Candidiasis Cough
Product Lariam Typhoid Vaccine Diphtheria And Tetaus Vaccine Yellow Fever Vaccine
Role PS C C C
Manufacturer
Route
Date:12/01/98ISR Number: 3164881-4Report Type:Expedited (15-DaCompany Report #107840 Outcome Hospitalization Initial or Prolonged PT White Blood Cell Count Increased Red Blood Cell Sedimentation Rate Increased Thrombocytosis Colitis Ulcerative Diarrhoea Haemorrhagic Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:F
Date:12/01/98ISR Number: 3164986-8Report Type:Expedited (15-DaCompany Report #108638 Outcome Other Serious PT Breast Mass Breast Cancer Female Premature Labour Report Source Foreign Consumer Other Product Lariam Role PS Manufacturer
Age:27 YR Route
Gender:Female Dose 250 MG 1 X PER WEEK OTHER
I/FU:I Duration
Date:12/03/98ISR Number: 3171304-8Report Type:Expedited (15-DaCompany Report #98676 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Psychotic Disorder Paresis Cholera Headache Drug Level Above Therapeutic Paraesthesia Hallucination Hypoaesthesia Suicidal Ideation Restlessness Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:12/03/98ISR Number: 3171305-XReport Type:Expedited (15-DaCompany Report #109425
Age:46 YR
Gender:Male
I/FU:I
PT Optic Neuritis Visual Impairment Papilloedema
Product Lariam Typhim Vi Engerix B
Role PS SS SS
Manufacturer
Route ORAL INTRAMUSCULAR INTRAMUSCULAR
Dose Duration 250 MG 1 X PER WEEK ORAL 1 X PER ONE DOSE INTRAMUSCULAR 1 X PER ONE Page: 83
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DOSE INTRAMUSCULAR 1 X PER PRN ORAL 1 X PER PRN ORAL
Profenid Propofan Sanmigran
SS SS C
ORAL ORAL
Date:12/03/98ISR Number: 3171306-1Report Type:Expedited (15-DaCompany Report #109197 Outcome Other Serious PT Ejection Fraction Abnormal Tachycardia Medication Error Dyspnoea Report Source Foreign Health Professional Product Lariam Lariam Role PS SS Manufacturer
Gender:Male
I/FU:I
Dose Duration 25 MG/KG ORAL 250 MG 1X PER WEEK ORAL
Date:12/08/98ISR Number: 3168310-6Report Type:Expedited (15-DaCompany Report #104882 Outcome Hospitalization Initial or Prolonged PT Convulsion Restlessness Feeling Abnormal Asthenia Paraesthesia Circulatory Collapse Balance Disorder Dizziness Confusional State Tachycardia Anxiety Cardiovascular Disorder Ventricular Extrasystoles Arrhythmia Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female
I/FU:F
Date:12/08/98ISR Number: 3168484-7Report Type:Expedited (15-DaCompany Report #109778 Outcome Hospitalization Initial or Prolonged PT Hypersensitivity Report Source Foreign Other Product Lariam Microgynon (Ethinyl Estradiol/Levonorges trel) Role PS Manufacturer
Age: Route ORAL
Gender:Unknown
I/FU:I
Age:48 YR
Gender:Female
I/FU:I
PT Influenza Like Illness Palpitations Urticaria Pyrexia Chills Anxiety Lung Consolidation Page: 84
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Q Fever Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Route ORAL Dose Duration 250 MG 1 X PER WEEK ORAL
Date:12/08/98ISR Number: 3168721-9Report Type:Expedited (15-DaCompany Report #108541 Outcome Hospitalization Initial or Prolonged PT Hyperpyrexia Gastroenteritis Shigella White Blood Cell Count Increased Report Source Foreign Study Health Professional Product Lariam Orlistat Role PS SS Manufacturer
Gender:Female
I/FU:I
Dose Duration 250 MG 1XPER WEEK ORAL 3XPER DAY ORAL
Date:12/10/98ISR Number: 3168961-9Report Type:Direct Outcome Other Serious PT Dizziness Diarrhoea Malaise
Gender:Male Dose 1 PILL PER WEEK
I/FU:I Duration
Date:12/10/98ISR Number: 3169049-3Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Weight Decreased Hallucination Hyperhidrosis Delusion Bipolar I Disorder Panic Attack Convulsion
Company Report # Report Source Product Larium 250mg (Mefloquine) Benztropinue Imxiete Haloperidol Role PS C C C Manufacturer Roche Rh 674414
Gender:Male Dose ORAL 250MG 1T TAB WEEKLY
I/FU:I Duration
Date:12/10/98ISR Number: 3169225-XReport Type:Expedited (15-DaCompany Report #8-98334-066A Outcome Hospitalization Initial or Prolonged PT Papilloedema Optic Neuritis Visual Impairment Report Source Foreign Health Professional Product Profenid (Ketoprofen) Hepatitis B Vaccine Injection Mefloquine Tablet Propavan (Propiomazine Role PS SS SS Manufacturer
Gender:Male Dose AS NEEDED ORAL INJECTABLE ONE TABLET WEEKLY; ORAL
I/FU:I Duration YR
ORAL
Maleate) Typhoid Vaccine Injection Cafeine +Paracetamol +Chlorphenamine Maleate 03-Apr-2012 09:37 AM
SS SS
AS NEEDED ONE INJECTION; INJECTABLE
YR
Page: 85
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report +Dextropropoxyphene +Carbasalate Calcium C
Date:12/10/98ISR Number: 3169279-0Report Type:Expedited (15-DaCompany Report #108731 Outcome Other Serious PT Atrial Fibrillation Arrhythmia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:12/10/98ISR Number: 3169280-7Report Type:Expedited (15-DaCompany Report #96761 Outcome Other Serious PT Liver Disorder Haemangioma Of Liver Nephrolithiasis Infection Parasitic Report Source Consumer Product Lariam Tetanus Booster Polio Booster Hepatitis A Vaccine Hepatitis B Vaccine Role PS C C C C Manufacturer
Gender:Male
I/FU:F
Date:12/14/98ISR Number: 3170021-8Report Type:Expedited (15-DaCompany Report #B0062044 Outcome Hospitalization Initial or Prolonged PT Decreased Appetite Vision Blurred Depression Vertigo Asthenia Gait Disturbance Abdominal Pain Nausea Malaise Report Source Foreign Product Zovirax Tablet Mefloquine (Formulation Unknown) Pristinamycin Role PS SS C Manufacturer
Gender:Female Dose ORAL ORAL
I/FU:I Duration
Date:12/14/98ISR Number: 3170131-5Report Type:Expedited (15-DaCompany Report #110216 Outcome Hospitalization PS Initial or Prolonged PT Psychomotor Hyperactivity ORAL Muscle Rigidity Psychotic Disorder Speech Disorder Depersonalisation Insomnia Screaming Crying Nightmare Report Source Foreign 250 MG 1XPER Other Product Lariam Role Manufacturer
Age:18 YR Route
Gender:Female Dose WEEK ORAL
I/FU:I Duration
Sedation Confusional State Delirium
03-Apr-2012
09:37 AM
Page: 86
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/98ISR Number: 3170215-1Report Type:Expedited (15-DaCompany Report #109968 Outcome Hospitalization Initial or Prolonged PT Decreased Appetite Vision Blurred Depression Nausea Asthenia Vertigo Gait Disturbance Abdominal Pain Fall Report Source Foreign Other Product Lariam Zovirax Pyostacine Role PS SS C Manufacturer Age:27 YR Route ORAL ORAL Gender:Female I/FU:I
Dose Duration 250 MG 1 X PER WEEK ORAL 800 MG DAILY ORAL
Date:12/14/98ISR Number: 3170217-5Report Type:Expedited (15-DaCompany Report #110362 Outcome Hospitalization Initial or Prolonged PT Depersonalisation Dizziness Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:12/14/98ISR Number: 3170236-9Report Type:Expedited (15-DaCompany Report #104407 Outcome Hospitalization Initial or Prolonged PT Chest Discomfort Lethargy Pain Loss Of Libido Restlessness Anxiety Abdominal Pain Panic Attack Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Male Dose 250 MG 1 X PER WEEK ORAL
I/FU:I Duration
Date:12/14/98ISR Number: 3170525-8Report Type:Expedited (15-DaCompany Report #104882 Outcome Hospitalization Initial or Prolonged PT Asthenia Paraesthesia Tachycardia Confusional State Condition Aggravated Convulsion Dizziness Depersonalisation Balance Disorder Cardiovascular Disorder Ventricular Extrasystoles Circulatory Collapse Restlessness Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer
Gender:Female
I/FU:F
Anxiety Panic Attack Arrhythmia
03-Apr-2012
09:37 AM
Page: 87
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/98ISR Number: 3170982-7Report Type:Expedited (15-DaCompany Report #110115 Outcome Hospitalization Initial or Prolonged PT Vomiting Abscess Nausea Abdominal Pain C-Reactive Protein Increased Dysuria Diverticulum Intestinal Diverticulitis Pyrexia White Blood Cell Count Increased Diarrhoea Report Source Foreign Other Product Lariam Role PS Manufacturer Age:63 YR Route ORAL Gender:Male I/FU:I
Date:12/16/98ISR Number: 3170984-0Report Type:Expedited (15-DaCompany Report #106675 Outcome Other Serious PT Ovarian Cancer Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
Date:12/16/98ISR Number: 3170987-6Report Type:Expedited (15-DaCompany Report #110313 Outcome Hospitalization Initial or Prolonged PT Loss Of Consciousness Grand Mal Convulsion Atrial Fibrillation Blood Cholesterol Increased Urinary Incontinence Heart Rate Irregular Report Source Foreign Literature Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration 250 MG 1 X PER WEEK ORAL 21 DAY
Date:12/24/98ISR Number: 3174151-6Report Type:Expedited (15-DaCompany Report #58978 Outcome Other Serious PT Heart Rate Increased Vertigo Psychotic Disorder Feeling Abnormal Visual Acuity Reduced Fatigue Circulatory Collapse
Age:31 YR
Gender:Male
I/FU:F
Asthenia Nervous System Disorder Nystagmus Drug Level Above Therapeutic Dyspnoea Amnesia Dizziness 03-Apr-2012 09:37 AM Page: 88
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance In Attention Head Injury Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Norflex Role Manufacturer Route Dose Duration
PS C
ORAL
250 MG 1XPER WEEK ORAL
Date:12/29/98ISR Number: 3176456-1Report Type:Expedited (15-DaCompany Report #102527 Outcome Hospitalization Initial or Prolonged PT Apallic Syndrome Electroencephalogram Abnormal Nightmare Amnesia Dystonia Depressed Level Of Consciousness Drug Effect Decreased Restlessness Pyrexia Asthenia Thrombocytopenia Disturbance In Attention Sinusitis Malaria Nervous System Disorder Report Source Foreign Health Professional Other Product Lariam Chinin Role PS C Manufacturer
Gender:Male
I/FU:I
Date:12/30/98ISR Number: 3176659-6Report Type:Expedited (15-DaCompany Report #108731 Outcome Hospitalization Initial or Prolonged PT Condition Aggravated Atrial Fibrillation Malaise Tachycardia Arrhythmia Report Source Foreign Health Professional Product Lariam Tetanus Vaccine (Tetanus Toxoid) Immunoglobulin (Globulin, Immune) Polio Vaccine (Poliomyelitis Vaccines) Role PS C C C Manufacturer
Gender:Male
I/FU:F
Date:12/30/98ISR Number: 3176664-XReport Type:Expedited (15-DaCompany Report #95713 Outcome PT
Age:29 YR
Gender:Female
I/FU:I
Hospitalization Initial or Prolonged Congenital Anomaly
White Blood Cell Count Increased Congenital Anomaly Blood Glucose Decreased Hyperbilirubinaemia Neonatal Foetal Haemoglobin Increased Page: 89
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Platelet Count Decreased Talipes Pyrexia Congenital Hip Deformity Maternal Drugs Affecting Foetus Hypoglycaemia Type 1 Diabetes Mellitus Blood Bilirubin Increased
Product Lariam
Role PS
Manufacturer
Route ORAL
Date:12/30/98ISR Number: 3176807-8Report Type:Expedited (15-DaCompany Report #107634 Outcome Other Serious PT Hypoaesthesia Ear Pain Hemiparesis Multiple Sclerosis Eustachian Tube Obstruction Paraesthesia Report Source Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Date:01/08/99ISR Number: 3178806-9Report Type:Expedited (15-DaCompany Report #111360 Outcome Other Serious PT Abortion Missed Report Source Foreign Health Professional Product Lariam Clotrimazol Role PS C Manufacturer
Gender:Female
I/FU:I
Date:01/08/99ISR Number: 3178807-0Report Type:Expedited (15-DaCompany Report #111442 Outcome Hospitalization Initial or Prolonged PT Neuropathy Peripheral Headache Nightmare Dysgeusia Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Female Dose 250 MG 1 X PER DOSE, ORAL
I/FU:I Duration
Date:01/08/99ISR Number: 3178853-7Report Type:Expedited (15-DaCompany Report #109968 Outcome Hospitalization Initial or Prolonged PT Nausea Asthenia Abdominal Pain Vertigo Fall Decreased Appetite Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Zovirax (Acyclovir) 200 Mg Role PS SS Manufacturer
Gender:Female Dose 250 1 X PER WEEK ORAL 800 MG DAILY ORAL
I/FU:F Duration
Depression Gait Disturbance Vision Blurred
Pyostacine (Pristinamycin)
03-Apr-2012
09:37 AM
Page: 90
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/99ISR Number: 3179344-XReport Type:Direct Outcome Other Serious PT Pyrexia Tremor Headache Chills Company Report # Report Source Product Lariam Role PS Manufacturer Age: Route Gender:Female Dose 1 PILL PER WEEK I/FU:I Duration
Date:01/11/99ISR Number: 3179642-XReport Type:Direct Outcome Disability PT Convulsion Insomnia Nausea Vision Blurred Paraesthesia Photophobia Fear Mania Psychotic Disorder Toxicity To Various Agents Feeling Of Body Temperature Change Fatigue Paranoia Dyspnoea Headache Decreased Appetite Dizziness
Company Report # Report Source Product Lariam Role PS Manufacturer Hoffman Laroche
Age:31 YR Route
Gender:Female Dose 250 MG, I TABLET PER WEEK FOR 10 WEEKS
I/FU:I Duration
Date:01/13/99ISR Number: 3180240-2Report Type:Direct Outcome Other Serious PT Depression Irritability Mood Altered Insomnia Palpitations Dizziness
Company Report # Report Source Consumer Product Lariam Role PS Manufacturer
Age:40 YR Route
Gender:Female
I/FU:I
Date:01/13/99ISR Number: 3180261-XReport Type:Direct Outcome Other Serious PT Loss Of Consciousness Partial Seizures Disorientation
Gender:Male
I/FU:I
Dose Duration 250MG /WK PO
Date:01/13/99ISR Number: 3180629-1Report Type:Expedited (15-DaCompany Report #93243 Outcome Other Serious 03-Apr-2012 09:37 AM PT Thrombocytopenia White Blood Cell Count
Age:58 YR
Gender:Male
I/FU:F
Page: 91
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Liver Function Test Abnormal Thrombocytosis Malaria
Report Source Foreign Health Professional Other
Product Lariam
Role PS
Manufacturer
Route ORAL
Date:01/14/99ISR Number: 3180688-6Report Type:Expedited (15-DaCompany Report #96727 Outcome Other Serious PT Thrombocytopenia Liver Function Test Abnormal Blood Alkaline Phosphatase Increased White Blood Cell Count Decreased Leukopenia Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:01/14/99ISR Number: 3180722-3Report Type:Expedited (15-DaCompany Report #96727 Outcome Other Serious PT Leukopenia White Blood Cell Count Decreased Thrombocytopenia Liver Function Test Abnormal Thrombocytosis Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:01/19/99ISR Number: 3182196-5Report Type:Expedited (15-DaCompany Report #111775 Outcome Congenital Anomaly PT Cleft Palate Maternal Drugs Affecting Foetus Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Date:01/19/99ISR Number: 3182565-3Report Type:Expedited (15-DaCompany Report #104407 Outcome Hospitalization Initial or Prolonged PT Lethargy Abdominal Pain Anxiety Panic Attack Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Chest Discomfort Restlessness
03-Apr-2012
09:37 AM
Page: 92
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/99ISR Number: 3184622-4Report Type:Expedited (15-DaCompany Report #92891 Outcome Other Serious PT Vertigo Gait Disturbance Balance Disorder Dizziness Report Source Foreign Health Professional Product Lariam Geluprane Role PS C Manufacturer Age:54 YR Route ORAL Gender:Male I/FU:F
Date:01/25/99ISR Number: 3185409-9Report Type:Expedited (15-DaCompany Report #112058 Outcome Hospitalization Initial or Prolonged PT Insomnia Anxiety Dizziness Gastritis Report Source Foreign Consumer Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration 250 MG 1X PER WEEK ORAL 28 DAY
Date:02/04/99ISR Number: 3191986-4Report Type:Expedited (15-DaCompany Report #112683 Outcome Hospitalization Initial or Prolonged PT Suicide Attempt Intentional Overdose Delusional Disorder, Persecutory Type Psychotic Disorder Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Female Dose 250 MG 1 X PER WEEK ORAL
I/FU:I Duration
Date:02/08/99ISR Number: 3193356-1Report Type:Direct Outcome Death PT Delusion Adjustment Disorder Depression
Age: Route ORAL
Gender:Male Dose 8/98 ORAL
I/FU:I Duration
Date:02/09/99ISR Number: 3194845-6Report Type:Direct Outcome PT Memory Impairment Dermatitis Alopecia
Age:24 YR Route
Gender:Male
I/FU:I
Dose Duration 1 PILL ONCE A WEEK 2 YR
Date:02/10/99ISR Number: 3195192-9Report Type:Direct Outcome Hospitalization PT Panic Attack
Company Report #
Age:32 YR
Gender:Female
I/FU:I
Saliva Altered Hypoaesthesia Balance Disorder Toxicity To Various Agents Muscular Weakness Paraesthesia Burning Sensation Page: 93
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Chest Pain Anxiety Headache Coordination Abnormal Insomnia Gait Disturbance Movement Disorder Malaria Fatigue Nightmare Salivary Hypersecretion Abdominal Pain Asthenia Sensation Of Heaviness Myalgia Diarrhoea Arthralgia
Report Source
Product Lariam
Role PS
Manufacturer Roche Labs
Route ORAL
Dose Duration 250 MG WEEKLY BY MOUTH
Date:02/16/99ISR Number: 3199935-XReport Type:Expedited (15-DaCompany Report #98676 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Bipolar I Disorder Loss Of Employment Ulnar Nerve Injury Depression Catatonia Mood Altered Restlessness Head Injury Perseveration Suicidal Ideation Paraesthesia Extrapyramidal Disorder Hypoaesthesia Schizophreniform Disorder Flat Affect Delusion Stress Paresis Anger Paranoia Headache Abnormal Behaviour Lethargy Bradyphrenia Hallucination Report Source Foreign Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:36 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
250 MG 1 PER DAY ORAL
Age:82 YR
Gender:Female
I/FU:I
Outcome Disability
PT Speech Disorder Dizziness Confusional State Medication Error Agitation Deafness 09:37 AM Page: 94
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coordination Abnormal Report Source Literature Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Route ORAL Dose ORAL Duration 61 DAY
Date:02/17/99ISR Number: 3200641-3Report Type:Expedited (15-DaCompany Report #113209 Outcome Hospitalization Initial or Prolonged PT Overdose Nausea Jaundice Hallucination Hepatic Failure Chromaturia Abdominal Pain Liver Function Test Abnormal Report Source Literature Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Primaquine (Primaqine Phosphate) Role Manufacturer
Age:45 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
1250 MG 1 PER ONE DOSE ORAL 1260 MG 1 PER ONE DOSE
SS
Date:02/17/99ISR Number: 3200745-5Report Type:Expedited (15-DaCompany Report #104407 Outcome Hospitalization Initial or Prolonged PT Abdominal Pain Restlessness Anxiety Panic Attack Chest Discomfort Lethargy Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:39 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:02/18/99ISR Number: 3201276-9Report Type:Direct Outcome PT Hallucination Chest Pain Paraesthesia Fatigue Headache Chills
Company Report # Report Source Product Mefloquine Role PS Manufacturer Roche Laboratories
Age: Route
Gender: Dose
I/FU:I Duration
Date:02/18/99ISR Number: 3201365-9Report Type:Direct Outcome Life-Threatening Hospitalization PT Hallucination Mania
Age:40 YR Route
Gender:Female Dose 1 PILL PER WEEK
I/FU:I Duration
Panic Attack Tachycardia Mental Disorder
03-Apr-2012
09:37 AM
Page: 95
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/99ISR Number: 3203383-3Report Type:Expedited (15-DaCompany Report #200209 Outcome Other Serious PT Nightmare Suicidal Ideation Paranoia Agitation Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:19 YR Route ORAL Gender:Male Dose 250 MG DAILY ORAL I/FU:I Duration
Date:02/18/99ISR Number: 3203385-7Report Type:Expedited (15-DaCompany Report #200139 Outcome Hospitalization Initial or Prolonged PT Drug Level Above Therapeutic Liver Transplant Rejection Drug Interaction Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Fk506 (Tacrolimus) Role Manufacturer
Age:4 YR Route
Gender:Male Dose
I/FU:I Duration
PS SS
ORAL
250 MG 1 PER WEEK ORAL
Date:02/19/99ISR Number: 3203427-9Report Type:Expedited (15-DaCompany Report #113217 Outcome Hospitalization Initial or Prolonged PT Decreased Appetite Nervousness Oedema Blood Albumin Decreased Vomiting Dehydration Inflammation Blood Calcium Decreased Weight Decreased Hepatomegaly Endoscopy Upper Gastrointestinal Tract Abnormal Hepatic Failure Oedema Peripheral Compartment Syndrome Abdominal Distension Liver Function Test Abnormal Depression Blood Potassium Decreased Diarrhoea Hepatic Steatosis Gastroenteritis Report Source Foreign Literature Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Female Dose 250 MG 1 PER WEEK ORAL
I/FU:I Duration
Company Report #
Age:51 YR
Gender:Unknown
I/FU:I
Outcome
PT Decreased Interest Insomnia Disturbance In Attention Cognitive Disorder Anxiety 09:37 AM
Product Lariam Halcion
Role PS C
Manufacturer
Route
Dose
Duration
03-Apr-2012
Page: 96
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/99ISR Number: 3204969-2Report Type:Expedited (15-DaCompany Report #113209 Outcome Hospitalization Initial or Prolonged PT Chromaturia Abdominal Pain Jaundice Nausea Liver Function Test Abnormal Hepatic Failure Hallucination Overdose Report Source Literature Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Primaquine (Primaquine Phosphate) Role Manufacturer Age:45 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
1250 MG 1 PER ONE DOSE ORAL 1260 MG 1 PER ONE DOSE
SS
Date:02/22/99ISR Number: 3205088-1Report Type:Expedited (15-DaCompany Report #98676 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Suicidal Ideation Paresis Extrapyramidal Disorder Restlessness Peripheral Nerve Lesion Disturbance In Attention Lethargy Hypoaesthesia Paranoia Schizophreniform Disorder Delusion Paraesthesia Bipolar I Disorder Catatonia Hallucination Report Source Foreign Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:36 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:02/24/99ISR Number: 3206756-8Report Type:Expedited (15-DaCompany Report #200139 Outcome Hospitalization Initial or Prolonged PT Drug Level Above Therapeutic Transplant Rejection Drug Interaction Report Source Foreign Health Professional Product Lariam Fk506 (Tacrolimus) Role PS SS Manufacturer
Age:4 YR Route ORAL
Gender:Male
I/FU:F
Dose Duration TABLETS, 1 PER WEEK ORAL
Date:02/26/99ISR Number: 3208126-5Report Type:Expedited (15-DaCompany Report #200527 Outcome Other Serious PT Toxoplasmosis Report Source Foreign Health Professional Product Lariam Beriglobin Role PS C Manufacturer
Gender:Female Dose 250MG 1 PER WEEK ORAL
I/FU:I Duration
Typhoral
03-Apr-2012
09:37 AM
Page: 97
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3208128-9Report Type:Expedited (15-DaCompany Report #200442 Outcome Other Serious PT Jaundice Condition Aggravated Haemolytic Anaemia Report Source Health Professional Product Lariam Role PS Manufacturer Age:32 YR Route ORAL Gender:Female Dose 250MG 1 PER WEEK ORAL I/FU:I Duration
Date:03/01/99ISR Number: 3209203-5Report Type:Expedited (15-DaCompany Report #200139 Outcome Hospitalization Initial or Prolonged PT Drug Interaction Liver Transplant Rejection Drug Level Above Therapeutic Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Fk506 (Tacrolimus) Role PS SS Manufacturer
Age:4 YR Route ORAL
Gender:Male Dose 1 PER WEEK ORAL
I/FU:F Duration
Date:03/01/99ISR Number: 3209298-9Report Type:Expedited (15-DaCompany Report #201094 Outcome Other Serious PT Speech Disorder Coordination Abnormal Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:03/01/99ISR Number: 3209366-1Report Type:Expedited (15-DaCompany Report #200926 Outcome Hospitalization Initial or Prolonged PT Hallucination Delusion Hepatitis Schizophrenia Jaundice Report Source Foreign Health Professional Product Laraim Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:03/03/99ISR Number: 3210714-7Report Type:Direct Outcome Disability Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Disturbance In Attention Feeling Abnormal Joint Stiffness Abdominal Pain Upper Insomnia Disorientation Dizziness Decreased Appetite Vision Blurred Chills
Company Report #
Age:69 YR
Gender:Female
I/FU:I
Tremor Fatigue Abdominal Pain Vertigo Arthralgia Dysgraphia Nausea Asthenia 03-Apr-2012 09:37 AM Page: 98
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Confusional State Anxiety Report Source Product Lariam Role PS Manufacturer Hoffman-La Roche Inc Route ORAL Dose Duration 250MG ONCE /WEEK ORALLY /8 WEEKS
Date:03/03/99ISR Number: 3214303-XReport Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Hypersomnia Hyperhidrosis Agoraphobia Malaria Depression Bipolar Disorder
Gender:Male Dose TAB 1T ORAL
Date:03/05/99ISR Number: 3214272-2Report Type:Expedited (15-DaCompany Report #201217 Outcome Death PT Fibrosis Hepatic Steatosis Ventricular Hypertrophy Obstruction Hepatosplenomegaly Malaise Ventricular Fibrillation Cardiomegaly Report Source Foreign Other Product Lariam Hepatitis A Vaccine (Hepatitis A Vaccine) Role PS SS Manufacturer
Gender:Male Dose
I/FU:I Duration
Date:03/05/99ISR Number: 3214273-4Report Type:Expedited (15-DaCompany Report #201099 Outcome Other Serious PT Deafness Neurosensory Deafness Report Source Health Professional Product Lariam Beta-Blocker (Beta Blocker Nos) Role PS C Manufacturer
Gender:Male
I/FU:I
Dose Duration 250 MG 1 PER WEEK
Date:03/08/99ISR Number: 3214076-0Report Type:Direct Outcome Disability PT Hypoaesthesia Palpitations Anxiety Pain Dermatitis
Age: Route
Gender:Female Dose ONCE.WK
I/FU:I Duration
Dizziness
03-Apr-2012
09:37 AM
Page: 99
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/99ISR Number: 3215137-2Report Type:Expedited (15-DaCompany Report #72710 Outcome Disability PT Deafness Speech Disorder Agitation Asthenia Coordination Abnormal Bundle Branch Block Medication Error Confusional State Respiratory Disorder Alanine Aminotransferase Increased Accidental Overdose Dizziness Report Source Literature Health Professional Product Lariam Cardizem Propoxyphene Desyrel (Trazodone Hydrochloride) Ultram Depakote Apresoline Role PS C C C C C C Manufacturer Age:82 YR Route ORAL Gender:Female I/FU:F
Dose Duration 250 MG 1 PER DAY ORAL
Date:03/08/99ISR Number: 3215139-6Report Type:Expedited (15-DaCompany Report #113215 Outcome Disability PT Deafness Agitation Confusional State Dizziness Medication Error Speech Disorder Coordination Abnormal Report Source Literature Health Professional Product Lariam Role PS Manufacturer
I/FU:F Duration 61 DAY
Date:03/08/99ISR Number: 3215142-6Report Type:Expedited (15-DaCompany Report #200926 Outcome Hospitalization Initial or Prolonged PT Abnormal Dreams Aggression Feeling Abnormal Injury Jaundice Stress Hepatitis Psychotic Disorder Schizophrenia Hepatic Enzyme Increased Delusion Asthenia Mental Disorder Hallucination Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female
I/FU:F
Dose Duration 250 MG 1 PER WEEK ORAL
Company Report #
Age:
Gender:Female
I/FU:I
PT Insomnia Restlessness Dizziness
Report Source
Product Lariam
Role PS
Manufacturer
Route
Dose Duration 1TAB PER WEEK FOR 3 WEEKS ; GIVEN SAMPLE IN MD'S OFFICE Page: 100
Celbrex 03-Apr-2012 09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diamox Prempro C C
Date:03/17/99ISR Number: 3223037-7Report Type:Expedited (15-DaCompany Report #200209 Outcome Other Serious PT Agitation Suicidal Ideation Nightmare Paranoia Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250mg Role PS Manufacturer
Gender:Male Dose 250 MG 1 PER WEEK ORAL
I/FU:F Duration
Date:03/24/99ISR Number: 3225735-8Report Type:Expedited (15-DaCompany Report #200442 Outcome Other Serious PT Anaemia Haemolytic Autoimmune Jaundice Diarrhoea Condition Aggravated Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:32 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
Date:03/25/99ISR Number: 3226364-2Report Type:Expedited (15-DaCompany Report #202374 Outcome Hospitalization Initial or Prolonged PT Lethargy Dizziness Colonic Polyp Haemoglobin Decreased Chromaturia Haemolytic Anaemia Abdominal Pain Lower Decreased Appetite Jaundice Haematocrit Decreased Neoplasm Malignant Pain Body Temperature Decreased Dehydration Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:64 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:03/30/99ISR Number: 3230064-2Report Type:Expedited (15-DaCompany Report #202571 Outcome Other Serious PT Haematuria Haematoma International Normalised Report Source Foreign Health Professional Product Lariam Previscan Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 250 MG 1 PER 1 WEEK ORAL
Ratio Increased Drug Level Above Therapeutic Nephrolithiasis Drug Interaction
(Fluindione)
SS
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 101
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/99ISR Number: 3230866-2Report Type:Expedited (15-DaCompany Report #200926 Outcome Hospitalization Initial or Prolonged PT Abnormal Dreams Abnormal Behaviour Schizophrenia Hallucination Asthenia Hepatitis Delusion Jaundice Aggression Stress Gamma-Glutamyltransferase Increased Alanine Aminotransferase Increased Psychotic Disorder Feeling Abnormal Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:57 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
Date:04/01/99ISR Number: 3231215-6Report Type:Direct Outcome Life-Threatening PT Dizziness Pyrexia Deafness Headache Malaise Insomnia Fatigue Dermatitis Nasal Congestion Pulmonary Congestion Hallucination Influenza Like Illness Pruritus Fear Paranoia Hyperhidrosis Chills Vomiting Decreased Appetite Aggression
Age:52 YR Route
Gender:Female Dose
I/FU:I Duration
Date:04/02/99ISR Number: 3232453-9Report Type:Expedited (15-DaCompany Report #202998 Outcome Hospitalization Initial or Prolonged PT Nausea Dizziness Report Source Foreign Health Product Lariam Tablets (Mefloquine Role Manufacturer
Age:34 YR Route
Gender:Female Dose
I/FU:I Duration
Anxiety Hearing Impaired
Professional
Hydrochloride) 250 Mg
PS
ORAL
250 MG 1 PER 1 WEEK ORAL
03-Apr-2012
09:37 AM
Page: 102
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/99ISR Number: 3236025-1Report Type:Expedited (15-DaCompany Report #203042 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Abnormal Labour Premature Rupture Of Membranes Maternal Drugs Affecting Foetus Uterine Spasm Metrorrhagia Premature Baby Report Source Foreign Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Prenatal Vitamins (Minerals Nos/Multivitamins Nos) Role Manufacturer Age: Route Gender: Dose I/FU:I Duration
PS
ORAL
Date:04/13/99ISR Number: 3239019-5Report Type:Expedited (15-DaCompany Report #202374 Outcome Hospitalization Initial or Prolonged PT Haemolytic Anaemia Chromaturia Reticulocyte Count Increased Colonic Polyp Dehydration Decreased Appetite Lethargy Jaundice Haematocrit Decreased Pain Decreased Activity Dizziness Abdominal Pain Lower Haemoglobin Decreased Neoplasm Malignant Amnesia Pyrexia Report Source Consumer Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:64 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:04/13/99ISR Number: 3239023-7Report Type:Expedited (15-DaCompany Report #105284 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Depression Hemiparesis Insomnia Head Injury Restlessness Suicide Attempt Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Tranxilium Atosil Resochin Role PS C C C Manufacturer
Gender:Female Dose 750 MG 1 PER ONE DOSE ORAL
I/FU:F Duration
Age:
Gender:Female
I/FU:I
Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM
PT Pyrexia Foreign Travel Panic Attack Vomiting Chest Discomfort Anxiety Page: 103
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydration Cough Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Route ORAL Dose 250 MG 1 PER WEEK ORAL Duration
Date:04/13/99ISR Number: 3239440-5Report Type:Expedited (15-DaCompany Report #58978 Outcome Other Serious PT Vertigo Dizziness Brain Contusion Amnesia Disturbance In Attention Feeling Abnormal Asthenia Emotional Distress Nystagmus Dyspnoea Heart Rate Increased Nervous System Disorder Psychotic Disorder Injury Mental Disability Decreased Activity Dysgraphia Fatigue Visual Impairment Reading Disorder Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Norflex Role PS C Manufacturer
I/FU:F Duration
Date:04/14/99ISR Number: 3239847-6Report Type:Direct Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage PT Palpitations Vertigo Anxiety Hypertension Myalgia
Company Report # Report Source Health Professional Product Lariam Tab Role PS Manufacturer Ud
Age:61 YR Route
Gender:Male Dose 1/ WK 6 WKS
I/FU:I Duration
Date:04/14/99ISR Number: 3239864-6Report Type:Expedited (15-DaCompany Report #107634 Outcome Other Serious PT Hypertension Nuclear Magnetic Resonance Imaging
Age:37 YR
Gender:Male
I/FU:F
Abnormal Blood Immunoglobulin G Increased Flushing Paraesthesia Hearing Impaired Hypoaesthesia Muscular Weakness 03-Apr-2012 09:37 AM Page: 104
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ear Pain Sensory Disturbance Multiple Sclerosis Dysgraphia Coordination Abnormal Demyelination Brain Stem Auditory Evoked Response Abnormal Motor Dysfunction Foreign Travel Ear Discomfort Cerebral Ischaemia
Product Lariam Tablets (Mefloquine Hydrochloride) 250mg
Role PS
Manufacturer
Route ORAL
Dose 250 MG 1 PER WEEK ORAL
Duration
Date:04/14/99ISR Number: 3239951-2Report Type:Expedited (15-DaCompany Report #203042 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Premature Baby Maternal Drugs Affecting Foetus Muscle Spasms Metrorrhagia Premature Rupture Of Membranes Abnormal Labour Report Source Foreign Consumer Product Lariam Prenatal Vitamins Role PS C Manufacturer
Age: Route TRANSPLACENTAL
Gender:Male
I/FU:F
Date:04/15/99ISR Number: 3240621-5Report Type:Expedited (15-DaCompany Report #102721 Outcome Other Serious PT Maternal Drugs Affecting Foetus Deafness Congenital Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) Vitamins Role PS C Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:04/15/99ISR Number: 3240622-7Report Type:Expedited (15-DaCompany Report #202571 Outcome Other Serious PT Nephrolithiasis Epistaxis Drug Interaction Haematuria Haematoma Subcutaneous Haematoma Renal Colic International Normalised Ratio Increased Report Source Foreign Health Professional Product Lariam Tablet (Mefloquine Hydrochloride) Previscan (Fluindione) Nitrofurantoine Role PS SS C Manufacturer
Gender:Female Dose 250 MG 1 PER WEEK ORAL 20 MG 1 PER 1 DAY ORAL
I/FU:F Duration
Date:04/20/99ISR Number: 3243445-8Report Type:Expedited (15-DaCompany Report #203837 Outcome Death PT Hallucination Nervous System Disorder Medication Error 09:37 AM
Age:
Gender:Male
I/FU:I
03-Apr-2012
Page: 105
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Completed Suicide Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Route ORAL Dose ORAL Duration
Date:04/26/99ISR Number: 3246927-8Report Type:Expedited (15-DaCompany Report #204205 Outcome Other Serious PT Paraesthesia Asthma Lethargy Anxiety Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:04/26/99ISR Number: 3247086-8Report Type:Expedited (15-DaCompany Report #202374 Outcome Hospitalization Initial or Prolonged PT Biopsy Bone Marrow Abnormal Dizziness Dehydration Reticulocyte Count Increased Abdominal Pain Lower Pyrexia Haemolytic Anaemia Decreased Appetite Jaundice Lethargy Colon Cancer Colonic Polyp Haemoglobin Decreased Chromaturia Haematocrit Decreased Pain Blood Lactate Dehydrogenase Increased Amnesia Blood Bilirubin Increased Report Source Consumer Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:64 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:04/27/99ISR Number: 3247569-0Report Type:Expedited (15-DaCompany Report #203042 Outcome Required Intervention to Prevent Permanent PT Premature Labour Premature Baby Maternal Drugs Affecting Report Source Foreign Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:F Duration
Impairment/Damage
Foetus Premature Rupture Of Membranes Small For Dates Baby Delayed Delivery Arrested Labour
Mg Prenatal Vitamins
PS C
ORAL
03-Apr-2012
09:37 AM
Page: 106
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/99ISR Number: 3247571-9Report Type:Expedited (15-DaCompany Report #204366 Outcome Other Serious PT Abortion Missed Abortion Spontaneous Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age: Route ORAL Gender:Unknown Dose ORAL I/FU:I Duration
Date:04/28/99ISR Number: 3249015-XReport Type:Expedited (15-DaCompany Report #104882 Outcome Hospitalization Initial or Prolonged PT Tachycardia Circulatory Collapse Balance Disorder Paraesthesia Ventricular Extrasystoles Panic Attack Cardiovascular Disorder Muscle Spasms Anxiety Arrhythmia Restlessness Asthenia Dizziness Confusional State Convulsion Feeling Abnormal Report Source Foreign Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:F Duration
Date:04/30/99ISR Number: 3251229-XReport Type:Expedited (15-DaCompany Report #106318 Outcome Hospitalization Initial or Prolonged PT Grand Mal Convulsion Dystonia Panic Attack Report Source Foreign Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Female Dose 250 MG 1 PER WEEK
I/FU:F Duration
Date:04/30/99ISR Number: 3251360-9Report Type:Expedited (15-DaCompany Report #58978 Outcome Other Serious PT Malaise Circulatory Collapse Asthenia Emotional Distress Decreased Activity Feeling Abnormal Mental Impairment Disturbance In Attention Heart Rate Increased
Age:31 YR
Gender:Male
I/FU:F
Vertigo Dyspnoea Amnesia Psychotic Disorder Dizziness Fatigue Nervous System Disorder Injury 03-Apr-2012 09:37 AM Page: 107
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nystagmus Visual Impairment Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Norflex Role Manufacturer Route Dose Duration
PS C
ORAL
Date:05/04/99ISR Number: 3253962-2Report Type:Expedited (15-DaCompany Report #202374 Outcome Hospitalization Initial or Prolonged PT Decreased Appetite Fatigue Jaundice Abdominal Pain Lower Coombs Direct Test Positive Chromaturia Pain Body Temperature Increased Dizziness Dehydration Amnesia Colonic Polyp Lethargy Haemolytic Anaemia Anaemia Haemolytic Autoimmune Colon Cancer Report Source Consumer Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:64 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:05/11/99ISR Number: 3258994-6Report Type:Expedited (15-DaCompany Report #99483 Outcome Other Serious PT Nausea Balance Disorder Diarrhoea Paralysis Tachycardia Abdominal Pain Upper Hypoaesthesia Ear Disorder Visual Impairment Pruritus Panic Attack Paraesthesia Tinnitus
Age:36 YR
Gender:Female
I/FU:I
Tremor Dizziness Flushing Condition Aggravated Depression Anxiety Toxicity To Various Agents 03-Apr-2012 09:37 AM Page: 108
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hearing Impaired Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250mg Contraceptive Role PS C Manufacturer Route ORAL Dose 250 MG 1 PER ONE DOSE ORAL Duration
Date:05/11/99ISR Number: 3258996-XReport Type:Expedited (15-DaCompany Report #205111 Outcome Hospitalization Initial or Prolonged Disability PT Palpitations Dyspnoea Psychotic Disorder Hypoaesthesia Confusional State Anxiety Muscle Spasms Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Mg Role 250 PS ORAL Manufacturer
Age:30 YR Route
Gender:Male Dose
I/FU:I Duration
Date:05/11/99ISR Number: 3259222-8Report Type:Expedited (15-DaCompany Report #205170 Outcome Other Serious PT Viith Nerve Paralysis Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250mg Role PS Manufacturer
Gender:Male Dose 250 MG 1 PER 1 WEEK ORAL
I/FU:I Duration
Date:05/13/99ISR Number: 3261143-1Report Type:Expedited (15-DaCompany Report #205270 Outcome Hospitalization Initial or Prolonged PT Musculoskeletal Stiffness Visual Impairment Insomnia Panic Attack Depression Dizziness Suicidal Ideation Fatigue Report Source Foreign Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Ketoprofene (Ketoprofen) Ibuprofene (Ibuprofen) Role Manufacturer
Age:30 YR Route
Gender:Male Dose
I/FU:I Duration
PS C C
ORAL
Date:05/20/99ISR Number: 3266172-XReport Type:Expedited (15-DaCompany Report #205574 Outcome Hospitalization PT Disturbance In Attention Report Source Foreign Product Lariam Tablets Role Manufacturer
Age:46 YR Route
Gender:Female Dose
I/FU:I Duration
Coordination Abnormal Vertigo Visual Field Defect
Consumer
(Mefloquine Hydrochloride) 250 Mg
PS
ORAL
03-Apr-2012
09:37 AM
Page: 109
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/99ISR Number: 3267645-6Report Type:Expedited (15-DaCompany Report #205170 Outcome Other Serious PT Viith Nerve Paralysis Report Source Foreign Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:31 YR Route Gender:Male Dose I/FU:F Duration
PS
ORAL
Date:05/21/99ISR Number: 3268957-2Report Type:Direct Outcome Other Serious PT Dissociation Dizziness Emotional Disorder Crying
Company Report # Report Source Health Professional Product Mefloquine Ocp'S Role PS C Manufacturer
Age:35 YR Route
Gender:Female
I/FU:I
Dose Duration ONCE PER WEEK X 6 WEEKS
Date:06/02/99ISR Number: 3275253-6Report Type:Expedited (15-DaCompany Report #99483 Outcome Hospitalization Initial or Prolonged PT Flushing Blood Cholesterol Increased Diarrhoea Vestibular Ataxia Tachycardia Pruritus Balance Disorder Refraction Disorder Hypoaesthesia Paralysis Tremor Depression Anxiety Abdominal Pain Upper Tinnitus Panic Attack Dizziness Visual Impairment Paraesthesia Ear Discomfort Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Contraceptive Role Manufacturer
Age:36 YR Route
Gender:Female Dose
I/FU:F Duration
PS C
ORAL
250 MG 1 PER ONE DOSE ORAL
Date:06/07/99ISR Number: 3285451-3Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Coma Malaria
Company Report #200588 Report Source Health Professional Product Lariam Tablets (Mefloquine Role Manufacturer
Age:18 MON Route
Gender:Male Dose
I/FU:I Duration
Chills Drug Ineffective Pyrexia
PS
ORAL
62.5 MG 1 PER WEEK ORAL
03-Apr-2012
09:37 AM
Page: 110
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3285452-5Report Type:Periodic Outcome Other Serious PT Abdominal Pain Dizziness Vertigo Nystagmus Insomnia Coma Anxiety Flatulence Diarrhoea Restlessness Company Report #202262 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Hormone Replacement Role Manufacturer Age:60 YR Route Gender:Female Dose I/FU:I Duration
PS C
ORAL
Date:06/07/99ISR Number: 3285453-7Report Type:Periodic Outcome Other Serious PT Delusion Paranoia Hallucination, Auditory
Company Report #202382 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:38 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285454-9Report Type:Periodic Outcome Other Serious PT Amnesia Convulsion Confusional State
Company Report #203056 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride ) 250 Mg Role Manufacturer
Age:6 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285455-0Report Type:Periodic Outcome Other Serious PT Cyst
Company Report #97937 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride ) 250 Mg Role Manufacturer
Age:21 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285456-2Report Type:Periodic Outcome Other Serious PT Dry Skin
Company Report #98216 Report Source Other Product Lariam Tablets Role Manufacturer
Age:70 YR Route
Gender:Female Dose
I/FU:I Duration
Rash Erythematous
(Mefloquiine Hydrochlorine) 250 Mg
PS
250MG
03-Apr-2012
09:37 AM
Page: 111
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3285457-4Report Type:Periodic Outcome Other Serious PT Vitreous Detachment Abnormal Behaviour Vitreous Floaters Photopsia Dermatitis Company Report #98284 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Estrogen/Progesteron e Role Manufacturer Age:59 YR Route Gender:Female Dose I/FU:I Duration
PS C
ORAL
Date:06/07/99ISR Number: 3285458-6Report Type:Periodic Outcome Other Serious PT Burning Sensation Headache Vomiting Nausea
Company Report #99463 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Premarin Role PS C Manufacturer
I/FU:I Duration
Date:06/07/99ISR Number: 3285459-8Report Type:Periodic Outcome Other Serious PT Respiratory Disorder Panic Attack Hyperhidrosis Delirium Nightmare Hallucination Pyrexia
Company Report #99776 Report Source Other Product Lariam Tablets ( Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:32 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285460-4Report Type:Periodic Outcome Other Serious PT Psoriasis
Company Report #99969 Report Source Product Lariam Tablets (Mefloquine Hydrocholride) 25omg Role PS Manufacturer
Age: Route ORAL
Gender: Dose 250 MG 1 PER WEEK ORAL
I/FU:I Duration
Date:06/07/99ISR Number: 3285461-6Report Type:Periodic Outcome Other Serious PT Prostatitis
Company Report #101038 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Role Manufacturer
Age:43 YR Route
Gender:Male Dose
I/FU:I Duration
Mg
PS
ORAL
42
DAY
03-Apr-2012
09:37 AM
Page: 112
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3285462-8Report Type:Periodic Outcome Other Serious PT Hypertension Company Report #101838 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:37 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285463-XReport Type:Periodic Outcome Other Serious PT Cystitis Nausea Pyrexia
Age:39 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285464-1Report Type:Periodic Outcome Other Serious PT Face Oedema Urticaria
Age:52 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285465-3Report Type:Periodic Outcome Other Serious PT Face Oedema Lip Disorder Skin Irritation Rash Erythematous
Age:26 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285466-5Report Type:Periodic Outcome Other Serious PT Menstruation Irregular
I/FU:I Duration
Date:06/07/99ISR Number: 3285467-7Report Type:Periodic Outcome Other Serious PT Throat Irritation Alopecia
Company Report #103331 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride ) 250 Mg Role Manufacturer
Age:36 YR Route
Gender:Female Dose
I/FU:I Duration
PS Page: 113
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ortho-Novum C
Date:06/07/99ISR Number: 3285468-9Report Type:Periodic Outcome Other Serious PT Hyperhidrosis Asthenia Vomiting Nausea Feeling Jittery Pyrexia Retching Chills Diarrhoea
Company Report #103366 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Prempro Role Manufacturer
Age:60 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
Date:06/07/99ISR Number: 3285469-0Report Type:Periodic Outcome Other Serious PT Asthenia Decreased Appetite Depression
Age:50 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
42
DAY
Date:06/07/99ISR Number: 3285470-7Report Type:Periodic Outcome Other Serious PT Eye Disorder Nervous System Disorder Burning Sensation Panic Disorder
Age:58 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285471-9Report Type:Periodic Outcome Disability PT Insomnia Anxiety Tremor Myalgia Balance Disorder Palpitations Hallucination Coma Muscle Twitching
Age:56 YR
Gender:Female
I/FU:I
Pyrexia Headache Depression Cough Dyspnoea Fatigue Extrasystoles Tachycardia 03-Apr-2012 09:37 AM Page: 114
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Paranoia Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Aspirin Biaxin Role Manufacturer Route Dose Duration
PS C C
ORAL
Date:06/07/99ISR Number: 3285472-0Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder
Company Report #99092 Report Source Health Professional Product Lariam Tablets (Mefoquine Hydrochloride) 250 Mg Role Manufacturer
Age:21 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285473-2Report Type:Periodic Outcome Other Serious PT Emotional Disorder Depression Amnesia Gait Disturbance Fatigue Dizziness Back Disorder
Company Report #100159 Report Source Consumer Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Cimetidine Prempro Questran Mevacor Role Manufacturer
Age:75 YR Route
Gender:Female Dose
I/FU:I Duration
PS C C C C
ORAL
Date:06/07/99ISR Number: 3285474-4Report Type:Periodic Outcome Other Serious PT Dry Mouth Dehydration Dyspnoea Paraesthesia Diarrhoea Dizziness Chest Discomfort Coma
Company Report #101158 Report Source Consumer Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Provera Cipro Calcium Herbal Estrace Multivitamin W Iron Role Manufacturer
Age:55 YR Route
Gender:Female Dose
I/FU:I Duration
PS C C C C C C
ORAL
Date:06/07/99ISR Number: 3285475-6Report Type:Periodic Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Anxiety Insomnia
Age:27 YR
Gender:Male
I/FU:I
Page: 115
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mania Psychotic Disorder Psychiatric Symptom Coma Paranoia
Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
Date:06/07/99ISR Number: 3285476-8Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Balance Disorder Mental Impairment Asthenia Confusional State Constipation Amnesia Myalgia Hyperhidrosis Fatigue Arthralgia Rash Pustular Sedation Coma Agitation Hypersensitivity
Company Report #104852 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Allegra Wellbutrin Role Manufacturer
Age:56 YR Route
Gender:Male Dose
I/FU:I Duration
PS C C
ORAL
Date:06/07/99ISR Number: 3285477-XReport Type:Periodic Outcome Hospitalization Initial or Prolonged PT Diarrhoea Coma Vomiting Dehydration
Company Report #105631 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:31 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285478-1Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Hypertension Tremor Tachycardia Ventricular Extrasystoles
Company Report #106904 Report Source Consumer Other Product Lariam Tablets (Mefloquine Hydrochloride) Multivitamin Folic Acid Flomax Role PS C C C Manufacturer
I/FU:I Duration
Baby Aspirin
03-Apr-2012
09:37 AM
Page: 116
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3285479-3Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Coma Drug Ineffective Malaria Fatigue Company Report #107363 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Accutane Aspirin Tenormin Axid Role Manufacturer Age:77 YR Route Gender:Male Dose I/FU:I Duration
PS C C C C
ORAL
Date:06/07/99ISR Number: 3285480-XReport Type:Periodic Outcome Other Serious PT Coma Bipolar I Disorder Mood Swings Hallucination
Age:31 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285481-1Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Confusional State
I/FU:I Duration
Date:06/07/99ISR Number: 3285482-3Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Lethargy Dizziness Movement Disorder Coma Vision Blurred Malaise Tremor
Company Report #111592 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Prevacid Zestril Role Manufacturer
Age:51 YR Route
Gender:Male Dose
I/FU:I Duration
PS C C
ORAL
ORAL
Date:06/07/99ISR Number: 3285483-5Report Type:Periodic Outcome Hospitalization PT Diarrhoea
Age:19 MON Route
Gender:Female Dose
I/FU:I Duration
Abdominal Pain
Professional
(Mefloquine Hydrochloride) Bactrim Paediatric
PS C
ORAL
03-Apr-2012
09:37 AM
Page: 117
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3285484-7Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Coma Hyperhidrosis Malaria Drug Ineffective Dehydration Leukocytosis Vomiting Pyrexia Chills Abdominal Pain Diarrhoea Lethargy Company Report #112461 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Prilosec Role PS C Manufacturer Age:54 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:06/07/99ISR Number: 3285485-9Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Pyrexia Vomiting Abdominal Pain Chills Chest Pain Coma Diarrhoea Hyperhidrosis Drug Ineffective
I/FU:I Duration
Date:06/07/99ISR Number: 3285486-0Report Type:Periodic Outcome Other Serious PT Weight Decreased Personality Change Depression Anxiety Coma
I/FU:I Duration
Date:06/07/99ISR Number: 3285487-2Report Type:Periodic Outcome Disability PT Nausea Asthenia Paraesthesia Depression Fatigue Disorientation
Company Report #113216 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Lamisil Role PS C Manufacturer
Gender:Male Dose 250 MG DAILY ORAL
I/FU:I Duration
Date:06/07/99ISR Number: 3285488-4Report Type:Periodic Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Malaria Coma
Age:35 YR
Gender:Female
I/FU:I
Page: 118
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Drug Ineffective Chills
Report Source Health Professional Other
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
Date:06/07/99ISR Number: 3285489-6Report Type:Periodic Outcome Other Serious PT Anxiety Coma Pyrexia Panic Attack Tremor
Age:23 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285530-0Report Type:Periodic Outcome Other Serious PT Abnormal Dreams Headache Palpitations Dizziness Chills Panic Attack Alopecia Nausea Hyperhidrosis Chest Pain Tremor Anxiety Decreased Appetite Vomiting Paraesthesia
Company Report #200733 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Estrogen (Estrogens Nos) Progestin (Progestin Nos) Role Manufacturer
Age:65 YR Route
Gender:Female Dose
I/FU:I Duration
PS C C
ORAL
Date:06/07/99ISR Number: 3285531-2Report Type:Periodic Outcome Other Serious PT Deafness
Company Report #200897 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Asa (Aspirin) Ibuprofen Role Manufacturer
Age:56 YR Route
Gender:Male Dose
I/FU:I Duration
PS C
ORAL
(Ibuprofen)
03-Apr-2012
09:37 AM
Page: 119
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3285532-4Report Type:Periodic Outcome Other Serious PT Headache Asthenia Ear Pain Company Report #201043 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:26 YR Route Gender:Male Dose I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285533-6Report Type:Periodic Outcome Other Serious PT Urticaria Ageusia Pruritus
Age:43 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285534-8Report Type:Periodic Outcome Other Serious PT Apathy Flat Affect Aggression
Age:35 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
1 PER WEEK ORAL
Date:06/07/99ISR Number: 3285535-XReport Type:Periodic Outcome Other Serious PT Aggression
Age:33 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285536-1Report Type:Periodic Outcome Other Serious PT Disturbance In Attention Dizziness Nausea
Company Report #202966 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Hydrochlorothiazide Role Manufacturer
Age:48 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
(Hydrochlorothiazide )
03-Apr-2012
09:37 AM
Page: 120
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3285537-3Report Type:Periodic Outcome Disability PT Nausea Chest Pain Vomiting Decreased Appetite Muscle Contractions Involuntary Headache Palpitations Paraesthesia Extrasystoles Lethargy Cough Upper Respiratory Tract Infection Pyrexia Insomnia Depression Oropharyngeal Pain Temperature Intolerance Weight Decreased Influenza Like Illness Company Report #55872 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Hepatitis A Vaccine (Hepatitis A Vaccine) Role Manufacturer Age:38 YR Route Gender:Female Dose I/FU:F Duration
PS
ORAL
Date:06/07/99ISR Number: 3285538-5Report Type:Periodic Outcome Other Serious PT Vision Blurred Gastrointestinal Disorder Amnesia Pain Pyrexia Ear Pain Headache Dizziness Dyspnoea Fatigue Asthenia Confusional State Malaise Palpitations
Company Report #72278 Report Source Consumer Product Lariam Tablets (Mefloquine Hyrdrochloride) 250 Mg Role Manufacturer
Age:24 YR Route
Gender: Dose
I/FU:F Duration
PS
ORAL
35
DAY
Date:06/07/99ISR Number: 3285539-7Report Type:Periodic Outcome Other Serious PT Flushing Pruritus Dermatitis
Company Report #97647 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Role Manufacturer
Age:58 YR Route
Gender:Female Dose
I/FU:F Duration
Rhinorrhoea
Mg Premarin (Estrogens, Conjugated)
PS C
ORAL
03-Apr-2012
09:37 AM
Page: 121
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3285592-0Report Type:Periodic Outcome Other Serious PT Face Oedema Coma Oropharyngeal Blistering Diarrhoea Company Report #103538 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Vivotif "Berna" (Typhoid Vaccines) Atarax Role Manufacturer Age:17 YR Route Gender:Female Dose I/FU:I Duration
PS SS C
ORAL ORAL
250 MG 1 PER WEEK ORAL 1 DOSE FORM 1 PER 2 DAY ORAL
Date:06/07/99ISR Number: 3285593-2Report Type:Periodic Outcome Other Serious PT Dizziness Chills Nausea Cold Sweat
Company Report #103551 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Cytotec Hormone Replacement Therapy Role Manufacturer
Age:52 YR Route
Gender:Female Dose
I/FU:I Duration
PS C C
ORAL
Date:06/07/99ISR Number: 3285594-4Report Type:Periodic Outcome Other Serious PT Pyrexia Cold Sweat Hypertension Dizziness Nausea
Company Report #103573 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Cardizem Vasotec Role Manufacturer
Age:56 YR Route
Gender:Male Dose
I/FU:I Duration
PS C C
ORAL
Date:06/07/99ISR Number: 3285595-6Report Type:Periodic Outcome Other Serious PT Decreased Appetite Nausea Tremor
Age:40 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285596-8Report Type:Periodic Outcome Other Serious PT Abdominal Pain Gastrointestinal Disorder Flatulence 09:37 AM
Age:50 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
250 MG 1 PER Page: 122
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report WEEK ORAL
Date:06/07/99ISR Number: 3285597-XReport Type:Periodic Outcome Other Serious PT Muscle Spasms Fatigue Neck Pain Chest Pain Pain In Extremity
Company Report #104454 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Tri-Levlen Role Manufacturer
Age:27 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
Date:06/07/99ISR Number: 3285598-1Report Type:Periodic Outcome Other Serious PT Flushing Hypertension Burning Sensation Abdominal Pain Headache Palpitations
Age:47 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285599-3Report Type:Periodic Outcome Other Serious PT Dermatitis Breast Discharge
Age:47 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285600-7Report Type:Periodic Outcome Other Serious PT Corneal Dystrophy
Age:42 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
250 MG 26 PER YEAR ORAL
Date:06/07/99ISR Number: 3285601-9Report Type:Periodic Outcome Other Serious PT Hypertension
Age:68 YR Route
Gender:Male Dose
I/FU:I Duration
Tinnitus Tachycardia
Health Professional
PS
ORAL
250 MG 1 PER DOSE ORAL
03-Apr-2012
09:37 AM
Page: 123
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3285602-0Report Type:Periodic Outcome Other Serious PT Dysuria Burning Sensation Company Report #106792 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age: Route ORAL Gender:Male Dose ORAL I/FU:I Duration
Date:06/07/99ISR Number: 3285603-2Report Type:Periodic Outcome Other Serious PT Serum Ferritin Abnormal
Company Report #106988 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Baycol (Cerivastatin Sodium) Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS SS
ORAL ORAL
250 MG 1 PER WEEK ORAL .3 MG DAILY ORAL
Date:06/07/99ISR Number: 3285604-4Report Type:Periodic Outcome Other Serious PT Nightmare Nausea Myalgia Anxiety Arthralgia Aggression Cough Pyrexia
Company Report #108987 Report Source Consumer Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:40 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285605-6Report Type:Periodic Outcome Other Serious PT Vertigo Joint Swelling Fatigue Dizziness Asthenia
Company Report #109650 Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Lipitor Lopressor Role Manufacturer
Age:50 YR Route
Gender:Male Dose
I/FU:I Duration
PS C C
ORAL
Age:37 YR Route
Gender:Female Dose
I/FU:I Duration
Other Serious
Metrorrhagia Menorrhagia
Consumer
Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Ortho-Cyclen
PS C
ORAL
03-Apr-2012
09:37 AM
Page: 124
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3285607-XReport Type:Periodic Outcome Other Serious PT Emotional Distress Emotional Disorder Company Report #110773 Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:28 YR Route Gender:Male Dose I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285608-1Report Type:Periodic Outcome Other Serious PT Skin Hyperpigmentation
Age:60 YR Route
Gender:Unknown Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285609-3Report Type:Periodic Outcome Other Serious PT Fatigue Visual Impairment
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/07/99ISR Number: 3285610-XReport Type:Periodic Outcome Other Serious PT Antinuclear Antibody Positive Neutropenia
I/FU:I Duration
Date:06/07/99ISR Number: 3285611-1Report Type:Periodic Outcome Other Serious PT Blood Alkaline Phosphatase Increased Hepatic Enzyme Increased Condition Aggravated Gamma-Glutamyltransferase Increased
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/09/99ISR Number: 3279221-XReport Type:Expedited (15-DaCompany Report #105648 Outcome Other Serious PT Cardiac Murmur Maternal Drugs Affecting Foetus Antepartum Haemorrhage 09:37 AM
Age:
Gender:Female
I/FU:I
03-Apr-2012
Page: 125
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premature Baby Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Route Dose Duration
PS
ORAL
Date:06/15/99ISR Number: 3285102-8Report Type:Expedited (15-DaCompany Report #104882 Outcome Hospitalization Initial or Prolonged PT Circulatory Collapse Asthenia Tachycardia Confusional State Dizziness Pyrexia Disturbance In Attention Helicobacter Gastritis Feeling Abnormal Muscle Spasms Anxiety Haematochezia Cardiovascular Disorder Arrhythmia Paraesthesia Abdominal Pain Balance Disorder Restlessness Ventricular Extrasystoles Panic Attack Report Source Foreign Consumer Health Professional Product Lariam Tablets (Melfloquine Hydrochloride) 250 Mg Role Manufacturer
Age:29 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
ORAL
Date:06/15/99ISR Number: 3285108-9Report Type:Expedited (15-DaCompany Report #207710 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Condition Aggravated Menometrorrhagia Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:50 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/17/99ISR Number: 3286062-6Report Type:Expedited (15-DaCompany Report #207703 Outcome Hospitalization PT Abortion Spontaneous Report Source Foreign Product Lariam Tablets Role Manufacturer
Age: Route
Gender:Unknown Dose
I/FU:I Duration
Other
PS
ORAL
50 MG DAILY ORAL
03-Apr-2012
09:37 AM
Page: 126
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/99ISR Number: 3286067-5Report Type:Expedited (15-DaCompany Report #207919 Outcome Other Serious PT Affective Disorder Nausea Abnormal Behaviour Crying Dizziness Mental Disorder Suicidal Ideation Visual Impairment Mania Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:34 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
Date:06/17/99ISR Number: 3286250-9Report Type:Expedited (15-DaCompany Report #207220 Outcome Hospitalization Initial or Prolonged PT Purulent Discharge Lymphocyte Count Decreased Monocyte Count Decreased Neutrophil Count Increased Headache Haematocrit Decreased Nasal Congestion Lymphocyte Morphology Abnormal Bacterial Infection Foreign Travel Sinusitis Pyrexia Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250mg Role PS Manufacturer
Gender:Male Dose 250MG 1 PER WEEK ORAL
I/FU:I Duration
Date:06/17/99ISR Number: 3287250-5Report Type:Expedited (15-DaCompany Report #207840 Outcome Hospitalization Initial or Prolonged PT Torticollis Gastritis Influenza Like Illness Lymphadenopathy Flushing Heart Rate Increased Inflammation White Blood Cell Count Increased Pharyngeal Oedema Myalgia Oropharyngeal Pain Ear Disorder Malaise Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
122
DAY
Bacterial Infection
03-Apr-2012
09:37 AM
Page: 127
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/99ISR Number: 3289600-2Report Type:Expedited (15-DaCompany Report #112331 Outcome Hospitalization Initial or Prolonged PT Premature Rupture Of Membranes Haemoglobin Decreased Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age: Route Gender:Female Dose I/FU:I Duration
PS
ORAL
250 MG 1 PER WEEK
Date:06/25/99ISR Number: 3292126-3Report Type:Expedited (15-DaCompany Report #208431 Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage PT Visual Acuity Reduced Vision Blurred Cataract Operation Foreign Travel Cataract Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:40 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:06/29/99ISR Number: 3294566-5Report Type:Expedited (15-DaCompany Report #208430 Outcome Other Serious PT Hearing Impaired Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:06/29/99ISR Number: 3294570-7Report Type:Expedited (15-DaCompany Report #208480 Outcome Other Serious PT Malaria Drug Ineffective Haemolytic Anaemia Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:21 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/30/99ISR Number: 3295144-4Report Type:Expedited (15-DaCompany Report #208901 Outcome Hospitalization Initial or Prolonged PT Decreased Appetite Gastric Haemorrhage Mucosal Erosion Pyrexia Constipation Malaria Haematemesis Dyspnoea
Age:61 YR
Gender:Male
I/FU:I
Ascites Oesophageal Disorder Abdominal Distension Chills Drug Ineffective Haematocrit Decreased Oedema Peripheral Blood Albumin Decreased 03-Apr-2012 09:37 AM Page: 128
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastritis Erosive Haemoglobin Decreased Condition Aggravated Faeces Discoloured
Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Rezulin Aspirin Glucotrol
Role
Manufacturer
Route
Dose
Duration
PS C C C
ORAL
Date:07/09/99ISR Number: 3300329-4Report Type:Expedited (15-DaCompany Report #209222 Outcome Hospitalization Initial or Prolonged PT Supraventricular Tachycardia Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:27 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:07/09/99ISR Number: 3300636-5Report Type:Expedited (15-DaCompany Report #203230 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Paraesthesia Cough Nausea Anxiety Asthma Panic Attack Dyspnoea Tinnitus Dehydration Chest Discomfort Vomiting Pyrexia Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
Date:07/13/99ISR Number: 3302667-8Report Type:Expedited (15-DaCompany Report #208480 Outcome Other Serious PT Drug Ineffective Pyrexia Haemolytic Anaemia Malaria Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:F
Date:07/14/99ISR Number: 3303518-8Report Type:Direct Outcome Other Serious PT Disorientation Skin Discolouration Confusional State Nail Disorder Pain In Extremity 09:37 AM
Company Report # Report Source Product Lariam 250mg Estra Role PS C Manufacturer
Gender:Female
I/FU:I
Dose Duration 1 PILL WEEKLY ORALLY
03-Apr-2012
Page: 129
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/99ISR Number: 3305371-5Report Type:Direct Outcome Other Serious PT Insomnia Neurological Symptom Hallucination, Tactile Restlessness Palpitations Agitation Company Report # Report Source Consumer Product Lariam Role PS Manufacturer Age: Route ORAL Gender:Female I/FU:I
Dose Duration 250 MG 1X WK ORALLY
Date:07/21/99ISR Number: 3308458-6Report Type:Expedited (15-DaCompany Report #210488 Outcome Hospitalization Initial or Prolonged PT Thrombotic Thrombocytopenic Purpura Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Female Dose 1 DOSE FORM 1 PER ONE DOSE ORAL
I/FU:I Duration
Date:07/23/99ISR Number: 3309996-2Report Type:Expedited (15-DaCompany Report #203230 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Tinnitus Paraesthesia Dehydration Chest Discomfort Anxiety Vomiting Cough Pyrexia Dyspnoea Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
Date:07/30/99ISR Number: 3315299-2Report Type:Expedited (15-DaCompany Report #210600 Outcome Hospitalization Initial or Prolonged PT Insomnia Coordination Abnormal Bipolar Disorder Hypersensitivity Tremor Pyrexia Flatulence Circulatory Collapse Balance Disorder Chest Discomfort Palpitations Diarrhoea Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Lithium (Lithium Nos) Lorazepam Atenolol Role Manufacturer
Age:59 YR Route
Gender:Male Dose
I/FU:I Duration
PS SS C C
ORAL ORAL
250 MG 1 PER WEEK ORAL 300 MG DAILY ORAL
Disorientation Psychotic Disorder Abdominal Pain Chest Pain Vomiting Syncope
03-Apr-2012
09:37 AM
Page: 130
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/99ISR Number: 3316743-7Report Type:Expedited (15-DaCompany Report #211408 Outcome Other Serious PT Depression Dizziness Suicidal Ideation Report Source Foreign Other Product Mefloquine Hydrochloride(Mefloq uine Hydrochloride) 250 Mg Antibiotics Nos Role Manufacturer Age:26 YR Route Gender:Female Dose I/FU:I Duration
PS C
ORAL
Date:08/02/99ISR Number: 3316746-2Report Type:Expedited (15-DaCompany Report #211405 Outcome Hospitalization Initial or Prolonged PT Malaria Mood Swings Abnormal Dreams Paraesthesia Condition Aggravated Pyrexia Malaise Toxicity To Various Agents Chest Pain Foreign Travel Agitation Personality Change Chills Headache Diarrhoea Anxiety Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Flucloxacillin Amoxycillin Role PS C C Manufacturer
I/FU:I Duration
Date:08/03/99ISR Number: 3316753-XReport Type:Expedited (15-DaCompany Report #210600 Outcome Hospitalization Initial or Prolonged PT Insomnia Abdominal Pain Pruritus White Blood Cell Count Increased Pyrexia Mania Drug Hypersensitivity Urticaria Nausea Circulatory Collapse Coordination Abnormal Vomiting Projectile Chest Pain Medication Error Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Lithium (Lithium Nos) Lorazepam Atenolol Role Manufacturer
Age:59 YR Route
Gender:Male Dose
I/FU:F Duration
PS SS C C
ORAL ORAL
Chest Discomfort Diarrhoea Bipolar Disorder Palpitations Tremor Flatulence
03-Apr-2012
09:37 AM
Page: 131
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/99ISR Number: 3316767-XReport Type:Expedited (15-DaCompany Report #211570 Outcome Congenital Anomaly PT Heart Valve Replacement Maternal Drugs Affecting Foetus Heart Disease Congenital Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:1 HR Route Gender: Dose I/FU:I Duration
PS
ORAL
Date:08/10/99ISR Number: 3322744-5Report Type:Expedited (15-DaCompany Report #211814 Outcome Hospitalization Initial or Prolonged PT Diabetes Mellitus Diarrhoea Nephrolithiasis Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:67 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:08/10/99ISR Number: 3322745-7Report Type:Expedited (15-DaCompany Report #211998 Outcome Other Serious PT Pain In Extremity Gastritis Erosive Gamma-Glutamyltransferase Increased Polyneuropathy Diverticulum Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:61 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:08/10/99ISR Number: 3322775-5Report Type:Expedited (15-DaCompany Report #206437 Outcome Other Serious PT Retinopathy Iris Atrophy Visual Impairment Vitreous Disorder Medication Error Visual Field Defect Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:37 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:08/12/99ISR Number: 3324870-3Report Type:Expedited (15-DaCompany Report #208901 Outcome Hospitalization Initial or Prolonged PT Ascites Oesophageal Disorder Drug Ineffective Pyrexia
Age:61 YR
Gender:Male
I/FU:F
Malaria Oedema Peripheral Gastric Haemorrhage Blood Albumin Decreased Chills Abdominal Distension Dyspnoea Haematemesis 03-Apr-2012 09:37 AM Page: 132
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phlebitis Hepatitis Constipation Faeces Discoloured Intervertebral Disc Disorder Mucosal Erosion Haemoglobin Decreased Haematocrit Decreased Gastrointestinal Haemorrhage
Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Rezulin Aspirin Glucotrol
Role
Manufacturer
Route
Dose
Duration
PS C C C
ORAL
Date:08/12/99ISR Number: 3324875-2Report Type:Expedited (15-DaCompany Report #212598 Outcome Other Serious PT Haematuria Nephrolithiasis Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:08/17/99ISR Number: 3327902-1Report Type:Expedited (15-DaCompany Report #205574 Outcome Hospitalization Initial or Prolonged PT Fatigue Eye Movement Disorder Visual Field Defect Vision Blurred Nausea Nystagmus Dizziness Arthropod Bite Vertigo Cerebellar Syndrome Disturbance In Attention Coordination Abnormal Phobia Report Source Foreign Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:46 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
Date:08/17/99ISR Number: 3327972-0Report Type:Expedited (15-DaCompany Report #202262 Outcome Other Serious PT Viiith Nerve Lesion Deafness Diarrhoea Restlessness Vertigo Anxiety Intervertebral Disc Protrusion Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Hormone Replacement Role Manufacturer
Age:60 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
Ototoxicity Insomnia Flatulence Nystagmus Abdominal Pain Lower Dizziness
03-Apr-2012
09:37 AM
Page: 133
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/99ISR Number: 3328019-2Report Type:Expedited (15-DaCompany Report #211301 Outcome Other Serious PT Brachial Plexopathy Paralysis Foreign Travel Neuropathy Peripheral Muscular Weakness Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Desmopressin (Desmopressin Acetate) Role Manufacturer Age:16 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
Date:08/17/99ISR Number: 3328996-XReport Type:Direct Outcome Disability PT Insomnia Dyspepsia Asthenia Fatigue Decreased Appetite Malaise Diarrhoea Weight Decreased Apathy Depression Dysphoria Mental Impairment Decreased Activity
Company Report # Report Source Health Professional Product Mefloquin / 125 Mg Role PS Manufacturer
Age:59 YR Route
Gender:Male Dose 1TBL/ 1 TBL
I/FU:I Duration
Date:08/19/99ISR Number: 3330225-8Report Type:Expedited (15-DaCompany Report #213079 Outcome Other Serious PT Myelodysplastic Syndrome Seronegative Arthritis Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Ciprofloxacin (Ciprofloxacin) Doxycycline Erythromycin Role Manufacturer
Age:52 YR Route
Gender:Female Dose
I/FU:I Duration
PS SS C C
ORAL ORAL
Date:08/24/99ISR Number: 3333682-6Report Type:Expedited (15-DaCompany Report #213259 Outcome Hospitalization PT Dyspnoea Report Source Foreign Product Lariam Tablets Role Manufacturer
Age:18 YR Route
Gender:Female Dose
I/FU:I Duration
Erythema Urticaria
Health Professional
PS
ORAL
03-Apr-2012
09:37 AM
Page: 134
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/99ISR Number: 3333861-8Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Convulsion Sedation Bite Movement Disorder Loss Of Consciousness Eye Movement Disorder Crying Company Report # Report Source Product Larium / 250 Mg / Hoffman La Roche Role PS Manufacturer Hoffman Laroche Age:25 YR Route Gender:Female Dose 250MG ONCE A WEEK I/FU:I Duration
Date:08/26/99ISR Number: 3334601-9Report Type:Direct Outcome Other Serious PT Insomnia Amnesia Fatigue Abnormal Dreams Dizziness Cold Sweat Malaise Chills Pyrexia Panic Attack Anxiety
Company Report # Report Source Product Lariam, 250mg, La Roche Immunization Immunization Polio Immunization Yellow Fever Immunization A For Tb For For C For Hep C Role PS C C Manufacturer La Roche
Age:31 YR Route
Gender:Male Dose 1 PILL/WK (LATE JUNE-JULY)
I/FU:I Duration
WK
Date:08/26/99ISR Number: 3335379-5Report Type:Expedited (15-DaCompany Report #213489 Outcome Congenital Anomaly PT Deafness Congenital Maternal Drugs Affecting Foetus Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:1 HR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:08/31/99ISR Number: 3338457-XReport Type:Expedited (15-DaCompany Report #213701 Outcome Hospitalization Initial or Prolonged PT Agitation Malaria Personality Change Drug Ineffective Sedation Toxicity To Various Agents Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Polio Vaccination Yellow Fever Vaccine Tetanus Vaccines Havrix Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS C C C C
ORAL
Typhoid Vaccines
03-Apr-2012
09:37 AM
Page: 135
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/99ISR Number: 3338460-XReport Type:Expedited (15-DaCompany Report #213852 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Tinnitus Hearing Impaired Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Thyroid Medication Role Manufacturer Age:64 YR Route Gender:Female Dose I/FU:I Duration
PS C
ORAL
Date:09/02/99ISR Number: 3339917-8Report Type:Expedited (15-DaCompany Report #210600 Outcome Hospitalization Initial or Prolonged PT Circulatory Collapse White Blood Cell Count Increased Chest Discomfort Vomiting Projectile Drug Hypersensitivity Diarrhoea Coordination Abnormal Mania Palpitations Urticaria Pyrexia Flatulence Insomnia Abdominal Pain Pruritus Chest Pain Bipolar Disorder Tremor Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Lithium (Lithium Nos) Lorazepam Atenolol Role Manufacturer
Age:59 YR Route
Gender:Male Dose
I/FU:F Duration
PS SS C C
ORAL ORAL
Date:09/03/99ISR Number: 3342519-0Report Type:Expedited (15-DaCompany Report #214112 Outcome Hospitalization Initial or Prolonged PT Intracranial Pressure Increased Fatigue Papilloedema Diplopia Oedema Peripheral Headache Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Contraceptive (Contraceptive Nos) Role Manufacturer
Age:18 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
Age:43 YR Route
Gender:Female Dose
I/FU:I Duration
Other Serious
Muscle Rigidity Malaise Pain Tremor Foreign Travel Parkinson'S Disease
Consumer
Lariam Tablets (Mefloquine Hydrochloride) 250 Mg
PS
ORAL
03-Apr-2012
09:37 AM
Page: 136
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/99ISR Number: 3347516-7Report Type:Expedited (15-DaCompany Report #214499 Outcome Other Serious PT Alopecia Amenorrhoea Abdominal Pain Infertility Diarrhoea Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:17 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
Date:09/14/99ISR Number: 3347543-XReport Type:Expedited (15-DaCompany Report #214801 Outcome Other Serious PT Hepatitis C Oedema Dyspnoea Condition Aggravated Heart Rate Irregular Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:61 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:09/14/99ISR Number: 3347546-5Report Type:Expedited (15-DaCompany Report #214510 Outcome Hospitalization Initial or Prolonged PT Myocarditis Sweat Gland Disorder Hormone Level Abnormal Thyroid Atrophy Constipation Amenorrhoea Echo Virus Infection Viral Infection Decreased Appetite Alcohol Intolerance Asthenia Oligomenorrhoea Paraesthesia Feeling Cold Hypotension Blood Thyroid Stimulating Hormone Abnormal Hypothyroidism Bradycardia Autonomic Nervous System Imbalance Syncope Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:22 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Age:24 YR Route
Gender:Male Dose
I/FU:I Duration
Embolism Arterial Peripheral Ischaemia Cardiac Fibrillation
Lariam Tablets (Mefloquine Hydrochloride) 250 Mg
PS
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 137
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/99ISR Number: 3354987-9Report Type:Expedited (15-DaCompany Report #215735 Outcome Other Serious PT Anxiety Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Prochlorperazine Role Manufacturer Age:47 YR Route Gender:Female Dose I/FU:I Duration
PS C
ORAL
Date:09/23/99ISR Number: 3356130-9Report Type:Expedited (15-DaCompany Report #215428 Outcome Hospitalization Initial or Prolonged PT Insomnia Oliguria Panic Reaction Agitation Dehydration Urinary Retention Report Source Consumer Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Tamoxifen Fosamax Role Manufacturer
Age:66 YR Route
Gender:Female Dose
I/FU:I Duration
PS C C
ORAL
250 MG PER WEEK ORAL
Date:09/23/99ISR Number: 3356132-2Report Type:Expedited (15-DaCompany Report #215861 Outcome Other Serious PT Circulatory Collapse Electrocardiogram Qt Prolonged Heart Rate Decreased Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:51 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:09/23/99ISR Number: 3356134-6Report Type:Expedited (15-DaCompany Report #214112 Outcome Hospitalization Initial or Prolonged PT Oedema Peripheral Benign Intracranial Hypertension Vith Nerve Paralysis Papilloedema Diplopia Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Contraceptive Role Manufacturer
Age:18 YR Route
Gender:Female Dose
I/FU:F Duration
PS C
ORAL
Age:47 YR
Gender:Female
I/FU:I
PT Palpitations Malaria Abdominal Pain Nodal Arrhythmia Paraesthesia Syncope
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
03-Apr-2012
09:37 AM
Page: 138
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/99ISR Number: 3356139-5Report Type:Expedited (15-DaCompany Report #215573 Outcome Hospitalization Initial or Prolonged PT Screaming Anxiety Dizziness Disturbance In Attention Crying Tremor Arrhythmia Emotional Disorder Confusional State Hyperventilation Nausea Arthralgia Headache Pain In Extremity Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:32 YR Route Gender:Male Dose I/FU:I Duration
PS
ORAL
Date:09/27/99ISR Number: 3359736-6Report Type:Expedited (15-DaCompany Report #215834 Outcome Other Serious PT Thrombotic Thrombocytopenic Purpura Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:20 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:09/28/99ISR Number: 3360051-5Report Type:Expedited (15-DaCompany Report #215428 Outcome Hospitalization Initial or Prolonged PT Oliguria Insomnia Dehydration Panic Reaction Anxiety Urinary Retention Agitation Circadian Rhythm Sleep Disorder Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Tamoxifen (Tamoxifen Citrate) Fosamax (Alendronate Sodium) Role Manufacturer
Age:66 YR Route
Gender:Female Dose
I/FU:F Duration
PS C C
ORAL
250 MG 1 PER WEEK
Date:09/28/99ISR Number: 3360064-3Report Type:Expedited (15-DaCompany Report #210600 Outcome Hospitalization Initial or Prolonged PT Chest Pain Vomiting Projectile Mania Coordination Abnormal
Age:59 YR
Gender:Male
I/FU:F
Bipolar Disorder White Blood Cell Count Increased Drug Hypersensitivity Psychotic Disorder Circulatory Collapse Pruritus Pyrexia 03-Apr-2012 09:37 AM Page: 139
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chest Discomfort Urticaria Insomnia Abdominal Pain Palpitations Disorientation Tremor Vomiting Diarrhoea
Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Lithium (Lithium Nos) Lorazepam (Lorazepam) Atenolol (Atenolol)
Role
Manufacturer
Route
Dose
Duration
PS SS C C
ORAL ORAL
250 MG 1 PER WEEK 300 MG DAILY
Date:09/28/99ISR Number: 3360067-9Report Type:Expedited (15-DaCompany Report #216020 Outcome Other Serious PT Eclampsia Pregnancy Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Moneva (Ethinyl Estradiol/Gestodine) Role Manufacturer
Age:32 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
250 MG 1 PER 1 WEEK
Date:09/28/99ISR Number: 3360071-0Report Type:Expedited (15-DaCompany Report #215907 Outcome Other Serious PT Speech Disorder Nervousness Psychotic Disorder Agitation Suicidal Ideation Anxiety Report Source Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Oral Contraception (Oral Contraceptive Nos) Role Manufacturer
Age:20 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
250 MG 1 PER WEEK
Date:09/28/99ISR Number: 3361765-3Report Type:Expedited (15-DaCompany Report #215928 Outcome Hospitalization Initial or Prolonged PT Hypervitaminosis Hepatitis Liver Function Test Abnormal Blood Bilirubin Increased Foreign Travel Jaundice Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Vitamin Nos (Vitamin Nos) Role Manufacturer
Age:35 YR Route
Gender:Female Dose
I/FU:I Duration
PS SS
ORAL
Kernicterus
03-Apr-2012
09:37 AM
Page: 140
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/99ISR Number: 3361769-0Report Type:Expedited (15-DaCompany Report #211998 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Diverticulum Intestinal Gastritis Erosive Paraesthesia Csf Protein Increased Peripheral Sensory Neuropathy Gamma-Glutamyltransferase Increased Pain In Extremity Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:61 YR Route Gender:Male Dose I/FU:F Duration
PS
ORAL
Date:10/01/99ISR Number: 3362900-3Report Type:Expedited (15-DaCompany Report #210600 Outcome Hospitalization Initial or Prolonged PT Abdominal Pain Hypersensitivity Condition Aggravated Urticaria Pyrexia Dry Skin Circulatory Collapse Coordination Abnormal Chest Discomfort Vomiting Bipolar Disorder Tremor White Blood Cell Count Increased Diarrhoea Pruritus Flatulence Insomnia Palpitations Vomiting Projectile Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Lithium (Lithium Nos) Lorazepam (Lorazepam) Atenolol (Atenolol) Role Manufacturer
Age:59 YR Route
Gender:Male Dose
I/FU:F Duration
PS SS C C
ORAL ORAL
Date:10/01/99ISR Number: 3363208-2Report Type:Expedited (15-DaCompany Report #216164 Outcome Hospitalization Initial or Prolonged PT Asthenia Neuropathy Peripheral Fatigue Aggression Sleep Disorder Gait Disturbance Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Fansidar (Pyrimethamine/Sulad oxine) Role PS Manufacturer
Gender:Male Dose 250 MG 3 PER DAY ORAL
I/FU:I Duration
Date:10/01/99ISR Number: 3363211-2Report Type:Expedited (15-DaCompany Report #211301 Outcome Other Serious PT Paralysis Muscular Weakness Neuropathy Peripheral 09:37 AM Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:16 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
250 MG 1 PER Page: 141
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report WEEK ORAL Desmopressin (Desmopressin Acetate) C
Date:10/01/99ISR Number: 3363214-8Report Type:Expedited (15-DaCompany Report #213623 Outcome Other Serious PT Maternal Drugs Affecting Foetus Pregnancy Foetal Distress Syndrome Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Jodetten (Potassium Iodine) Vitaferro (Ferrous Sulfate) Lafol (Folic Acid) Role Manufacturer
Age: Route
Gender: Dose
I/FU:I Duration
PS C C C
ORAL
Date:10/05/99ISR Number: 3364678-6Report Type:Expedited (15-DaCompany Report #215428 Outcome Hospitalization Initial or Prolonged Disability PT Insomnia Urinary Retention Agitation Panic Attack Oliguria Urinary Tract Infection Dehydration Anxiety Report Source Consumer Other Product Lariam Tablets (Mefloquine Hydrochloride) 250mg Tamoxifen (Tamoxifen Citrate) Fosamax (Alendronate Sodium) Role PS C C Manufacturer
I/FU:F Duration
Date:10/05/99ISR Number: 3364679-8Report Type:Expedited (15-DaCompany Report #215735 Outcome Disability PT Anxiety Decreased Activity Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250mg Prochlorperazine (Prochlorperazine) Role PS C Manufacturer
I/FU:F Duration
Date:10/08/99ISR Number: 3369296-1Report Type:Expedited (15-DaCompany Report #216832 Outcome Hospitalization Initial or Prolonged PT Back Pain Nervous System Disorder Report Source Health Professional Product Lariam Tablets (Mefloquine Role Manufacturer
Age:30 YR Route
Gender:Male Dose
I/FU:I Duration
Grand Mal Convulsion Movement Disorder Gait Disturbance Foreign Travel Loss Of Consciousness
PS
ORAL
03-Apr-2012
09:37 AM
Page: 142
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/99ISR Number: 3371543-7Report Type:Expedited (15-DaCompany Report #216747 Outcome Death PT Skin Discolouration Emotional Disorder Injury Lichen Planus Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250mg Role PS Manufacturer Age: Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:10/13/99ISR Number: 3371544-9Report Type:Expedited (15-DaCompany Report #216810 Outcome Death PT Emotional Disorder Lichen Planus Skin Discolouration Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:10/13/99ISR Number: 3371546-2Report Type:Expedited (15-DaCompany Report #206437 Outcome Other Serious PT Scintillating Scotoma Retinopathy Retinal Depigmentation Iris Atrophy Macular Oedema Visual Field Defect Pigmentation Disorder Visual Impairment Vitreous Disorder Report Source Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:37 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:10/13/99ISR Number: 3371556-5Report Type:Expedited (15-DaCompany Report #216859 Outcome Death PT Skin Discolouration Lichen Planus Emotional Disorder Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:10/14/99ISR Number: 3372847-4Report Type:Expedited (15-DaCompany Report #217046 Outcome Death PT Sudden Death Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Role Manufacturer
Age:27 YR Route
Gender:Female Dose
I/FU:I Duration
Mg Na Paludrine (Choroguanide Hydrochloride) Diane 35 (Cyproterone Acetate/Ethinyl 03-Apr-2012 09:37 AM
PS SS C
ORAL
ORAL
Page: 143
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Estradiol) C
Date:10/14/99ISR Number: 3372852-8Report Type:Expedited (15-DaCompany Report #216957 Outcome Hospitalization Initial or Prolonged PT Nausea Fatigue Arthralgia Hepatic Fibrosis Autoimmune Hepatitis Liver Function Test Abnormal Bile Duct Stone Blood Bilirubin Increased Hepatic Pain Jaundice Hepatomegaly Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Na Dpt Injection (Diphtheria Toxoid/Pertussis Vaccine/Tetanus Toxoid) Immunoglobulin Human Normal (Globulin, Immune) Role Manufacturer
Age:52 YR Route
Gender:Female Dose
I/FU:I Duration
PS SS
ORAL
C C
Date:10/14/99ISR Number: 3372855-3Report Type:Expedited (15-DaCompany Report #216944 Outcome Congenital Anomaly PT Abortion Spontaneous Maternal Drugs Affecting Foetus Limb Malformation Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Na Role Manufacturer
Age: Route
Gender: Dose
I/FU:I Duration
PS SS
ORAL
Date:10/15/99ISR Number: 3372126-5Report Type:Direct Outcome Other Serious PT Anxiety Acute Stress Disorder
Company Report # Report Source Health Professional Product Lariam 250mg Po Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration 250 MG PO QWK TOOK 1/2 TABLET BIW 3 MON
Date:10/15/99ISR Number: 3374199-2Report Type:Expedited (15-DaCompany Report #216908 Outcome Hospitalization Initial or Prolonged PT Autoimmune Hepatitis Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Jaundice Aspartate Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250mg Polio Vaccine (Poliomyelitis Role PS Manufacturer
Gender:Female Dose 250 MG 1 PER 1 WEEK ORAL
I/FU:I Duration
Aminotransferase Increased Alanine Aminotransferase Increased
Vaccines) Hepatitis B Vaccine (Hepatitis B Virus Vaccine Inactivated)
C C
03-Apr-2012
09:37 AM
Page: 144
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/99ISR Number: 3377417-XReport Type:Expedited (15-DaCompany Report #200442 Outcome Other Serious PT Haemolytic Anaemia Anaemia Foreign Travel Haptoglobin Decreased Blood Bilirubin Increased Jaundice Diarrhoea Reticulocyte Count Increased Report Source Health Professional Product Lariam Tablets (Mefloquine/Hydrochl oride) 250 Mg Role PS Manufacturer Age:36 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
Date:10/19/99ISR Number: 3375976-4Report Type:Expedited (15-DaCompany Report #215628 Outcome Other Serious PT Cytogenetic Abnormality Pregnancy Neck Deformity Maternal Drugs Affecting Foetus Ultrasound Scan Abnormal Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender: Dose
I/FU:I Duration
PS
ORAL
Date:10/19/99ISR Number: 3376135-1Report Type:Expedited (15-DaCompany Report #215861 Outcome Hospitalization Initial or Prolonged PT Pulse Absent Circulatory Collapse Electrocardiogram Qt Prolonged Cholinergic Syndrome Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:51 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:10/19/99ISR Number: 3376138-7Report Type:Expedited (15-DaCompany Report #217368 Outcome Hospitalization Initial or Prolonged PT Chills Red Blood Cell Sedimentation Rate Increased Liver Function Test Abnormal Arthralgia Pyrexia Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:61 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Age:
Gender:Female
I/FU:F
Outcome Death
PT Injury Lichen Planus Emotional Disorder Family Stress Skin Discolouration 09:37 AM
Report Source Other
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
250 MG 1 PER WEEK ORAL Page: 145
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/99ISR Number: 3378796-XReport Type:Expedited (15-DaCompany Report #216859 Outcome Death PT Skin Discolouration Emotional Disorder Lichen Planus Report Source Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age: Route Gender:Male Dose I/FU:F Duration
PS
ORAL
Date:10/25/99ISR Number: 3381772-4Report Type:Expedited (15-DaCompany Report #215928 Outcome Hospitalization Initial or Prolonged PT Jaundice Liver Function Test Abnormal Hypervitaminosis Blood Bilirubin Increased Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Vitamin Nos (Vitamin Nos) Role Manufacturer
Age:35 YR Route
Gender:Female Dose
I/FU:F Duration
PS SS
ORAL
Date:10/25/99ISR Number: 3382580-0Report Type:Expedited (15-DaCompany Report #217696 Outcome Life-Threatening PT Sleep Disorder Balance Disorder Weight Decreased Memory Impairment Decreased Appetite Visual Impairment Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:35 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:10/27/99ISR Number: 3383793-4Report Type:Expedited (15-DaCompany Report #217808 Outcome Hospitalization Initial or Prolonged PT Malaise Depressed Mood Hallucination Memory Impairment Insomnia Confusional State Anxiety Decreased Appetite Restlessness Foreign Travel Visual Impairment Balance Disorder Diarrhoea Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:24 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:10/28/99ISR Number: 3383896-4Report Type:Expedited (15-DaCompany Report #206437 Outcome Other Serious PT Iris Atrophy Retinopathy Macular Oedema 09:37 AM
Age:37 YR
Gender:Male
I/FU:F
03-Apr-2012
Page: 146
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Iris Disorder Visual Impairment Retinal Pigmentation Vitreous Disorder
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
250 MG 1 PER WEEK
Date:10/29/99ISR Number: 3386323-6Report Type:Expedited (15-DaCompany Report #217046 Outcome Death PT Brain Oedema Sudden Death Pulmonary Oedema Toxicity To Various Agents Cyanosis Pulmonary Congestion Toxicologic Test Abnormal Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Diane 35 (Cyproterone Acetate/Ethinyl Estradiol) Ethyl Alcohol (Alcohol) Paludrine (Chloroguanide Hydrochloride) Role Manufacturer
Age:27 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
C C C
Date:10/29/99ISR Number: 3386327-3Report Type:Expedited (15-DaCompany Report #218344 Outcome Congenital Anomaly PT Haemangioma Abortion Induced Foetal Disorder Maternal Drugs Affecting Foetus Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Unknown Dose
I/FU:I Duration
PS
ORAL
Date:11/01/99ISR Number: 3387632-7Report Type:Expedited (15-DaCompany Report #202330 Outcome Congenital Anomaly PT Maternal Drugs Affecting Foetus Pregnancy Ventricular Septal Defect Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:11/04/99ISR Number: 3388785-7Report Type:Expedited (15-DaCompany Report #209222 Outcome Hospitalization Initial or Prolonged PT Supraventricular Tachycardia Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:27 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
250 MG
1 Page: 147
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PER WEEK ORAL
Date:11/04/99ISR Number: 3388786-9Report Type:Expedited (15-DaCompany Report #104160 Outcome Congenital Anomaly Required Intervention to Prevent Permanent Impairment/Damage PT Tricuspid Valve Incompetence Cardiomegaly Heart Disease Congenital Pregnancy Maternal Drugs Affecting Foetus Cyanosis Neonatal Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:11/04/99ISR Number: 3388787-0Report Type:Expedited (15-DaCompany Report #218871 Outcome Hospitalization Initial or Prolonged PT Depression Visual Field Defect Anxiety Nightmare Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Pondocillin (Pivampicillin Hydrochloride) Klorokinfosfat (Chloroquine Phosphate) Role Manufacturer
Age:45 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
C C
Date:11/05/99ISR Number: 3390188-6Report Type:Expedited (15-DaCompany Report #218942 Outcome Other Serious PT Grand Mal Convulsion Electroencephalogram Abnormal Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:11/09/99ISR Number: 3391768-4Report Type:Expedited (15-DaCompany Report #218954 Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Delusion Muscle Disorder Report Source Foreign Health Professional Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration 250 MG 1 PER WEEK
Hypotonia Cachexia Personality Change
03-Apr-2012
09:37 AM
Page: 148
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/99ISR Number: 3391823-9Report Type:Expedited (15-DaCompany Report #218956 Outcome Other Serious PT Paralysis Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age: Route Gender:Female Dose I/FU:I Duration
PS
ORAL
Date:11/09/99ISR Number: 3391874-4Report Type:Expedited (15-DaCompany Report #218938 Outcome Hospitalization Initial or Prolonged PT Vomiting Diarrhoea Blood Bilirubin Increased Dizziness Leukocytosis Pyrexia Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:47 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
ORAL
DAY
Date:11/09/99ISR Number: 3391875-6Report Type:Expedited (15-DaCompany Report #218945 Outcome Other Serious PT Arrhythmia Depression Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:11/09/99ISR Number: 3391907-5Report Type:Expedited (15-DaCompany Report #218933 Outcome Other Serious PT Brain Scan Abnormal Nervous System Disorder Dyspnoea Paraesthesia Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
ORAL
Date:11/12/99ISR Number: 3396228-2Report Type:Expedited (15-DaCompany Report #218934 Outcome Other Serious PT Aphasia Mental Disorder Grand Mal Convulsion Dyskinesia Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:32 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:11/12/99ISR Number: 3396231-2Report Type:Expedited (15-DaCompany Report #218937 Outcome Other Serious PT Dizziness Pallor Gastric Ulcer Haemorrhage 09:37 AM
Age:59 YR
Gender:Male
I/FU:I
03-Apr-2012
Page: 149
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Melaena Abdominal Distension Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Vaccine Nos (Vaccine Nos) Role Manufacturer Route Dose Duration
PS C
ORAL
Date:11/12/99ISR Number: 3396477-3Report Type:Expedited (15-DaCompany Report #8-98334-066A Outcome Hospitalization Initial or Prolonged PT Visual Impairment Papilloedema Optic Ischaemic Neuropathy Optic Neuritis Report Source Health Professional Other Product Profenid Capsule (Ketoprofen) Propavan Mefloquine Hepatitis B Vaccine Mefloquine Hepatitis B Vaccine Caffeine +Paracetamol +Chlorphenamine Maleate +Dextropropoxyphene Propavan (Propiomazine Maleate) Typhoid Vaccine Role PS SS SS SS C C Manufacturer
Age:46 YR Route ORAL ORAL PARENTERAL
Gender:Male Dose ASS NEEDED AS NEEDED ONE TABLET WEEKLY
I/FU:F Duration
3 1
WK MON
C C C
Date:11/15/99ISR Number: 3398080-8Report Type:Expedited (15-DaCompany Report #219447 Outcome Hospitalization Initial or Prolonged PT Cerebellar Syndrome Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:22 YR Route
Gender:Male Dose
I/FU:I Duration
PS
Date:11/15/99ISR Number: 3398082-1Report Type:Expedited (15-DaCompany Report #205111 Outcome Hospitalization Initial or Prolonged Disability PT Anxiety Palpitations Suicidal Ideation Fatigue
Age:30 YR
Gender:Male
I/FU:F
Insomnia Foreign Travel Muscle Spasms Dyspnoea Hypoaesthesia Psychotic Disorder Visual Impairment Confusional State 03-Apr-2012 09:37 AM Page: 150
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Depression Musculoskeletal Stiffness
Report Source Foreign Consumer Health Professional
Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Ketoprofene (Ketoprofene) Ibuprofene (Ibuprofene)
Role
Manufacturer
Route
Dose
Duration
PS C C
ORAL
Date:11/15/99ISR Number: 3398085-7Report Type:Expedited (15-DaCompany Report #219442 Outcome Hospitalization Initial or Prolonged PT Abnormal Behaviour Visual Impairment Aggression Delirium Foreign Travel Schizophrenia Speech Disorder Anxiety Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:20 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:11/15/99ISR Number: 3398090-0Report Type:Expedited (15-DaCompany Report #205270 Outcome Hospitalization Initial or Prolonged PT Depression Insomnia Musculoskeletal Stiffness Fatigue Foreign Travel Panic Attack Suicidal Ideation Visual Impairment Dizziness Report Source Foreign Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Ketoprofene (Ketoprofene) Ibuprofene (Ibuprofene) Role Manufacturer
Age:30 YR Route
Gender:Male Dose
I/FU:F Duration
PS C C
ORAL
Date:11/15/99ISR Number: 3398476-4Report Type:Expedited (15-DaCompany Report #218871 Outcome Hospitalization Initial or Prolonged PT Depression Anxiety Visual Field Defect Nightmare Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Pondocillin (Pivampicillin Role Manufacturer
Age:45 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
ORAL
Hydrochloride) Klorokinfosfat (Chloroquine Phosphate)
C C
03-Apr-2012
09:37 AM
Page: 151
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/99ISR Number: 3399224-4Report Type:Expedited (15-DaCompany Report #109425 Outcome Hospitalization Initial or Prolonged PT Visual Impairment Optic Neuritis Papilloedema Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Profenid (Ketoprofen) Propofan (Acetaminophen/Caffe ine/Calcium Carbimide/Chlorpheni ramine Engerix B (Hepatitis B Virus Vaccine Inactivated) 20 Mcg Ml Typhim Vi Sanmigram Role Manufacturer Age:46 YR Route Gender:Male Dose I/FU:F Duration
PS SS
ORAL ORAL
250 MG 1 PER WEEK ORAL 1 PER PRN ORAL
SS
ORAL
1 PER PRN ORAL
SS C C
INTRAMUSCULAR
INTRAMUSCULAR
Date:11/17/99ISR Number: 3398607-6Report Type:Direct Outcome Other Serious PT Anxiety Insomnia Panic Attack Depression Heart Rate Increased Dehydration
Company Report # Report Source Product Mefloquene Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration WEEKLY 250MG ORAL 1 WK
Date:11/18/99ISR Number: 3399120-2Report Type:Direct Outcome PT Insomnia Crying Suicidal Ideation Psychotic Disorder Abnormal Behaviour Flat Affect Foreign Travel Depression
Age: Route
Gender: Dose
I/FU:I Duration
Age:65 YR
Gender:Male
I/FU:I
PT Deafness
Role PS
Manufacturer
Route ORAL
Duration
03-Apr-2012
09:37 AM
Page: 152
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/99ISR Number: 3402792-7Report Type:Expedited (15-DaCompany Report #219706 Outcome Other Serious PT Skin Discolouration Oedema Pyrexia Upper Respiratory Tract Infection Rash Erythematous Tenderness Burning Sensation Tendonitis Erythema Multiforme Arthralgia Cough Drug Interaction Pallor Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Cipro (Ciprofloxacin Hydrochloride) 500 Mg Aspirin (Baby Aspirin) Fosamax (Alendronate Sodium) Premarin (Estrogens, Conjugated) Role Manufacturer Age:71 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
SS C C C
ORAL
Date:11/22/99ISR Number: 3405855-5Report Type:Expedited (15-DaCompany Report #220064 Outcome Hospitalization Initial or Prolonged PT Skin Exfoliation Dermatitis Exfoliative Hypersensitivity Vomiting Dehydration Rash Maculo-Papular Pain In Extremity Face Oedema Viral Infection Rash Pruritic Rash Erythematous Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:13 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:11/23/99ISR Number: 3405398-9Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Jaundice Liver Function Test Abnormal Toxicity To Various Agents Blood Bilirubin Increased
Company Report # Report Source Health Professional Product Larium Polio + Engenix B Vaccines Role PS Manufacturer
Gender:Female Dose ORAL TABLET PER WEEK (047)
I/FU:I Duration
Date:11/23/99ISR Number: 3415180-4Report Type:Expedited (15-DaCompany Report #215471 Outcome PT
Age:79 YR
Gender:Male
I/FU:I
Other Serious
Sciatica Abdominal Pain Gamma-Glutamyltransferase Increased Blood Uric Acid Increased Diarrhoea Nausea Malaise 09:37 AM Page: 153
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asthenia Blood Cholesterol Increased Decreased Appetite Myalgia Joint Ankylosis Retching Abnormal Faeces
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
Date:11/23/99ISR Number: 3415182-8Report Type:Expedited (15-DaCompany Report #220347 Outcome Other Serious PT Cardiac Arrest Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:11/23/99ISR Number: 3415185-3Report Type:Expedited (15-DaCompany Report #220219 Outcome Other Serious PT Eclampsia Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Ibuprofen (Ibuprofen) Duspatal (Mebeverine Hydrochloride) Hepatitis A Vaccine Role Manufacturer
Age:31 YR Route
Gender:Female Dose
I/FU:I Duration
PS C C C
ORAL
Date:11/26/99ISR Number: 3409794-5Report Type:Expedited (15-DaCompany Report #104160 Outcome Congenital Anomaly Required Intervention to Prevent Permanent Impairment/Damage PT Pregnancy Maternal Drugs Affecting Foetus Tricuspid Valve Incompetence Cyanosis Neonatal Heart Disease Congenital Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:F Duration
PS
TRANSPLACENTAL
Age:25 YR
Gender:Female
I/FU:I
Disability Required Intervention to Prevent Permanent Impairment/Damage
Scotoma Brain Oedema Haemoglobin Decreased Blood Potassium Increased Blood Urea Increased Blood Creatinine Increased Vomiting Page: 154
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dialysis Alanine Aminotransferase Increased Visual Acuity Reduced Visual Impairment White Blood Cell Count Increased Platelet Count Decreased Blood Bilirubin Increased Colour Blindness Cardiovascular Disorder Nuclear Magnetic Resonance Imaging Abnormal Renal Disorder Aspartate Aminotransferase Increased
Product Lariam Gabexate Mesilate (Gabexate) Minocycline Hydrochloride (Minocycline Hydrochloride) Quinimax (Cinchonidine/Cincho nine/Quinidine/Quini ne)
Role PS SS
Manufacturer
Route ORAL INTRAVENOUS
Dose Duration 1000 MG DAILY ORAL 800 MG 2 PER DAY INTRAVENOUS
SS
INTRAVENOUS
100 MG 2 PER DAY INTRAVENOUS
SS
INTRAVENOUS
500 MG 2 PER DAY INTRAVENOUS
Date:12/01/99ISR Number: 3411908-8Report Type:Expedited (15-DaCompany Report #215628 Outcome Congenital Anomaly PT Cystic Lymphangioma Foetal Disorder Pregnancy Maternal Drugs Affecting Foetus Abortion Induced Trisomy 21 Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender: Dose
I/FU:F Duration
PS
ORAL
Date:12/03/99ISR Number: 3413305-8Report Type:Direct Outcome Other Serious PT Paraesthesia Convulsion Neuropathy Peripheral Abnormal Dreams Anxiety Dizziness Panic Attack Paranoia Depression Palpitations Disorientation Foreign Travel Visual Impairment
Company Report # Report Source Product Lariam Standard (For Anti-Malarial Role PS Manufacturer
Age:21 YR Route
Gender:Male Dose STRADARD USE
I/FU:I Duration
Muscle Spasms Emotional Distress Panic Disorder
03-Apr-2012
09:37 AM
Page: 155
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/99ISR Number: 3413543-4Report Type:Expedited (15-DaCompany Report #210600 Outcome Hospitalization Initial or Prolonged PT Mania Diarrhoea Disorientation Leukocytosis Pruritus Bipolar Disorder Palpitations Hypertension Drug Hypersensitivity Vomiting Projectile Tremor Circulatory Collapse Abdominal Pain Chest Discomfort Urticaria Dry Skin Pyrexia Insomnia Coordination Abnormal Flatulence Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Lithium (Lithium Nos) Lorazepam (Lorazepam) Atenolol (Atenolol) Role Manufacturer Age:59 YR Route Gender:Male Dose I/FU:F Duration
PS SS C C
ORAL ORAL
Date:12/03/99ISR Number: 3413545-8Report Type:Expedited (15-DaCompany Report #220944 Outcome Life-Threatening PT Mental Disorder Suicide Attempt Paranoia Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:59 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:12/06/99ISR Number: 3414688-5Report Type:Expedited (15-DaCompany Report #204459 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Foetal Malposition Prolonged Labour Ultrasound Scan Abnormal Maternal Drugs Affecting Foetus Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Na Role Manufacturer
Age: Route
Gender:Female Dose
I/FU:I Duration
PS SS
ORAL
Date:12/07/99ISR Number: 3415578-4Report Type:Expedited (15-DaCompany Report #203725 Outcome Hospitalization PT Premature Baby Report Source Foreign Product Lariam Tablets Role Manufacturer
Age: Route
Gender: Dose
I/FU:I Duration
Maternal Drugs Affecting Foetus Premature Labour
Health Professional
(Mefloquine Hydrochcloride) 250 Mg
PS
ORAL
250 MG 1 PER WEEK
03-Apr-2012
09:37 AM
Page: 156
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/99ISR Number: 3417792-0Report Type:Expedited (15-DaCompany Report #221602 Outcome Other Serious PT Delusional Disorder, Persecutory Type Hepatitis Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:47 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:12/09/99ISR Number: 3417793-2Report Type:Expedited (15-DaCompany Report #220219 Outcome Other Serious PT Eclampsia Pregnancy Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Ibuprofen (Ibuprofen) Duspatal (Mebeverine Hydrochloride) Hepatitis A Vaccine (Hepatitis A Vaccine) Role Manufacturer
Age:31 YR Route
Gender:Female Dose
I/FU:F Duration
PS C C C
ORAL
Date:12/09/99ISR Number: 3417794-4Report Type:Expedited (15-DaCompany Report #200926 Outcome Hospitalization Initial or Prolonged PT Feeling Abnormal Jaundice Stress Asthenia Hallucination Abnormal Dreams Foreign Travel Psychotic Disorder Aggression Delusion Hepatitis Hepatic Enzyme Increased Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Female Dose 250 MG 1 PER WEEK ORAL 250 MG 1 PER WEEK ORAL
I/FU:F Duration
SS
ORAL
Date:12/14/99ISR Number: 3421134-4Report Type:Expedited (15-DaCompany Report #216908 Outcome Hospitalization Initial or Prolonged PT Toxicity To Various Agents Autoimmune Hepatitis Liver Function Test Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:35 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
250 MG 1 PER
Abnormal Hepatocellular Injury Jaundice
1 WEEK ORAL Polio Vaccine (Poliomyelitis Vaccines) Hepatitis B Vaccine (Hepatitis B Virus Vaccine Inactivated) C C Page: 157
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/99ISR Number: 3421219-2Report Type:Expedited (15-DaCompany Report #215861 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Circulatory Collapse Heart Rate Decreased Cholinergic Syndrome Pulse Absent Apnoea Electrocardiogram Qt Prolonged Report Source Foreign Consumer Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 200 Mg Role Manufacturer Age:49 YR Route Gender:Male Dose I/FU:F Duration
PS
ORAL
Date:12/14/99ISR Number: 3422046-2Report Type:Expedited (15-DaCompany Report #215928 Outcome Hospitalization Initial or Prolonged PT Scleral Discolouration Hypervitaminosis Jaundice Hepatitis Hepatocellular Injury Toxicity To Various Agents Blood Bilirubin Increased Liver Function Test Abnormal Spleen Disorder Autoimmune Disorder Hepatic Necrosis Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Vitamin Nos (Vitamin Nos) Role Manufacturer
Age:35 YR Route
Gender:Female Dose
I/FU:F Duration
PS SS
ORAL
Date:12/20/99ISR Number: 3426590-3Report Type:Expedited (15-DaCompany Report #222412 Outcome Hospitalization Initial or Prolonged PT Malaria Neuropathy Peripheral Report Source Foreign Health Professional Product Laroxyl (Amitriptyline Hydrochloride) Lariam (Mefloquine Hydrochloride) Lariam (Mefloquine Hydrochloride) Rohypnol (Flunitrazepam) Fumafer (Ferrous Fumarate) Stilnox (Zolpidem Tartrate) Role PS SS SS SS C C ORAL ORAL ORAL Manufacturer
Age:40 YR Route
Gender:Female Dose UNK 1 DOSE FORM 1 PER WEEK ORAL ORAL ORAL
I/FU:I Duration
Age:73 YR
Gender:Male
I/FU:I
PT Malaise Electroencephalogram Abnormal Pallor Fatigue Bradycardia Page: 158
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Balance Disorder Cardiomegaly Candidiasis Myalgia Depressed Level Of Consciousness Weight Decreased Pyrexia Hypertension Vomiting Headache Bradyphrenia Oesophagitis Osteoarthritis Bradypnoea
Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Timolol (Timolol) Influenza Vaccine (Influenza Virus Vaccine) Atarax (Hydroxyine Hydrochloride)
Role
Manufacturer
Route
Dose
Duration
PS C C C
ORAL
Date:12/21/99ISR Number: 3426947-0Report Type:Expedited (15-DaCompany Report #214472 Outcome Other Serious PT Cerebellar Atrophy Dysgraphia Fear Balance Disorder Dysarthria Movement Disorder Coordination Abnormal Cerebellar Syndrome Clumsiness Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:49 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:12/29/99ISR Number: 3434420-9Report Type:Expedited (15-DaCompany Report #223142 Outcome Hospitalization Initial or Prolonged PT Biopsy Bone Marrow Abnormal Platelet Count Decreased Mouth Haemorrhage White Blood Cell Count Decreased Bone Marrow Failure Epistaxis Petechiae Haematocrit Decreased Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:29 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
Date:01/04/00ISR Number: 3435387-XReport Type:Direct Outcome PT
Company Report # Report Source Product Role Manufacturer
Age:53 YR Route
Gender:Female Dose
I/FU:I Duration
Other Serious
Depression Tremor Insomnia Movement Disorder Panic Attack Heart Rate Increased
Lariam (Mefoquine) 250mg-La Roche
PS
La-Roche
1 TABLET EACH WEEK
03-Apr-2012
09:37 AM
Page: 159
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/00ISR Number: 3439115-3Report Type:Expedited (15-DaCompany Report #220064 Outcome Hospitalization Initial or Prolonged PT Palmar Erythema Pain In Extremity Dermatitis Rash Generalised Face Oedema Vomiting Dehydration Pruritus Rash Pruritic Rash Papular Skin Exfoliation Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:13 YR Route Gender:Female Dose I/FU:F Duration
PS
ORAL
Date:01/06/00ISR Number: 3439121-9Report Type:Expedited (15-DaCompany Report #223797 Outcome Congenital Anomaly PT Abortion Induced Trisomy 21 Pregnancy Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender: Dose
I/FU:I Duration
PS
ORAL
ORAL
Date:01/12/00ISR Number: 3443106-6Report Type:Direct Outcome Disability PT Fatigue Decreased Appetite Chills Depression Anxiety Panic Attack Paraesthesia Parosmia Hypoaesthesia Muscle Spasms Insomnia Dermatitis Headache
Company Report # Report Source Product Lariam (Mefloquine) Role PS Manufacturer
Age:53 YR Route
Gender:Male
I/FU:I
Dose Duration 250MG, MOUTH ONCE WEEKLY
Date:01/12/00ISR Number: 3443550-7Report Type:Expedited (15-DaCompany Report #215212 Outcome Other Serious PT Flatulence Pancreatitis Cholelithiasis Pancreatic Disorder Report Source Foreign Other Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) 250 Role Manufacturer
Age:68 YR Route
Gender:Male Dose
I/FU:I Duration
Abdominal Pain Dyspepsia Blood Amylase Increased
Mg
PS
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 160
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/00ISR Number: 3443552-0Report Type:Expedited (15-DaCompany Report #215378 Outcome Other Serious PT Chest Pain Chest Discomfort Palpitations Ventricular Extrasystoles Dyspnoea Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Brevinor-1 (Ethinyl Estradiol / Norethindrone) Role Manufacturer Age:38 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
Date:01/12/00ISR Number: 3443559-3Report Type:Expedited (15-DaCompany Report #223961 Outcome Hospitalization Initial or Prolonged PT Myasthenic Syndrome Antibody Test Positive Eye Disorder Eyelid Ptosis Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Sotalex (Sotalol Hydrochloride) Piascledine (Avocado/Soybean Oil) Role Manufacturer
Age:67 YR Route
Gender:Male Dose
I/FU:I Duration
PS C C
ORAL
Date:01/12/00ISR Number: 3443767-1Report Type:Expedited (15-DaCompany Report #215513 Outcome Other Serious PT Suicidal Ideation Depersonalisation Depression Paranoia Dissociative Disorder Anxiety Fear Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:16 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:01/12/00ISR Number: 3443770-1Report Type:Expedited (15-DaCompany Report #215542 Outcome Other Serious PT Pyrexia Hepatitis Cholestatic Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Noroxin (Norfloxacin) Role Manufacturer
Age:51 YR Route
Gender:Male Dose
I/FU:I Duration
PS SS
ORAL
250 MG 1 PER WEEK ORAL 1 DOSE FORM
DAILY Vancomycin Hydrochloride (Vancomycin Hydrochloride) Imodium (Loperamide Hydrochloride) 03-Apr-2012 09:37 AM
SS SS 1 DOSE FORM DAILY Page: 161
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/00ISR Number: 3445475-XReport Type:Expedited (15-DaCompany Report #106318 Outcome Hospitalization Initial or Prolonged PT Blister Dystonia Hallucination Panic Attack Dermatitis Grand Mal Convulsion Insomnia Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Oral Contraceptive Nos (Oral Contraceptive Nos) Sedative Nos (Sedative Nos) Role Manufacturer Age:37 YR Route Gender:Female Dose I/FU:F Duration
PS
ORAL
C C
Date:01/19/00ISR Number: 3445477-3Report Type:Expedited (15-DaCompany Report #215861 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Cardiac Arrest Cholinergic Syndrome Circulatory Collapse Pulse Absent Electrocardiogram Qt Prolonged Apnoea Report Source Foreign Consumer Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:49 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:01/19/00ISR Number: 3445854-0Report Type:Expedited (15-DaCompany Report #224407 Outcome Other Serious PT Herpes Simplex Hepatitis Blood Immunoglobulin G Increased Liver Function Test Abnormal Report Source Foreign Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:57 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:01/19/00ISR Number: 3446071-0Report Type:Expedited (15-DaCompany Report #224923 Outcome Hospitalization Initial or Prolonged PT Hallucination Suicide Attempt Theft Acute Psychosis Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Female Dose 1.5 DOSE FORM 1 PER WEEK ORAL
I/FU:I Duration
14
DAY
Age:49 YR
Gender:Male
I/FU:F
PT Cardiac Arrest
Role PS
Manufacturer
Route ORAL
Duration
03-Apr-2012
09:37 AM
Page: 162
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/00ISR Number: 3446442-2Report Type:Expedited (15-DaCompany Report #218871 Outcome Hospitalization Initial or Prolonged PT Depression Nightmare Visual Field Defect Paranoia Anxiety Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Kodimagnyl (Aspirin/Codeine Phosphate) Panodil (Acetaminophen) Klorokinfosfat (Chloroquine Phosphate) Pondocillin (Pivampicillin Hydrochloride) Role Manufacturer Age:45 YR Route Gender:Female Dose I/FU:F Duration
PS C C C C
ORAL
ORAL
Date:01/28/00ISR Number: 3447825-7Report Type:Direct Outcome Disability PT Gait Disturbance Nervous System Disorder Paralysis Feeling Abnormal
Company Report # Report Source Product Larium (Mefloquin) Role PS Manufacturer
Age:34 YR Route
Gender:Male Dose
I/FU:I Duration
Date:01/28/00ISR Number: 3448097-XReport Type:Expedited (15-DaCompany Report #223142 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Thrombocytopenia Petechiae Epistaxis Leukopenia Haematocrit Decreased Mouth Haemorrhage Megakaryocytes Abnormal Bone Marrow Failure Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:29 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
Date:01/28/00ISR Number: 3448154-8Report Type:Expedited (15-DaCompany Report #225350 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Tinnitus Deafness Report Source Foreign Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:02/02/00ISR Number: 3451029-1Report Type:Expedited (15-DaCompany Report #226681 Outcome Disability 03-Apr-2012 09:37 AM PT Haemolysis Report Source Foreign Health
Age:
Gender:Male
I/FU:I
Page: 163
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Route Dose Duration
PS
ORAL
ORAL
Date:02/04/00ISR Number: 3452318-7Report Type:Expedited (15-DaCompany Report #216832 Outcome Hospitalization Initial or Prolonged PT Loss Of Consciousness Back Pain Grand Mal Convulsion Neurological Symptom Movement Disorder Gait Disturbance Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:30 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:02/08/00ISR Number: 3454673-0Report Type:Expedited (15-DaCompany Report #227211 Outcome Other Serious PT Oesophagitis Oesophageal Pain Sensation Of Pressure Bundle Branch Block Right Supraventricular Extrasystoles Dyspnoea Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:51 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
250 MG 1 PER 1 WEEK, ORAL
28
DAY
Date:02/08/00ISR Number: 3454675-4Report Type:Expedited (15-DaCompany Report #227013 Outcome Hospitalization Initial or Prolonged Disability PT Asthenia Cerebrovascular Accident Feeling Abnormal Thrombocytopenia Cerebral Infarction Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hudrochloride) 250 Mg Role Manufacturer
Age:40 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:02/08/00ISR Number: 3455315-0Report Type:Expedited (15-DaCompany Report #220944 Outcome Life-Threatening PT Suicide Attempt Paranoia Mental Disorder Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:59 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
250 MG 1 PER
WEEK ORAL
03-Apr-2012
09:37 AM
Page: 164
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/00ISR Number: 3455449-0Report Type:Expedited (15-DaCompany Report #215471 Outcome Other Serious PT Pain In Extremity Blood Cholesterol Increased Decreased Appetite Retching Polymyalgia Rheumatica Joint Ankylosis Abnormal Faeces Diarrhoea Arthralgia Malaise Asthenia Sciatica Myalgia Foreign Travel Nausea Abdominal Pain Report Source Foreign Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:79 YR Route Gender:Male Dose I/FU:F Duration
PS
ORAL
Date:02/11/00ISR Number: 3457006-9Report Type:Expedited (15-DaCompany Report #215928 Outcome Hospitalization Initial or Prolonged PT Hypervitaminosis Hepatitis Liver Function Test Abnormal Autoimmune Disorder Spleen Disorder Blood Bilirubin Increased Hepatic Necrosis Jaundice Report Source Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Vitamin Nos (Vitamin Nos) Role Manufacturer
Age:35 YR Route
Gender:Female Dose
I/FU:F Duration
PS SS
ORAL
Date:02/11/00ISR Number: 3457009-4Report Type:Expedited (15-DaCompany Report #217772 Outcome Hospitalization Initial or Prolonged PT Condition Aggravated Ventricular Hypertrophy Bradycardia Drug Interaction Hypertension Muscular Weakness Ejection Fraction Abnormal Dizziness Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Timoptol Eye Drops (Timolol Maleate) 5 Mg/Ml Bethahistine Hydrochloride Role Manufacturer
Age:53 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
250 MG 1 PER WEEK ORAL .05 DOSE FORM DAILY OPHTHALMIC
SS
OPHTHALMIC
(Bethahistine)
03-Apr-2012
09:37 AM
Page: 165
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/00ISR Number: 3457011-2Report Type:Expedited (15-DaCompany Report #215889 Outcome Hospitalization Initial or Prolonged PT Foreign Travel Eye Pain Csf Lymphocyte Count Increased Csf White Blood Cell Count Positive Optic Neuritis Headache Vision Blurred Visual Acuity Reduced C-Reactive Protein Increased Blood Glucose Increased Sinusitis Blood Triglycerides Increased Glucose Tolerance Impaired Meningitis Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:53 YR Route Gender:Male Dose I/FU:I Duration
PS
ORAL
56
DAY
Date:02/14/00ISR Number: 3457666-2Report Type:Expedited (15-DaCompany Report #224407 Outcome Other Serious PT Liver Function Test Abnormal Blood Immunoglobulin G Increased Hepatitis Herpes Simplex Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:57 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:02/15/00ISR Number: 3458375-6Report Type:Expedited (15-DaCompany Report #227783 Outcome Other Serious PT Hypotonia Maternal Drugs Affecting Foetus Chondromalacia Congenital Gastric Anomaly Congenital Hair Disorder Microphthalmos Gastrooesophageal Reflux Disease Finger Deformity Oesophageal Dilatation Feeding Disorder Neonatal
Age:8 WK
Gender:Male
I/FU:I
Microcephaly Congenital Anomaly Congenital Nose Malformation Vomiting Dyskinesia Oesophageal Dysmorphism Blood Pressure Increased 03-Apr-2012 09:37 AM Page: 166
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oesophageal Achalasia Congenital Central Nervous System Anomaly Neck Deformity Developmental Delay Salivary Hypersecretion Convulsion Joint Contracture Micrognathia Respiratory Arrest Ear Malformation
Report Source Foreign Literature Health Professional
Role PS
Manufacturer
Route ORAL
Duration
Date:02/16/00ISR Number: 3458485-3Report Type:Direct Outcome Life-Threatening Disability PT Panic Attack Dizziness Asthenia Disturbance In Attention Eye Pain
Company Report # Report Source Product Lariam/Roche Role PS Manufacturer Roche
Age:27 YR Route BUCCAL
Gender:Male Dose 6 TABLE BUCCAL
I/FU:I Duration
Date:02/16/00ISR Number: 3458909-1Report Type:Expedited (15-DaCompany Report #217772 Outcome Hospitalization Initial or Prolonged PT Ventricular Hypertrophy Muscular Weakness Bradycardia Hypertension Ejection Fraction Abnormal Dizziness Drug Interaction Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Timoptol Eye Drops (Timolol Maleate) 5mg/Ml Betahistine Hydrochloride (Betahistine) Role Manufacturer
Age:53 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
250 MG 1 PER WEEK ORAL .05 MG DOSE FORM DAILY OPHTHALMIC
SS
OPHTHALMIC
Date:02/17/00ISR Number: 3459446-0Report Type:Expedited (15-DaCompany Report #207736 Outcome Congenital Anomaly PT Maternal Drugs Affecting Foetus Congenital Cystic Kidney Disease Congenital Anomaly Renal Hypertrophy Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:02/18/00ISR Number: 3459354-5Report Type:Expedited (15-DaCompany Report #58978 Outcome Other Serious 03-Apr-2012 09:37 AM PT Back Pain Vestibular Disorder
Age:31 YR
Gender:Male
I/FU:F
Page: 167
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sensation Of Pressure Dyspnoea Hyperhidrosis Balance Disorder Anxiety Ear Discomfort Drug Hypersensitivity Cerebellar Ataxia Nystagmus Thrombocytopenia Headache Tachycardia Accident Chest Pain Road Traffic Accident Palpitations Vomiting Asthenia Confusional State Vertigo Spinal Fracture Syncope Clonic Convulsion Anaemia Fatigue Neck Pain Amnesia Abdominal Pain Sinus Headache Dizziness Gait Disturbance Disturbance In Attention Nausea Feeling Abnormal Platelet Count Abnormal Scoliosis Epistaxis
Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Norflex (Orphenadrine Citrate)
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
Date:02/18/00ISR Number: 3459955-4Report Type:Expedited (15-DaCompany Report #228385 Outcome Hospitalization Initial or Prolonged PT Mania Psychotic Disorder Thinking Abnormal Bipolar Disorder Weight Decreased Psychomotor Hyperactivity Magical Thinking Foreign Travel Abnormal Behaviour Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Chloroquine (Chloroquine) Role Manufacturer
Age:20 YR Route
Gender:Male Dose
I/FU:I Duration
PS C
ORAL
Date:02/18/00ISR Number: 3459957-8Report Type:Expedited (15-DaCompany Report #224949 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Malaise Hypoxia Oedema Peripheral
Age:67 YR
Gender:Male
I/FU:I
Page: 168
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pruritus Pain In Extremity Dyspnoea Exertional Dehydration Subcutaneous Emphysema Vein Pain Dry Skin Pneumothorax Traumatic Pleural Effusion Pain Blood Alkaline Phosphatase Increased Jaundice Lung Consolidation Diarrhoea Ecchymosis Blood Sodium Increased Fall Bacterial Test Positive Rib Fracture Bronchospasm Blood Bilirubin Increased Decreased Appetite Injury Liver Function Test Abnormal Haemorrhoids Cholestasis Chromaturia Wound Infection Pulmonary Oedema Dyspnoea Staphylococcal Infection
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
Date:02/18/00ISR Number: 3459961-XReport Type:Expedited (15-DaCompany Report #213259 Outcome Hospitalization Initial or Prolonged PT Malaise Pharyngitis Drug Hypersensitivity Cough Erythema Urticaria Pyrexia Eyelid Oedema Dyspnoea Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Clamoxyl Duo (Amoxicillin Sodium/*Clavulanate Potassium) Imudon (Lysates, Bacterial) Doliprane (Acetaminophen) Hexomedine Collutoire Role PS Manufacturer
I/FU:F Duration
SS SS C
ORAL ORAL
2 GRAM DAILY ORAL ORAL
(Hexamidine/Tetracai ne Hydrochloride)
03-Apr-2012
09:37 AM
Page: 169
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3461482-5Report Type:Expedited (15-DaCompany Report #228826 Outcome Other Serious PT Aplastic Anaemia Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age: Route Gender:Male Dose I/FU:I Duration
PS
ORAL
42
DAY
Date:02/24/00ISR Number: 3462565-6Report Type:Expedited (15-DaCompany Report #228880 Outcome Hospitalization Initial or Prolonged PT Euphoric Mood Dizziness Nausea Photophobia Palpitations Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Dimetapp (Brompheniramine Maleate/*Phenylephri ne Hydrochloride/Phenyl Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:02/24/00ISR Number: 3462569-3Report Type:Expedited (15-DaCompany Report #228555 Outcome Death PT Splenomegaly Diarrhoea Fear Dizziness Oropharyngeal Pain Hypoaesthesia Burning Sensation Panic Disorder Peripheral Coldness Psychotic Disorder Chills Confusional State Intentional Self-Injury Depression Anxiety Myocarditis Pyrexia Bone Pain Completed Suicide Dyspnoea Disorientation Headache Report Source Foreign Literature Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Co-Trimoxazol (Sulfamethoxazole/Tr imethoprim) Penicillin V (Penicillin V) Intravenous Glucose (Glucose) Paracetamol (Acetaminophen) Codeine Phosphate (Codeine Phosphate) Fansidar (Pyrimethamine/Sulfa doxine) Quinine (Quinine) Antimalarial Agent Nos (Antimalarial Agent Nos) Role Manufacturer
Age:33 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
C C C C C C C C
Aspirin (Aspirin)
03-Apr-2012
09:37 AM
Page: 170
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/00ISR Number: 3462570-XReport Type:Expedited (15-DaCompany Report #225350 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Audiogram Abnormal Tinnitus Deafness Report Source Foreign Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:59 YR Route Gender:Male Dose I/FU:F Duration
PS
ORAL
Date:02/24/00ISR Number: 3462575-9Report Type:Expedited (15-DaCompany Report #223797 Outcome Congenital Anomaly PT Congenital Anomaly Trisomy 21 Pregnancy Abortion Induced Maternal Drugs Affecting Foetus Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Unknown Dose
I/FU:F Duration
PS
ORAL
Date:02/24/00ISR Number: 3462577-2Report Type:Expedited (15-DaCompany Report #211640 Outcome Hospitalization Initial or Prolonged Disability PT Pyrexia Paralysis Gait Disturbance Myalgia Facial Pain Pain In Extremity Headache Asthenia Polyneuropathy Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:46 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:02/24/00ISR Number: 3462580-2Report Type:Expedited (15-DaCompany Report #228268 Outcome Hospitalization Initial or Prolonged PT Premature Separation Of Placenta Menometrorrhagia Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Unknown Dose
I/FU:I Duration
PS
ORAL
Date:02/28/00ISR Number: 3464073-5Report Type:Direct Outcome Other Serious PT Photophobia
Company Report # Report Source Product Lariam (Mefloquine) Role PS Manufacturer
Age:34 YR Route
Gender:Female
I/FU:I
Dose Duration TABLET WEEKLY
Headache Ear Discomfort Hypersensitivity
FOR 7 WEEKS
03-Apr-2012
09:37 AM
Page: 171
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/00ISR Number: 3464099-1Report Type:Direct Outcome Other Serious PT Tinnitus Company Report # Report Source Product Lariam (Mefloquine) Role PS Manufacturer Age:33 YR Route ORAL Gender:Male I/FU:I
Dose Duration 1 TABLET WEEKLY FOR 7 WEEKS (ORAL)
Date:02/29/00ISR Number: 3465856-8Report Type:Expedited (15-DaCompany Report #228826 Outcome Other Serious PT Aplastic Anaemia Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
Date:02/29/00ISR Number: 3465857-XReport Type:Expedited (15-DaCompany Report #229472 Outcome Disability PT Fall Neuropathy Peripheral Diarrhoea Coordination Abnormal Paraesthesia Oral Gait Disturbance Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Atenolol (Atenolol) Role PS C Manufacturer
I/FU:I Duration
Date:03/01/00ISR Number: 3467533-6Report Type:Direct Outcome Disability Other Serious PT Disturbance In Attention Anxiety Hallucination Feeling Abnormal Restlessness Muscle Twitching Depression Sleep Disorder Paranoia Alopecia
Company Report # Report Source Health Professional Product Laraim Role PS Manufacturer
Age: Route
Gender:Female Dose TABLET WEEKLY
I/FU:I Duration
Date:03/02/00ISR Number: 3468068-7Report Type:Expedited (15-DaCompany Report #223959 Outcome Hospitalization Initial or Prolonged PT Paranoia Deja Vu Illusion Anxiety Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:27 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
250 MG 1 PER
Panic Attack Insomnia Delirium Depersonalisation Abnormal Behaviour Hallucination, Auditory Confusional State Mental Disorder 03-Apr-2012 09:37 AM
WEEK ORAL
Page: 172
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/00ISR Number: 3468986-XReport Type:Expedited (15-DaCompany Report #222412 Outcome Hospitalization Initial or Prolonged PT Neuropathy Peripheral Asthenia Insomnia Red Blood Cell Sedimentation Rate Increased Hyporeflexia Depression Malaria Report Source Foreign Health Professional Product Laroxyl (Amitriptyline Hydrochloride) 25 Mg Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Stilnox (Zolpidem Tartrate) Fumafer (Ferrous Fumarate) Quinine (Quinine) Rohypnol (Flunitrazepam) Role PS Manufacturer Age:40 YR Route ORAL Gender:Female Dose 25 MG DAILY ORAL I/FU:F Duration
SS C C C C
ORAL
Date:03/08/00ISR Number: 3471240-3Report Type:Direct Outcome PT Nausea Influenza Like Illness Pyrexia Vertigo Tremor Medication Error Depression Headache Dizziness Lethargy
Age:41 YR Route
Gender:Female Dose 1 TABLET / ONCE A WEEK
I/FU:I Duration
Date:03/09/00ISR Number: 3472238-1Report Type:Direct Outcome Other Serious PT Nightmare Insomnia Anxiety
Gender:Male
I/FU:I
Dose Duration 250MG 1 PO QD
Date:03/09/00ISR Number: 3473493-4Report Type:Expedited (15-DaCompany Report #230147 Outcome Hospitalization Initial or Prolonged PT Hallucination Monoparesis Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:03/09/00ISR Number: 3473498-3Report Type:Expedited (15-DaCompany Report #227783 Outcome Other Serious 03-Apr-2012 09:37 AM PT Congenital Musculoskeletal Anomaly
Age:8 WK
Gender:Male
I/FU:F
Page: 173
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Microcephaly Salivary Hypersecretion Congenital Nose Malformation Oesophageal Dilatation Growth Retardation Developmental Coordination Disorder Dyskinesia Oesophageal Gastrooesophageal Reflux Disease Congenital Jaw Malformation Micrognathia Congenital Hair Disorder Developmental Delay Hypertension Congenital Oral Malformation Convulsion Microphthalmos Respiratory Disorder Neonatal Hypercapnia Respiratory Arrest Hypotonia Hypertonia Feeding Disorder Maternal Drugs Affecting Foetus Oesophageal Achalasia Congenital Gastric Anomaly Congenital Central Nervous System Anomaly Mental Impairment Joint Contracture Microstomia Autosomal Chromosome Anomaly Dysmorphism Congenital Foot Malformation Ear Malformation
Role PS
Manufacturer
Route ORAL
Duration
Date:03/10/00ISR Number: 3474446-2Report Type:Expedited (15-DaCompany Report #75640 Outcome Congenital Anomaly PT Hypercapnia Clumsy Child Syndrome
Age:
Gender:Unknown
I/FU:F
Oesophageal Achalasia Feeding Disorder Muscular Dystrophy Pregnancy Congenital Jaw Malformation Hypertension Obstructive Airways 03-Apr-2012 09:37 AM Page: 174
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorder Maternal Drugs Affecting Foetus Growth Retardation Autoimmune Disorder Hypotonia Dysmorphism Mental Disorder Microcephaly Multiple Congenital Abnormalities Malnutrition Oesophageal Disorder Gastrooesophageal Reflux Disease
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
Date:03/10/00ISR Number: 3474449-8Report Type:Expedited (15-DaCompany Report #207736 Outcome Congenital Anomaly PT Congenital Anomaly Congenital Cystic Kidney Disease Renal Hypertrophy Pregnancy Maternal Drugs Affecting Foetus Report Source Foreign Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:03/13/00ISR Number: 3474365-1Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Lethargy Headache Dysentery Asthenia Decreased Appetite Nausea Vertigo Dizziness Pyrexia Diarrhoea
Company Report # Report Source Product Lariam 250mg Hoffmann-La Roche Inc Metrodozole Tinidozole Anti-Biotics Role PS C C C Manufacturer Hoffmann-La Roche Inc
Age:21 YR Route
Gender:Male Dose
I/FU:I Duration
ORAL
250MG WEEKLY ORAL
Date:03/14/00ISR Number: 3475522-0Report Type:Expedited (15-DaCompany Report #230503 Outcome Other Serious PT Dysphonia Depression Gait Disturbance Speech Disorder Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Male Dose 250 MG ORAL
I/FU:I Duration
Date:03/14/00ISR Number: 3475572-4Report Type:Expedited (15-DaCompany Report #230342 Outcome Other Serious 03-Apr-2012 09:37 AM PT Overdose Nervous System Disorder
Age:
Gender:Male
I/FU:I
Page: 175
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gamma-Glutamyltransferase Increased Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Route ORAL Dose ORAL Duration 7 DAY
Date:03/14/00ISR Number: 3475596-7Report Type:Expedited (15-DaCompany Report #224949 Outcome Hospitalization Initial or Prolonged PT Jaundice Ecchymosis Haemorrhoids Dyspnoea Exertional Decreased Appetite Wound Infection Pulmonary Oedema Fall Subcutaneous Emphysema Chromaturia Pruritus Pain Pneumothorax Blood Bilirubin Increased Hypoxia Lung Consolidation Pleural Effusion Bronchospasm Cholestasis Malaise Diarrhoea Liver Function Test Abnormal Rib Fracture Staphylococcal Infection Oedema Peripheral Benign Prostatic Hyperplasia Haemothorax Vein Pain Dry Skin Injury Dehydration Report Source Foreign Consumer Product Lariam Tablets (Mefloquine Hydrochloride ) 250 Mg Role Manufacturer
Age:67 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:03/14/00ISR Number: 3475600-6Report Type:Expedited (15-DaCompany Report #229994 Outcome Disability PT Dyspnoea Report Source Health Professional Product Lariam Tablets (Mefloquine Role Manufacturer
Age:19 YR Route
Gender:Female Dose
I/FU:I Duration
Hydrochloride)
PS
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 176
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/00ISR Number: 3475487-1Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Hallucination, Visual Paranoia Arthralgia Confusional State Panic Attack Company Report # Report Source Product Mefloquine (Lariam) Roche Pharm. 250 Mg Role PS Manufacturer Roche Pharm. Age:52 YR Route ORAL Gender:Female Dose ORAL 1/ WEEK I/FU:I Duration
Date:03/16/00ISR Number: 3476231-4Report Type:Direct Outcome Other Serious PT Depression Anxiety
Company Report # Report Source Health Professional Product Lariam Role PS Manufacturer
Age:32 YR Route
Gender:Male Dose
I/FU:I Duration
Date:03/20/00ISR Number: 3478147-6Report Type:Expedited (15-DaCompany Report #231049 Outcome Hospitalization Initial or Prolonged PT Asthenia Vomiting Nausea Nystagmus Dizziness Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL
I/FU:I Duration
Date:03/21/00ISR Number: 3478539-5Report Type:Expedited (15-DaCompany Report #225350 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Tinnitus Deafness Report Source Foreign Consumer Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:59 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:03/23/00ISR Number: 3479213-1Report Type:Expedited (15-DaCompany Report #224949 Outcome Hospitalization Initial or Prolonged PT Bronchospasm Chest X-Ray Abnormal Vein Pain Chromaturia Wound Infection Gait Disturbance Dry Skin
Age:67 YR
Gender:Male
I/FU:F
Injury Tenderness Pain Jaundice Ecchymosis Alanine Aminotransferase Increased Cholestasis 03-Apr-2012 09:37 AM Page: 177
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypoxia Diarrhoea Emphysema Decreased Appetite Pruritus Oedema Peripheral Dyspnoea Exertional Pulmonary Oedema Haemorrhoids Staphylococcal Infection Gamma-Glutamyltransferase Increased Blood Alkaline Phosphatase Increased Pleural Effusion Pneumothorax Blood Bilirubin Increased Haemorrhage Rib Fracture Dehydration
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
Date:03/23/00ISR Number: 3479216-7Report Type:Expedited (15-DaCompany Report #231053 Outcome Hospitalization Initial or Prolonged PT Muscular Weakness Paraesthesia Sensory Disturbance Hyporeflexia Bacterial Infection Myalgia Gait Disturbance Csf Protein Increased Dyspnoea Guillain-Barre Syndrome Antibody Test Positive Dizziness Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Proscar (Finasteride) Role Manufacturer
Age:62 YR Route
Gender:Male Dose
I/FU:I Duration
PS C
ORAL
Date:03/23/00ISR Number: 3479288-XReport Type:Direct Outcome Hospitalization Initial or Prolonged Disability Other Serious PT Dizziness Dyspnoea Headache Vomiting Panic Attack Fatigue Chills Palpitations Paraesthesia
Company Report # Report Source Product Lariam (Mefloquine) 250mg Role PS Manufacturer Hoffman Laroche
Age: Route
Gender: Dose 1 WEEKLY FOR 7 WKS
I/FU:I Duration
Diarrhoea Hallucination Tremor
03-Apr-2012
09:37 AM
Page: 178
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/00ISR Number: 3479360-4Report Type:Direct Outcome Other Serious PT Nightmare Hyperhidrosis Palpitations Fear Company Report # Report Source Product Mefloquine Hydrochloride (Lariam) Role PS Manufacturer Age:54 YR Route Gender:Male Dose 1T WEEKLY I/FU:I Duration
Date:03/27/00ISR Number: 3480434-2Report Type:Expedited (15-DaCompany Report #214472 Outcome Disability PT Dysgraphia Clumsiness Cerebellar Atrophy Neurological Examination Abnormal Coordination Abnormal Dysarthria Cerebellar Syndrome Movement Disorder Balance Disorder Report Source Foreign Health Professional Product Lariam Tablets(Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:49 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:03/30/00ISR Number: 3482118-3Report Type:Expedited (15-DaCompany Report #231507 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Haemolysis Inborn Error Of Metabolism Malaria Fatigue Anaemia Pyrexia Chromaturia Report Source Foreign Literature Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Male Dose 1.5 GRAM DAILY 1 PER 8 HOUR ORAL
I/FU:I Duration
Date:04/05/00ISR Number: 3484145-9Report Type:Expedited (15-DaCompany Report #231049 Outcome Hospitalization Initial or Prolonged PT Asthenia Vomiting Vertigo Nystagmus Alanine Aminotransferase Increased Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Ventoline (Albuterol Or Albuterol Sulfate) Role PS Manufacturer
I/FU:F Duration
Date:04/05/00ISR Number: 3484146-0Report Type:Expedited (15-DaCompany Report #231053 Outcome Hospitalization Initial or Prolonged PT Dyspnoea Csf Protein Increased Gait Disturbance Guillain-Barre Syndrome Bacterial Infection
Age:62 YR
Gender:Male
I/FU:F
03-Apr-2012
09:37 AM
Page: 179
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sensory Disturbance Myalgia Dizziness Blood Immunoglobulin G Increased Hyporeflexia Muscular Weakness Paraesthesia
Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Proscar (Finasteride)
Role
Manufacturer
Route
Dose
Duration
PS C
ORAL
Date:04/05/00ISR Number: 3484147-2Report Type:Expedited (15-DaCompany Report #218956 Outcome Other Serious PT Guillain-Barre Syndrome Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
70
DAY
Date:04/05/00ISR Number: 3484148-4Report Type:Expedited (15-DaCompany Report #218954 Outcome Hospitalization Initial or Prolonged PT Personality Change Pyrexia Delusion Neurodermatitis Hypotonia Dermatitis Psychotic Disorder Cachexia Diarrhoea Abscess Muscle Disorder Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:23 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
61
DAY
Date:04/05/00ISR Number: 3484149-6Report Type:Expedited (15-DaCompany Report #218938 Outcome Hospitalization Initial or Prolonged PT Leukocytosis Diarrhoea Dizziness Pyrexia Vomiting Blood Bilirubin Increased Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
ORAL
Date:04/05/00ISR Number: 3484150-2Report Type:Expedited (15-DaCompany Report #218934 Outcome Other Serious PT Expressive Language Disorder Dyskinesia Mental Disorder Grand Mal Convulsion 09:37 AM Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:32 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/00ISR Number: 3484151-4Report Type:Expedited (15-DaCompany Report #218937 Outcome Other Serious PT Gastric Ulcer Haemorrhage Melaena Dizziness Pallor Abdominal Distension Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Vaccines Nos (Vaccine Nos) Role Manufacturer Age:59 YR Route Gender:Male Dose I/FU:F Duration
PS C
ORAL
Date:04/05/00ISR Number: 3484152-6Report Type:Expedited (15-DaCompany Report #218933 Outcome Other Serious PT Dyspnoea Paraesthesia Nervous System Disorder Brain Scan Abnormal Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:65 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
ORAL
Date:04/05/00ISR Number: 3484159-9Report Type:Expedited (15-DaCompany Report #232718 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Psychotic Disorder Dystonia Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Chlorpromazine (Chlorpromazine) Role PS SS Manufacturer
Gender:Male Dose 1 PER 1 WEEK ORAL
I/FU:I Duration
Date:04/05/00ISR Number: 3484160-5Report Type:Expedited (15-DaCompany Report #232293 Outcome Hospitalization Initial or Prolonged PT Sedation Depression Circulatory Collapse Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
Date:04/05/00ISR Number: 3484188-5Report Type:Expedited (15-DaCompany Report #218942 Outcome Other Serious PT Grand Mal Convulsion Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:53 YR Route
Gender:Male Dose
I/FU:F Duration
PS
ORAL
Date:04/06/00ISR Number: 3485079-6Report Type:Expedited (15-DaCompany Report #218953 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Blood Glucose Decreased Circadian Rhythm Sleep Disorder
Age:30 YR
Gender:Male
I/FU:I
Page: 181
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Loss Of Consciousness Bite Muscle Spasms Prostatitis Grand Mal Convulsion Tremor Urethritis Tongue Disorder
Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Rytmonorm (Propafenone Hydrochloride) 300 Mg Polio Vaccine (Poliomyelitis Vaccines) Hepatitis A Vaccine (Hepatitis A Vaccine) Diphtheria Vaccine (Diphtheria Toxoid) Tetanus Vaccine (Tetanus Toxoid)
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
ORAL
SS C C C C
ORAL
ORAL
Date:04/07/00ISR Number: 3485171-6Report Type:Direct Outcome Disability Congenital Anomaly Required Intervention to Prevent Permanent Impairment/Damage PT Dizziness Pyrexia Dysuria Headache Insomnia Diarrhoea Arthralgia Hypoaesthesia Paraesthesia Back Pain Oropharyngeal Pain Neck Pain
Company Report # Report Source Product Lariam 250 Mg Roche Role PS Manufacturer Roche
Gender:Male Dose 1 WEEK ORAL
I/FU:I Duration
Date:04/07/00ISR Number: 3485372-7Report Type:Expedited (15-DaCompany Report #20000400108 Outcome Hospitalization Initial or Prolonged PT Hemiplegia Haemorrhage Cerebral Artery Occlusion Aphasia Sedation Atrial Fibrillation Report Source Foreign Health Professional Product Prilosec Lariam Imovane Role PS SS SS Manufacturer
Gender:Female Dose 40 MG QD PO
I/FU:I Duration
Date:04/07/00ISR Number: 3485913-XReport Type:Expedited (15-DaCompany Report #232768 Outcome Hospitalization Initial or Prolonged PT Feeling Hot Paraesthesia Dizziness Antinuclear Antibody
Age:32 YR
Gender:Female
I/FU:I
03-Apr-2012
09:37 AM
Page: 182
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Positive Nausea Weight Increased Disturbance In Attention Vision Blurred Balance Disorder Vertigo Decreased Appetite Wolff-Parkinson-White Syndrome Hypophagia Peripheral Coldness Headache Abdominal Pain Demyelination Hyperacusis
Role PS
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:04/07/00ISR Number: 3485989-XReport Type:Expedited (15-DaCompany Report #232633 Outcome Hospitalization Initial or Prolonged PT Cerebral Artery Occlusion Atrial Flutter Aphasia Cerebral Infarction Sedation Cerebrovascular Accident Hemiplegia Pyrexia Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Mopral (Omeprazole) 20 Mg Imovane (Zopiclone) 7.5 Mg Role Manufacturer
Age:69 YR Route
Gender:Female Dose
I/FU:I Duration
PS SS SS
ORAL ORAL ORAL
250 MG 1 PER ONE DOSE ORAL 40 MG DAILY ORAL 7.5 MG DAILY ORAL
Date:04/07/00ISR Number: 3485993-1Report Type:Expedited (15-DaCompany Report #232902 Outcome Other Serious PT Lacrimation Decreased Dizziness Accommodation Disorder Vertigo Eye Pain Feeling Abnormal Condition Aggravated Headache Vision Blurred Nystagmus Gait Disturbance Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Resochin (Chloroquine Phosphate) Role Manufacturer
Age:39 YR Route
Gender:Male Dose
I/FU:I Duration
PS C
ORAL
ORAL
Age:22 YR
Gender:Female
I/FU:I
PT Delusion Depression Suicidal Ideation
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/00ISR Number: 3488028-XReport Type:Expedited (15-DaCompany Report #229994 Outcome Disability PT Dyspnoea Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:19 YR Route ORAL Gender:Female Dose ORAL I/FU:F Duration
Date:04/14/00ISR Number: 3488468-9Report Type:Direct Outcome Other Serious PT Insomnia Nightmare Anxiety Fear Panic Attack Hallucination
Gender:Male
I/FU:I
Dose Duration 1 TABLE ONCE PER ORAL
Date:04/17/00ISR Number: 3489298-4Report Type:Expedited (15-DaCompany Report #228385 Outcome Hospitalization Initial or Prolonged PT Mania Weight Decreased Psychotic Disorder Abnormal Behaviour Psychomotor Hyperactivity Magical Thinking Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Chloroquine Role Manufacturer
Age:20 YR Route
Gender:Male Dose
I/FU:F Duration
PS C
ORAL
250 MG 1PER WEEK ORAL
Date:04/17/00ISR Number: 3489299-6Report Type:Expedited (15-DaCompany Report #233759 Outcome Other Serious PT Disturbance In Attention Depression Pulmonary Oedema Mountain Sickness Acute Abnormal Dreams Lethargy Nightmare Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:04/18/00ISR Number: 3488728-1Report Type:Direct Outcome PT Convulsion
Company Report # Report Source Product Lariam Dilantin Role PS SS Manufacturer
Age: Route
Gender:
I/FU:I
Dose Duration 250MG WEEKLY 400MG DAILY
Date:04/18/00ISR Number: 3489912-3Report Type:Expedited (15-DaCompany Report #233467 Outcome Other Serious PT Amnesia Visual Impairment Reading Disorder 09:37 AM Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age:54 YR Route
Gender:Male Dose
I/FU:I Duration
03-Apr-2012
Page: 184
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/00ISR Number: 3489913-5Report Type:Expedited (15-DaCompany Report #233599 Outcome Hospitalization Initial or Prolonged PT Atrial Fibrillation Syncope Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer Age:70 YR Route ORAL Gender:Male Dose DOSE FORM 1 PER WEEK, ORAL I/FU:I Duration
Date:04/19/00ISR Number: 3490412-5Report Type:Expedited (15-DaCompany Report #233987 Outcome Hospitalization Initial or Prolonged PT Hallucination Feeling Abnormal Visual Impairment Disturbance In Attention Fatigue Orthostatic Hypotension Memory Impairment Hypoaesthesia Retching Speech Disorder Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Ibuprofen (Ibuprofen) Role Manufacturer
Age:54 YR Route
Gender:Male Dose
I/FU:I Duration
PS C
ORAL
Date:04/20/00ISR Number: 3490517-9Report Type:Expedited (15-DaCompany Report #233963 Outcome Hospitalization Initial or Prolonged PT Haptoglobin Decreased Haemolytic Anaemia Medication Error Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:04/24/00ISR Number: 3492276-2Report Type:Expedited (15-DaCompany Report #232768 Outcome Hospitalization Initial or Prolonged PT Malaise Feeling Hot Blood Glucose Decreased Wolff-Parkinson-White Syndrome Multiple Sclerosis Dizziness Vision Blurred Weight Increased Dehydration Pyrexia Antinuclear Antibody Positive Lethargy
Age:32 YR
Gender:Female
I/FU:F
Demyelination Hyperacusis Headache Asthenia Vertigo Vomiting Disorientation Peripheral Coldness 03-Apr-2012 09:37 AM Page: 185
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Balance Disorder Migraine Nausea Fatigue Abdominal Pain Paraesthesia Sensation Of Foreign Body Disturbance In Attention Dysphagia
Role PS
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:04/24/00ISR Number: 3492277-4Report Type:Expedited (15-DaCompany Report #234272 Outcome Disability PT Cough Loss Of Consciousness Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:04/26/00ISR Number: 3494185-1Report Type:Expedited (15-DaCompany Report #234319 Outcome Other Serious PT Hallucination Paresis Delusion Anxiety Sleep Disorder Alopecia Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:04/28/00ISR Number: 3494447-8Report Type:Expedited (15-DaCompany Report #234391 Outcome Disability PT Amnesia Accidental Overdose Loss Of Control Of Legs Blindness Transient Nausea Medication Error Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:56 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:05/02/00ISR Number: 3495586-8Report Type:Expedited (15-DaCompany Report #231507 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent PT Pyrexia Haemolytic Anaemia Anaemia Malaria Inborn Error Of Report Source Foreign Literature Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Male Dose 1.5 GRAM DAILY 1 PER 8 HOUR ORAL
I/FU:I Duration
Impairment/Damage
Metabolism Fatigue Chromaturia
03-Apr-2012
09:37 AM
Page: 186
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/00ISR Number: 3495850-2Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Bronchitis Dyspnoea Tachycardia Anxiety Company Report # Report Source Consumer Product Lariam (Mefloquine) 250 Mg Once A Week Levoquin Role PS C Manufacturer Hoffman-Roche Pharmaceuticals Age:28 YR Route ORAL Gender:Female Dose PO ONCE A WEEK 250 MG I/FU:I Duration
Date:05/03/00ISR Number: 3495910-6Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Fatigue Headache Insomnia Abnormal Dreams Skin Discolouration Malaise Palpitations Hypertension
Company Report # Report Source Health Professional Product Larium (Mefloquine Hcl) 250 Mg Role PS Manufacturer
Age:63 YR Route
Gender:Female Dose 1 TABLET (250MG) PER WEEK
I/FU:I Duration
Date:05/03/00ISR Number: 3497235-1Report Type:Expedited (15-DaCompany Report #234271 Outcome Hospitalization Initial or Prolonged PT Syncope Malaise Blood Cholesterol Increased Pleural Fibrosis Renal Cyst Hypertension Sinoatrial Block Nausea Report Source Foreign Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:05/04/00ISR Number: 3495964-7Report Type:Direct Outcome Other Serious PT Anxiety Fear Fear Of Disease
Company Report # Report Source Consumer Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Male Dose ONCE A 3 TIMES ORAL
I/FU:I Duration
Date:05/04/00ISR Number: 3502895-2Report Type:Direct Outcome PT Hallucination
Age:22 YR Route
Gender:Male Dose
I/FU:I Duration
Abnormal Dreams
03-Apr-2012
09:37 AM
Page: 187
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/00ISR Number: 3497017-0Report Type:Expedited (15-DaCompany Report #234723 Outcome Other Serious PT Convulsion Drug Interaction Report Source Foreign Literature Health Professional Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Ofloxacin (Ofloxacin) Role Manufacturer Age: Route Gender:Male Dose I/FU:I Duration
PS SS
Date:05/05/00ISR Number: 3497133-3Report Type:Expedited (15-DaCompany Report #234722 Outcome Other Serious PT Convulsion Drug Interaction Report Source Foreign Literature Health Professional Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Sparfloxacin (Sparfloxacin) Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS SS
Date:05/05/00ISR Number: 3497134-5Report Type:Expedited (15-DaCompany Report #234734 Outcome Other Serious PT Convulsion Drug Interaction Report Source Foreign Literature Health Professional Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Ciprofloxacin (Ciprofloxacin) Role Manufacturer
Age: Route
Gender:Female Dose
I/FU:I Duration
PS SS
Date:05/05/00ISR Number: 3497136-9Report Type:Expedited (15-DaCompany Report #234751 Outcome Hospitalization Initial or Prolonged PT Cough Loss Of Consciousness Report Source Foreign Consumer Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:05/08/00ISR Number: 3497838-4Report Type:Expedited (15-DaCompany Report #234954 Outcome Other Serious PT Vith Nerve Paralysis Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:68 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
ORAL
Date:05/08/00ISR Number: 3497843-8Report Type:Direct Outcome Other Serious 03-Apr-2012 09:37 AM PT Anxiety Constipation
Company Report #
Age:35 YR
Gender:Male
I/FU:I
Page: 188
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Fatigue Dizziness
Report Source
Product Larium 250mg Roche
Role PS
Manufacturer Roche
Route ORAL
Dose ORALLY
Duration
Date:05/08/00ISR Number: 3498350-9Report Type:Expedited (15-DaCompany Report #233329 Outcome Hospitalization Initial or Prolonged PT Headache Feeling Drunk Dizziness Balance Disorder Memory Impairment Nystagmus Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:05/08/00ISR Number: 3498353-4Report Type:Expedited (15-DaCompany Report #234272 Outcome Disability PT Loss Of Consciousness Cough Report Source Foreign Health Professional Product Lariam Allopurinol (Allopurinol) Role PS C Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:05/11/00ISR Number: 3498920-8Report Type:Direct Outcome Other Serious PT Dizziness Crying Hallucination Gastrointestinal Disorder Panic Attack Sedation Mood Altered Balance Disorder Visual Impairment
Company Report # Report Source Consumer Other Product Lariam Role PS Manufacturer
I/FU:I Duration
Date:05/16/00ISR Number: 3500997-8Report Type:Expedited (15-DaCompany Report #235343 Outcome Other Serious PT Epileptic Aura Aphasia Loss Of Consciousness Report Source Foreign Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:39 YR Route
Gender:Male Dose
I/FU:I Duration
PS
Hoffmann La Roche Inc
ORAL
Date:05/17/00ISR Number: 3501085-7Report Type:Direct Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM
Company Report #
Age:39 YR
Gender:Male
I/FU:I
Page: 189
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Nausea Back Pain Emotional Disorder Dizziness Diarrhoea Muscle Spasms Loss Of Consciousness Anxiety Hypoaesthesia Paraesthesia Panic Attack Pain In Extremity Tinnitus Abnormal Dreams Neck Pain Headache Abdominal Pain Report Source Consumer Product Lariam-Mefloquine 250mg Roche Role PS Manufacturer Roche Route ORAL Dose 250MG 1 PER WEEK ORAL Duration
Date:05/24/00ISR Number: 3504590-2Report Type:Direct Outcome Other Serious PT Nausea Paranoia Paraesthesia Panic Attack Pyrexia Dyspnoea Palpitations Sleep Disorder Diarrhoea Dizziness Decreased Appetite Weight Decreased Nervousness Cold Sweat
Company Report # Report Source Health Professional Product Mefloquine-Lariam-/ 250 Mg. Role PS Manufacturer
Date:05/26/00ISR Number: 3505463-1Report Type:Expedited (15-DaCompany Report #234272 Outcome Other Serious PT Cough Syncope Report Source Foreign Health Professional Product Lariam Allopurinol (Allopurinol) Role PS C Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:05/31/00ISR Number: 3506616-9Report Type:Expedited (15-DaCompany Report #236845 Outcome Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM PT Pregnancy Abortion Incomplete Antepartum Haemorrhage Maternal Drugs Affecting Foetus Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Gender:Unknown Dose 250 MG 1 PER WEEK ORAL
I/FU:I Duration
Page: 190
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/00ISR Number: 3507011-9Report Type:Expedited (15-DaCompany Report #236875 Outcome Disability PT Abdominal Pain Upper Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Female Dose ORAL I/FU:I Duration
Date:06/02/00ISR Number: 3507714-6Report Type:Expedited (15-DaCompany Report #940320860001 Outcome Other Serious PT Anaemia Hepatitis A Antibody Positive Pain Complement Factor Decreased Red Blood Cell Sedimentation Rate Decreased Gastrointestinal Disorder Sleep Disorder Condition Aggravated Tinnitus Dyspnoea Arrhythmia Immunosuppression Swelling Blood Cholesterol Increased Blepharitis Pain In Jaw Immunology Test Abnormal Trigeminal Nerve Disorder Lymphadenopathy Fatigue Blood Immunoglobulin G Increased Angiopathy Immune System Disorder Laryngeal Disorder Autoimmune Disorder Antinuclear Antibody Positive Mononucleosis Heterophile Test Positive Cd4 Lymphocytes Decreased Arterial Disorder Hyperaesthesia Arthropathy Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/02/00ISR Number: 3507717-1Report Type:Expedited (15-DaCompany Report #236161 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Purpura Renal Impairment Hepatic Enzyme Increased Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Gender:Male Dose 1 DOSE FORM 1 PER WEEK ORAL
I/FU:I Duration
Page: 191
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Previscan (Fluindione) Lasilix (Furosemide) Seloken (Metoprolol Tartrate) Pyostacine (Pristinamycin) Cordarone (Amiodarone) Levothyrox (Levothyroxine Sodium)
SS C C C C C
ORAL
ORAL
Date:06/02/00ISR Number: 3507718-3Report Type:Expedited (15-DaCompany Report #233138 Outcome Hospitalization Initial or Prolonged PT Suicidal Ideation Electroencephalogram Abnormal Depression Social Avoidant Behaviour Hallucination, Auditory Gait Disturbance Disturbance In Attention Anxiety Personality Disorder Rash Erythematous Mood Swings Decreased Appetite Psychotic Disorder Feeling Abnormal Cognitive Disorder Insomnia Delusion Blood Bilirubin Increased Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:06/05/00ISR Number: 3507999-6Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Hypertension Pyrexia Migraine Toxicity To Various Agents Depressed Mood Diarrhoea Nightmare
Company Report # Report Source Product Lariam 500mg Role PS Manufacturer
Age:21 YR Route
Gender:Female Dose
I/FU:I Duration
Date:06/06/00ISR Number: 3509002-0Report Type:Expedited (15-DaCompany Report #237147 Outcome Hospitalization Initial or Prolonged PT Urinary Retention Dermatitis Report Source Foreign Other Product Lariam Suspected Unspecified Drug 03-Apr-2012 09:37 AM Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 250 MG ORAL
I/FU:I Duration
Page: 192
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Generic Component(S) Unknown)
SS
ORAL
1 DOSE FORM DAILY ORAL
Date:06/06/00ISR Number: 3509005-6Report Type:Expedited (15-DaCompany Report #236953 Outcome Other Serious PT Hepatic Enzyme Increased Myopathy Nerve Root Lesion Blood Creatine Phosphokinase Increased Paraesthesia Drug Level Above Therapeutic Insomnia Report Source Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Date:06/06/00ISR Number: 3510082-7Report Type:Periodic Outcome Other Serious PT Drug Interaction Chills Pyrexia
Company Report #211352 Report Source Health Professional Product Lariam Cipro Role PS SS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 250 MG 1 PER 1 WEEK ORAL 1 DOSE FORM ORAL
I/FU:I Duration
Date:06/06/00ISR Number: 3510083-9Report Type:Periodic Outcome Other Serious PT Acne Nightmare Photophobia
Company Report #211684 Report Source Consumer Product Lariam Ibuprofen Role PS C Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/06/00ISR Number: 3510084-0Report Type:Periodic Outcome Other Serious PT Vision Blurred Dyspepsia
Company Report #212626 Report Source Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Age:35 YR
Gender:Male
I/FU:I
PT Fatigue Eosinophilia Haematuria Vision Blurred Blood Pressure Increased
Product Lariam
Role PS
Manufacturer Hoffmann La Roche Inc
Route ORAL
Duration
03-Apr-2012
09:37 AM
Page: 193
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/00ISR Number: 3510086-4Report Type:Periodic Outcome Other Serious PT Heart Rate Increased Coordination Abnormal Tremor Hyperhidrosis Anxiety Headache Company Report #212713 Report Source Other Product Lariam Progesterone Ogen Role PS C C Manufacturer Hoffmann La Roche Inc Age:54 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:06/06/00ISR Number: 3510087-6Report Type:Periodic Outcome Other Serious PT Dizziness Anxiety Arthralgia Abnormal Dreams
Company Report #215004 Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/06/00ISR Number: 3510088-8Report Type:Periodic Outcome Other Serious PT Gingival Erosion
Company Report #216929 Report Source Health Professional Product Lariam Calcium Supplements Role PS C Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/06/00ISR Number: 3510089-XReport Type:Periodic Outcome Other Serious PT Anxiety Fatigue Dizziness Oropharyngeal Pain
Age: Route ORAL
I/FU:I Duration
Date:06/06/00ISR Number: 3510090-6Report Type:Periodic Outcome Other Serious PT Amenorrhoea
Company Report #218907 Report Source Consumer Health Professional Product Lariam Birth Control Pills Role PS SS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 250 MG 1 PER WEEK ORAL ORAL
I/FU:I Duration
Age:55 YR
Gender:Female
I/FU:I
PT Malaise Vertigo
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
03-Apr-2012
09:37 AM
Page: 194
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/00ISR Number: 3510094-3Report Type:Periodic Outcome Other Serious PT Insomnia Asthenia Mental Impairment Balance Disorder Company Report #219667 Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:61 YR Route ORAL Gender:Male Dose ORAL I/FU:I Duration
Date:06/06/00ISR Number: 3510097-9Report Type:Periodic Outcome Other Serious PT Vertigo Malaise
Company Report #219671 Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/06/00ISR Number: 3510098-0Report Type:Periodic Outcome Other Serious PT Feeling Abnormal Malaise
I/FU:I Duration
Date:06/06/00ISR Number: 3510100-6Report Type:Periodic Outcome Other Serious PT Sedation Mood Swings Red Blood Cell Count Increased Dizziness Electrocardiogram Abnormal Conversion Disorder Electrocardiogram Change Nightmare Psychotic Disorder Confusional State Disorientation Paranoia Insomnia Crying Night Sweats Hallucination
Company Report #220897 Report Source Consumer Product Lariam Oral Contraceptive Nos Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 250 MG DAILY ORAL
I/FU:I Duration
Age:36 YR
Gender:Male
I/FU:I
PT Insomnia Anxiety Depression Dehydration Panic Attack Heart Rate Increased 09:37 AM
Report Source Consumer Other
Product Lariam Lotensin
Role PS C
Route ORAL
Duration
03-Apr-2012
Page: 195
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/00ISR Number: 3510106-7Report Type:Periodic Outcome Other Serious PT Body Temperature Increased Nasopharyngitis Fatigue Blood Pressure Diastolic Increased Urinary Tract Infection Tachycardia Anxiety Dizziness Decreased Appetite Productive Cough Dyspnoea Oropharyngeal Pain Pyrexia Company Report #222392 Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:28 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:06/06/00ISR Number: 3510107-9Report Type:Periodic Outcome Other Serious PT Fatigue Diarrhoea
Date:06/06/00ISR Number: 3510109-2Report Type:Periodic Outcome Other Serious PT Oedema Peripheral Lethargy
Age: Route ORAL
Date:06/06/00ISR Number: 3510111-0Report Type:Periodic Outcome Other Serious PT Delusion Tachycardia Dizziness Pyrexia Anxiety Diarrhoea Hypoaesthesia Upper Respiratory Tract Infection Fatigue Dysphoria
Company Report #224970 Report Source Health Professional Product Lariam Fosamax Role PS C Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Hypoaesthesia Oral Disturbance In Attention Dyspnoea Abdominal Pain Hypoventilation
03-Apr-2012
09:37 AM
Page: 196
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/00ISR Number: 3510113-4Report Type:Periodic Outcome Other Serious PT Insomnia Chest Discomfort Chest Pain Anxiety Company Report #227110 Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:35 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:06/06/00ISR Number: 3510116-XReport Type:Periodic Outcome Other Serious PT Panic Attack Nausea Headache Anxiety Paraesthesia Tremor Dizziness Hyperhidrosis Palpitations Abnormal Dreams Decreased Appetite Chills Chest Pain Alopecia Vomiting
Company Report #200733 Report Source Consumer Product Lariam Estrogen (Estrogens Nos) Progestin (Progestin Nos) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
C C
Date:06/06/00ISR Number: 3510118-3Report Type:Periodic Outcome Other Serious PT Asthenia Ear Disorder Eye Disorder Discomfort Headache
I/FU:I Duration
Date:06/06/00ISR Number: 3510120-1Report Type:Periodic Outcome Other Serious PT Dizziness Asthenia Tachycardia Irritability Hyperacusis Insomnia Disturbance In Attention Paranoia
I/FU:I Duration
Date:06/06/00ISR Number: 3510124-9Report Type:Periodic Outcome Other Serious 03-Apr-2012 09:37 AM PT Tachycardia Flushing
Age:36 YR
Gender:Female
I/FU:I
Page: 197
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Syncope Hypotension
Product Lariam Synthroid (Levothyroxine Sodium)
Role PS
Route ORAL
Dose 1 PER WEEK ORAL
Duration
Date:06/06/00ISR Number: 3510127-4Report Type:Periodic Outcome Other Serious PT Nuclear Magnetic Resonance Imaging Abnormal Tinnitus Malaria Alopecia Vision Blurred Drug Ineffective
I/FU:I Duration
Date:06/06/00ISR Number: 3510131-6Report Type:Periodic Outcome Other Serious PT Muscle Spasms Syncope Abdominal Pain Coordination Abnormal Diarrhoea Dizziness
I/FU:I Duration
Date:06/06/00ISR Number: 3510134-1Report Type:Periodic Outcome Other Serious PT Condition Aggravated Balance Disorder Panic Attack Phobia
Company Report #212816 Report Source Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/06/00ISR Number: 3510137-7Report Type:Periodic Outcome Other Serious PT Eye Movement Disorder Loss Of Consciousness
Gender:Female Dose 250 MG 1 PER
I/FU:I Duration
Crying Convulsion Bite Tremor Amnesia Fall
ONE DOSE ORAL
03-Apr-2012
09:37 AM
Page: 198
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/00ISR Number: 3510140-7Report Type:Periodic Outcome Other Serious PT Pyrexia Drug Ineffective Malaria Diarrhoea Headache Company Report #214497 Report Source Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:29 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:06/06/00ISR Number: 3510142-0Report Type:Periodic Outcome Other Serious PT Malaria Pyrexia Drug Ineffective Haematocrit Decreased Chills White Blood Cell Count Decreased Platelet Count Decreased
I/FU:I Duration
Date:06/06/00ISR Number: 3510147-XReport Type:Periodic Outcome Other Serious PT Alopecia Dizziness Hallucination Vomiting Suicidal Ideation
Age: Route ORAL
I/FU:I Duration
Date:06/06/00ISR Number: 3510150-XReport Type:Periodic Outcome Disability PT Dyspnoea Constipation Choking Muscle Twitching Diarrhoea Panic Attack
Company Report #227106 Report Source Health Professional Other Product Lariam Ortho-Novum (Ethinyl Estradiol Or Mestranol/Norethidro ne) Aspirin (Aspirin) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
C C
Age:46 YR Route
Gender:Male Dose
I/FU:I Duration
Other Serious
Syncope Hyperhidrosis Dyspnoea Oxygen Saturation Decreased Bradycardia
Health Professional
Lariam
PS
ORAL
03-Apr-2012
09:37 AM
Page: 199
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/00ISR Number: 3510156-0Report Type:Periodic Outcome Other Serious PT Iritis Scotoma Eye Pain Dermatitis Atopic Blindness Company Report #205795 Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:50 YR Route ORAL Gender:Female Dose ORAL I/FU:I Duration
Date:06/06/00ISR Number: 3510158-4Report Type:Periodic Outcome Other Serious PT Tongue Disorder
Company Report #205967 Report Source Health Professional Product Lariam Relafen (Nabmetone) Prednisone (Prednisone) Plaquenil (Hydrochloroquine Sulfate) Role PS C C C Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:06/06/00ISR Number: 3510160-2Report Type:Periodic Outcome Other Serious PT Anxiety Petechiae
Age: Route ORAL
I/FU:I Duration
Date:06/06/00ISR Number: 3510164-XReport Type:Periodic Outcome Other Serious PT Fatigue Pyrexia Blood Thyroid Stimulating Hormone Increased Liver Function Test Abnormal Chills
Company Report #208862 Report Source Health Professional Product Lariam Vitamin C (Ascorbic Acid) Inhaler Nos (Inhalant Nos) Multivitamin (Multivitamin Nos) Beta-Carotene (Beta Carotene) Unknown Drug (Generic Component(S) Unknown) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
C C C C
Ventolin Inhaler (Albuterol) Calcium (Calcium Nos)
C C
03-Apr-2012
09:37 AM
Page: 200
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/00ISR Number: 3510165-1Report Type:Periodic Outcome Other Serious PT Visual Acuity Reduced Gout Company Report #208888 Report Source Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:60 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:06/06/00ISR Number: 3510169-9Report Type:Periodic Outcome Other Serious PT Haematuria
Gender: Dose ORAL
I/FU:I Duration
Date:06/06/00ISR Number: 3510172-9Report Type:Periodic Outcome Other Serious PT Blood Pressure Increased Pallor Dizziness
I/FU:I Duration
Date:06/06/00ISR Number: 3510191-2Report Type:Periodic Outcome Other Serious PT Dizziness Vertigo Memory Impairment Disturbance In Attention Chills Headache Tinnitus Insomnia
Gender:Male Dose 1.25 GRAM 1 PER ONE DOSE ORAL
I/FU:I Duration
Date:06/06/00ISR Number: 3510193-6Report Type:Periodic Outcome Other Serious PT Feeling Abnormal Depression Fatigue
Company Report #231666 Report Source Consumer Product Lariam Ativan (Lorazepam) Celexa (Citalopram) Role PS C C Manufacturer Hoffmann La Roche Inc
Age: Route
Gender:Female Dose
I/FU:I Duration
Age:21 YR
Gender:Male
I/FU:I
Other Serious
Feeling Abnormal Asthma Vertigo Panic Attack Paranoia Anxiety Fatigue Insomnia 09:37 AM Page: 201
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Restlessness Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Route ORAL Dose 1 PER WEEK ORAL Duration
Date:06/06/00ISR Number: 3510196-1Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Lethargy Chills Drug Ineffective Diarrhoea Hyperhidrosis Vomiting Malaria Abdominal Pain Dehydration Leukocytosis Pyrexia
Company Report #112461 Report Source Consumer Health Professional Product Lariam Prilosec (Omeprazole) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:06/06/00ISR Number: 3510198-5Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Paranoia Depression Delusion
I/FU:I Duration
Date:06/06/00ISR Number: 3510200-0Report Type:Periodic Outcome Other Serious PT Confusional State Convulsion Amnesia
Age:6 YR Route ORAL
I/FU:I Duration
Date:06/08/00ISR Number: 3510582-XReport Type:Expedited (15-DaCompany Report #237264 Outcome Other Serious PT Spinal Fracture Convulsion Dizziness Fall Drug Ineffective Report Source Foreign Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:06/08/00ISR Number: 3510583-1Report Type:Expedited (15-DaCompany Report #237590 Outcome Other Serious PT Intra-Uterine Death Accidental Exposure 09:37 AM Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route
Gender:Unknown Dose
I/FU:I Duration
03-Apr-2012
Page: 202
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/00ISR Number: 3510584-3Report Type:Expedited (15-DaCompany Report #237544 Outcome Hospitalization Initial or Prolonged PT Malaria Malaise Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route Gender:Male Dose I/FU:I Duration
Date:06/08/00ISR Number: 3510585-5Report Type:Expedited (15-DaCompany Report #237143 Outcome Hospitalization Initial or Prolonged PT Pyrexia Hallucination Arthralgia Aspartate Aminotransferase Increased Alanine Aminotransferase Increased Jaundice Nausea Asthenia Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 1 DOSE FORM ORAL
I/FU:I Duration
Date:06/08/00ISR Number: 3510586-7Report Type:Expedited (15-DaCompany Report #236875 Outcome Disability PT Pain Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:06/09/00ISR Number: 3510997-XReport Type:Expedited (15-DaCompany Report #237587 Outcome Other Serious PT Intra-Uterine Death Accidental Exposure Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route
Gender: Dose
I/FU:I Duration
Date:06/09/00ISR Number: 3517524-1Report Type:Periodic Outcome Other Serious PT Rash Pruritic Dermatitis Skin Wrinkling
Company Report #73316 Report Source Consumer Product Accutane Lariam Tablets (Mefloquine Hydrochloride) 250 Role PS Manufacturer Hlr Technology
Gender:Female Dose 20 MG 3 PER DAY ORAL
I/FU:I Duration
Mg Ortho Novum (Ethinyl Estradiol Or Mestranol/Norethindr one) Synthroid (Levothyroxine 03-Apr-2012 09:37 AM
SS
ORAL
Page: 203
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C
Date:06/13/00ISR Number: 3513543-XReport Type:Expedited (15-DaCompany Report #237062 Outcome Hospitalization Initial or Prolonged PT Insomnia Agitation Anxiety Delirium Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/15/00ISR Number: 3514429-7Report Type:Expedited (15-DaCompany Report #237672 Outcome Other Serious PT Vision Blurred Cataract Visual Impairment Disturbance In Attention Report Source Foreign Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/20/00ISR Number: 3516339-8Report Type:Expedited (15-DaCompany Report #215628 Outcome Congenital Anomaly PT Ultrasound Antenatal Screen Abnormal Trisomy 21 Amniocentesis Abnormal Abortion Induced Foetal Disorder Maternal Drugs Affecting Foetus Cystic Lymphangioma Pregnancy Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Gender:Unknown Dose 250 MG 1 PER WEEK ORAL
I/FU:F Duration
Date:06/20/00ISR Number: 3516343-XReport Type:Expedited (15-DaCompany Report #237264 Outcome Other Serious PT Convulsion Malaria Paraesthesia Spinal Fracture Fall Drug Ineffective Feeling Abnormal Dizziness Headache Report Source Foreign Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:06/21/00ISR Number: 3517156-5Report Type:Expedited (15-DaCompany Report #237147 Outcome Hospitalization Initial or Prolonged PT Anuria Thrombocytosis Urinary Retention Pyrexia
Age:39 YR
Gender:Female
I/FU:F
03-Apr-2012
09:37 AM
Page: 204
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysuria Erythema Hypokalaemia Exfoliative Rash C-Reactive Protein Increased Skin Disorder Cystitis Neurogenic Bladder Pyelonephritis Dermatitis
Product Lariam Suspected Unspecified Drug (Generic Component(S) Unknown) Suspected Unspecified Drug (Generic Component(S) Unknown)
Role PS
Route ORAL
Dose 250 MG ORAL
Duration
SS
6 DOSE FORM DAILY
SS
ORAL
1 DOSE FORM DAILY ORAL
Date:06/21/00ISR Number: 3517158-9Report Type:Expedited (15-DaCompany Report #238384 Outcome Hospitalization Initial or Prolonged PT Liver Function Test Abnormal Abdominal Pain Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:06/23/00ISR Number: 3518681-3Report Type:Expedited (15-DaCompany Report #238706 Outcome Other Serious PT Tendon Rupture Report Source Foreign Other Product Lariam Atenolol (Atenolol) Role PS C Manufacturer Hoffmann La Roche Inc
Date:06/26/00ISR Number: 3520477-3Report Type:Expedited (15-DaCompany Report #238943 Outcome Hospitalization Initial or Prolonged PT Hypoproteinaemia Blood Bilirubin Increased Jaundice Ascites Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/27/00ISR Number: 3520664-4Report Type:Expedited (15-DaCompany Report #238749 Outcome Hospitalization Initial or Prolonged PT Malaria Tremor
Age:
Gender:Male
I/FU:I
Disability
Hallucination Sensory Disturbance Pupils Unequal Chest Pain Coordination Abnormal Fatigue Drug Ineffective Headache 09:37 AM Page: 205
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Visual Impairment Emotional Disorder Depression Pain In Extremity Blood Pressure Increased Paranoia Muscle Twitching Disturbance In Attention Circulatory Collapse Nightmare Abnormal Dreams Asthenia Nervous System Disorder Feeling Of Body Temperature Change
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
Date:06/27/00ISR Number: 3520667-XReport Type:Expedited (15-DaCompany Report #237264 Outcome Life-Threatening PT Paraesthesia Dizziness Headache Malaria Feeling Abnormal Drug Ineffective Spinal Fracture Pain Fall Convulsion Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:06/27/00ISR Number: 3520673-5Report Type:Expedited (15-DaCompany Report #237544 Outcome Hospitalization Initial or Prolonged PT Malaise Malaria Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:06/28/00ISR Number: 3521532-4Report Type:Expedited (15-DaCompany Report #232833 Outcome Hospitalization Initial or Prolonged PT Sleep Disorder Nausea Tremor Depression Mental Disorder Neuropathy Peripheral Depressed Mood Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:06/28/00ISR Number: 3521542-7Report Type:Expedited (15-DaCompany Report #231053 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Hyporeflexia Csf Protein Increased
Age:62 YR
Gender:Male
I/FU:F
Page: 206
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lumbar Puncture Abnormal Dizziness Gait Disturbance Antibody Test Positive Myalgia Muscular Weakness Polyneuropathy Balance Disorder Dyspnoea Paraesthesia
Product Lariam Proscar (Finasteride)
Role PS
Route ORAL
Duration
Date:06/29/00ISR Number: 3522435-1Report Type:Expedited (15-DaCompany Report #238730 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Blood Pressure Systolic Increased Calcinosis Enterococcal Bacteraemia Computerised Tomogram Abnormal Vomiting Low Cardiac Output Syndrome Malaise Red Blood Cell Sedimentation Rate Increased Pyrexia Loss Of Consciousness Hepatitis B Antibody Positive Urinary Tract Infection Hepatitis Dehydration C-Reactive Protein Increased Liver Function Test Abnormal Hepatic Function Abnormal Asthenia Torsade De Pointes Culture Urine Positive Circulatory Collapse Electrocardiogram Qt Prolonged Report Source Foreign Other Product Lariam Budesonide (Budesonide) Warfarin (Warfarin Sodium) Bumetanide (Bumetanide) Metformin (Metformin) Amiodarone (Amiodarone) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
C C C C C
Age:32 YR Route
Gender:Male Dose
I/FU:I Duration
Other Serious
Amyotrophic Lateral Sclerosis
Foreign Other
Lariam
PS
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 207
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/00ISR Number: 3524097-6Report Type:Direct Outcome PT Insomnia Vomiting Feeling Cold Flushing Pain Pyrexia Cold Sweat Diarrhoea Decreased Appetite Company Report # Report Source Product Lariam 250mg Hoffman/Roche Tylenol-Acetaminioph en Role PS C Manufacturer Hoffman/Roche Age:23 YR Route ORAL Gender:Male Dose 250MG ONCE WEEKLY ORAL I/FU:I Duration
Date:07/05/00ISR Number: 3524160-XReport Type:Expedited (15-DaCompany Report #236161 Outcome Hospitalization Initial or Prolonged PT Purpura Hepatic Infarction Renal Impairment Hepatic Enzyme Increased Report Source Foreign Health Professional Product Lariam Previscan (Fluindione) Lasilix Seloken Pyostacine Praxilene Cordarone Levothyrox Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL ORAL
Gender:Male Dose 1 DOSE FORM 1 PER WEEK ORAL ORAL
I/FU:F Duration
SS C C C C C C
Date:07/05/00ISR Number: 3524263-XReport Type:Direct Outcome Other Serious PT Gastrointestinal Pain Fatigue Back Pain
Company Report # Report Source Product Lariam 250mg (Hoffman Laroche Ltd) Role PS Manufacturer Hoffman Laroche Ltd
Gender:Male Dose 1 PILL , 1 X WEEK, ORAL 047
I/FU:I Duration
Date:07/05/00ISR Number: 3524267-7Report Type:Direct Outcome PT Gastrointestinal Pain Eye Pain Vomiting Dizziness Headache Diarrhoea Balance Disorder
Company Report # Report Source Product Lariam -250mg (Hoffmann-La Roche, Ltd) Role PS Manufacturer Hoffmann-La Roche, Ltd
Age:57 YR Route
Gender:Female Dose
I/FU:I Duration
ORAL
1 PILL, 1X WEEK, ORAL 047
Rash Pruritic Abdominal Pain Upper Discomfort
03-Apr-2012
09:37 AM
Page: 208
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/00ISR Number: 3524360-9Report Type:Expedited (15-DaCompany Report #237264 Outcome Life-Threatening PT Spinal Fracture Pain Malaria Convulsion Paraesthesia Drug Ineffective Fall Headache Feeling Abnormal Dizziness Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:50 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
Date:07/05/00ISR Number: 3524794-2Report Type:Expedited (15-DaCompany Report #239438 Outcome Hospitalization Initial or Prolonged PT Deafness Drug Level Above Therapeutic Medication Error Tinnitus Electrocardiogram Qt Prolonged Vomiting Report Source Foreign Other Product Lariam Quinimax (Cinchonidine/Cincho nine/Quinidine/Quini ne) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
SS
ORAL
ORAL
Date:07/07/00ISR Number: 3526201-2Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Fatigue Depression Amnesia Headache Insomnia Abnormal Behaviour Cranial Nerve Disorder Judgement Impaired Dislocation Of Vertebra Emotional Disorder Toxicity To Various Agents Nervous System Disorder Decreased Appetite
Company Report # Report Source Consumer Product Larium / Mefloquin 250mg Role PS Manufacturer
Gender:Female Dose 250MG/ WEEKLY/ ORAL
I/FU:I Duration
Age:33 YR
Gender:Male
I/FU:F
Death
Splenomegaly Psychotic Disorder Completed Suicide Pyrexia Malaise Bone Pain Oropharyngeal Pain Burning Sensation 09:37 AM Page: 209
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Panic Disorder Dyspnoea Peripheral Coldness Dizziness Disorientation Headache Malaria Depression Anxiety Hypoaesthesia Fear Cardiomyopathy Chills Confusional State Myocarditis Diarrhoea
Report Source Foreign Literature Health Professional Other
Product Lariam Co-Trimoxazol Penicillin V Intravenous Glucose Paracetamol Codeine Phosphate Fansidar Quinine Antimalarial Agent Aspirin
Role PS C C C C C C C C C
Route ORAL
Dose 500 MG 1 PER ONE DOSE ORAL
Duration
Date:07/11/00ISR Number: 3527822-3Report Type:Expedited (15-DaCompany Report #239809 Outcome Other Serious PT Obsessive-Compulsive Disorder Anxiety Aggression Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:07/11/00ISR Number: 3527823-5Report Type:Expedited (15-DaCompany Report #203837 Outcome Death PT Insomnia Decreased Appetite Agitation Chills Flushing Staring Lethargy Obsessive-Compulsive Disorder Nervous System Disorder Depression Hallucination Hyperhidrosis Weight Decreased Coma Fatigue Completed Suicide Urinary Hesitation Feeling Abnormal Anxiety Delusional Disorder,
Age:54 YR
Gender:Male
I/FU:F
Persecutory Type Amnesia Cognitive Disorder Musculoskeletal Stiffness Delirium Adjustment Disorder Polydipsia Hallucinations, Mixed 03-Apr-2012 09:37 AM Page: 210
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mental Disorder Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Route ORAL Dose 250 MG 1 PER 1 WEEK ORAL Duration
Date:07/11/00ISR Number: 3527825-9Report Type:Expedited (15-DaCompany Report #235479 Outcome Disability PT Corneal Disorder Corneal Oedema Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:07/12/00ISR Number: 3528437-3Report Type:Expedited (15-DaCompany Report #236649 Outcome Hospitalization Initial or Prolonged PT Nausea Fatigue Decreased Appetite Abdominal Pain Oesophageal Candidiasis Gastritis Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:07/14/00ISR Number: 3529989-XReport Type:Expedited (15-DaCompany Report #239896 Outcome Other Serious PT Hepatitis E Hypertriglyceridaemia Blood Immunoglobulin A Increased Blood Immunoglobulin M Increased Serum Ferritin Increased High Density Lipoprotein Decreased Jaundice Cholestasis Blood Bilirubin Increased Liver Function Test Abnormal Hypercholesterolaemia Blood Immunoglobulin G Increased Monocytosis Hepatitis Report Source Foreign Health Professional Product Lariam Sortis (Atorvastatin Calcium) Havrix (Hepatitis A Vaccine) Omeprazole (Omeprazole) Hb-Vax-Dna (Hepatitis B Virus Vaccine Inactivated) Hepatitis B Immunoglobulin (Hepatitis B Immune Globulin) Beloc Zok Mite (Metoprolol Succinate) Delix (Ramipril) Ass (Aspirin) Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Gender:Male Dose 250 MG 1 PER WEEK ORAL 30 MG DAILY
I/FU:I Duration
SS C C C
C C C C
Date:07/20/00ISR Number: 3532363-3Report Type:Direct Outcome Required Intervention to 03-Apr-2012 09:37 AM
Company Report #
Age:
Gender:Female
I/FU:I
Page: 211
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Dizziness Lethargy Disturbance In Attention Mental Impairment Nausea Emotional Distress Report Source Product Lariam 250mg Laroche Bi-Est Estriol/Estradiol Progesterone Role PS C C C Manufacturer Laroche Route ORAL Dose Duration 250MG WEEKLY ORAL
Date:07/21/00ISR Number: 3534058-9Report Type:Expedited (15-DaCompany Report #240830 Outcome Other Serious PT Hallucination Injury Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:07/24/00ISR Number: 3533956-XReport Type:Direct Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Paranoia
Company Report # Report Source Product Mefloquin Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration SMALL WEEKLY / LARGE ONE TIME / ORAL
Deployment Vaccines For Us Army And Gulf War 90-91
Date:07/24/00ISR Number: 3533962-5Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Insomnia Decreased Appetite Weight Decreased Depression Anxiety
Company Report # Report Source Product Mefloqine Lariam Roche Role PS Manufacturer Roche
Gender:Male Dose 1 PILL WEEK ORAL
I/FU:I Duration
Date:07/25/00ISR Number: 3534612-4Report Type:Direct Outcome Disability PT Insomnia Fatigue Attention Deficit/Hyperactivity Disorder
Company Report # Report Source Product Lariam Mephloquine Role PS Manufacturer Roche Laboratories
Age: Route ORAL
Gender:Female Dose 1/10 DAYS ORAL
I/FU:I Duration
Headache Disturbance In Attention Anxiety Amnesia Communication Disorder Tinnitus Hearing Impaired 03-Apr-2012 09:37 AM Page: 212
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/00ISR Number: 3535273-0Report Type:Expedited (15-DaCompany Report #213831 Outcome Other Serious PT Premature Baby Maternal Drugs Affecting Foetus Report Source Foreign Health Professional Product Lariam Zovirax Role PS C Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:07/26/00ISR Number: 3535783-6Report Type:Expedited (15-DaCompany Report #241048 Outcome Hospitalization Initial or Prolonged PT Cerebellar Syndrome Csf White Blood Cell Count Positive Physical Examination Abnormal Coma Pyrexia Blood Pressure Diastolic Decreased Csf Protein Increased Bradycardia Confusional State Encephalitis Agitation Hallucination, Visual Musculoskeletal Stiffness Abnormal Behaviour Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 150 MG 1 PER ONE DOSE ORAL
I/FU:I Duration
Date:07/27/00ISR Number: 3536477-3Report Type:Expedited (15-DaCompany Report #219219 Outcome Congenital Anomaly PT Pregnancy Maternal Drugs Affecting Foetus Neonatal Disorder Cardiac Murmur Congenital Anomaly Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:07/28/00ISR Number: 3537250-2Report Type:Direct Outcome Other Serious PT Asthenia Abnormal Dreams
Age:71 YR Route
Gender:Male Dose
I/FU:I Duration
Date:08/01/00ISR Number: 3539212-8Report Type:Expedited (15-DaCompany Report #240839 Outcome Hospitalization Initial or Prolonged Disability PT Hypomania Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 213
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/00ISR Number: 3539316-XReport Type:Expedited (15-DaCompany Report #240830 Outcome Other Serious PT Hallucination Haemorrhage Nightmare Injury Amnesia Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:24 YR Route ORAL Gender:Male Dose ORAL I/FU:F Duration
Date:08/01/00ISR Number: 3539356-0Report Type:Expedited (15-DaCompany Report #241365 Outcome Disability PT Anxiety Headache Vertigo Dizziness Depression Panic Attack Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:08/01/00ISR Number: 3539359-6Report Type:Expedited (15-DaCompany Report #241539 Outcome Other Serious PT Tremor Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Date:08/01/00ISR Number: 3539361-4Report Type:Expedited (15-DaCompany Report #241249 Outcome Other Serious PT Paranoia Social Avoidant Behaviour Intentional Overdose Suicide Attempt Report Source Foreign Health Professional Product Lariam Paracetamol/Pseudoep hedrine (Acetaminophen/Pseud oephedrine Hydrochloride) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
SS
Date:08/01/00ISR Number: 3539370-5Report Type:Expedited (15-DaCompany Report #241194 Outcome Other Serious PT Deafness Congenital Maternal Drugs Affecting Foetus Psychomotor Retardation Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age:3 YR Route ORAL
Date:08/02/00ISR Number: 3539668-0Report Type:Direct Outcome Other Serious PT Medication Error
Company Report # Report Source Consumer Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:
I/FU:I
Dose Duration 250MG TABLET
03-Apr-2012
09:37 AM
Page: 214
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/00ISR Number: 3544183-4Report Type:Expedited (15-DaCompany Report #233963 Outcome Hospitalization Initial or Prolonged PT Blood Lactate Dehydrogenase Increased Leukopenia Haptoglobin Decreased Haemolytic Anaemia Overdose Balance Disorder Medication Error Thrombocytopenia Dizziness Hypokalaemia Report Source Foreign Health Professional Product Lariam Prodafalgan Potassium Quinimax Role PS C C C Manufacturer Hoffmann La Roche Inc Age:39 YR Route ORAL Gender:Female Dose ORAL I/FU:F Duration
Date:08/07/00ISR Number: 3544187-1Report Type:Expedited (15-DaCompany Report #241950 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Malaria Malaise Anaphylactic Shock Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:08/10/00ISR Number: 3547668-XReport Type:Expedited (15-DaCompany Report #232139 Outcome Hospitalization Initial or Prolonged PT Astigmatism Staphylococcal Infection Hypoaesthesia Feeling Abnormal Vertigo Pyrexia Alanine Aminotransferase Increased Gastritis Visual Impairment Nystagmus Temperature Regulation Disorder Facial Nerve Disorder Tinnitus Malaise Palpitations Hearing Impaired Nervous System Disorder Arthritis Diarrhoea Conduction Disorder Binocular Eye Movement Disorder
Age:33 YR
Gender:Male
I/FU:I
Antibody Test Negative Neck Pain Gait Disturbance Hyporeflexia Csf Test Abnormal Balance Disorder Eye Movement Disorder Diplopia 03-Apr-2012 09:37 AM Page: 215
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Folliculitis Eye Disorder Hyperreflexia Hypertension Paraesthesia Optic Disc Disorder Influenza Like Illness Hepatosplenomegaly Rash Pustular
Product Lariam
Role PS
Route ORAL
Dose 250 MG 1 PER 15 DAY ORAL
Duration
Date:08/11/00ISR Number: 3549527-5Report Type:Expedited (15-DaCompany Report #238191 Outcome Other Serious PT Nausea Fatigue Syncope Diarrhoea Dizziness Disturbance In Attention Balance Disorder Report Source Foreign Health Professional Product Lariam Vertigoheel (Ambra/Cocculus/Coni um/Petrolatum) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:08/11/00ISR Number: 3549531-7Report Type:Expedited (15-DaCompany Report #241757 Outcome Hospitalization Initial or Prolonged PT Disturbance In Attention Conjunctival Hyperaemia Fatigue Sedation Eyelid Oedema Abdominal Pain Panic Attack Decreased Activity Visual Impairment Nervous System Disorder Report Source Foreign Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:08/11/00ISR Number: 3549536-6Report Type:Expedited (15-DaCompany Report #237672 Outcome Other Serious PT Balance Disorder Condition Aggravated Cataract Visual Impairment Vision Blurred Confusional State Memory Impairment Alopecia Disturbance In Attention Report Source Foreign Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Fatigue Dizziness
03-Apr-2012
09:37 AM
Page: 216
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/00ISR Number: 3551061-3Report Type:Expedited (15-DaCompany Report #242221 Outcome Other Serious PT Retinal Haemorrhage Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Female Dose ORAL I/FU:I Duration
Date:08/15/00ISR Number: 3551062-5Report Type:Expedited (15-DaCompany Report #238943 Outcome Hospitalization Initial or Prolonged PT Hypoproteinaemia Jaundice Ascites Blood Bilirubin Increased Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:08/16/00ISR Number: 3551060-1Report Type:Expedited (15-DaCompany Report #240839 Outcome Hospitalization Initial or Prolonged Disability PT Hypomania Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:08/16/00ISR Number: 3551475-1Report Type:Expedited (15-DaCompany Report #242474 Outcome Congenital Anomaly PT Hydrocephalus Cerebellar Hypoplasia Hearing Impaired Visual Impairment Congenital Anomaly Convulsion Electroencephalogram Abnormal Maternal Drugs Affecting Foetus Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Date:08/17/00ISR Number: 3552270-XReport Type:Expedited (15-DaCompany Report #58978 Outcome Other Serious PT Nausea Back Pain Fatigue Affective Disorder Stress Anger
Age:31 YR
Gender:Male
I/FU:F
Spinal Disorder Clonic Convulsion Amnesia Multiple Sclerosis Emotional Disorder Balance Disorder Nervous System Disorder Diarrhoea 03-Apr-2012 09:37 AM Page: 217
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypoaesthesia Ligament Sprain Asthenia Irritability Fasciitis Infarction Arthropathy Panic Attack Gait Disturbance Dyspnoea Vertigo Syncope Coordination Abnormal Nervousness Dermatitis Throat Tightness Road Traffic Accident Hearing Impaired Drug Hypersensitivity Spinal Fracture Derealisation Arthralgia Neck Pain Cerebellar Ataxia Anxiety Sinus Headache Dizziness Disturbance In Attention Feeling Abnormal Vestibular Disorder Sensation Of Pressure Disorientation Headache Opticokinetic Nystagmus Tests Abnormal Confusional State Oropharyngeal Pain Heart Rate Increased Pain Nystagmus Vomiting Dysphagia
Product Lariam Norflex (Orphenadrine Citrate)
Role PS
Route ORAL
Duration
Date:08/17/00ISR Number: 3552322-4Report Type:Expedited (15-DaCompany Report #242515 Outcome Hospitalization Initial or Prolonged PT Pyrexia Vomiting Hallucination Depression Sedation Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Confusional State
03-Apr-2012
09:37 AM
Page: 218
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/00ISR Number: 3553097-5Report Type:Direct Outcome Other Serious PT Malaise Bipolar I Disorder Depression Mood Swings Anxiety Hallucination Lethargy Psychiatric Symptom Visual Acuity Reduced Hypoaesthesia Company Report # Report Source Product Lariam 250mg Roche Role PS Manufacturer Roche Age:30 YR Route ORAL Gender:Female Dose 250MG ONCE PER ORAL I/FU:I Duration
Date:08/18/00ISR Number: 3553806-5Report Type:Expedited (15-DaCompany Report #242746 Outcome Hospitalization Initial or Prolonged PT Depressed Level Of Consciousness Encephalitis Disorientation Lymphocytosis Report Source Foreign Other Product Lariam Stamaril Unidose (Yellow Fever Vaccine) Role PS Manufacturer Hoffmann La Roche Inc
Age:56 YR Route ORAL SUBCUTANEOUS
Gender:Male Dose ORAL 1 DOSE FORM 1 PER DAY SUBCUTANEOUS
I/FU:I Duration
SS
Date:08/22/00ISR Number: 3554807-3Report Type:Direct Outcome PT Panic Attack Insomnia Depression Suicidal Ideation Paranoia Headache Anxiety
Company Report # Report Source Product Lariam-Mefloquine Hcl-250mg Hoffman-La Roche Role PS Manufacturer Hoffman-La Roche
Gender:Female Dose 1 TABLET WEEK ORAL
I/FU:I Duration
Date:08/22/00ISR Number: 3555499-XReport Type:Expedited (15-DaCompany Report #215928 Outcome Hospitalization Initial or Prolonged PT Jaundice Hepatic Necrosis Liver Function Test Abnormal Toxicity To Various Agents Spleen Disorder Autoimmune Disorder Report Source Consumer Health Professional Product Lariam Vitamin Nos Role PS SS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Blood Bilirubin Increased
03-Apr-2012
09:37 AM
Page: 219
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/00ISR Number: 3556414-5Report Type:Expedited (15-DaCompany Report #242880 Outcome Other Serious PT Amnesia Fear Alopecia Depression Crying Dizziness Nausea Toxicity To Various Agents Thinking Abnormal Panic Reaction Feeling Jittery Delusion Nightmare Abdominal Distension Diarrhoea Anxiety Report Source Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Date:08/24/00ISR Number: 3557763-7Report Type:Expedited (15-DaCompany Report #243099 Outcome Death PT Completed Suicide Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:08/24/00ISR Number: 3557764-9Report Type:Expedited (15-DaCompany Report #243090 Outcome Hospitalization Initial or Prolonged PT Nervousness Urinary Tract Infection Headache Flushing Tremor Muscle Spasms Palpitations Fear Diarrhoea Phobia Myalgia Asthenia Weight Decreased Malaise Dizziness Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Age:28 YR
Gender:Male
I/FU:I
PT Panic Attack Circulatory Collapse Dizziness Disturbance In Attention Chest Pain Pyrexia Page: 220
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Palpitations Anxiety Paraesthesia
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
Date:08/25/00ISR Number: 3559237-6Report Type:Expedited (15-DaCompany Report #243079 Outcome Other Serious PT Extrasystoles Maternal Drugs Affecting Foetus Polyhydramnios Pregnancy Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route
Gender:Unknown Dose
Date:08/25/00ISR Number: 3559244-3Report Type:Expedited (15-DaCompany Report #243061 Outcome Other Serious PT Stillbirth Accidental Exposure Maternal Drugs Affecting Foetus Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route
Gender:Unknown Dose
I/FU:I Duration
Date:08/25/00ISR Number: 3559246-7Report Type:Expedited (15-DaCompany Report #243107 Outcome Other Serious PT Pregnancy Intra-Uterine Death Accidental Exposure Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:08/25/00ISR Number: 3559248-0Report Type:Expedited (15-DaCompany Report #243034 Outcome Death Life-Threatening PT Sedation Gastric Perforation Nuclear Magnetic Resonance Imaging Abnormal Stupor Cardio-Respiratory Arrest Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 2 DOSE FORM 1 PER ONE DOSE ORAL
I/FU:I Duration
Age:
Gender:Unknown
I/FU:F
PT Intra-Uterine Death Accidental Exposure
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
03-Apr-2012
09:37 AM
Page: 221
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/00ISR Number: 3561965-3Report Type:Expedited (15-DaCompany Report #243061 Outcome Other Serious PT Intra-Uterine Death Stillbirth Pregnancy Accidental Exposure Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route Gender:Unknown Dose I/FU:F Duration
Date:08/30/00ISR Number: 3561967-7Report Type:Expedited (15-DaCompany Report #243107 Outcome Other Serious PT Accidental Exposure Intra-Uterine Death Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:08/30/00ISR Number: 3561969-0Report Type:Expedited (15-DaCompany Report #224923 Outcome Hospitalization Initial or Prolonged PT Suicide Attempt Abnormal Behaviour Hallucination Acute Psychosis Report Source Foreign Consumer Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 1.5 DOSE FORM 1 PER WEEK ORAL
I/FU:F Duration
14
DAY
Date:08/30/00ISR Number: 3561972-0Report Type:Expedited (15-DaCompany Report #243661 Outcome Hospitalization Initial or Prolonged PT Depression Dizziness Fatigue Dissociation Gait Disturbance Eating Disorder Anxiety Vomiting Speech Disorder Panic Attack Hallucination Balance Disorder Dyspnoea Report Source Foreign Consumer Other Product Lariam Chloroquine Hcl (Chloroquine Hydrochloride (Injection)) Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:08/30/00ISR Number: 3562000-3Report Type:Expedited (15-DaCompany Report #243398 Outcome Hospitalization Initial or Prolonged PT Fatigue Mental Disorder Report Source Foreign Health Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 7 DOSE FORM 1
I/FU:I Duration
Abnormal Behaviour Nervous System Disorder Hemiparesis Cerebral Venous Thrombosis Malaria
Professional
PER ONE DOSE ORAL
03-Apr-2012
09:37 AM
Page: 222
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/00ISR Number: 3562002-7Report Type:Expedited (15-DaCompany Report #243587 Outcome Hospitalization Initial or Prolonged PT Bipolar Disorder Mania Report Source Foreign Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:26 YR Route ORAL Gender:Male Dose ORAL I/FU:I Duration
Date:08/30/00ISR Number: 3562005-2Report Type:Expedited (15-DaCompany Report #237590 Outcome Other Serious PT Intra-Uterine Death Pregnancy Accidental Exposure Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:08/31/00ISR Number: 3562208-7Report Type:Direct Outcome PT Insomnia Heart Rate Increased Nausea Abdominal Pain
Gender:Female Dose 1 PER WEEK ORAL
I/FU:I Duration
Date:09/01/00ISR Number: 3562944-2Report Type:Direct Outcome PT Abnormal Dreams Anxiety Paraesthesia Flushing Insomnia Chills
Age:35 YR Route
Gender:Female Dose
I/FU:I Duration
Date:09/01/00ISR Number: 3564122-XReport Type:Expedited (15-DaCompany Report #243633 Outcome Other Serious PT Dysgraphia Migraine Reading Disorder Visual Acuity Reduced Disturbance In Attention Report Source Foreign Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Age:
Gender:Female
I/FU:I
PT Vomiting Hepatitis Headache Nausea Disorientation Dizziness 09:37 AM Page: 223
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Hyperhidrosis Hepatocellular Injury Weight Decreased Haematemesis Nightmare Tremor
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
Date:09/01/00ISR Number: 3564124-3Report Type:Expedited (15-DaCompany Report #243535 Outcome Hospitalization Initial or Prolonged PT Bradycardia Paraesthesia Chest Pain Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:09/06/00ISR Number: 3565002-6Report Type:Expedited (15-DaCompany Report #242880 Outcome Other Serious PT Thinking Abnormal Feeling Jittery Diarrhoea Alopecia Abdominal Pain Crying Dizziness Delusion Malaise Depression Nightmare Nausea Anxiety Fear Amnesia Panic Reaction Abdominal Distension Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
Date:09/06/00ISR Number: 3565005-1Report Type:Expedited (15-DaCompany Report #243099 Outcome Death PT Completed Suicide Personality Change Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:F Duration
Age:
Gender:Female
I/FU:F
Asthenia Flushing Muscle Spasms Malaise Diarrhoea Weight Decreased Fear Dizziness Page: 224
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nervousness Urinary Tract Infection Tremor Headache Palpitations Myalgia Phobia
Report Source
Product Lariam Tablets
Role PS
Manufacturer Roche
Route
Dose
Duration
Date:09/06/00ISR Number: 3565032-4Report Type:Expedited (15-DaCompany Report #243085 Outcome Hospitalization Initial or Prolonged PT Syncope Chest Pain Palpitations Paraesthesia Panic Attack Tension Dizziness Disturbance In Attention Circulatory Collapse Anxiety Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:28 YR Route
Gender:Male Dose
I/FU:F Duration
Date:09/06/00ISR Number: 3565049-XReport Type:Expedited (15-DaCompany Report #244099 Outcome Other Serious PT Neuralgia Pruritus Urticaria Muscular Weakness Balance Disorder Fatigue Haematoma Cartilage Injury Ecchymosis Muscle Disorder Dizziness Report Source Product Lariam Tablets Zoloft Neurontin Vioxx Provera Role PS C C C C Manufacturer Roche
Age:48 YR Route
Gender:Female Dose
I/FU:I Duration
123 FOR 12 DAYS BETWEEN JUL 1999 AND JULY 2000 AT 2.5 MG.
DAY
CURRENTLY Synthroid Premarin C C
Date:09/07/00ISR Number: 3565856-3Report Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability PT Depression Anxiety Panic Attack Headache Vertigo Dizziness Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:24 YR Route
Gender:Female Dose ESTIMATED 5 DOSES IN TOTAL.
Date:09/07/00ISR Number: 3565886-1Report Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability 03-Apr-2012 09:37 AM PT Headache Panic Attack Depression
Age:24 YR
Gender:Female
I/FU:F
Page: 225
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vertigo Dizziness Anxiety
Report Source
Role PS
Manufacturer Roche
Route
Dose ESTIMATED 5 DOSES IN TOTAL.
Duration 21 DAY
Date:09/07/00ISR Number: 3565888-5Report Type:Expedited (15-DaCompany Report #243398 Outcome Hospitalization Initial or Prolonged PT Personality Change Due To A General Medical Condition Gastroenteritis Nervous System Disorder Diarrhoea Encephalitis Faecal Incontinence Fatigue Extensor Plantar Response Psychomotor Retardation Confusional State Vomiting Urinary Incontinence Hemiparesis Mental Disorder Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:35 YR Route
Gender:Male Dose
I/FU:F Duration
Date:09/07/00ISR Number: 3565942-8Report Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability PT Panic Attack Headache Dizziness Anxiety Depression Vertigo Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:24 YR Route
Date:09/07/00ISR Number: 3565949-0Report Type:Expedited (15-DaCompany Report #243398 Outcome Hospitalization Initial or Prolonged PT Vomiting Faecal Incontinence Urinary Incontinence Encephalitis Gastroenteritis Diarrhoea Personality Change Due To
Age:35 YR
Gender:Male
I/FU:F
A General Medical Condition Hemiparesis Mental Disorder Fatigue Confusional State Nervous System Disorder Psychomotor Retardation 03-Apr-2012 09:37 AM Page: 226
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Extensor Plantar Response Report Source Product Lariam Tablets Role PS Manufacturer Roche Route Dose Duration
Date:09/07/00ISR Number: 3566017-4Report Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability PT Anxiety Headache Vertigo Depression Panic Attack Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:24 YR Route
Date:09/07/00ISR Number: 3565858-7Report Type:Expedited (15-DaCompany Report #243398 Outcome Hospitalization Initial or Prolonged PT Oliguria Nervous System Disorder Fatigue Hemiparesis Gastroenteritis Encephalitis Viral Extensor Plantar Response Overdose Personality Change Due To A General Medical Condition Diarrhoea Cerebral Venous Thrombosis Confusional State Toxicity To Various Agents Vomiting Mental Disorder Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:35 YR Route
Gender:Male Dose
I/FU:F Duration
Date:09/08/00ISR Number: 3566999-0Report Type:Expedited (15-DaCompany Report #72278 Outcome Other Serious PT Visual Impairment Abdominal Pain Skin Irritation Hearing Impaired Pain Full Blood Count Abnormal Syncope
Age:24 YR
Gender:Male
I/FU:F
Campbell De Morgan Spots Deafness Neutropenia Lymphadenopathy Vision Blurred Diarrhoea Eosinophil Count Increased 03-Apr-2012 09:37 AM Page: 227
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Skin Papilloma Renal Colic Pco2 Abnormal Muscle Spasms Dizziness Cough Neck Pain Bone Marrow Failure Coordination Abnormal Migraine Depersonalisation Nausea Chills Asthenia Cyst Oropharyngeal Pain Amnesia Biopsy Bone Marrow Abnormal Lipids Abnormal Blood Potassium Decreased Arthralgia Abscess Basophilia Penile Ulceration Hyperhidrosis Blood Lactate Dehydrogenase Increased Abdominal Tenderness Pharyngitis Bladder Pain Dissociation Liver Function Test Abnormal Amoebiasis Haemorrhoids Hypokalaemia Paraesthesia Haematocrit Increased Asthenopia Vertigo Blood Heavy Metal Increased Herpes Simplex Dysphagia Rash Pustular Drug Level Below Therapeutic Hyperglycaemia Hypersensitivity Hypoglycaemia Fatigue Confusional State
Hypersomnia Pain In Extremity Swelling Red Blood Cell Count Increased Disorientation Tinnitus Tremor 03-Apr-2012 09:37 AM Page: 228
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Ear Pain Schistosomiasis Hepatic Pain Malaria Thinking Abnormal Back Pain Feeling Abnormal Bradycardia Palpitations Blood Phosphorus Decreased Vestibular Disorder Pyrexia Flatulence Malaise Blood Urea Increased Muscular Weakness Balance Disorder Gastrointestinal Disorder Anxiety Blood Triglycerides Increased Headache
Report Source
Role PS
Manufacturer Roche
Route
Dose
Duration 35 DAY
Date:09/08/00ISR Number: 3567004-2Report Type:Expedited (15-DaCompany Report #216747 Outcome Death PT Skin Discolouration Skin Infection Scar Agitation Emotional Disorder Skin Necrosis Lichen Planus Fear Psychosexual Disorder Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
Date:09/08/00ISR Number: 3568264-4Report Type:Expedited (15-DaCompany Report #244099 Outcome Other Serious PT Haematoma Myalgia Muscle Disorder Muscle Spasms Dizziness Asthenia Ecchymosis Pruritus
Age:48 YR
Gender:Female
I/FU:I
Urticaria Depression Ammonia Increased Balance Disorder Cartilage Injury Muscular Weakness Paraesthesia Asthenopia 03-Apr-2012 09:37 AM Page: 229
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Neuralgia Burning Sensation Tetany
Product Lariam Zoloft Vioxx Premarin Provera Synthroid Neurontin
Role PS C C C C C C
Route ORAL
Dose ORAL
Duration
Date:09/08/00ISR Number: 3568266-8Report Type:Expedited (15-DaCompany Report #242880 Outcome Other Serious PT Delusion Toxicity To Various Agents Feeling Jittery Anxiety Thinking Abnormal Depression Nightmare Amnesia Nausea Dizziness Abdominal Distension Phobia Panic Reaction Pain Diarrhoea Alopecia Abdominal Pain Report Source Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:09/08/00ISR Number: 3568316-9Report Type:Expedited (15-DaCompany Report #72278 Outcome Other Serious PT Coordination Abnormal Malaria Vision Blurred Basophil Count Increased Blood Potassium Decreased Liver Function Test Abnormal Blood Heavy Metal Increased Dyspnoea Hearing Impaired Asthenopia
Age:24 YR
Gender:Unknown
I/FU:I
Nausea Muscular Weakness Anxiety Palpitations Lipids Abnormal Diarrhoea Tinnitus Amoebiasis 03-Apr-2012 09:37 AM Page: 230
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Penile Ulceration Depersonalisation Malaise Visual Impairment Feeling Abnormal Bradycardia Antibody Test Positive Amnesia Skin Irritation Paraesthesia Hypersensitivity Vestibular Disorder Vertigo Disorientation Schistosomiasis Abscess Photopsia Hyperhidrosis Fatigue Abdominal Pain Balance Disorder Confusional State Oropharyngeal Pain Blood Triglycerides Increased Swelling Eye Disorder Pharyngitis Muscle Spasms Dysphagia Pyrexia Rash Pustular Hypoglycaemia Low Density Lipoprotein Increased Migraine Drug Level Below Therapeutic Pain In Extremity Lymphocyte Count Increased Bladder Pain Pain Tremor Ear Pain Flatulence Headache Lymphadenopathy Asthenia Hypersomnia Biopsy Bone Marrow Abnormal
Neutrophil Count Decreased Blood Phosphorus Decreased Blood Cholesterol Increased Full Blood Count Abnormal Neck Pain 03-Apr-2012 09:37 AM Page: 231
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Campbell De Morgan Spots Thinking Abnormal Back Pain Chills Cyst Gastrointestinal Disorder White Blood Cell Count Decreased Monocyte Count Increased Herpes Simplex Arthralgia Dizziness Cough
Product Lariam
Role PS
Route ORAL
Duration 35 DAY
Date:09/08/00ISR Number: 3568345-5Report Type:Expedited (15-DaCompany Report #230098 Outcome Hospitalization Initial or Prolonged PT Agitation Crying Conversion Disorder Hypertension Furuncle Psychotic Disorder Dizziness Fatigue Abdominal Discomfort Depression Agoraphobia Retching Tinnitus Hyperventilation Hyperhidrosis Nausea Paraesthesia Mental Disorder Blood Pressure Systolic Increased Chills Report Source Foreign Consumer Health Professional Product Lariam Hismanal Jodthyrox Role PS C C Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:09/08/00ISR Number: 3568346-7Report Type:Expedited (15-DaCompany Report #219219 Outcome Congenital Anomaly PT Neonatal Disorder Cardiac Murmur Maternal Drugs Affecting Foetus Congenital Anomaly Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:09/08/00ISR Number: 3568522-3Report Type:Expedited (15-DaCompany Report #243099 Outcome Death PT Completed Suicide Report Source Foreign Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route
Gender:Male Dose
I/FU:F Duration
03-Apr-2012
09:37 AM
Page: 232
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/00ISR Number: 3568523-5Report Type:Expedited (15-DaCompany Report #243085 Outcome Hospitalization Initial or Prolonged PT Disturbance In Attention Paraesthesia Dizziness Anxiety Circulatory Collapse Panic Attack Syncope Chest Pain Anhedonia Pyrexia Malaise Palpitations Report Source Foreign Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:28 YR Route ORAL Gender:Male Dose ORAL I/FU:F Duration
Date:09/08/00ISR Number: 3568524-7Report Type:Expedited (15-DaCompany Report #243090 Outcome Hospitalization Initial or Prolonged PT Myalgia Dizziness Phobia Malaise Weight Decreased Tremor Headache Flushing Diarrhoea Urinary Tract Infection Muscle Spasms Asthenia Palpitations Report Source Foreign Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:09/08/00ISR Number: 3569032-XReport Type:Expedited (15-DaCompany Report #234391 Outcome Disability PT Amnesia Emotional Distress Overdose Nausea Loss Of Control Of Legs Medication Error Blindness Transient Brain Injury Decreased Activity Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 250 MG 2 PER DAY
Age:11 YR
Gender:Female
I/FU:I
PT Tachycardia Malaise Dizziness Fatigue Chills Loss Of Consciousness Page: 233
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Report Source Product Lariam Tablets Role PS Manufacturer Roche Route Dose Duration 15 DAY
Date:09/08/00ISR Number: 3567021-2Report Type:Expedited (15-DaCompany Report #244148 Outcome Other Serious PT Maternal Drugs Affecting Foetus Talipes Klinefelter'S Syndrome Pregnancy Abortion Induced Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Not SpecifiI/FU:I Dose Duration 34 DAY
Date:09/11/00ISR Number: 3568894-XReport Type:Direct Outcome Other Serious PT Tinnitus Paraesthesia Burning Sensation Headache Panic Attack Crying Melaena Depression Lethargy Dizziness Anxiety Disturbance In Attention Diarrhoea
Company Report # Report Source Consumer Product Lariam 250 Mg Tablet Roche Role PS Manufacturer Roche
Gender:Male Dose 1 TABLET ONCE A WEEK ORAL
I/FU:I Duration
Date:09/11/00ISR Number: 3569224-XReport Type:Expedited (15-DaCompany Report #216747 Outcome Death PT Emotional Disorder Fear Injury Agitation Lichen Planus Infection Skin Discolouration Report Source Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Age:11 YR
Gender:Female
I/FU:I
PT Dizziness Fatigue Tachycardia Hypotension Malaise Chills Loss Of Consciousness
Product Lariam
Role PS
Route ORAL
Dose 250 MG 1PER WEEK ORAL
Duration
03-Apr-2012
09:37 AM
Page: 234
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/00ISR Number: 3569301-3Report Type:Expedited (15-DaCompany Report #244148 Outcome Other Serious PT Talipes Maternal Drugs Affecting Foetus Klinefelter'S Syndrome Abortion Induced Pregnancy Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Unknown Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:09/11/00ISR Number: 3569673-XReport Type:Expedited (15-DaCompany Report #216747 Outcome Death PT Skin Discolouration Injury Agitation Infection Fear Emotional Disorder Lichen Planus Report Source Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:09/11/00ISR Number: 3570099-3Report Type:Expedited (15-DaCompany Report #72278 Outcome Other Serious PT Coordination Abnormal Lymphadenopathy Asthenia Gastrointestinal Disorder Lipids Abnormal Diarrhoea Swelling Neck Pain Hypouricaemia Lymphadenitis Neutrophil Count Decreased Hypercholesterolaemia Thinking Abnormal Back Pain Malaise Balance Disorder Anxiety Blood Phosphorus Decreased Disorientation Tinnitus Ear Pain Headache Rash Pustular
Age:24 YR
Gender:Male
I/FU:F
Ear Discomfort Skin Papilloma Gait Disturbance Penile Ulceration Malaria Confusional State Vertigo Schistosomiasis 03-Apr-2012 09:37 AM Page: 235
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Drunk Haematocrit Increased Abdominal Tenderness Haemoglobin Increased Arthralgia Vision Blurred Hypersomnia Palpitations Muscle Spasms Haemorrhoids Cough Pyrexia Campbell De Morgan Spots Bone Marrow Failure Nasopharyngitis Hyperglycaemia Depersonalisation Migraine Drug Ineffective Oropharyngeal Pain Skin Irritation Paraesthesia Hypersensitivity Asthenopia Full Blood Count Abnormal Liver Function Test Abnormal Dizziness Hypokalaemia Syncope Abscess Toxicity To Various Agents Eosinophil Count Increased Enthesopathy Amoebiasis Nausea Chills Muscular Weakness Hearing Impaired Tenderness Gastrointestinal Pain Chronic Fatigue Syndrome Hypoglycaemia Herpes Simplex Vestibular Disorder Bladder Pain Tremor Dysphagia Dyspnoea Flatulence Spleen Disorder
High Density Lipoprotein Increased Viral Infection Condition Aggravated Monocyte Count Increased Blood Heavy Metal Increased Hyperhidrosis 03-Apr-2012 09:37 AM Page: 236
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Visual Impairment Pharyngitis Streptococcal Feeling Abnormal Abdominal Pain Bradycardia Cyst Amnesia Pain In Extremity Pain Red Blood Cell Count Increased Nystagmus
Product Lariam
Role PS
Route ORAL
Duration 35 DAY
Date:09/12/00ISR Number: 3568900-2Report Type:Expedited (15-DaCompany Report #244099 Outcome Other Serious PT Depression Haematoma Urticaria Ecchymosis Paraesthesia Myalgia Muscular Weakness Asthenia Balance Disorder Dizziness Cartilage Injury Burning Sensation Fatigue Tetany Pruritus Muscle Disorder Muscle Spasms Report Source Product Lariam Tablets Zoloft Vioxx Premarin Provera Role PS C C C C Manufacturer Roche
Age:48 YR Route
Gender:Female Dose
FOR 12 DAYS BETWEEN JUL 1999 AND JULY 2000 AT 2.5 MG.
CURRENTLY Synthroid Neurontin C C
Date:09/12/00ISR Number: 3568893-8Report Type:Expedited (15-DaCompany Report #241248 Outcome Hospitalization Initial or Prolonged PT Barotrauma Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:49 YR Route
Gender:Male Dose
I/FU:F Duration
Date:09/13/00ISR Number: 3569968-XReport Type:Expedited (15-DaCompany Report #241757 Outcome Hospitalization Initial or Prolonged PT Eyelid Oedema Panic Attack Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:37 YR Route
Gender:Female Dose
Abdominal Pain Conjunctival Hyperaemia Visual Impairment Disturbance In Attention Fatigue Sedation
03-Apr-2012
09:37 AM
Page: 237
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/00ISR Number: 3571074-5Report Type:Expedited (15-DaCompany Report #243398 Outcome Hospitalization Initial or Prolonged PT Fatigue Mental Disorder Urinary Incontinence Personality Change Due To A General Medical Condition Faecal Incontinence Toxicity To Various Agents Vomiting Hemiparesis Psychomotor Retardation Confusional State Nervous System Disorder Diarrhoea Gastroenteritis Overdose Encephalitis Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:35 YR Route ORAL Gender:Male Dose 7 DOSE FORM 1 PER ONE DOSE ORAL I/FU:F Duration
Date:09/13/00ISR Number: 3571321-XReport Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability PT Vertigo Depression Headache Anxiety Panic Attack Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 250 MG 1 PER WEEK PO
I/FU:F Duration
Date:09/14/00ISR Number: 3571509-8Report Type:Expedited (15-DaCompany Report #241248 Outcome Hospitalization Initial or Prolonged PT Barotrauma Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:09/14/00ISR Number: 3571842-XReport Type:Expedited (15-DaCompany Report #244099 Outcome Other Serious PT Muscular Weakness Balance Disorder Burning Sensation Urticaria Tetany Cartilage Injury
Age:48 YR
Gender:Female
I/FU:F
Depression Ecchymosis Myalgia Haematoma Injury Neuralgia Paraesthesia Ammonia Increased 03-Apr-2012 09:37 AM Page: 238
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pruritus Asthenia Muscle Disorder Asthenopia Muscle Spasms Fatigue Dizziness
Product Lariam Zoloft Vioxx Premarin Provera (Medroxyprogesterone ) Synthroid Neurontin
Role PS C C C C C C
Route ORAL
Dose ORAL
Duration
Date:09/14/00ISR Number: 3570925-8Report Type:Expedited (15-DaCompany Report #220387 Outcome Other Serious PT Induced Labour Postmature Baby Pregnancy Abnormal Labour Report Source Product Lariam Tablets Logynon Role PS C Manufacturer Roche
Age: Route
Gender:Unknown Dose
Date:09/14/00ISR Number: 3570928-3Report Type:Expedited (15-DaCompany Report #244551 Outcome Other Serious PT Aplastic Anaemia Fatigue Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:62 YR Route
Gender:Male Dose
Date:09/15/00ISR Number: 3572844-XReport Type:Expedited (15-DaCompany Report #241757 Outcome Hospitalization Initial or Prolonged PT Conjunctival Hyperaemia Eyelid Oedema Visual Impairment Disturbance In Attention Fatigue Sedation Abdominal Pain Panic Attack Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:09/15/00ISR Number: 3571353-1Report Type:Expedited (15-DaCompany Report #244484 Outcome Other Serious PT Tinnitus Viith Nerve Paralysis Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:30 YR Route
Gender:Male Dose
Date:09/18/00ISR Number: 3572388-5Report Type:Expedited (15-DaCompany Report #244551 Outcome Other Serious 03-Apr-2012 09:37 AM PT Fatigue Aplastic Anaemia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:62 YR Route
Gender:Male Dose
I/FU:I Duration 29 DAY Page: 239
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/00ISR Number: 3574528-0Report Type:Expedited (15-DaCompany Report #220387 Outcome Other Serious PT Caesarean Section Pregnancy Abnormal Labour Report Source Foreign Health Professional Product Lariam Logynon (Ethinyl Estradiol / Levonorgestrel) Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Unknown Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:09/19/00ISR Number: 3573038-4Report Type:Expedited (15-DaCompany Report #235479 Outcome Disability PT Corneal Oedema Corneal Disorder Vision Blurred Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:76 YR Route
Gender:Male Dose
I/FU:F Duration
Date:09/19/00ISR Number: 3573039-6Report Type:Expedited (15-DaCompany Report #242474 Outcome Congenital Anomaly PT Hydrocephalus Maternal Drugs Affecting Foetus Congenital Anomaly Cerebellar Hypoplasia Pregnancy Ultrasound Antenatal Screen Abnormal Convulsion Visual Impairment Hearing Impaired Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
Date:09/19/00ISR Number: 3573049-9Report Type:Expedited (15-DaCompany Report #243079 Outcome Other Serious PT Bradycardia Arrhythmia Neonatal Palpitations Maternal Drugs Affecting Foetus Polyhydramnios Extrasystoles Neonatal Disorder Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
Company Report #
Age:32 YR
Gender:Female
I/FU:I
PT Nausea Anxiety Fear Diarrhoea Dissociation Dizziness Page: 240
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Asthenia Paraesthesia Hallucination Balance Disorder Somnambulism Abnormal Dreams Depression
Report Source
Product Larium
Role PS
Manufacturer
Route
Dose
Duration
Date:09/19/00ISR Number: 3574500-0Report Type:Expedited (15-DaCompany Report #244484 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Tinnitus Viith Nerve Paralysis Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:09/19/00ISR Number: 3575054-5Report Type:Expedited (15-DaCompany Report #235479 Outcome Disability PT Corneal Oedema Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:09/19/00ISR Number: 3575202-7Report Type:Expedited (15-DaCompany Report #245061 Outcome Other Serious PT Physical Assault Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:09/19/00ISR Number: 3575223-4Report Type:Expedited (15-DaCompany Report #244870 Outcome Death PT Completed Suicide Report Source Foreign Other Product Lariam Tetavax (Adsorbed Tetanus Vaccine) Havrix (Hepatitis A Vaccine) Typhim Iv (Typhoid Vaccines) Role PS C C C Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Age:30 YR
Gender:Male
I/FU:I
PT Idiopathic Thrombocytopenic Purpura Purpura
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
03-Apr-2012
09:37 AM
Page: 241
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/00ISR Number: 3575226-XReport Type:Expedited (15-DaCompany Report #243079 Outcome Other Serious PT Palpitations Polyhydramnios Extrasystoles Pregnancy Bradycardia Maternal Drugs Affecting Foetus Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration 35 DAY
Date:09/19/00ISR Number: 3575228-3Report Type:Expedited (15-DaCompany Report #242474 Outcome Congenital Anomaly PT Hearing Impaired Congenital Hydrocephalus Congenital Anomaly Vision Abnormal Neonatal Convulsion Neonatal Electroencephalogram Abnormal Apgar Score Low Developmental Delay Maternal Drugs Affecting Foetus Cerebellar Hypoplasia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Date:09/19/00ISR Number: 3573037-2Report Type:Expedited (15-DaCompany Report #244736 Outcome Other Serious PT Idiopathic Thrombocytopenic Purpura Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:30 YR Route
Gender:Male Dose
I/FU:I Duration
Date:09/19/00ISR Number: 3573045-1Report Type:Expedited (15-DaCompany Report #244870 Outcome Death PT Completed Suicide Report Source Product Lariam Tablets Havrix Typhim Vi Tetavax Role PS C C C Manufacturer Roche
Age:36 YR Route
Gender:Male Dose
I/FU:I Duration 1 1 1 DAY DAY DAY
Date:09/19/00ISR Number: 3573048-7Report Type:Expedited (15-DaCompany Report #245061 Outcome Other Serious PT Physical Assault Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Human Bite Injury
03-Apr-2012
09:37 AM
Page: 242
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/00ISR Number: 3575612-8Report Type:Expedited (15-DaCompany Report #245128 Outcome Other Serious PT Extrapyramidal Disorder Gastrooesophageal Reflux Disease Report Source Foreign Health Professional Product Lariam Primperan Role PS C Manufacturer Hoffmann La Roche Inc Age:16 YR Route ORAL Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Date:09/20/00ISR Number: 3576586-6Report Type:Direct Outcome Other Serious PT Fear Psychotic Disorder Disturbance In Attention Hallucination Abnormal Dreams Irritability Panic Attack Sleep Disorder
Company Report # Report Source Product Lariam Cant Remember 500mg?? Hoffman Laroche Role PS Manufacturer Hoffman Laroche
Gender:Male Dose ONE PER ORAL
I/FU:I Duration
Date:09/20/00ISR Number: 3573885-9Report Type:Expedited (15-DaCompany Report #245128 Outcome Other Serious PT Gastrooesophageal Reflux Disease Extrapyramidal Disorder Report Source Product Lariam Tablets Primperan Role PS C Manufacturer Roche
Age:16 YR Route
Gender:Female Dose
I/FU:I Duration 63 DAY 1 DAY
Date:09/21/00ISR Number: 3575082-XReport Type:Expedited (15-DaCompany Report #200841 Outcome Hospitalization Initial or Prolonged PT Accommodation Disorder Fatigue Insomnia Nausea Vision Blurred Hyperventilation Lacrimation Increased Paraesthesia Hallucination, Visual Psychomotor Retardation Diplopia Arrhythmia Emotional Disorder Crying Asthenia Paraplegia Tinnitus
Age:42 YR
Gender:Male
I/FU:F
Malaise Dry Mouth Balance Disorder Diarrhoea Fall Dyspnoea Speech Disorder Anxiety 03-Apr-2012 09:37 AM Page: 243
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Disorder Convulsion Memory Impairment Stress Movement Disorder Cognitive Disorder Hydrocephalus Mental Disorder Heterophoria Disturbance In Attention Visual Impairment Sedation Panic Attack Tremor Dysphagia Reading Disorder
Report Source
Product Lariam Tablets Meningococcal Vaccine Flu Vaccine
Role PS
Manufacturer Roche
Route
Dose CUMULATIVE DOSAGE= 750 MG
Duration 380 1 1 DAY DAY DAY
C C
Date:09/21/00ISR Number: 3576532-5Report Type:Direct Outcome Other Serious PT Depression Depersonalisation Anxiety Abnormal Dreams Dizziness Nausea
Gender:Female Dose 1 PILL PER WEEK ORAL
I/FU:I Duration
Date:09/25/00ISR Number: 3578070-2Report Type:Expedited (15-DaCompany Report #245128 Outcome Other Serious PT Nervousness Gastrooesophageal Reflux Disease Throat Tightness Tremor Extrapyramidal Disorder Report Source Product Primperan Lariam Tablets Role PS SS Manufacturer Roche
Age:15 YR Route
Gender:Female Dose
I/FU:F Duration 1 DAY 63 DAY
Date:09/25/00ISR Number: 3578162-8Report Type:Expedited (15-DaCompany Report #245128 Outcome Other Serious PT Extrapyramidal Disorder Tremor Nervousness Throat Tightness Gastrooesophageal Reflux Disease Report Source Product Primperan Lariam Tablets Role PS SS Manufacturer Roche
Age:15 YR Route
Gender:Female Dose
Date:09/25/00ISR Number: 3578203-8Report Type:Expedited (15-DaCompany Report #245128 Outcome Other Serious PT Extrapyramidal Disorder Tremor Gastrooesophageal Reflux 09:37 AM
Age:15 YR
Gender:Female
I/FU:F
03-Apr-2012
Page: 244
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disease Nervousness Report Source Product Lariam Tablets Primperan Role PS SS Manufacturer Roche Route Dose Duration 63 DAY 1 DAY
Date:09/25/00ISR Number: 3578365-2Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Panic Attack Dyspnoea Dizziness
Company Report # Report Source Product Larium 250 Mg Role PS Manufacturer
Age: Route
Gender:Male Dose Q WEEK PO
I/FU:I Duration
Date:09/25/00ISR Number: 3579511-7Report Type:Expedited (15-DaCompany Report #245128 Outcome Other Serious PT Throat Tightness Extrapyramidal Disorder Tremor Gastrooesophageal Reflux Disease Nervousness Report Source Foreign Health Professional Product Lariam Primperan Role PS SS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL 1 DOSE FORM 2 PER DAY ORAL
I/FU:F Duration
Date:09/26/00ISR Number: 3578972-7Report Type:Expedited (15-DaCompany Report #237672 Outcome Other Serious PT Vision Blurred Confusional State Memory Impairment Alopecia Cataract Disturbance In Attention Fatigue Visual Impairment Visual Field Defect Dizziness Balance Disorder Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:55 YR Route
Gender:Female Dose
Date:09/26/00ISR Number: 3580409-9Report Type:Expedited (15-DaCompany Report #237672 Outcome Other Serious PT Memory Impairment Vision Blurred Fatigue Confusional State Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 250 MG 1 PER WEEK; ORAL
I/FU:F Duration
Visual Field Defect Balance Disorder Disturbance In Attention Dizziness Cataract Visual Impairment Alopecia 03-Apr-2012 09:37 AM
Other
Page: 245
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3580555-XReport Type:Direct Outcome Other Serious PT Fear Anxiety Panic Disorder Company Report # Report Source Product Lariam Role PS Manufacturer Age: Route Gender:Female Dose 1 I/FU:I Duration
Date:09/27/00ISR Number: 3581501-5Report Type:Expedited (15-DaCompany Report #245340 Outcome Hospitalization Initial or Prolonged PT Dyskinesia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:09/27/00ISR Number: 3580067-3Report Type:Expedited (15-DaCompany Report #245340 Outcome Hospitalization Initial or Prolonged PT Dyskinesia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:16 YR Route
Gender:Male Dose
I/FU:I Duration
Date:09/29/00ISR Number: 3582445-5Report Type:Expedited (15-DaCompany Report #245721 Outcome Hospitalization Initial or Prolonged PT Anxiety Depressed Mood Panic Attack Report Source Product Mefloquine Hydrochloride Fluoxetine Role PS C Manufacturer Roche
Age:39 YR Route
Gender:Male Dose
I/FU:I Duration
Date:10/02/00ISR Number: 3584867-5Report Type:Direct Outcome Other Serious PT Paraesthesia Hypoaesthesia
Gender:Female
I/FU:I
Dose Duration 1TAB PO Q WK FOR 16 WKS
Date:10/02/00ISR Number: 3584214-9Report Type:Expedited (15-DaCompany Report #245885 Outcome Other Serious PT Amnesia Depression Decreased Activity Anxiety Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:56 YR Route
Gender:Male Dose
Date:10/02/00ISR Number: 3584219-8Report Type:Expedited (15-DaCompany Report #245766 Outcome Other Serious PT Visual Acuity Reduced Papilloedema Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 246
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/00ISR Number: 3586759-4Report Type:Expedited (15-DaCompany Report #245766 Outcome Other Serious PT Visual Acuity Reduced Papilloedema Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Male Dose ORAL I/FU:I Duration
Date:10/03/00ISR Number: 3586870-8Report Type:Expedited (15-DaCompany Report #245974 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Syncope Anaphylactic Reaction Ill-Defined Disorder Report Source Foreign Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:10/03/00ISR Number: 3586878-2Report Type:Expedited (15-DaCompany Report #245885 Outcome Other Serious PT Anxiety Amnesia Depression Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:10/03/00ISR Number: 3585187-5Report Type:Expedited (15-DaCompany Report #245974 Outcome Other Serious PT Anaphylactic Shock Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:10/04/00ISR Number: 3586112-3Report Type:Expedited (15-DaCompany Report #245994 Outcome Hospitalization Initial or Prolonged PT Ischaemic Stroke Haemorrhage Intracranial Hemianopia Homonymous Cerebral Infarction Report Source Product Mefloquine Hydrochloride Aspirin Cardio Role PS C Manufacturer Roche
Age:62 YR Route
Gender:Male Dose
I/FU:I Duration
Date:10/04/00ISR Number: 3587874-1Report Type:Expedited (15-DaCompany Report #246098 Outcome Other Serious PT Visual Impairment Aphasia Anxiety Paranoia Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Date:10/04/00ISR Number: 3586113-5Report Type:Expedited (15-DaCompany Report #246098 Outcome Other Serious 03-Apr-2012 09:37 AM PT Anxiety Visual Impairment
Age:22 YR
Gender:Male
I/FU:I
Page: 247
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Aphasia Report Source Product Lariam Tablets Role PS Manufacturer Roche Route Dose Duration 28 DAY
Date:10/05/00ISR Number: 3587508-6Report Type:Expedited (15-DaCompany Report #241950 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Malaria Tachycardia Hypotension Loss Of Consciousness Malaise Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:11 YR Route
Gender:Male Dose
I/FU:F Duration
Date:10/06/00ISR Number: 3588421-0Report Type:Expedited (15-DaCompany Report #61443 Outcome Hospitalization Initial or Prolonged PT Delirium Mental Disorder Depression Anxiety Suicide Attempt Overdose Abnormal Behaviour Report Source Product Lariam Tablets Lysanxia Role PS C Manufacturer Roche
Age:42 YR Route
Gender:Female Dose
Date:10/06/00ISR Number: 3589373-XReport Type:Direct Outcome Hospitalization Initial or Prolonged Disability Congenital Anomaly PT Autism Spectrum Disorder Maternal Drugs Affecting Foetus Nervous System Disorder Grand Mal Convulsion
Age:42 YR Route
Gender:Female Dose WEEKLY
I/FU:I Duration
Date:10/06/00ISR Number: 3590758-6Report Type:Expedited (15-DaCompany Report #61443 Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Depression Anxiety Persecutory Delusion Partner Stress Abnormal Behaviour Delirium Suicide Attempt Report Source Foreign Other Product Lariam Lysanxia (Prazepam) Role PS C Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:10/10/00ISR Number: 3591920-9Report Type:Expedited (15-DaCompany Report #216859 Outcome Other Serious 03-Apr-2012 09:37 AM PT Emotional Disorder Rhinorrhoea
Age:20 YR
Gender:Male
I/FU:F
Page: 248
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lymphadenopathy Erythema Bronchospasm Headache Pharyngitis Streptococcal Pharyngitis Lichen Planus Skin Discolouration
Product Lariam
Role PS
Route ORAL
Duration
Date:10/11/00ISR Number: 3593063-7Report Type:Expedited (15-DaCompany Report #246417 Outcome Other Serious PT Hallucination Mania Psychotic Disorder Depression Schizophreniform Disorder Delusion Paranoia Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:10/11/00ISR Number: 3593064-9Report Type:Expedited (15-DaCompany Report #245340 Outcome Hospitalization Initial or Prolonged PT Grand Mal Convulsion Speech Disorder Malaria Clonic Convulsion Disorientation Pyrexia Chorea Vomiting Dyskinesia Agitation Abnormal Behaviour Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:10/11/00ISR Number: 3593110-2Report Type:Expedited (15-DaCompany Report #246415 Outcome Other Serious PT Pyrexia Tremor Delirium Asthenia Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Age:17 YR
Gender:Male
I/FU:F
PT Malaria Chorea Speech Disorder Dyskinesia Disorientation Agitation Clonic Convulsion Page: 249
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Abnormal Behaviour Vomiting
Role PS
Manufacturer Roche
Route
Dose
Duration 2 DAY
Date:10/12/00ISR Number: 3592642-0Report Type:Expedited (15-DaCompany Report #216859 Outcome Other Serious PT Lymphadenopathy Nasal Congestion Pharyngitis Bronchospasm Emotional Disorder Emotional Distress Erythema Lichen Planus Skin Discolouration Rash Erythematous Oropharyngeal Pain Rhinorrhoea Headache Report Source Health Professional Product Lariam Tablets Role PS Manufacturer Roche
Age:20 YR Route
Gender:Male Dose
Date:10/12/00ISR Number: 3593005-4Report Type:Direct Outcome Life-Threatening Disability Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Sleep Terror Delusion Suicidal Ideation Disturbance In Attention Paranoia Screaming Anxiety
Company Report # Report Source Product Larium , F. Hoffmann-La Roche Ltd Role PS Manufacturer F. Hoffmann-La Roche Ltd
Age: Route
Gender:Male Dose
I/FU:I Duration
ORAL
250-MG, WEEK, ORAL
Date:10/12/00ISR Number: 3594160-2Report Type:Direct Outcome Other Serious PT Tachycardia Hyperventilation Anxiety Influenza Depression Disturbance In Attention Insomnia Feeling Abnormal Hypertension Irritable Bowel Syndrome
Company Report # Report Source Product Lariam-Mefloquin Role PS Manufacturer
Age: Route
Gender:Female
I/FU:I
Paranoia Panic Attack Fatigue
03-Apr-2012
09:37 AM
Page: 250
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/00ISR Number: 3594368-6Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Paranoia Restlessness Myocardial Infarction Hypertension Musculoskeletal Stiffness Fatigue Confusional State Tachycardia Headache Sedation Muscle Spasms Depression Weight Increased Panic Attack Insomnia Muscle Disorder Chest Pain Company Report # Report Source Product Lariam Role PS Manufacturer Roche Age:49 YR Route ORAL Gender:Female I/FU:I
Dose Duration ONE PER 8 WKS ORAL
Date:10/12/00ISR Number: 3592569-4Report Type:Expedited (15-DaCompany Report #246415 Outcome Other Serious PT Tremor Pyrexia Delirium Asthenia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:46 YR Route
Gender:Male Dose
I/FU:I Duration
Date:10/12/00ISR Number: 3592586-4Report Type:Expedited (15-DaCompany Report #246417 Outcome Other Serious PT Psychotic Disorder Delusion Schizophreniform Disorder Depression Paranoia Mania Hallucination Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:53 YR Route
Gender:Female Dose
I/FU:I Duration
Date:10/13/00ISR Number: 3594815-XReport Type:Expedited (15-DaCompany Report #246414 Outcome Other Serious PT Psychotic Disorder Pyrexia Delirium Dermatitis Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Delusion Rash Maculo-Papular Paranoia Neurosis Confusional State
03-Apr-2012
09:37 AM
Page: 251
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/00ISR Number: 3594523-5Report Type:Expedited (15-DaCompany Report #216859 Outcome Other Serious PT Pharyngitis Thermal Burn Lichen Planus Skin Discolouration Emotional Disorder Lymphadenopathy Bronchospasm Pharyngitis Streptococcal Erythema Rhinorrhoea Headache Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:20 YR Route Gender:Male Dose I/FU:F Duration 50 DAY
Date:10/16/00ISR Number: 3594525-9Report Type:Expedited (15-DaCompany Report #216747 Outcome Other Serious PT Skin Discolouration Infection Skin Exfoliation Economic Problem Fibrous Histiocytoma Agitation Eczema Hyperkeratosis Lichen Planus Marital Problem Libido Decreased Emotional Distress Lichenification Depression Fear Neurosis Neurodermatitis Dermatitis Blister Folliculitis Emotional Disorder Pruritus Skin Disorder Condition Aggravated Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
Date:10/16/00ISR Number: 3594532-6Report Type:Expedited (15-DaCompany Report #216810 Outcome Other Serious PT Skin Discolouration Lichen Planus Emotional Distress Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:26 YR Route
Gender:Female Dose
Skin Disorder Emotional Disorder Depression
03-Apr-2012
09:37 AM
Page: 252
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/00ISR Number: 3595588-7Report Type:Direct Outcome Other Serious PT Disturbance In Attention Abnormal Dreams Joint Stiffness Dermatitis Dizziness Syncope Back Pain Diarrhoea Company Report # Report Source Product Lariam 250 Mg Roche Laboratories Role PS Manufacturer Roche Laboratories Age: Route ORAL Gender:Female Dose 250 MG 1X WEEK/4 ORAL I/FU:I Duration
Date:10/16/00ISR Number: 3595592-9Report Type:Direct Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage PT Pain Phobia Panic Reaction Dizziness Paranoia Headache Abnormal Dreams Lethargy Hallucination Hypersomnia
Company Report # Report Source Product Larium Roche Role PS Manufacturer Roche
Age:28 YR Route
Gender:Male Dose 1 OTHER
I/FU:I Duration
Date:10/16/00ISR Number: 3595866-1Report Type:Expedited (15-DaCompany Report #216810 Outcome Other Serious PT Skin Discolouration Skin Disorder Depression Emotional Disorder Lichen Planus Report Source Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:10/16/00ISR Number: 3595867-3Report Type:Expedited (15-DaCompany Report #216859 Outcome Other Serious PT Lymphadenopathy Skin Discolouration Rhinorrhoea Pharyngitis Streptococcal Headache Rash Erythematous Emotional Disorder Pharyngitis Oropharyngeal Pain Report Source Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 250 MG 1 PER WEEK; ORAL
I/FU:F Duration
Lichen Planus Skin Disorder Bronchospasm Thermal Burn
03-Apr-2012
09:37 AM
Page: 253
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/00ISR Number: 3595868-5Report Type:Expedited (15-DaCompany Report #216747 Outcome Other Serious PT Lichen Planus Agitation Ulcer Blister Folliculitis Skin Lesion Pruritus Medication Error Partner Stress Skin Exfoliation Eczema Necrosis Marital Problem Skin Hyperpigmentation Hyperkeratosis Infection Neurodermatitis Skin Discolouration Condition Aggravated Emotional Disorder Fear Report Source Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
Date:10/16/00ISR Number: 3596305-7Report Type:Expedited (15-DaCompany Report #246861 Outcome Other Serious PT Deep Vein Thrombosis Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:10/16/00ISR Number: 3594515-6Report Type:Expedited (15-DaCompany Report #246414 Outcome Other Serious PT Psychotic Disorder Confusional State Pyrexia Delirium Paranoia Delusion Neurosis Rash Maculo-Papular Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:37 YR Route
Gender:Male Dose
Date:10/16/00ISR Number: 3594534-XReport Type:Expedited (15-DaCompany Report #246861 Outcome PT Report Source Product Role Manufacturer
Age:54 YR Route
Gender:Unknown Dose
I/FU:I Duration
Other Serious
Deep Vein Thrombosis
Mefloquine Hydrochloride
PS
Roche
29
DAY
03-Apr-2012
09:37 AM
Page: 254
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/00ISR Number: 3595469-9Report Type:Expedited (15-DaCompany Report #245766 Outcome Other Serious PT Visual Acuity Reduced Scotoma Optic Nerve Glioma Leukaemia Visual Field Defect Optic Neuropathy Lipoma Meningioma Sarcoidosis Empty Sella Syndrome Optic Ischaemic Neuropathy Lymphoma Papilloedema Metastasis Report Source Product Lariam Tablets Role PS Manufacturer Roche Age: Route Gender:Male Dose I/FU:F Duration
Date:10/17/00ISR Number: 3596671-2Report Type:Direct Outcome Other Serious PT Nausea Restlessness Panic Disorder
Company Report # Report Source Product Lariam Mefloquine 250 Mg Role PS Manufacturer Roche Lab.
Gender:Male Dose ONE TABLE/WEEKLY/ ORAL
I/FU:I Duration
Date:10/19/00ISR Number: 3597344-2Report Type:Expedited (15-DaCompany Report #235163 Outcome Other Serious PT Abortion Missed Pregnancy Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Not SpecifiI/FU:F Dose Duration 32 DAY
Date:10/20/00ISR Number: 3598149-9Report Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability PT Vertigo Anxiety Panic Attack Dizziness Headache Depression Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:24 YR Route
Age:1 HR
Gender:Female
I/FU:F
Outcome Congenital Anomaly
PT Cardiac Valve Disease Mitral Valve Incompetence Heart Disease Congenital Maternal Drugs Affecting Foetus
Report Source
Role PS
Manufacturer Roche
Route
Dose
Duration
03-Apr-2012
09:37 AM
Page: 255
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/00ISR Number: 3599182-3Report Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability PT Drug Level Above Therapeutic Anxiety Panic Attack Vertigo Dizziness Depression Headache Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:24 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
Date:10/20/00ISR Number: 3599647-4Report Type:Expedited (15-DaCompany Report #235163 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Pregnancy Abortion Missed Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Gender:Unknown Dose 1 DOSE FORM 1PER WEEK ORAL
I/FU:I Duration
Date:10/20/00ISR Number: 3599649-8Report Type:Expedited (15-DaCompany Report #247262 Outcome Hospitalization Initial or Prolonged PT Suicide Attempt Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:10/20/00ISR Number: 3599650-4Report Type:Expedited (15-DaCompany Report #211570 Outcome Congenital Anomaly PT Congenital Mitral Valve Incompetence Heart Disease Congenital Cardiac Valve Disease Maternal Drugs Affecting Foetus Heart Valve Replacement Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age:1 HR Route ORAL
I/FU:F Duration
Date:10/20/00ISR Number: 3599651-6Report Type:Expedited (15-DaCompany Report #247267 Outcome Hospitalization Initial or Prolonged PT Hypoxia Lung Infiltration Pneumonitis Pyrexia Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Dyspnoea
03-Apr-2012
09:37 AM
Page: 256
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/00ISR Number: 3599766-2Report Type:Expedited (15-DaCompany Report #245766 Outcome Other Serious PT Papilloedema Visual Field Defect Visual Acuity Reduced Empty Sella Syndrome Lipoma Optic Neuritis Retinal Exudates Optic Neuropathy Optic Nerve Disorder Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Male Dose ORAL I/FU:F Duration
Date:10/20/00ISR Number: 3598163-3Report Type:Expedited (15-DaCompany Report #247262 Outcome Hospitalization Initial or Prolonged PT Suicide Attempt Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:47 YR Route
Gender:Male Dose
I/FU:I Duration
Date:10/20/00ISR Number: 3598168-2Report Type:Expedited (15-DaCompany Report #247267 Outcome Hospitalization Initial or Prolonged PT Hypoxia Pneumonitis Dyspnoea Pyrexia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:34 YR Route
Gender:Female Dose
Date:10/23/00ISR Number: 3599859-XReport Type:Direct Outcome Disability PT Amnesia Nightmare Insomnia Fatigue Vertigo Dizziness Confusional State Listless Paranoia Disturbance In Attention Lethargy Headache Depression
Company Report # Report Source Consumer Product Larium -MefloquineRoche Role PS Manufacturer Roche
Gender:Male Dose ONE PILL WEEK ORAL
I/FU:I Duration
Age:36 YR
Gender:Female
I/FU:I
PT Menorrhagia
Product Lariam
Role PS
Route ORAL
Duration
03-Apr-2012
09:37 AM
Page: 257
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/00ISR Number: 3599102-1Report Type:Expedited (15-DaCompany Report #245745 Outcome Other Serious PT Vaginal Haemorrhage Menorrhagia Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:36 YR Route Gender:Female Dose I/FU:F Duration 36 DAY
Date:10/24/00ISR Number: 3600623-3Report Type:Direct Outcome Other Serious PT Insomnia Mental Impairment Amnesia Disturbance In Attention
Company Report # Report Source Product Larium Once A Week Role PS Manufacturer
Gender:Male Dose ONCE A WEEK ORAL
I/FU:I Duration
Date:10/24/00ISR Number: 3601395-9Report Type:Expedited (15-DaCompany Report #247406 Outcome Other Serious PT Abnormal Dreams Dyskinesia Eye Movement Disorder Movement Disorder Disorientation Report Source Foreign Other Product Lariam Salmonella Vaccine (Typhoid Vaccines) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:10/24/00ISR Number: 3599672-3Report Type:Expedited (15-DaCompany Report #247406 Outcome Other Serious PT Disorientation Abnormal Dreams Eye Movement Disorder Movement Disorder Report Source Product Lariam Tablets Salmonella Vaccine Role PS C Manufacturer Roche
Age:22 YR Route
Gender:Female Dose
Date:10/26/00ISR Number: 3601036-0Report Type:Expedited (15-DaCompany Report #243034 Outcome Death Life-Threatening PT Stupor Abdominal Pain Gastrointestinal Disorder Extensor Plantar Response X-Ray Gastrointestinal Tract Abnormal Nuclear Magnetic Resonance Imaging Abnormal Mental Disorder Due To A General Medical Condition
Age:80 YR
Gender:Female
I/FU:F
Gastric Perforation Cardio-Respiratory Arrest Angiopathy Dyspnoea Gastrointestinal Sounds Abnormal Sedation Cardiac Failure 03-Apr-2012 09:37 AM Page: 258
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abdominal Tenderness C-Reactive Protein Increased Hypophagia Arrhythmia Shock Respiratory Failure Flatulence Blood Lactate Dehydrogenase Increased Depressed Level Of Consciousness Asthenia Confusional State Cardiac Murmur Oedema
Report Source
Role PS
Manufacturer Roche
Route
Dose
Duration 1 DAY
Date:10/26/00ISR Number: 3601049-9Report Type:Expedited (15-DaCompany Report #246474 Outcome Disability PT Psoriasis Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:61 YR Route
Gender:Female Dose
Date:10/27/00ISR Number: 3602925-3Report Type:Expedited (15-DaCompany Report #246474 Outcome Disability PT Psoriasis Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:10/27/00ISR Number: 3603403-8Report Type:Expedited (15-DaCompany Report #243034 Outcome Death Life-Threatening PT Asthenia Endoscopy Abnormal Abdominal Pain Extensor Plantar Response Gastric Perforation Confusional State Abdominal Tenderness Respiratory Failure Cardiac Failure X-Ray Gastrointestinal Tract Abnormal Respiratory Disorder Shock Blood Lactate Dehydrogenase Increased
Age:80 YR
Gender:Female
I/FU:F
Ill-Defined Disorder Mental Disorder Due To A General Medical Condition Nuclear Magnetic Resonance Imaging Abnormal C-Reactive Protein Increased 03-Apr-2012 09:37 AM Page: 259
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Ileus Paralytic Cardio-Respiratory Arrest Dyspnoea Arrhythmia
Product Lariam
Role PS
Route ORAL
Dose 2 DOSE FORM 1 PER ONE DOSE ORAL
Duration
Date:10/30/00ISR Number: 3602885-5Report Type:Expedited (15-DaCompany Report #87481 Outcome Disability PT Thinking Abnormal Bone Pain Feeling Abnormal Job Dissatisfaction Sleep Apnoea Syndrome Vomiting Loss Of Employment Brain Injury Amnesia Burning Sensation Oedema Respiratory Disorder Disorientation Dizziness Drug Level Above Therapeutic Disturbance In Attention Visual Impairment Hypertension Medication Error Pain Mental Impairment Mastoid Disorder Neck Pain Nausea Asthenia Accidental Overdose Vision Blurred Depression Sleep Disorder Upper Respiratory Tract Infection Visual Acuity Reduced Paraesthesia Neurological Symptom Cough Hypoaesthesia Nocturia Fatigue Dysgeusia Report Source Product Lariam Tablets Lamisil Role PS C Manufacturer Roche
Age:53 YR Route
Gender:Male Dose
Oedema Peripheral Mental Disorder
03-Apr-2012
09:37 AM
Page: 260
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/00ISR Number: 3602919-8Report Type:Expedited (15-DaCompany Report #200841 Outcome Hospitalization Initial or Prolonged Disability PT Tremor Asthenia Disturbance In Attention Visual Impairment Convulsion Abnormal Behaviour Mental Disorder Condition Aggravated Lacrimation Increased Stress Arrhythmia Hallucination Dyspnoea Diplopia Malaise Sedation Paraesthesia Fall Movement Disorder Crying Fatigue Hallucination, Visual Panic Attack Nausea Speech Disorder Balance Disorder Dysphagia Tinnitus Hyperventilation Vision Blurred Accommodation Disorder Dry Mouth Diarrhoea Hydrocephalus Heterophoria Report Source Product Lariam Tablets Meningococcal Vaccine Flu Vaccine Role PS Manufacturer Roche Age:42 YR Route Gender:Male Dose CUMULATIVE DOSAGE= 750 MG I/FU:F Duration 380 1 1 DAY DAY DAY
C C
Date:10/30/00ISR Number: 3603006-5Report Type:Direct Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage PT Anxiety Nightmare Insomnia Mania Mental Disorder Depression Nervous System Disorder
Company Report # Report Source Product Lariam-Mefloquine Role PS Manufacturer
Age:18 YR Route
Gender:Male Dose 1 / WEEK
I/FU:I Duration
Date:10/30/00ISR Number: 3603605-0Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability 03-Apr-2012 09:37 AM PT Psychotic Disorder Paranoia Hallucinations, Mixed Feeling Abnormal
Company Report #
Age:36 YR
Gender:Female
I/FU:I
Page: 261
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Persecutory Delusion Report Source Product Larium Role PS Manufacturer Route Dose 1 PER WEEK Duration
Date:10/30/00ISR Number: 3603668-2Report Type:Expedited (15-DaCompany Report #247733 Outcome Other Serious PT Visual Field Defect Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:10/30/00ISR Number: 3603957-1Report Type:Expedited (15-DaCompany Report #87481 Outcome Disability PT Hypoaesthesia Nausea Depression Paraesthesia Vomiting Disorientation Visual Impairment Asthenia Medication Error Dysgeusia Oedema Hypertension Dizziness Fatigue Accidental Overdose Report Source Literature Health Professional Product Lariam Lamisil (Terbinafine) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:10/30/00ISR Number: 3602890-9Report Type:Expedited (15-DaCompany Report #247733 Outcome Other Serious PT Visual Field Defect Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:35 YR Route
Gender:Male Dose THE PATIENT RECEIVED A TOTAL OF 2 TABLETS.
I/FU:I Duration
16
DAY
Date:11/01/00ISR Number: 3604078-4Report Type:Expedited (15-DaCompany Report #245340 Outcome Hospitalization Initial or Prolonged PT Stupor Insomnia
Age:17 YR
Gender:Male
I/FU:F
Ear Disorder Ventricular Hypertrophy Clonic Convulsion Blood Bilirubin Increased Tinnitus Dizziness Neutrophilia C-Reactive Protein 03-Apr-2012 09:37 AM Page: 262
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Headache Speech Disorder Confusional State Anxiety Dyskinesia Agitation Drug Tolerance Decreased Electroencephalogram Abnormal Abnormal Behaviour Vomiting Pyrexia Diplopia Thrombocytosis Chorea
Report Source
Product Lariam Tablets Advil
Role PS C
Manufacturer Roche
Route
Dose
Duration 2 DAY
Date:11/01/00ISR Number: 3605361-9Report Type:Direct Outcome Other Serious PT Dyspnoea Fatigue Dizziness Chills Vision Blurred Drug Hypersensitivity Hypoaesthesia Anxiety Headache Nausea Dehydration Pyrexia
Company Report # Report Source Product Larium Mefloquine Role PS Manufacturer
Age:31 YR Route OROPHARINGEAL
Gender:Female
I/FU:I
Dose Duration 1 PILL 1 TIME W OROPHARINGEAL
Date:11/01/00ISR Number: 3605668-5Report Type:Expedited (15-DaCompany Report #245340 Outcome Hospitalization Initial or Prolonged PT Clonic Convulsion Insomnia Malaria Confusional State Anxiety C-Reactive Protein Increased Leukocytosis Stupor Electroencephalogram Abnormal Headache Chorea Blood Lactate
Age:17 YR
Gender:Male
I/FU:F
Dehydrogenase Increased Thrombocytosis Ventricular Hypertrophy Dizziness Pyrexia Diplopia Haematocrit Decreased Vomiting 03-Apr-2012 09:37 AM Page: 263
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tinnitus Agitation Depressed Level Of Consciousness White Blood Cells Urine Positive Blood Bilirubin Increased Disorientation Speech Disorder Abnormal Behaviour Cardiomegaly Dyskinesia
Product Lariam Advil (Ibuprofen)
Role PS C
Route ORAL
Dose ORAL
Duration
Date:11/02/00ISR Number: 3605199-2Report Type:Expedited (15-DaCompany Report #247893 Outcome Hospitalization Initial or Prolonged PT Syncope Muscle Spasms Epistaxis Mouth Haemorrhage Report Source Consumer Product Lariam Tablets Plendil Moduretic Role PS C C Manufacturer Roche
Age:66 YR Route
Gender:Female Dose
Date:11/03/00ISR Number: 3605736-8Report Type:Expedited (15-DaCompany Report #245128 Outcome Other Serious PT Anxiety Tremor Extrapyramidal Disorder Gastrooesophageal Reflux Disease Throat Tightness Report Source Product Primperan Lariam Tablets Role PS SS Manufacturer Roche
Age:15 YR Route
Gender:Female Dose
Date:11/03/00ISR Number: 3605741-1Report Type:Expedited (15-DaCompany Report #230098 Outcome Hospitalization Initial or Prolonged PT Hyperhidrosis Tinnitus Depression Psychotic Disorder Paraesthesia Furuncle Mental Disorder Agoraphobia Retching Dizziness Blood Pressure Systolic Increased Nausea Report Source Product Lariam Tablets Jodthyrox Hismanal Role PS C C Manufacturer Roche
Age:42 YR Route
Gender:Female Dose
Chills
03-Apr-2012
09:37 AM
Page: 264
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/00ISR Number: 3608144-9Report Type:Expedited (15-DaCompany Report #245128 Outcome Other Serious PT Tremor Extrapyramidal Disorder Gastrooesophageal Reflux Disease Nervousness Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:15 YR Route ORAL Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL 1 DOSE FORM 2 PER DAY ORAL I/FU:F Duration
Primperan (Metoclopramide Hydrochloride)
SS
ORAL
Date:11/06/00ISR Number: 3608146-2Report Type:Expedited (15-DaCompany Report #230098 Outcome Hospitalization Initial or Prolonged PT Hyperhidrosis Fatigue Retching Crying Agoraphobia Phobia Dizziness Anxiety Tinnitus Agitation Conversion Disorder Abdominal Discomfort Nausea Chills Depression Obsessive-Compulsive Disorder Mental Disorder Hyperventilation Psychotic Disorder Blood Pressure Systolic Increased Stress Paraesthesia Furuncle Report Source Foreign Consumer Health Professional Product Lariam Hismanal (Astemizole) Hismanal (Astemizole) Jodthyrox (Levothyroxine Sodium/Potassium Iodide) Role PS C C Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:11/06/00ISR Number: 3608353-9Report Type:Expedited (15-DaCompany Report #244563 Outcome Hospitalization Initial or Prolonged PT Depression Paraesthesia Mental Impairment Syncope
Age:47 YR
Gender:Male
I/FU:I
Adjustment Disorder Orgasm Abnormal Emotional Disorder Weight Decreased Fear Fatigue Asthenia Stress 03-Apr-2012 09:37 AM Page: 265
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance In Attention Vision Blurred Feeling Abnormal Emotional Distress Abnormal Dreams Anxiety Crying Psychiatric Symptom Panic Attack Obsessive-Compulsive Personality Disorder Dizziness Tremor Insomnia Libido Decreased Mood Swings Bradyphrenia
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
Date:11/06/00ISR Number: 3606583-3Report Type:Expedited (15-DaCompany Report #244563 Outcome Hospitalization Initial or Prolonged PT Mental Impairment Feeling Abnormal Tremor Vision Blurred Fatigue Anxiety Orgasm Abnormal Obsessive-Compulsive Disorder Emotional Disorder Disturbance In Attention Asthenia Abnormal Dreams Dizziness Sleep Disorder Depression Syncope Weight Decreased Libido Decreased Panic Attack Paraesthesia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:47 YR Route
Gender:Male Dose
I/FU:F Duration
Date:11/08/00ISR Number: 3608713-6Report Type:Direct Outcome Other Serious Required Intervention to PT Depression Heart Rate Increased Feeling Abnormal
Company Report # Report Source Product Lariam / Mefloquine / 250mg / Roche Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose 250MG ONCE A WEEK ORAL
I/FU:I Duration
Social Phobia Dizziness Insomnia Hypertension Confusional State Panic Attack
03-Apr-2012
09:37 AM
Page: 266
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/00ISR Number: 3608796-3Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Dizziness Angina Pectoris Fatigue Company Report # Report Source Product Melfoquine Felodipine Lariam Role PS C Manufacturer Age:33 YR Route ORAL Gender:Male I/FU:I
Dose Duration 1 1PER WEEK ORAL
Date:11/08/00ISR Number: 3608799-9Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Chest Pain
Company Report # Report Source Product Mefloquine Felodipine Morphine (Lariam) Role PS C C Manufacturer
Gender:Male
I/FU:I
Dose Duration 1 1 PER WEEK ORAL
Date:11/13/00ISR Number: 3610011-1Report Type:Expedited (15-DaCompany Report #60555 Outcome Hospitalization Initial or Prolonged PT Depression Chest Pain Anxiety Palpitations Report Source Product Lariam Tablets Dormonoct Prothiaden Role PS C C Manufacturer Roche
Age:45 YR Route
Gender:Female Dose
Date:11/13/00ISR Number: 3610049-4Report Type:Expedited (15-DaCompany Report #85415 Outcome Life-Threatening PT Dizziness Nightmare Alopecia Depression Suicidal Ideation Nausea Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:26 YR Route
Gender:Female Dose
Date:11/13/00ISR Number: 3611050-7Report Type:Expedited (15-DaCompany Report #60555 Outcome Hospitalization Initial or Prolonged PT Chest Pain Palpitations Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 250 MG 1 PER
I/FU:F Duration
Depression Anxiety
WEEK ORAL Dormonoct (Loprazolam) Prothiaden (Dothiepin Hydrochloride) C C
03-Apr-2012
09:37 AM
Page: 267
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/00ISR Number: 3610058-5Report Type:Expedited (15-DaCompany Report #910100239001 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Suicide Attempt Depression Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:20 YR Route Gender:Male Dose I/FU:F Duration 15 DAY
Date:11/14/00ISR Number: 3612201-0Report Type:Expedited (15-DaCompany Report #216859 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Lymphadenopathy Pharyngitis Rhinorrhoea Thermal Burn Skin Discolouration Oropharyngeal Pain Emotional Disorder Emotional Distress Lichen Planus Pharyngitis Streptococcal Erythema Refraction Disorder Bronchospasm Sinus Congestion Headache Report Source Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:11/15/00ISR Number: 3611274-9Report Type:Expedited (15-DaCompany Report #216859 Outcome Other Serious PT Headache Skin Discolouration Thermal Burn Lichen Planus Rhinorrhoea Refraction Disorder Lymphadenopathy Emotional Disorder Erythema Pharyngitis Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:20 YR Route
Gender:Male Dose
Date:11/15/00ISR Number: 3611309-3Report Type:Expedited (15-DaCompany Report #237590 Outcome Other Serious PT Intra-Uterine Death Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
Date:11/15/00ISR Number: 3611310-XReport Type:Expedited (15-DaCompany Report #237587 Outcome Other Serious PT Intra-Uterine Death Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
03-Apr-2012
09:37 AM
Page: 268
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/00ISR Number: 3611397-4Report Type:Direct Outcome Disability PT Anxiety Dizziness Insomnia Paranoia Abnormal Dreams Abnormal Behaviour Mood Altered Confusional State Depression Company Report # Report Source Product Lariam 250mg Roche Lab Inc Role PS Manufacturer Roche Lab Inc Age:31 YR Route ORAL Gender:Female Dose 3 1 PER WEEK ORAL I/FU:I Duration
Date:11/15/00ISR Number: 3612397-0Report Type:Expedited (15-DaCompany Report #85415 Outcome Life-Threatening PT Nausea Alopecia Depression Dizziness Nightmare Suicidal Ideation Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:11/15/00ISR Number: 3612515-4Report Type:Expedited (15-DaCompany Report #237587 Outcome Other Serious PT Accidental Exposure Abortion Missed Intra-Uterine Death Report Source Foreign Consumer Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:11/15/00ISR Number: 3612728-1Report Type:Expedited (15-DaCompany Report #910100239001 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Suicidal Ideation Overdose Dysthymic Disorder Tremor Suicide Attempt Agitation Nervousness Depression Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Age:
Gender:Male
I/FU:F
PT Abortion Missed Intra-Uterine Death Maternal Drugs Affecting Foetus Accidental Exposure 09:37 AM
Report Source Foreign Consumer Health Professional Other
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
03-Apr-2012
Page: 269
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/00ISR Number: 3612864-XReport Type:Expedited (15-DaCompany Report #244563 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Decreased Appetite Pneumonia Tremor Chills Orgasm Abnormal Panic Attack Eosinophilia Haemoglobin Decreased Feeling Abnormal Musculoskeletal Stiffness Lymphadenopathy Dry Mouth Emotional Disorder Sleep Disorder Cognitive Disorder Headache Vision Blurred Asthenia Bradycardia Paraesthesia Obsessive-Compulsive Disorder Diarrhoea Mental Impairment Dehydration Syncope Disturbance In Attention Bronchitis Skin Lesion Abnormal Dreams Fatigue Depression Anxiety Dizziness Upper Respiratory Tract Infection Libido Decreased Mood Swings Stress Dysuria Weight Decreased Report Source Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:47 YR Route ORAL Gender:Male Dose ORAL I/FU:F Duration
Date:11/16/00ISR Number: 3613028-6Report Type:Expedited (15-DaCompany Report #234234 Outcome Other Serious PT Stillbirth Premature Labour Placental Insufficiency Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Caesarean Section Maternal Drugs Affecting Foetus
Meningococcal Vaccine (Meningococcal Vaccines Nos) Diphtheria Vaccine (Diphtheria Toxoid) Cholera Vaccine (Cholera Vaccine)
C C C Page: 270
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Typhus Vaccine (Typhus Vaccine) Hepatitis A Vaccine (Hepatitis A Vaccine)
C C
Date:11/16/00ISR Number: 3613117-6Report Type:Expedited (15-DaCompany Report #248735 Outcome Other Serious PT Drug Interaction International Normalised Ratio Increased Report Source Foreign Health Professional Product Lariam Warfarin (Warfarin Sodium) Co Proxamol (Acetaminophen / Prophoxyphene Hydrochloride) Role PS SS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:11/17/00ISR Number: 3613227-3Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Arthropathy Diarrhoea Vomiting Abdominal Pain Arthritis
Company Report # Report Source Product Lariam 1 Pill Weekly Role PS Manufacturer
Age:21 YR Route
Gender:Female Dose 1 PILL
I/FU:I Duration
Date:11/21/00ISR Number: 3613999-8Report Type:Expedited (15-DaCompany Report #85415 Outcome Life-Threatening PT Suicidal Ideation Alopecia Nightmare Depression Dizziness Nausea Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:26 YR Route
Gender:Female Dose
Date:11/21/00ISR Number: 3614000-2Report Type:Expedited (15-DaCompany Report #89618 Outcome Other Serious PT Muscle Contractions Involuntary Paraesthesia Insomnia Abnormal Dreams Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:42 YR Route
Gender:Female Dose
Psychotic Disorder Crying Hyperreflexia Panic Reaction Palpitations Hypoaesthesia Hyperhidrosis Decreased Appetite 03-Apr-2012 09:37 AM Page: 271
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/00ISR Number: 3614035-XReport Type:Expedited (15-DaCompany Report #910100239001 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Suicide Attempt Depression Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:20 YR Route Gender:Male Dose I/FU:F Duration 15 DAY
Date:11/21/00ISR Number: 3614074-9Report Type:Expedited (15-DaCompany Report #930202261001 Outcome Hospitalization Initial or Prolonged Disability PT Panic Reaction Diarrhoea Decreased Appetite Vertigo Abnormal Behaviour Hyperhidrosis Visual Impairment Dermatitis Chromaturia Weight Decreased White Blood Cell Count Increased Suicidal Ideation Gastritis Nausea Fatigue Hyperaesthesia Depression Balance Disorder Pollakiuria Anxiety Crying Dyspepsia Malaise Pharyngeal Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age:41 YR Route
Gender:Female Dose
Date:11/21/00ISR Number: 3615482-2Report Type:Expedited (15-DaCompany Report #910100239001 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Overdose Suicide Attempt Suicidal Ideation Tremor Agitation Nervousness Depression Dysthymic Disorder Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:11/21/00ISR Number: 3615623-7Report Type:Expedited (15-DaCompany Report #930202261001 Outcome Hospitalization Initial or Prolonged Disability 03-Apr-2012 09:37 AM PT Hyperhidrosis Fatigue Dyspepsia
Age:41 YR
Gender:Female
I/FU:F
Page: 272
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Injury Gastritis White Blood Cell Count Increased Suicidal Ideation Balance Disorder Diarrhoea Weight Decreased Abnormal Faeces Insomnia Chromaturia Dermatitis Depression Anxiety Malaise Visual Impairment Abnormal Behaviour Paraesthesia Pollakiuria Decreased Appetite Nausea Foreign Body Feeling Abnormal Crying Vertigo
Product Lariam
Role PS
Route ORAL
Duration
Date:11/21/00ISR Number: 3615624-9Report Type:Expedited (15-DaCompany Report #89618 Outcome Other Serious PT Movement Disorder Dyspnoea Decreased Appetite Psychotic Disorder Insomnia Hyperhidrosis Hypophagia Hyperreflexia Hypoaesthesia Palpitations Panic Attack Abnormal Dreams Crying Paraesthesia Muscle Contractions Involuntary Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Age:72 YR Route
Gender:Female Dose
I/FU:I Duration
Other Serious
Neuritis Inner Ear Disorder Dizziness Dermatitis
Foreign Consumer
Lariam
PS
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 273
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/00ISR Number: 3615646-8Report Type:Expedited (15-DaCompany Report #85415 Outcome Life-Threatening PT Depression Suicidal Dizziness Alopecia Nausea Nightmare Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:26 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
Date:11/21/00ISR Number: 3614037-3Report Type:Expedited (15-DaCompany Report #249131 Outcome Other Serious PT Gamma-Glutamyltransferase Increased Blood Alkaline Phosphatase Increased Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:11/21/00ISR Number: 3614045-2Report Type:Expedited (15-DaCompany Report #249135 Outcome Life-Threatening PT Respiratory Arrest Report Source Product Lariam Tablets Doxycyclin Role PS C Manufacturer Roche
Age:61 YR Route
Gender:Male Dose
I/FU:I Duration
Date:11/21/00ISR Number: 3614079-8Report Type:Expedited (15-DaCompany Report #248917 Outcome Other Serious PT Ear Disorder Dermatitis Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:72 YR Route
Gender:Female
I/FU:I
Dose Duration TWO DOSES OF LARIAM TAKEN, ONE ON 7 JAN 00 AND ONE ON 14 JAN 00. 9 DAY
Date:11/22/00ISR Number: 3615108-8Report Type:Expedited (15-DaCompany Report #203837 Outcome Death PT Weight Decreased Agitation Flushing Delusional Disorder, Persecutory Type Nervous System Disorder Cognitive Disorder Urinary Hesitation Hyperhidrosis Fatigue
Age:54 YR
Gender:Male
I/FU:F
Musculoskeletal Stiffness Depression Polydipsia Delirium Anxiety Insomnia Abnormal Dreams Completed Suicide 03-Apr-2012 09:37 AM Page: 274
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amnesia Chills Headache Decreased Appetite Obsessive-Compulsive Disorder Hallucinations, Mixed Adjustment Disorder
Report Source
Role PS
Manufacturer Roche
Route
Dose
Duration 50 DAY
Date:11/22/00ISR Number: 3616466-0Report Type:Expedited (15-DaCompany Report #248917 Outcome Other Serious PT Dizziness Ear Disorder Neuritis Dermatitis Balance Disorder Vestibular Disorder Report Source Foreign Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:11/22/00ISR Number: 3616467-2Report Type:Expedited (15-DaCompany Report #85415 Outcome Life-Threatening PT Nausea Dizziness Alopecia Nightmare Depression Suicidal Ideation Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:11/22/00ISR Number: 3616469-6Report Type:Expedited (15-DaCompany Report #249131 Outcome Other Serious PT Red Blood Cell Sedimentation Rate Increased Liver Function Test Abnormal Gamma-Glutamyltransferase Increased Blood Uric Acid Increased Blood Alkaline Phosphatase Increased Blood Iron Decreased Condition Aggravated Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:11/22/00ISR Number: 3616470-2Report Type:Expedited (15-DaCompany Report #249135 Outcome Life-Threatening PT Respiratory Arrest Convulsion Circulatory Collapse Report Source Foreign Other Product Lariam Doxycyclin (Doxycycline) Role PS C Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 275
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/00ISR Number: 3617622-8Report Type:Expedited (15-DaCompany Report #203837 Outcome Death PT Sleep Disorder Nervous System Disorder Insomnia Fatigue Depression Musculoskeletal Stiffness Polydipsia Anxiety Social Problem Dissociation Hallucinations, Mixed Delusion Flushing Delirium Obsessive-Compulsive Disorder Decreased Appetite Chills Memory Impairment Mental Impairment Weight Decreased Delusional Disorder, Persecutory Type Amnesia Lethargy Personality Disorder Nightmare Dysgraphia Staring Cognitive Disorder Adjustment Disorder Hyperhidrosis Abnormal Dreams Agitation Completed Suicide Urinary Hesitation Fear Headache Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:54 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
Date:11/24/00ISR Number: 3617901-4Report Type:Expedited (15-DaCompany Report #249282 Outcome Disability PT Atrioventricular Block Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:11/27/00ISR Number: 3616037-6Report Type:Expedited (15-DaCompany Report #249282 Outcome Disability PT Atrioventricular Block Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:48 YR Route
Gender:Female Dose
03-Apr-2012
09:37 AM
Page: 276
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/00ISR Number: 3616670-1Report Type:Expedited (15-DaCompany Report #225972 Outcome Congenital Anomaly PT Kidney Malformation Hypospadias Maternal Drugs Affecting Foetus Report Source Health Professional Product Lariam Tablets Magne-B6 Tardyferon Speciafoldine Aspegic Role PS C C C C Manufacturer Roche Age: Route Gender:Male Dose I/FU:F Duration 42 DAY
Date:11/28/00ISR Number: 3616675-0Report Type:Expedited (15-DaCompany Report #232768 Outcome Hospitalization Initial or Prolonged PT Vision Blurred Demyelination Peripheral Coldness Disturbance In Attention Pyrexia Fatigue Vertigo Abdominal Pain Lethargy Headache Wolff-Parkinson-White Syndrome Dizziness Balance Disorder Hyperacusis Nausea Weight Increased Antinuclear Antibody Positive Migraine Eating Disorder Disorientation Vomiting Paraesthesia Feeling Hot Dehydration Dysphagia Report Source Health Professional Product Lariam Tablets Role PS Manufacturer Roche
Age:27 YR Route
Gender:Female Dose
I/FU:F Duration
Date:11/28/00ISR Number: 3617657-5Report Type:Expedited (15-DaCompany Report #225972 Outcome Congenital Anomaly PT Maternal Drugs Affecting Foetus Kidney Malformation Hypospadias Report Source Product Lariam Tablets Magne-B6 Tardyferon Speciafoldine Aspegic Role PS C C C C Manufacturer Roche
Age: Route
Gender:Male Dose
Date:11/28/00ISR Number: 3617658-7Report Type:Expedited (15-DaCompany Report #214112 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Oedema Peripheral Headache Nightmare
Age:18 YR
Gender:Female
I/FU:F
Page: 277
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Vith Nerve Paralysis Fatigue Csf Pressure Decreased Benign Intracranial Hypertension Csf Protein Increased Papilloedema Diplopia
Report Source
Product Lariam Tablets Contraceptive
Role PS C
Manufacturer Roche
Route
Dose
Duration 71 DAY
Date:11/28/00ISR Number: 3617664-2Report Type:Expedited (15-DaCompany Report #232768 Outcome Hospitalization Initial or Prolonged PT Hyperacusis Dehydration Weight Increased Fatigue Wolff-Parkinson-White Syndrome Migraine Disorientation Abdominal Pain Paraesthesia Pyrexia Dizziness Lethargy Balance Disorder Vision Blurred Antinuclear Antibody Positive Anxiety Angiopathy Demyelination Vomiting Depression Peripheral Coldness Dysphagia Vertigo Headache Disturbance In Attention Eating Disorder Malaise Nausea Feeling Hot Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:27 YR Route
Gender:Female Dose
I/FU:F Duration
Date:11/28/00ISR Number: 3617700-3Report Type:Expedited (15-DaCompany Report #248975 Outcome Disability PT Neuropathy Peripheral Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:54 YR Route
Gender:Male Dose
Lethargy Paraesthesia Myalgia
03-Apr-2012
09:37 AM
Page: 278
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/00ISR Number: 3617710-6Report Type:Expedited (15-DaCompany Report #249339 Outcome Hospitalization Initial or Prolonged PT Lichen Planus Pruritus Blister Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:38 YR Route Gender:Male Dose I/FU:I Duration 80 DAY
Date:11/28/00ISR Number: 3617714-3Report Type:Expedited (15-DaCompany Report #249491 Outcome Other Serious PT Cognitive Disorder Gait Disturbance Amnesia Dyspraxia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:59 YR Route
Gender:Male Dose
I/FU:I Duration
Date:11/28/00ISR Number: 3617717-9Report Type:Expedited (15-DaCompany Report #249476 Outcome Other Serious PT Petit Mal Epilepsy Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:33 YR Route
Gender:Male Dose
Date:11/28/00ISR Number: 3618062-8Report Type:Expedited (15-DaCompany Report #225972 Outcome Congenital Anomaly PT Congenital Anomaly Hypospadias Maternal Drugs Affecting Foetus Renal Disorder Placental Disorder Report Source Foreign Health Professional Product Lariam Magen-86 (Magnesium Nos/Pyridoxine Hydrochloride) Tardyferon (Ferrous Sulfate) Speciafolidine (Folic Acid) Aspegic (Aspirin Dl-Lysine) Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
C C C C
Date:11/28/00ISR Number: 3618065-3Report Type:Expedited (15-DaCompany Report #232768 Outcome Hospitalization Initial or Prolonged PT Paraesthesia Vomiting Hypoaesthesia Feeling Hot Hyperacusis Peripheral Coldness
Age:27 YR
Gender:Female
I/FU:F
Vision Blurred Balance Disorder Lethargy Weight Increased Eating Disorder Disturbance In Attention Antinuclear Antibody Positive 03-Apr-2012 09:37 AM Page: 279
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Migraine Malaise Abdominal Pain Vertigo Blood Glucose Decreased Dizziness Dehydration Disorientation Dysphagia Headache Fatigue Anxiety Wolff-Parkinson-White Syndrome Pyrexia Demyelination
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
Date:11/29/00ISR Number: 3619066-1Report Type:Expedited (15-DaCompany Report #248735 Outcome Other Serious PT International Normalised Ratio Increased Drug Interaction Report Source Foreign Health Professional Product Lariam Warfarin (Warfarin Sodium) Co Proxamol (Acetaminophen/ Propoxyphene Hydrochloride) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
SS
Date:11/29/00ISR Number: 3619067-3Report Type:Expedited (15-DaCompany Report #248975 Outcome Disability PT Neuropathy Peripheral Lethargy Pain In Extremity Paraesthesia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:11/29/00ISR Number: 3619068-5Report Type:Expedited (15-DaCompany Report #214112 Outcome Hospitalization Initial or Prolonged PT Csf Protein Increased Diplopia Nightmare Fatigue Vith Nerve Paralysis Oedema Peripheral Report Source Foreign Health Professional Product Lariam Contraceptive (Contraceptive Nos) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Papilloedema Benign Intracranial Hypertension
03-Apr-2012
09:37 AM
Page: 280
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/00ISR Number: 3618871-5Report Type:Expedited (15-DaCompany Report #249379 Outcome Hospitalization Initial or Prolonged PT Arrhythmia Bradycardia Hypertension Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:27 YR Route Gender:Male Dose I/FU:I Duration 36 DAY
Date:11/30/00ISR Number: 3618882-XReport Type:Expedited (15-DaCompany Report #249874 Outcome Disability PT Agitation Electroencephalogram Abnormal Psychotic Disorder Balance Disorder Amnesia Insomnia Emotional Distress Nightmare Headache Visual Impairment Educational Problem Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
Date:12/01/00ISR Number: 3620945-XReport Type:Expedited (15-DaCompany Report #249874 Outcome Disability PT Headache Insomnia Emotional Distress Electroencephalogram Abnormal Nightmare Amnesia Psychotic Disorder Learning Disorder Agitation Visual Impairment Balance Disorder Report Source Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:12/01/00ISR Number: 3621130-8Report Type:Expedited (15-DaCompany Report #249379 Outcome Hospitalization Initial or Prolonged PT Bradycardia Arrhythmia Hypertension Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:12/06/00ISR Number: 3622972-5Report Type:Expedited (15-DaCompany Report #242660 Outcome Disability PT Parosmia Nasopharyngitis Ageusia 09:37 AM Report Source Product Lariam Tablets Stamaril Unidose Havrix Role PS C C Manufacturer Roche
Age:53 YR Route
Gender:Female Dose
I/FU:F Duration 1 1 DAY DAY Page: 281
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prophylactic Medication
Date:12/06/00ISR Number: 3622973-7Report Type:Expedited (15-DaCompany Report #249748 Outcome Hospitalization Initial or Prolonged PT Agitation Confusional State Mutism Hypertonia Delusion Acute Psychosis Speech Disorder Disorientation Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:55 YR Route
Gender:Male Dose
I/FU:I Duration
Date:12/07/00ISR Number: 3623547-4Report Type:Expedited (15-DaCompany Report #249977 Outcome Death PT Dizziness Decreased Appetite Malaise Skull Fracture Drowning Head Injury Hypophagia Fatigue Restlessness Haemorrhage Subcutaneous Mutism Scratch Confusional State Personality Change Fall Influenza Like Illness Brain Contusion Depression Aggression Skull Fractured Base Report Source Product Lariam Tablets Havrix Typhim Role PS C C Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration 1 DAY 1 DAY 1 DAY
Date:12/07/00ISR Number: 3624751-1Report Type:Expedited (15-DaCompany Report #249748 Outcome Hospitalization Initial or Prolonged PT Agitation Confusional State Persecutory Delusion Pyrexia Delusion Report Source Foreign Literature Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age:55 YR Route
Gender:Male Dose
I/FU:I Duration
Hypertonia Mutism Disorientation Speech Disorder Acute Psychosis
03-Apr-2012
09:37 AM
Page: 282
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/00ISR Number: 3624753-5Report Type:Expedited (15-DaCompany Report #242660 Outcome Disability PT Nasopharyngitis Anosmia Ageusia Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:53 YR Route ORAL Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Stamaril Unidose (Yellow Fever Vaccine) Havrix (Hepatitis A Vaccine) Prophylactic Medication (Prophylactic Medication Nos)
C C
Date:12/08/00ISR Number: 3624451-8Report Type:Expedited (15-DaCompany Report #249746 Outcome Hospitalization Initial or Prolonged PT Decreased Appetite Persecutory Delusion Depressed Mood Abnormal Behaviour Depression Delusion Of Reference Hallucinations, Mixed Soliloquy Insomnia Anger Suicidal Ideation Crying Anxiety Report Source Product Mefloquine Hydrochloride Zopiclone Bromazepam Role PS C C Manufacturer Roche
Age:43 YR Route
Gender:Female Dose
I/FU:I Duration
Date:12/08/00ISR Number: 3625505-2Report Type:Expedited (15-DaCompany Report #249977 Outcome Death PT Dizziness Skull Fractured Base Depression Brain Contusion Mutism Fall Head Injury Restlessness Skull Fracture Fatigue Confusional State Victim Of Crime Report Source Foreign Other Product Lariam Havrix (Hepatitis A Vaccine) Typhim (Typhoid Vaccines) Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
C C
Scratch Drowning Haemorrhage Subcutaneous Decreased Appetite Malaise Personality Change
03-Apr-2012
09:37 AM
Page: 283
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/00ISR Number: 3625248-5Report Type:Expedited (15-DaCompany Report #250469 Outcome Other Serious PT Pain In Extremity Hypoaesthesia Optic Neuritis Neurological Symptom Report Source Product Lariam Tablets Role PS Manufacturer Roche Age: Route Gender:Female Dose I/FU:I Duration
Date:12/11/00ISR Number: 3625253-9Report Type:Expedited (15-DaCompany Report #250135 Outcome Hospitalization Initial or Prolonged PT Coma Convulsion Overdose Agitation Toxicity To Various Agents Report Source Product Lariam Tablets Neuroleptic Nos Gardenal Unknown Benzodiazepines Role PS C C C Manufacturer Roche
Age:58 YR Route
Gender:Male Dose
I/FU:I Duration 8 DAY 1 DAY 1 DAY 1 DAY
Date:12/11/00ISR Number: 3627203-8Report Type:Expedited (15-DaCompany Report #249746 Outcome Hospitalization Initial or Prolonged PT Suicidal Ideation Depression Decreased Appetite Delusion Hallucinations, Mixed Report Source Foreign Literature Health Professional Product Lariam Zopiclone (Zopiclone) Bromazepam (Bromazepam) Role PS C C Manufacturer Hoffmann La Roche Inc
Age:43 YR Route
Gender:Female Dose
I/FU:I Duration
Date:12/12/00ISR Number: 3626644-2Report Type:Expedited (15-DaCompany Report #250525 Outcome Other Serious PT Weight Decreased Renal Failure Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:15 YR Route
Gender:Male Dose
Date:12/12/00ISR Number: 3627119-7Report Type:Direct Outcome Disability PT Psychotic Disorder
Gender:Male
I/FU:I
Dose Duration ONE WEE ORAL
Date:12/12/00ISR Number: 3627669-3Report Type:Expedited (15-DaCompany Report #250469 Outcome Other Serious PT Neurological Symptom Report Source Health Product Lariam Role PS Manufacturer Hoffmann La Roche
Age: Route
Gender:Female Dose
I/FU:I Duration
Hypoaesthesia Pain In Extremity Optic Neuritis
Professional
Inc
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 284
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/00ISR Number: 3628092-8Report Type:Expedited (15-DaCompany Report #250135 Outcome Hospitalization Initial or Prolonged PT Convulsion Coma Agitation Report Source Foreign Other Product Lariam Neuroleptic Nos (Neuroleptic Nos) Gardenal (Phenobarbital) Unknown Benzodiazepines (Benzodiazepine Nos) Role PS Manufacturer Hoffmann La Roche Inc Age:58 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
C C C
Date:12/13/00ISR Number: 3627583-3Report Type:Expedited (15-DaCompany Report #228520 Outcome Other Serious PT Bradycardia Maternal Drugs Affecting Foetus Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Male
I/FU:F
Dose Duration CUMULATIVE DOSE 2000 MG. 60 DAY
Date:12/13/00ISR Number: 3629372-2Report Type:Expedited (15-DaCompany Report #250525 Outcome Other Serious PT Renal Failure Weight Decreased Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:12/14/00ISR Number: 3628891-2Report Type:Expedited (15-DaCompany Report #250525 Outcome Other Serious PT Renal Failure Weight Decreased Blood Albumin Increased Report Source Health Professional Product Lariam Tablets Role PS Manufacturer Roche
Age:15 YR Route
Gender:Male Dose
Date:12/14/00ISR Number: 3630418-6Report Type:Expedited (15-DaCompany Report #228520 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Bradycardia Maternal Drugs Affecting Foetus Report Source Foreign Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:12/15/00ISR Number: 3630208-4Report Type:Direct Outcome Disability PT Paranoia Pyrexia Delirium Tremor 09:37 AM
Company Report # Report Source Product Lariam 250 Mg Hoffman-La-Roche Role PS Manufacturer Hoffman-La-Roche
Gender:Male Dose 1-250 MG 10 DAYS ORAL
I/FU:I Duration
03-Apr-2012
Page: 285
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/00ISR Number: 3630214-XReport Type:Direct Outcome Other Serious PT Feeling Abnormal Panic Reaction Mental Impairment Company Report # Report Source Product Lariam Role PS Manufacturer Age:31 YR Route ORAL Gender:Male Dose ONCE ORAL I/FU:I Duration
Date:12/15/00ISR Number: 3630289-8Report Type:Expedited (15-DaCompany Report #250670 Outcome Disability PT Personality Change Agitation Report Source Product Lariam Tablets Antimalarial Nos Triludan Role PS SS SS Manufacturer Roche
Age:22 YR Route
Gender:Male Dose
I/FU:I Duration
Date:12/15/00ISR Number: 3631006-8Report Type:Expedited (15-DaCompany Report #248735 Outcome Other Serious PT International Normalised Ratio Increased Drug Interaction Report Source Product Lariam Tablets Co Proxamol Warfarin Role PS C I Manufacturer Roche
Age:55 YR Route
Gender:Female Dose
I/FU:F Duration
Date:12/15/00ISR Number: 3631966-5Report Type:Expedited (15-DaCompany Report #250525 Outcome Other Serious PT Weight Decreased Renal Failure Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:12/18/00ISR Number: 3633587-7Report Type:Direct Outcome Disability Other Serious PT Inappropriate Affect Crying Insomnia Anxiety Mental Impairment Panic Reaction
Company Report # Report Source Product Lariam Role PS Manufacturer Hoffmann-Laroche
Gender:Male Dose 1 TABLE ORAL DAY
I/FU:I Duration
Date:12/19/00ISR Number: 3632679-6Report Type:Expedited (15-DaCompany Report #250403 Outcome Life-Threatening PT Bradycardia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:61 YR Route
Gender:Female Dose
Ventricular Fibrillation Blood Potassium Decreased Head Injury Condition Aggravated Syncope Torsade De Pointes Electrocardiogram Qt Prolonged
Moduretic
03-Apr-2012
09:37 AM
Page: 286
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/00ISR Number: 3633799-2Report Type:Expedited (15-DaCompany Report #250469 Outcome Other Serious PT Hypoaesthesia Emotional Disorder Pain In Extremity Neurological Symptom Report Source Product Lariam Tablets Role PS Manufacturer Roche Age: Route Gender:Female I/FU:F
Dose Duration REPORTED THE PATIENT TOOK THREE LARIAM TABLETS.
Date:12/20/00ISR Number: 3633802-XReport Type:Expedited (15-DaCompany Report #251020 Outcome Hospitalization Initial or Prolonged PT Myositis Phlebitis Report Source Product Lariam Tablets Contraceptive Pill Role PS C Manufacturer Roche
Age:28 YR Route
Gender:Female Dose
I/FU:I Duration
Date:12/20/00ISR Number: 3634802-6Report Type:Expedited (15-DaCompany Report #250403 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Ventricular Fibrillation Torsade De Pointes Condition Aggravated Electrocardiogram Qt Prolonged Heart Disease Congenital Bradycardia Blood Potassium Decreased Syncope Head Injury Report Source Foreign Health Professional Other Product Lariam Moduretic (Amiloride Hydrochloride/Hydroc hlorothiazide) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:12/20/00ISR Number: 3635602-3Report Type:Expedited (15-DaCompany Report #250670 Outcome Disability PT Personality Change Agitation Report Source Foreign Health Professional Product Lariam Antimalarial Nos (Antimalarial Agent Nos) Triludan (Terfenadine) Role PS Manufacturer Hoffmann La Roche Inc
Age:22 YR Route
Gender:Male Dose
I/FU:I Duration
SS SS
Date:12/21/00ISR Number: 3634463-6Report Type:Expedited (15-DaCompany Report #910100239001 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Depression Nervousness Tremor Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:20 YR Route
Gender:Male Dose
Disability
Dysthymic Disorder Suicide Attempt
03-Apr-2012
09:37 AM
Page: 287
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/00ISR Number: 3635906-4Report Type:Expedited (15-DaCompany Report #251020 Outcome Hospitalization Initial or Prolonged PT Swelling Pain Erythema Phlebitis Myositis Report Source Foreign Health Professional Product Lariam Contraceptive Pill (Oral Contraceptive Nos) Role PS Manufacturer Hoffmann La Roche Inc Age:28 YR Route ORAL Gender:Female Dose 250MG, 1 PER WEEK ORAL I/FU:I Duration
Date:12/22/00ISR Number: 3636105-2Report Type:Expedited (15-DaCompany Report #250469 Outcome Other Serious PT Hypoaesthesia Pain In Extremity Neurological Symptom Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:12/22/00ISR Number: 3637192-8Report Type:Periodic Outcome Other Serious PT Tinnitus Vertigo
Company Report #A031374 Report Source Consumer Product Zithromax Lariam Role PS SS Manufacturer Pfizer Chemicals Div Pfizer Inc
Gender:Female Dose 500.00 MG TOTAL: ORAL
I/FU:I Duration
Date:12/26/00ISR Number: 3638713-1Report Type:Expedited (15-DaCompany Report #910100239001 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Depression Tremor Condition Aggravated Nervousness Obsessive-Compulsive Disorder Suicidal Ideation Agitation Dysthymic Disorder Suicide Attempt Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 1 DOSE FORM 1 WEEK ORAL
I/FU:F Duration
Date:01/02/01ISR Number: 3639580-2Report Type:Expedited (15-DaCompany Report #247262 Outcome Hospitalization Initial or Prolonged PT Drug Interaction Spinal Fracture Suicide Attempt Report Source Health Professional Product Lariam Tablets Prozac Xanax Role PS I I Manufacturer Roche
Age:47 YR Route
Gender:Male Dose
Depression
03-Apr-2012
09:37 AM
Page: 288
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/01ISR Number: 3639591-7Report Type:Expedited (15-DaCompany Report #247262 Outcome Hospitalization Initial or Prolonged PT Spinal Fracture Depression Suicide Attempt Report Source Health Professional Product Lariam Tablets Prozac Xanax Role PS C C Manufacturer Roche Age:47 YR Route Gender:Male Dose I/FU:F Duration 46 DAY
Date:01/02/01ISR Number: 3639595-4Report Type:Expedited (15-DaCompany Report #251020 Outcome Hospitalization Initial or Prolonged PT Myositis Phlebitis Vasculitis Report Source Health Professional Product Lariam Tablets Contraceptive Pill Role PS C Manufacturer Roche
Age:28 YR Route
Gender:Female Dose
I/FU:F Duration
Date:01/02/01ISR Number: 3639605-4Report Type:Expedited (15-DaCompany Report #251435 Outcome Other Serious PT Sleep Disorder Headache Tremor Dizziness Stupor Flushing Vomiting Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:36 YR Route
Gender:Female Dose 750 MG AND THEN SIX HOURS LATER 500 MG.
I/FU:I Duration
DAY
Date:01/02/01ISR Number: 3639613-3Report Type:Expedited (15-DaCompany Report #251577 Outcome Hospitalization Initial or Prolonged PT Epilepsy Confusional State Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:60 YR Route
Gender:Male Dose
Date:01/02/01ISR Number: 3639619-4Report Type:Expedited (15-DaCompany Report #251466 Outcome Other Serious PT Insomnia Diarrhoea Decreased Appetite Vomiting Anxiety Shock Dizziness Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:25 YR Route
Gender:Female
I/FU:I
Dose Duration PATIENT RECEIVED 1 X 750 MG AND 6 HOURS LATER 1 X 500 MG. 1 DAY
Company Report #
Age:53 YR
Gender:Male
I/FU:I
Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM
PT Depression
Report Source
Product Lariam 250 Mg Lariam Benzodiazapines Paxil
Role PS SS C C
Manufacturer
Route ORAL ORAL
Dose Duration 1 PER 7 WEEKS ORAL 1 PER 2 WEEKS ORAL
Page: 289
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sleeping Aids C
Date:01/03/01ISR Number: 3641446-9Report Type:Expedited (15-DaCompany Report #251577 Outcome Hospitalization Initial or Prolonged PT Epilepsy Confusional State Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:01/03/01ISR Number: 3641477-9Report Type:Expedited (15-DaCompany Report #247262 Outcome Hospitalization Initial or Prolonged PT Fracture Drug Interaction Suicide Attempt Depression Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 1 DOSE FORM 1 PER 1 WEEK ORAL 1 DOSE FORM DAILY ORAL 0.5 MG DAILY ORAL
I/FU:F Duration
Prozac (Fluoxetine Hydrochloride) Xanax (Alprazolam) 0.25 Mg
SS SS
ORAL ORAL
Date:01/03/01ISR Number: 3641530-XReport Type:Expedited (15-DaCompany Report #247262 Outcome Hospitalization Initial or Prolonged PT Suicide Attempt Spinal Fracture Depression Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Prozac (Fluoxetine Hydrochloride) Xanax (Alprazolam)
C C
Date:01/03/01ISR Number: 3641657-2Report Type:Expedited (15-DaCompany Report #251466 Outcome Other Serious PT Insomnia Diarrhoea Shock Anxiety Decreased Appetite Vomiting Dizziness Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 1250 MG, DAILY, ORAL
I/FU:I Duration
Date:01/03/01ISR Number: 3641658-4Report Type:Expedited (15-DaCompany Report #251435 Outcome Other Serious PT Vomiting Dizziness Nausea 09:37 AM
Age:36 YR
Gender:Female
I/FU:I
03-Apr-2012
Page: 290
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Stupor Flushing Sleep Disorder Tremor
Product Lariam
Role PS
Route ORAL
Dose 1250 MG DAILY, ORAL
Duration
Date:01/03/01ISR Number: 3641659-6Report Type:Expedited (15-DaCompany Report #251020 Outcome Hospitalization Initial or Prolonged PT Vasculitis Myositis Phlebitis Report Source Foreign Health Professional Product Lariam Contraceptive Pill (Oral Contraceptive Nos) Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 250 MG, 1 PER WEEK, ORAL
I/FU:F Duration
Date:01/04/01ISR Number: 3640928-3Report Type:Expedited (15-DaCompany Report #251435 Outcome Other Serious PT Sleep Disorder Flushing Tremor Nausea Dizziness Headache Stupor Vomiting Report Source Consumer Product Lariam Tablets Role PS Manufacturer Roche
Age:36 YR Route
Gender:Female Dose 750 MG AND THEN SIX HOURS LATER 500 MG.
I/FU:F Duration
DAY
Date:01/05/01ISR Number: 3642323-XReport Type:Expedited (15-DaCompany Report #249929 Outcome Hospitalization Initial or Prolonged PT Face Oedema Depression Road Traffic Accident Jaundice Gastritis Thinking Abnormal Blood Alkaline Phosphatase Increased Diarrhoea Urticaria Weight Decreased Insomnia Malaise Constipation Drug Hypersensitivity
Age:38 YR
Gender:Female
I/FU:F
Respiratory Rate Increased Hepatomegaly Haematemesis Haemoglobin Decreased Liver Tenderness Decreased Appetite Abnormal Dreams 03-Apr-2012 09:37 AM Page: 291
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Chills Feeling Hot Night Sweats Heart Rate Increased Urinary Tract Infection
Report Source
Role PS
Manufacturer Roche
Route
Dose
Duration 32 DAY
Date:01/05/01ISR Number: 3642795-0Report Type:Expedited (15-DaCompany Report #251435 Outcome Other Serious PT Stupor Flushing Dizziness Headache Sleep Disorder Vomiting Tremor Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:01/08/01ISR Number: 3642763-9Report Type:Expedited (15-DaCompany Report #251768 Outcome Congenital Anomaly PT Abortion Induced Pregnancy Maternal Drugs Affecting Foetus Limb Malformation Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Unknown Dose
I/FU:I Duration
Date:01/08/01ISR Number: 3643675-7Report Type:Expedited (15-DaCompany Report #249929 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Haemoglobin Decreased Abnormal Dreams Disturbance In Attention Depression Feeling Hot Respiratory Rate Increased Blister Hallucination, Visual Night Sweats Urticaria Hepatomegaly Liver Disorder Heart Rate Increased Body Temperature Increased Thinking Abnormal
Age:38 YR
Gender:Female
I/FU:I
Diarrhoea Haematemesis Insomnia Chills Face Oedema Gastritis Malaise Urinary Tract Infection 03-Apr-2012 09:37 AM Page: 292
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Constipation Road Traffic Accident Decreased Appetite Rash Pruritic
Report Source Foreign Consumer Other
Product Lariam
Role PS
Route ORAL
Duration
Date:01/09/01ISR Number: 3643443-6Report Type:Expedited (15-DaCompany Report #246474 Outcome Disability PT Psoriasis Gait Disturbance Report Source Health Professional Product Lariam Tablets Role PS Manufacturer Roche
Age:61 YR Route
Gender:Female Dose
Date:01/09/01ISR Number: 3643457-6Report Type:Expedited (15-DaCompany Report #247733 Outcome Other Serious PT Visual Field Defect Pituitary Tumour Benign Report Source Health Professional Product Lariam Tablets Role PS Manufacturer Roche
Age:35 YR Route
Gender:Male Dose THE PATIENT RECEIVED A TOTAL OF 2 TABLETS.
I/FU:F Duration
16
DAY
Date:01/09/01ISR Number: 3644647-9Report Type:Expedited (15-DaCompany Report #251768 Outcome Congenital Anomaly PT Maternal Drugs Affecting Foetus Foetal Disorder Pregnancy Abortion Induced Limb Reduction Defect Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Gender: Dose 1 DOSE FORM 1 PER WEEK ORAL
I/FU:I Duration
Date:01/10/01ISR Number: 3645682-7Report Type:Expedited (15-DaCompany Report #247733 Outcome Other Serious PT Pituitary Tumour Benign Visual Field Defect Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:01/10/01ISR Number: 3645686-4Report Type:Expedited (15-DaCompany Report #246474 Outcome Disability PT Decreased Activity Psoriasis Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 1 PER WEEK
I/FU:F Duration
ORAL
03-Apr-2012
09:37 AM
Page: 293
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/01ISR Number: 3645661-XReport Type:Expedited (15-DaCompany Report #251020 Outcome Hospitalization Initial or Prolonged PT Phlebitis Myositis Vasculitis Report Source Health Professional Product Lariam Tablets Contraceptive Pill Role PS C Manufacturer Roche Age:28 YR Route Gender:Female Dose I/FU:F Duration
Date:01/12/01ISR Number: 3647272-9Report Type:Expedited (15-DaCompany Report #251020 Outcome Hospitalization Initial or Prolonged PT Vasculitis Myositis Phlebitis Report Source Foreign Health Professional Product Lariam Contraceptive Pill (Oral Contraceptive Nos) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:01/16/01ISR Number: 3647463-7Report Type:Expedited (15-DaCompany Report #252294 Outcome Other Serious PT Back Pain Prostatic Specific Antigen Increased Dysuria Haematuria Report Source Product Lariam Tablets Multivitamins Role PS C Manufacturer Roche
Age:58 YR Route
Gender:Male Dose
Date:01/16/01ISR Number: 3647467-4Report Type:Expedited (15-DaCompany Report #234319 Outcome Other Serious PT Disturbance In Attention Anxiety Paresis Hallucination Illusion Alopecia Sensory Disturbance Sleep Disorder Delusion Mental Disorder Nightmare Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:20 YR Route
Gender:Female Dose
Date:01/16/01ISR Number: 3647469-8Report Type:Expedited (15-DaCompany Report #252574 Outcome Hospitalization PT Pyrexia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:21 YR Route
Gender:Female Dose TWO DOSES
I/FU:I Duration
Hyperventilation Loss Of Consciousness Convulsion Dyspnoea Mental Disorder
TAKEN.
DAY
03-Apr-2012
09:37 AM
Page: 294
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/01ISR Number: 3648112-4Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Face Oedema Urticaria Eyelid Oedema Joint Swelling Pruritus Anaphylactoid Reaction Company Report # Report Source Product Mefloquine Role PS Manufacturer Age:45 YR Route ORAL Gender:Female I/FU:I
Dose Duration 1 TAB Q 7 DAYS P.O.; FROM ONSET OF RASH FOR 10 DAYS 10 DAY
Date:01/17/01ISR Number: 3649402-1Report Type:Expedited (15-DaCompany Report #234319 Outcome Other Serious PT Hallucination Disturbance In Attention Delusion Illusion Alopecia Sensory Disturbance Nightmare Anxiety Mental Disorder Paresis Sleep Disorder Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:01/17/01ISR Number: 3649403-3Report Type:Expedited (15-DaCompany Report #252574 Outcome Hospitalization Initial or Prolonged PT Mental Disorder Pyrexia Hyperventilation Tetany Dyspnoea Convulsion Loss Of Consciousness Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 1 PER 1 WEEK ORAL
I/FU:I Duration
Date:01/17/01ISR Number: 3649448-3Report Type:Expedited (15-DaCompany Report #252294 Outcome Other Serious PT Prostatic Specific Antigen Increased Dysuria Haematuria Back Pain Report Source Consumer Product Lariam Multivitamins Nos (Multivitamins Nos) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:01/22/01ISR Number: 3651513-1Report Type:Expedited (15-DaCompany Report #252739 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Chest Pain Dyspnoea Bradycardia Report Source Product Lariam Tablets Climen Role PS C Manufacturer Roche
Age:59 YR Route
Gender:Female Dose
03-Apr-2012
09:37 AM
Page: 295
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/01ISR Number: 3652329-2Report Type:Expedited (15-DaCompany Report #252778 Outcome Life-Threatening PT Persecutory Delusion Mood Altered Paranoia Suicide Attempt Hallucination, Auditory Insomnia Report Source Product Lariam Tablets Stamaril Unidose Role PS C Manufacturer Roche Age:35 YR Route Gender:Male Dose I/FU:I Duration 11 DAY 1 DAY
Date:01/23/01ISR Number: 3652402-9Report Type:Direct Outcome PT Medication Error
Age: Route
Gender: Dose
I/FU:I Duration
Date:01/23/01ISR Number: 3653816-3Report Type:Expedited (15-DaCompany Report #252739 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Back Pain Dyspnoea Chest Pain Bradycardia Report Source Foreign Health Professional Product Lariam Climen Role PS C Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:01/24/01ISR Number: 3653477-3Report Type:Expedited (15-DaCompany Report #252788 Outcome Other Serious PT Abnormal Behaviour Delusion Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:74 YR Route
Gender:Male Dose
I/FU:I Duration
Date:01/24/01ISR Number: 3653480-3Report Type:Expedited (15-DaCompany Report #252779 Outcome Other Serious PT Uterine Leiomyoma Gestational Diabetes Gonorrhoea Appendicitis Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:32 YR Route
Gender:Female Dose
Date:01/24/01ISR Number: 3654504-XReport Type:Expedited (15-DaCompany Report #252778 Outcome Life-Threatening PT Asthenia Nightmare Paranoia
Age:35 YR
Gender:Male
I/FU:I
Hallucination, Auditory Headache Psychotic Disorder Anxiety Sleep Disorder Dizziness Irritability Suicide Attempt 03-Apr-2012 09:37 AM Page: 296
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Persecutory Delusion Report Source Foreign Other Product Lariam Stamaril Unidose (Yellow Fever Vaccine) Role PS Manufacturer Hoffmann La Roche Inc Route ORAL Dose 250 MG 1 PER WEEK ORAL Duration
Date:01/25/01ISR Number: 3654162-4Report Type:Expedited (15-DaCompany Report #249232 Outcome Other Serious PT Affective Disorder Anxiety Diarrhoea Delusion Vision Blurred Depression Paranoia Asthenia Insomnia Nightmare Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:22 YR Route
Gender:Female
I/FU:F
Dose Duration TOTAL DOSE OF LARIAM TAKEN BY THE PATIENT: 2 TABLETS. 8 DAY
Date:01/25/01ISR Number: 3655969-XReport Type:Expedited (15-DaCompany Report #252779 Outcome Other Serious PT Appendicitis Pregnancy Gestational Diabetes Gonorrhoea Uterine Leiomyoma Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose DOSE FORM 1 PER WEEK ORAL
I/FU:I Duration
Date:01/25/01ISR Number: 3655974-3Report Type:Expedited (15-DaCompany Report #252788 Outcome Other Serious PT Abnormal Behaviour Delusion Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:01/26/01ISR Number: 3654951-6Report Type:Expedited (15-DaCompany Report #252788 Outcome Other Serious PT Delusion Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:74 YR Route
Gender:Male Dose
I/FU:F Duration
Date:01/29/01ISR Number: 3656105-6Report Type:Expedited (15-DaCompany Report #235479 Outcome Disability PT Corneal Oedema Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:76 YR Route
Gender:Male Dose
I/FU:F Duration
03-Apr-2012
09:37 AM
Page: 297
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/01ISR Number: 3656134-2Report Type:Expedited (15-DaCompany Report #252730 Outcome Other Serious PT Blood Pressure Increased Ventricular Hypertrophy Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:70 YR Route Gender:Male Dose I/FU:F Duration
Date:01/29/01ISR Number: 3657437-8Report Type:Expedited (15-DaCompany Report #252788 Outcome Other Serious PT Delusion Abnormal Behaviour Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:01/30/01ISR Number: 3657556-6Report Type:Expedited (15-DaCompany Report #252730 Outcome Other Serious PT Ventricular Hypertrophy Blood Pressure Increased Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age:70 YR Route
Gender:Male Dose 250 MG 1 PER WEEK
I/FU:I Duration
Date:01/30/01ISR Number: 3659264-4Report Type:Expedited (15-DaCompany Report #235479 Outcome Disability PT Corneal Oedema Corneal Transplant Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:01/31/01ISR Number: 3657664-XReport Type:Expedited (15-DaCompany Report #252574 Outcome Hospitalization Initial or Prolonged PT Dyspnoea Loss Of Consciousness Convulsion Mental Disorder Pyrexia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:21 YR Route
Gender:Female Dose TWO DOSES TAKEN.
Date:02/01/01ISR Number: 3659145-6Report Type:Expedited (15-DaCompany Report #252574 Outcome Hospitalization Initial or Prolonged PT Pyrexia Loss Of Consciousness Mental Disorder Tetany Dyspnoea Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Hyperventilation
03-Apr-2012
09:37 AM
Page: 298
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/01ISR Number: 3658970-5Report Type:Expedited (15-DaCompany Report #249748 Outcome Hospitalization Initial or Prolonged PT Disorientation Delusion Hypertonia Persecutory Delusion Agitation Acute Psychosis Confusional State Speech Disorder Mutism Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:55 YR Route Gender:Male Dose I/FU:F Duration
Date:02/02/01ISR Number: 3658974-2Report Type:Expedited (15-DaCompany Report #253219 Outcome Other Serious PT Atrial Fibrillation Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:02/02/01ISR Number: 3658987-0Report Type:Expedited (15-DaCompany Report #253380 Outcome Disability PT Blood Pressure Increased Retinal Haemorrhage Vision Blurred Report Source Product Lariam Tablets Unspecified Immunizations Role PS C Manufacturer Roche
Age:47 YR Route
Gender:Male Dose
Date:02/02/01ISR Number: 3658988-2Report Type:Expedited (15-DaCompany Report #244551 Outcome Other Serious PT Aplastic Anaemia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:62 YR Route
Gender:Male Dose
Date:02/02/01ISR Number: 3659017-7Report Type:Expedited (15-DaCompany Report #253574 Outcome Disability PT Hypoaesthesia Hallucination Tinnitus Agoraphobia Paraesthesia Palpitations Paranoia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:29 YR Route
Gender:Female Dose
Age:53 YR
Gender:Female
I/FU:I
PT Clonic Convulsion Hypercholesterolaemia
Report Source
Role PS
Manufacturer Roche
Route
Dose
Duration 33 DAY
03-Apr-2012
09:37 AM
Page: 299
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/01ISR Number: 3660323-0Report Type:Expedited (15-DaCompany Report #249232 Outcome Other Serious PT Insomnia Paranoia Depression Asthenia Affective Disorder Anxiety Nightmare Diarrhoea Delusion Vision Blurred Report Source Foreign Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:22 YR Route ORAL Gender:Female Dose 1 DOSE FORM 1 PER 1 WEEK ORAL I/FU:I Duration
Date:02/02/01ISR Number: 3660344-8Report Type:Expedited (15-DaCompany Report #249748 Outcome Hospitalization Initial or Prolonged PT Disorientation Persecutory Delusion Psychotic Disorder Agitation Mutism Confusional State Hypertonia Pyrexia Speech Disorder Report Source Foreign Literature Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age:55 YR Route
Gender:Male Dose
I/FU:F Duration
Date:02/05/01ISR Number: 3659704-0Report Type:Direct Outcome Disability PT Dry Eye Fatigue Dry Mouth Feeling Abnormal Balance Disorder Tremor Nausea
I/FU:I Duration
Date:02/05/01ISR Number: 3662891-1Report Type:Expedited (15-DaCompany Report #253574 Outcome Disability PT Hallucination Nausea Paraesthesia Palpitations Dizziness Hypoaesthesia Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose DOSE FORM ORAL
I/FU:I Duration
Agoraphobia Visual Impairment Tinnitus Paranoia
03-Apr-2012
09:37 AM
Page: 300
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/01ISR Number: 3662893-5Report Type:Expedited (15-DaCompany Report #253380 Outcome Disability PT Hypertension Vision Blurred Retinal Haemorrhage Report Source Foreign Consumer Product Lariam Unspecified Immunizations (Immunisation) Role PS Manufacturer Hoffmann La Roche Inc Age:47 YR Route ORAL Gender:Male Dose ORAL I/FU:I Duration 70 DAY
Date:02/05/01ISR Number: 3662894-7Report Type:Expedited (15-DaCompany Report #253632 Outcome Other Serious PT Blood Cholesterol Increased Clonic Convulsion Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:02/06/01ISR Number: 3660174-7Report Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability PT Vertigo Panic Attack Depression Headache Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:24 YR Route
Date:02/07/01ISR Number: 3661122-6Report Type:Expedited (15-DaCompany Report #220210 Outcome Hospitalization Initial or Prolonged PT Headache Obesity Hypertension Chlamydial Infection Vision Blurred Visual Impairment Pupillary Disorder Measles Antibody Positive Antinuclear Antibody Positive Inflammation Drug Hypersensitivity Accommodation Disorder Folate Deficiency Binocular Eye Movement Disorder Smooth Muscle Antibody Positive Cytogenetic Abnormality Laboratory Test Abnormal Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:17 YR Route
Gender:Male Dose
I/FU:F Duration
Diplopia Coagulopathy Platelet Count Decreased
03-Apr-2012
09:37 AM
Page: 301
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/01ISR Number: 3661137-8Report Type:Expedited (15-DaCompany Report #247340 Outcome Disability PT Vertigo Positional Motor Dysfunction Nightmare Dizziness Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:42 YR Route Gender:Male Dose FOR MANY YEARS. I/FU:F Duration
Date:02/07/01ISR Number: 3661805-8Report Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability PT Depression Vertigo Panic Attack Dizziness Headache Anxiety Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:02/08/01ISR Number: 3662801-7Report Type:Expedited (15-DaCompany Report #220210 Outcome Hospitalization Initial or Prolonged PT Antinuclear Antibody Positive Hypertension Visual Acuity Reduced Vision Blurred Platelet Count Decreased Inflammation Headache Laboratory Test Abnormal Iris Disorder Diplopia Csf Test Abnormal Binocular Eye Movement Disorder Dna Antibody Positive Measles Antibody Positive Pupillary Reflex Impaired Chlamydial Infection Sinusitis Herpes Simplex Visual Impairment Folate Deficiency Infectious Mononucleosis Accommodation Disorder Herpes Zoster Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:02/08/01ISR Number: 3662860-1Report Type:Expedited (15-DaCompany Report #247340 Outcome Disability PT Nightmare Gait Disturbance Vertigo Positional Vomiting Dizziness 09:37 AM
Age:42 YR
Gender:Male
I/FU:I
03-Apr-2012
Page: 302
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Motor Dysfunction Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Route ORAL Dose ORAL Duration
Date:02/09/01ISR Number: 3662550-5Report Type:Expedited (15-DaCompany Report #254219 Outcome Disability PT Depression Suicidal Ideation Disturbance In Attention Sinusitis Hallucination Influenza Like Illness Abnormal Dreams Anxiety Insomnia Lethargy Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
Date:02/12/01ISR Number: 3663406-4Report Type:Expedited (15-DaCompany Report #254186 Outcome Other Serious PT Tongue Oedema Angioedema Face Oedema Report Source Product Lariam Tablets Vit B12 Zestoretic Ranitidine Role PS C C C Manufacturer Roche
Age:50 YR Route
Gender:Male Dose LAST INJECTION WAS 02 JAN 2001.
Date:02/12/01ISR Number: 3663685-3Report Type:Direct Outcome Other Serious PT Oropharyngeal Pain Mood Swings Decreased Activity Nausea Pain In Extremity Rickettsiosis Insomnia Sleep Attacks Fatigue Fibromyalgia Arthralgia
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:02/12/01ISR Number: 3664102-XReport Type:Expedited (15-DaCompany Report #254219 Outcome Disability PT Sinusitis Anxiety Suicidal Ideation Depression Hallucination 09:37 AM
Age:
Gender:Male
I/FU:I
03-Apr-2012
Page: 303
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Disturbance In Attention Influenza Like Illness Abnormal Dreams Lethargy
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
Date:02/13/01ISR Number: 3664562-4Report Type:Expedited (15-DaCompany Report #254226 Outcome Hospitalization Initial or Prolonged PT Inborn Error Of Metabolism Blood Lactate Dehydrogenase Increased Biopsy Bronchus Abnormal Haemoglobin Decreased Lung Disorder Haematocrit Decreased White Blood Cell Count Increased Pneumonitis Lymphocyte Count Decreased Blood Alkaline Phosphatase Increased Neutrophil Count Increased Malaise Laboratory Test Abnormal Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:64 YR Route
Gender:Male Dose
I/FU:I Duration
Date:02/13/01ISR Number: 3666432-4Report Type:Expedited (15-DaCompany Report #254186 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Angioedema Face Oedema Tongue Oedema Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Vit B12 (Cyanocobalamin) Zestoretic (Hydrochlorothiazide /Lisinopril) Ranitidine (Ranitidine) Role Manufacturer
Age:50 YR Route
Gender:Male Dose
I/FU:I Duration
PS C C C
ORAL
42
DAY
Age:68 YR
Gender:Male
I/FU:I
PT Nausea Asthenia Cardiac Murmur Venous Pressure Jugular Increased Hepatomegaly Blood Urea Increased Page: 304
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Red Blood Cell Sedimentation Rate Increased Hepatitis Decreased Appetite Atrial Flutter Fatigue Blood Creatinine Increased Jaundice Chest X-Ray Abnormal Electrocardiogram Abnormal Dehydration Condition Aggravated
Report Source
Product Mefloquine Hydrochloride Allopurinol Spironolactone Warfarin Propafenone Digoxin Furosemide
Role PS SS C C C C C
Manufacturer Roche Roche
Route
Dose
Duration 42 DAY
Date:02/14/01ISR Number: 3667666-5Report Type:Expedited (15-DaCompany Report #254226 Outcome Hospitalization Initial or Prolonged PT Pneumonia Inborn Error Of Metabolism Lung Disorder Report Source Foreign Literature Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:64 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:02/15/01ISR Number: 3665573-5Report Type:Expedited (15-DaCompany Report #249135 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Respiratory Arrest Loss Of Consciousness Condition Aggravated Electroencephalogram Abnormal Pulse Absent Ventricular Extrasystoles Hypertension Echocardiogram Abnormal Electrocardiogram T Wave Amplitude Decreased Convulsion Electrocardiogram St Segment Depression Supraventricular Extrasystoles Report Source Product Lariam Tablets Ibuprofen Doxycyclin Role PS C C Manufacturer Roche
Age:61 YR Route
Gender:Male Dose
I/FU:F Duration 20 20 DAY DAY
Age:
Gender:Not SpecifiI/FU:I
PT Dysmorphism Skull Malformation Congenital Foot Malformation Cleft Palate Congenital Anomaly Syndactyly Page: 305
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Low Set Ears Pregnancy Maternal Drugs Affecting Foetus Abortion Induced Congenital Eye Disorder Thymus Disorder Congenital Central Nervous System Anomaly
Report Source
Product Lariam Tablets Yellow Fever Vaccine
Role PS C
Manufacturer Roche
Route
Dose
Duration 28 DAY
Date:02/15/01ISR Number: 3666602-5Report Type:Expedited (15-DaCompany Report #254230 Outcome Hospitalization Initial or Prolonged PT Fatigue Venous Pressure Jugular Increased Asthenia Dehydration Blood Urea Increased Nausea International Normalised Ratio Increased White Blood Cell Count Increased Hepatotoxicity Decreased Appetite Cardiac Murmur Platelet Count Decreased Chest X-Ray Abnormal Hepatomegaly Atrial Flutter Red Blood Cell Sedimentation Rate Increased Hepatitis Report Source Foreign Literature Health Professional Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Allopurinol (Allopurinol) Warfarin (Warfarin Sodium) Propafenone (Propafenone Hydrochloride) Spironolactone (Spironolactone) Role Manufacturer
Age:68 YR Route
Gender:Male Dose
I/FU:I Duration
PS SS C C C
250 MG 1 PER WEEK 100 MG DAILY
42
DAY
Date:02/16/01ISR Number: 3668044-5Report Type:Expedited (15-DaCompany Report #254480 Outcome Congenital Anomaly PT Thymus Disorder Congenital Jaw Malformation Congenital Nose Malformation Abortion Induced Cleft Palate Dysmorphism Maternal Drugs Affecting Foetus
Age:
Gender:Unknown
I/FU:I
Skull Malformation Congenital Foot Malformation Multiple Congenital Abnormalities Congenital Central Nervous System Anomaly Congenital Eye Disorder 03-Apr-2012 09:37 AM Page: 306
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndactyly Ear Malformation Report Source Foreign Other Product Lariam Yellow Fever Vaccine (Yellow Fever Vaccine) Role PS Manufacturer Hoffmann La Roche Inc Route ORAL Dose 250 MG 1 PER WEEK ORAL Duration 28 DAY
Date:02/16/01ISR Number: 3668050-0Report Type:Expedited (15-DaCompany Report #249135 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Convulsive Threshold Lowered Respiratory Arrest Supraventricular Extrasystoles Coronary Artery Disease Convulsion Myocardial Ischaemia Circulatory Collapse Cardiac Disorder Ventricular Extrasystoles Hypertension Report Source Foreign Other Product Lariam Ibuprofen (Ibuprofen) Doxycyclin (Doxycycline) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
C C
Date:02/20/01ISR Number: 3666693-1Report Type:Expedited (15-DaCompany Report #220210 Outcome Hospitalization Initial or Prolonged PT Dysgraphia Reading Disorder Accommodation Disorder Visual Impairment Diplopia Drug Hypersensitivity Thrombocytosis Lipids Increased Antibody Test Positive Binocular Eye Movement Disorder Folate Deficiency Smooth Muscle Antibody Positive Csf Test Abnormal Obesity Dna Antibody Positive Nuclear Magnetic Resonance Imaging Brain Abnormal
Age:17 YR
Gender:Male
I/FU:F
Visual Evoked Potentials Abnormal Hypertension Laboratory Test Abnormal Pupillary Disorder Measles Antibody Positive Headache Inflammation 03-Apr-2012 09:37 AM Page: 307
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Viral Infection Report Source Product Lariam Tablets Role PS Manufacturer Roche Route Dose Duration
Date:02/20/01ISR Number: 3667169-8Report Type:Direct Outcome Other Serious PT Nausea Panic Attack Muscular Weakness Feeling Of Body Temperature Change Vision Blurred Balance Disorder
Gender:Female
I/FU:I
Dose Duration 1 A WEEK ORAL
Date:02/20/01ISR Number: 3669532-8Report Type:Expedited (15-DaCompany Report #254595 Outcome Hospitalization Initial or Prolonged Disability PT Dermatomyositis Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:02/21/01ISR Number: 3667469-1Report Type:Expedited (15-DaCompany Report #254186 Outcome Other Serious PT Angioedema Report Source Health Professional Product Lariam Tablets Ranitidine Vit B12 Zestoretic Role PS SS C C Manufacturer Roche
Age:50 YR Route
Gender:Male Dose LAST INJECTION WAS 02 JAN 2001.
I/FU:F Duration
Date:02/21/01ISR Number: 3669477-3Report Type:Expedited (15-DaCompany Report #220210 Outcome Hospitalization Initial or Prolonged PT Inflammation Diplopia Infectious Mononucleosis Apolipoprotein A-I Increased Vision Blurred Iris Disorder Binocular Eye Movement Disorder
Age:17 YR
Gender:Male
I/FU:F
Folate Deficiency Blood Immunoglobulin G Increased Accommodation Disorder Herpes Zoster Hypertension Headache Dysgraphia 03-Apr-2012 09:37 AM Page: 308
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Viral Infection Chlamydial Infection Thrombocytosis Reading Disorder Geniculate Ganglionitis
Product Lariam
Role PS
Route ORAL
Duration
Date:02/22/01ISR Number: 3669931-4Report Type:Expedited (15-DaCompany Report #254186 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Angioedema Report Source Foreign Health Professional Product Lariam Ranitidine (Ranitidine) Vit B12 (Cyanocobalamin) Zestoretic (Hydrohlorothiazide/ Lisnopril) Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 250 MG 1 PER WEEK ORAL ORAL
I/FU:F Duration
SS C C
Date:02/26/01ISR Number: 3669114-8Report Type:Expedited (15-DaCompany Report #252730 Outcome Other Serious PT Blood Pressure Increased Ventricular Hypertrophy Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:70 YR Route
Gender:Male Dose
Date:02/27/01ISR Number: 3670332-3Report Type:Expedited (15-DaCompany Report #203837 Outcome Death PT Amnesia Flushing Hepatic Steatosis Agitation Weight Decreased Cardiomegaly Nightmare Chills Depression Adjustment Disorder Obsessive-Compulsive Disorder Urinary Hesitation Delusional Disorder, Persecutory Type Decreased Appetite
Age:53 YR
Gender:Male
I/FU:F
Nervous System Disorder Musculoskeletal Stiffness Polydipsia Ventricular Hypertrophy Insomnia Abnormal Dreams Completed Suicide Anxiety 03-Apr-2012 09:37 AM Page: 309
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucinations, Mixed Headache Hyperhidrosis Delirium Cognitive Disorder Arteriosclerosis
Role PS
Manufacturer Roche
Route
Dose
Duration 50 DAY
Date:02/27/01ISR Number: 3671565-2Report Type:Expedited (15-DaCompany Report #252730 Outcome Other Serious PT Hypertension Ventricular Hypertrophy Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:02/28/01ISR Number: 3671793-6Report Type:Expedited (15-DaCompany Report #200111100GDS Outcome Other Serious PT Drug Interaction Hypertension Heart Rate Increased Report Source Foreign Other Product Avelox Mefloquine Altace Moduret Role PS SS C C Manufacturer Bayer Corp Pharmaceutical Div
Gender:Male Dose 400 MG DAILY ORAL 250 MG DAILY ORAL
I/FU:I Duration
Date:02/28/01ISR Number: 3671960-1Report Type:Expedited (15-DaCompany Report #203837 Outcome Death PT Depression Hyperhidrosis Arterial Injury Hallucinations, Mixed Musculoskeletal Stiffness Hepatic Steatosis Staring Agitation Lethargy Spinal Fracture Subarachnoid Haemorrhage Abnormal Behaviour Psychotic Disorder Decreased Appetite Polydipsia Flushing Urinary Hesitation Delusional Disorder, Persecutory Type
Age:53 YR
Gender:Male
I/FU:F
Hepatic Necrosis Insomnia Delirium Obsessive-Compulsive Disorder Abnormal Dreams Amnesia Cardiomegaly 03-Apr-2012 09:37 AM Page: 310
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Hypertrophy Arteriosclerosis Respiratory Disorder Injury Chills Anxiety Cognitive Disorder Weight Decreased Headache Fatigue Completed Suicide Nervous System Disorder Nightmare Adjustment Disorder
Product Lariam
Role PS
Route ORAL
Dose 250 MG 1 PER 1 WEEK ORAL
Duration
Date:03/01/01ISR Number: 3672141-8Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Nausea Dry Mouth Anxiety Dyspnoea Pain Fatigue Tinnitus Insomnia Migraine Visual Impairment Muscular Weakness Headache Coordination Abnormal Heart Rate Increased
Company Report # Report Source Product Lariam / 250 Mg Role PS Manufacturer
Gender:Male Dose 1 TABLET WEEKLY ORAL
I/FU:I Duration
Date:03/07/01ISR Number: 3674831-XReport Type:Expedited (15-DaCompany Report #255461 Outcome Hospitalization Initial or Prolonged PT Dystonia Report Source Product Lariam Tablets Contraceptive Pill Role PS C Manufacturer Roche
Age:16 YR Route
Gender:Female Dose
I/FU:I Duration
Date:03/07/01ISR Number: 3674843-6Report Type:Expedited (15-DaCompany Report #250525 Outcome Other Serious PT Speech Disorder Gastroenteritis Insomnia Back Pain Sedation
Age:14 YR
Gender:Male
I/FU:F
Memory Impairment Psychiatric Symptom Nightmare Renal Failure Irritability Laboratory Test Abnormal Learning Disorder Eczema 03-Apr-2012 09:37 AM Page: 311
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Alpha 2 Globulin Decreased Educational Problem Hypogammaglobulinaemia Crying Asthenia Blood Albumin Increased Alpha 1 Globulin Decreased Fatigue Condition Aggravated Protein Total Increased Anxiety Bronchitis Herpes Virus Infection Weight Decreased
Report Source
Role PS
Manufacturer Roche
Route
Dose THE PATIENT RECEIVED 8 TABLETS IN TOTAL.
Duration
50
DAY
Date:03/07/01ISR Number: 3675235-6Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Dizziness Anxiety Suicidal Ideation Diarrhoea Panic Reaction Hallucinations, Mixed Nightmare Crying Insomnia Fear Decreased Activity
Company Report # Report Source Product Lariam Hoffman/Laroche Role PS Manufacturer Hoffman / Larouche
Gender:Female Dose ONE PILL ONCE WEEKLY ORAL
I/FU:I Duration
Date:03/08/01ISR Number: 3676534-4Report Type:Expedited (15-DaCompany Report #250525 Outcome Other Serious PT Back Pain Weight Decreased Bronchitis Nightmare Fatigue Herpes Virus Infection Gastroenteritis Eczema Renal Failure Irritability Anxiety Asthenia Insomnia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Pyrexia Crying Psychiatric Symptom
03-Apr-2012
09:37 AM
Page: 312
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/01ISR Number: 3676700-8Report Type:Expedited (15-DaCompany Report #200111100GDS Outcome Other Serious PT Dizziness Drug Interaction Vomiting Headache Hypertension Heart Rate Increased Sensation Of Pressure Dry Mouth Report Source Foreign Health Professional Other Product Avelox Mefloquine Altace Moduret Role PS SS C C Manufacturer Bayer Corp Pharmaceutical Div Age:46 YR Route ORAL ORAL Gender:Male Dose 400 MG DAILY ORAL 250 MG DAILY ORAL I/FU:F Duration
Date:03/08/01ISR Number: 3676818-XReport Type:Expedited (15-DaCompany Report #255461 Outcome Hospitalization Initial or Prolonged PT Dystonia Report Source Foreign Other Product Lariam Contraceptive Pill (Oral Contraceptive Nos) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:03/09/01ISR Number: 3676793-8Report Type:Expedited (15-DaCompany Report #255903 Outcome Disability PT Hallucination, Visual Panic Reaction Amnesia Nightmare Insomnia Headache Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:36 YR Route
Gender:Male Dose
Date:03/09/01ISR Number: 3676802-6Report Type:Expedited (15-DaCompany Report #255897 Outcome Other Serious PT Hepatitis Report Source Product Lariam Tablets Ethambutol Pirazinamide Role PS C C Manufacturer Roche
Age:56 YR Route
Gender:Female Dose
Date:03/12/01ISR Number: 3678135-0Report Type:Expedited (15-DaCompany Report #254595 Outcome Hospitalization Initial or Prolonged Disability PT Pain Blood Creatinine Increased Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:54 YR Route
Gender:Female Dose
Myalgia Dermatomyositis Malaise Dermatitis
03-Apr-2012
09:37 AM
Page: 313
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/01ISR Number: 3680792-XReport Type:Expedited (15-DaCompany Report #255903 Outcome Disability PT Headache Amnesia Insomnia Panic Reaction Nightmare Hallucination Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:36 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:03/12/01ISR Number: 3680802-XReport Type:Expedited (15-DaCompany Report #255897 Outcome Other Serious PT Jaundice Hepatitis Report Source Foreign Other Product Lariam Ethambutol (Ethambutol Hydrochloride) Pirazinamide (Pyrazinamide) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
C C
Date:03/13/01ISR Number: 3680675-5Report Type:Expedited (15-DaCompany Report #254595 Outcome Hospitalization Initial or Prolonged Disability PT Dermatomyositis Malaise Dermatitis Blood Creatinine Increased Myalgia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:03/14/01ISR Number: 3680020-5Report Type:Expedited (15-DaCompany Report #253034 Outcome Hospitalization Initial or Prolonged PT Erythema Nodosum Pyrexia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:49 YR Route
Gender:Female Dose
Date:03/15/01ISR Number: 3681154-1Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Hallucinations, Mixed Psychotic Disorder Panic Attack Delusional Disorder,
Gender:Male
I/FU:I
Dose Duration PO ( 3 TABS TOTAL)
Persecutory Type
03-Apr-2012
09:37 AM
Page: 314
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/01ISR Number: 3682140-8Report Type:Expedited (15-DaCompany Report #253034 Outcome Hospitalization Initial or Prolonged PT Erythema Nodosum Pyrexia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:49 YR Route ORAL Gender:Female Dose ORAL I/FU:I Duration
Date:03/16/01ISR Number: 3681869-5Report Type:Expedited (15-DaCompany Report #235171 Outcome Other Serious PT Delivery Abnormal Labour Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female
I/FU:F
Dose Duration THE PATIENT TOOK A TOTAL OF 7 TABLETS WHILE SHE WAS A FEW WEEKS 50 DAY
Date:03/20/01ISR Number: 3684540-9Report Type:Expedited (15-DaCompany Report #252574 Outcome Hospitalization Initial or Prolonged PT Mental Disorder Loss Of Consciousness Dyspnoea Hyperventilation Convulsion Pyrexia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:21 YR Route
Gender:Female
I/FU:F
Dose Duration TWO DOSES TAKEN (THREE TABLETS IN TOTAL).
Date:03/20/01ISR Number: 3684549-5Report Type:Expedited (15-DaCompany Report #256591 Outcome Hospitalization Initial or Prolonged PT Alveolitis Report Source Product Lariam Tablets Prozac Role PS C Manufacturer Roche
Age:58 YR Route
Gender:Female Dose
I/FU:I Duration
Date:03/20/01ISR Number: 3685099-2Report Type:Direct Outcome Other Serious PT Social Avoidant Behaviour Agitation Ear Disorder Mental Disorder Emotional Disorder Depression
Gender:Male
I/FU:I
Dose Duration 1 WEEKLY ORAL
Company Report #
Age:58 YR
Gender:Female
I/FU:I
PT Asthma Hypoaesthesia Insomnia Discomfort Feeling Jittery
Report Source
Product Lariam
Role PS
Manufacturer
Route
Dose 1 TABLET WEEKLY
Duration
03-Apr-2012
09:37 AM
Page: 315
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/01ISR Number: 3687541-XReport Type:Expedited (15-DaCompany Report #256591 Outcome Hospitalization Initial or Prolonged PT Alveolitis Report Source Foreign Health Professional Product Lariam Prozac (Fluoxetine Hydrochloride) Role PS Manufacturer Hoffmann La Roche Inc Age:58 YR Route ORAL Gender:Female Dose 250 MG 1 PER 1 WEEK ORAL I/FU:I Duration
Date:03/21/01ISR Number: 3687543-3Report Type:Expedited (15-DaCompany Report #252574 Outcome Hospitalization Initial or Prolonged PT Mental Disorder Pyrexia Po2 Decreased Agitation Fear Depressed Level Of Consciousness Arthralgia Respiratory Disorder Depression Convulsion Dyspnoea Malaise Fatigue Stress Blood Ph Increased Tenderness Apnoea Panic Attack Hyperventilation Electroencephalogram Abnormal Nausea Loss Of Consciousness Restlessness Autonomic Nervous System Imbalance Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:03/22/01ISR Number: 3688672-0Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Dizziness Panic Attack Balance Disorder Anxiety Nausea Diarrhoea
Company Report # Report Source Product Lariam 250mg Roche Lab Role PS Manufacturer Roche Lab
Age: Route ORAL
Gender:Male Dose 250MG ONCE A WEEK ORAL
I/FU:I Duration
Disorientation
03-Apr-2012
09:37 AM
Page: 316
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/01ISR Number: 3688177-7Report Type:Expedited (15-DaCompany Report #256731 Outcome Death PT Sudden Death Drug Interaction Hypertrophic Cardiomyopathy Report Source Product Lariam Tablets Acetylcysteine Dirithromycin Halofantrine Role PS C I I Manufacturer Roche Age:22 YR Route Gender:Male Dose I/FU:I Duration
Date:03/26/01ISR Number: 3690128-6Report Type:Expedited (15-DaCompany Report #256731 Outcome Death PT Hypertrophic Cardiomyopathy Malaria Sudden Death Drug Interaction Bronchopneumonia Circulatory Collapse Headache Report Source Literature Health Professional Product Lariam Halofantrine (Halofantrine Hydrochloride) Dirithromycin (Dirithromycin) Acetylcysteine (Acetylcysteine) Role PS Manufacturer Hoffmann La Roche Inc
Age:22 YR Route ORAL ORAL ORAL
Gender:Male Dose ORAL ORAL ORAL
I/FU:I Duration
SS SS C
Date:03/29/01ISR Number: 3691252-4Report Type:Expedited (15-DaCompany Report #252574 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Mental Disorder Pyrexia Loss Of Consciousness Influenza Like Illness Convulsion Dyspnoea Hyperventilation Report Source Foreign Health Professional Product Lariam Tablets Role PS Manufacturer Roche
Age:21 YR Route
Gender:Female Dose 4 TABLETS TAKEN IN TOTAL.
Date:03/29/01ISR Number: 3691267-6Report Type:Expedited (15-DaCompany Report #256952 Outcome Other Serious PT Tachycardia Atrial Fibrillation Anxiety Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:65 YR Route
Gender:Male Dose
Date:03/29/01ISR Number: 3692700-6Report Type:Expedited (15-DaCompany Report #252574 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Autonomic Neuropathy Restlessness Convulsion
Age:21 YR
Gender:Female
I/FU:F
Pyrexia Agitation Cyanosis Psychotic Disorder Malaise Fatigue Hyperventilation Electroencephalogram 03-Apr-2012 09:37 AM Page: 317
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Stress Panic Attack Apnoea Influenza Like Illness Neck Pain Fear Drug Effect Decreased Blood Ph Increased Depressed Level Of Consciousness Depression Mental Disorder Muscle Spasms Nausea Loss Of Consciousness Pco2 Decreased Arthralgia Dyspnoea
Product Lariam
Role PS
Route ORAL
Dose 250 MG 1PER WEEK ORAL
Duration
Date:03/30/01ISR Number: 3692381-1Report Type:Expedited (15-DaCompany Report #256952 Outcome Other Serious PT Anxiety Tachycardia Atrial Fibrillation Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:65 YR Route
Gender:Male Dose
Date:03/30/01ISR Number: 3693076-0Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Chest Pain Abnormal Dreams Dizziness Gait Disturbance
Gender:Male Dose ONCE ORAL
I/FU:I Duration
Date:04/02/01ISR Number: 3693472-1Report Type:Expedited (15-DaCompany Report #257483 Outcome Hospitalization Initial or Prolonged PT Renal Failure Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:50 YR Route
Gender:Male Dose
I/FU:I Duration
Age:10 YR
Gender:Male
I/FU:I
PT Myalgia Nausea Blood Creatine Phosphokinase Increased
Report Source
Role PS
Manufacturer Roche
Route
Dose Duration REPORTED DOSE = 192.5 MG/WEEK, TOTAL DOSE = 5 TABLETS. 22 DAY
03-Apr-2012
09:37 AM
Page: 318
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/01ISR Number: 3694495-9Report Type:Expedited (15-DaCompany Report #256591 Outcome Hospitalization Initial or Prolonged PT Alveolitis Report Source Foreign Health Professional Product Lariam Tablets Prozac Role PS C Manufacturer Roche Age:58 YR Route Gender:Female Dose I/FU:F Duration 29 DAY
Date:04/03/01ISR Number: 3694515-1Report Type:Expedited (15-DaCompany Report #257527 Outcome Other Serious PT Disturbance In Attention Confusional State Balance Disorder Anxiety Amnesia Crying Report Source Foreign Consumer Product Lariam Tablets Role PS Manufacturer Roche
Age:49 YR Route
Gender:Male Dose
Date:04/03/01ISR Number: 3694523-0Report Type:Expedited (15-DaCompany Report #257719 Outcome Disability PT Dissociation Dizziness Amnesia Suicidal Ideation Headache Balance Disorder Confusional State Hypertension Anxiety Agoraphobia Report Source Health Professional Product Lariam Tablets Role PS Manufacturer Roche
Age:32 YR Route
Gender:Male
I/FU:I
Dose Duration SEVEN TABLETS TAKEN IN TOTAL.
Date:04/03/01ISR Number: 3694813-1Report Type:Direct Outcome Other Serious PT Visual Impairment Palpitations Dizziness Panic Attack Tremor
Company Report # Report Source Product Lariam Hoffman Laroche Role PS Manufacturer Hoffman Laroche
I/FU:I Duration
Date:04/03/01ISR Number: 3695222-1Report Type:Expedited (15-DaCompany Report #257483 Outcome Hospitalization Initial or Prolonged PT Renal Failure Epilepsy Report Source Foreign Health Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose DOSE FORM 1
I/FU:I Duration
Dialysis
Professional
PER WEEK ORAL
03-Apr-2012
09:37 AM
Page: 319
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/01ISR Number: 3695224-5Report Type:Expedited (15-DaCompany Report #257610 Outcome Other Serious PT Aspartate Aminotransferase Increased Muscle Spasms Myalgia Blood Creatine Phosphokinase Increased Nausea Blood Lactate Dehydrogenase Increased Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:10 YR Route ORAL Gender:Male Dose 192.5 MG ORAL I/FU:I Duration
Age:61 YR Route
Gender:Female Dose
Date:04/04/01ISR Number: 3695261-0Report Type:Expedited (15-DaCompany Report #256317 Outcome Disability PT Fatigue Diarrhoea Myalgia Alopecia Mental Impairment Depression Anxiety Sleep Disorder Mood Swings Weight Decreased Nightmare Report Source Product Lariam Tablets Unknown Medication Role PS C Manufacturer Roche
Age:54 YR Route
Gender:Male Dose MEDICATIONS TAKEN IN 1994,1995 AND 1999.
Doxycycline
Date:04/04/01ISR Number: 3696973-5Report Type:Expedited (15-DaCompany Report #257719 Outcome Disability PT Confusional State Hypertension Feeling Abnormal Headache Amnesia Dissociative Disorder Anxiety Agoraphobia Balance Disorder Dizziness Report Source Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Suicidal Ideation
03-Apr-2012
09:37 AM
Page: 320
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/01ISR Number: 3697929-9Report Type:Expedited (15-DaCompany Report #257527 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Amnesia Disturbance In Attention Balance Disorder Crying Confusional State Anxiety Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:49 YR Route ORAL Gender:Male Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Date:04/04/01ISR Number: 3697932-9Report Type:Expedited (15-DaCompany Report #256591 Outcome Hospitalization Initial or Prolonged PT Alveolitis Report Source Foreign Health Professional Product Lariam Prozac (Fluoxetine Hydrochloride) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:04/05/01ISR Number: 3699597-9Report Type:Expedited (15-DaCompany Report #256317 Outcome Disability PT Disturbance In Attention Myalgia Fatigue Irritability Anxiety Sleep Disorder Mood Swings Alopecia Mental Impairment Muscular Weakness Nightmare Diarrhoea Weight Decreased Depression Report Source Other Product Lariam Unknown Medication (Generic Component(S) Unknown) Doxycycline (Doxycycline) Role PS Manufacturer Hoffmann La Roche Inc
Age:54 YR Route
Gender:Male Dose
I/FU:I Duration
C C
Date:04/05/01ISR Number: 3699598-0Report Type:Expedited (15-DaCompany Report #246474 Outcome Disability PT Psoriasis Gait Disturbance Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Company Report #
Age:45 YR
Gender:Female
I/FU:I
Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM
PT Myalgia Influenza Like Illness Malaise Feeling Abnormal
Report Source
Product Lariam / 250 Mg. / Roche
Role PS
Manufacturer Roche
Route ORAL
Dose 1 TABLET 1 PR WK/8 ORAL
Duration
Page: 321
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/01ISR Number: 3701040-8Report Type:Direct Outcome Disability PT Vertigo Positional Depression Dehydration Sleep Disorder Headache Circadian Rhythm Sleep Disorder Chest Pain Weight Increased Dizziness Abnormal Dreams Ear Infection Balance Disorder Stress Fall Mountain Sickness Acute Anxiety Company Report # Report Source Product Lariam (Tablets 250mg) Milk Thistle Vitamins Ginger Tums Aspirin Role PS C C C C C Manufacturer Age: Route Gender:Male Dose 1 TAB ONCE WEEKLY I/FU:I Duration 10 WK
Date:04/09/01ISR Number: 3701071-8Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Chest Pain Dizziness Abnormal Dreams Feeling Abnormal Gait Disturbance
Company Report # Report Source Product Lariam Roche Role PS Manufacturer Roche
Gender:Male Dose ONCE ORAL
I/FU:I Duration
Age:61 YR Route
Gender:Female Dose
Date:04/11/01ISR Number: 3702283-XReport Type:Expedited (15-DaCompany Report #258083 Outcome Other Serious PT Hepatitis Abdominal Pain Report Source Product Lariam Tablets Evening Primrose Oil Calcium Carbonate Ibuprofen Role PS C C C Manufacturer Roche
Age:52 YR Route
Gender:Female Dose
Date:04/11/01ISR Number: 3703089-8Report Type:Direct Outcome Other Serious PT Diarrhoea Insomnia Pain Dehydration Vomiting 09:37 AM
Gender:Male Dose 1 TABLE WEEKLY ORAL
I/FU:I Duration
03-Apr-2012
Page: 322
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/01ISR Number: 3703237-XReport Type:Direct Outcome Other Serious PT Affective Disorder Decreased Appetite Lethargy Headache Dermatitis Company Report # Report Source Product Lariam / 250mg Role PS Manufacturer Age:25 YR Route ORAL Gender:Male I/FU:I
Dose Duration 250 MG ONCE A WEEK ORAL
Date:04/11/01ISR Number: 3703278-2Report Type:Direct Outcome Other Serious PT Urinary Incontinence Circulatory Collapse Loss Of Consciousness Fall Dyskinesia
Company Report # Report Source Product Lariam (Mefloquine) 250 Mg. Roche Laboratories Role PS Manufacturer Roche Laboratories
Age:75 YR Route
Gender:Female Dose 1 TABLET WEEKLY BEGINNING 1 WEEK BEFORE TRIP
I/FU:I Duration
Date:04/11/01ISR Number: 3703298-8Report Type:Expedited (15-DaCompany Report #246474 Outcome Disability PT Psoriasis Skin Lesion Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:04/12/01ISR Number: 3704261-3Report Type:Expedited (15-DaCompany Report #258083 Outcome Other Serious PT Abdominal Pain Hepatitis Report Source Foreign Other Product Lariam Evening Primrose Oil (Evening Primrose Oil) Calcium Carbonate (Calcium Carbonate) Ibuprofen (Ibuprofen) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
C C C
Date:04/16/01ISR Number: 3720297-0Report Type:Expedited (15-DaCompany Report #EM2001-0474 Outcome Other Serious PT Rash Pruritic Report Source Study Product Proleukin Role Manufacturer
Age:53 YR Route
Gender:Male Dose
I/FU:I Duration
Injection Site Inflammation Gait Disturbance Injection Site Pain Injection Site Reaction Hypersensitivity Urticaria 03-Apr-2012 09:37 AM
Health Professional
(Aldesleukin)Injecti on Lariam (Mefloquine) Ddi (Didanosine) Hydrocortisone (Hydrocortisone) Nevirapine
PS SS C C
Chiron Corporation
SUBCUTANEOUS
4.5 MIU BID, SUBCUTAN
Page: 323
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Nevirapine) Sudafed (Pseudoephedrine Hydrochloride) Tylenol (Paracetamol) Nizoral (Ketoconazole) Motrin (Ibuprofen) Zerit (Stavudine) Indinavir (Indinavir) Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloide, C C C C C C C
Date:04/17/01ISR Number: 3705506-6Report Type:Expedited (15-DaCompany Report #235171 Outcome Other Serious PT Delivery Abnormal Labour Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female
I/FU:F
Date:04/17/01ISR Number: 3705513-3Report Type:Expedited (15-DaCompany Report #246098 Outcome Other Serious PT Visual Impairment Anxiety Aphasia Speech Disorder Paranoia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:22 YR Route
Gender:Male Dose
Date:04/17/01ISR Number: 3705516-9Report Type:Expedited (15-DaCompany Report #257483 Outcome Hospitalization Initial or Prolonged PT Renal Failure Rhabdomyolysis Malaise Diarrhoea Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:50 YR Route
Gender:Male Dose
I/FU:F Duration
Age:74 YR
Gender:Male
I/FU:F
PT Delusion Abnormal Behaviour
Report Source
Role PS
Manufacturer Roche
Route
Dose
Duration
03-Apr-2012
09:37 AM
Page: 324
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/17/01ISR Number: 3706802-9Report Type:Direct Outcome PT Fatigue Anxiety Arthralgia Depression Convulsion Suicidal Ideation Anger Thinking Abnormal Sleep Disorder Company Report # Report Source Product Larium Role PS Manufacturer Age: Route ORAL Gender:Male Dose ORAL I/FU:I Duration
Date:04/18/01ISR Number: 3707820-7Report Type:Expedited (15-DaCompany Report #235171 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Abnormal Labour Caesarean Section Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:04/18/01ISR Number: 3707821-9Report Type:Expedited (15-DaCompany Report #246098 Outcome Other Serious PT Aphasia Anxiety Visual Impairment Paranoia Speech Disorder Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Date:04/18/01ISR Number: 3707822-0Report Type:Expedited (15-DaCompany Report #252788 Outcome Other Serious PT Delusion Abnormal Behaviour Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:04/18/01ISR Number: 3707823-2Report Type:Expedited (15-DaCompany Report #257483 Outcome Hospitalization Initial or Prolonged PT Malaise Diarrhoea Dialysis Rhabdomyolysis Renal Failure Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Epilepsy
03-Apr-2012
09:37 AM
Page: 325
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/01ISR Number: 3708595-8Report Type:Expedited (15-DaCompany Report #246098 Outcome Other Serious PT Speech Disorder Anxiety Paranoia Visual Impairment Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:22 YR Route Gender:Male Dose I/FU:F Duration 28 DAY
Date:04/24/01ISR Number: 3709086-0Report Type:Expedited (15-DaCompany Report #242380 Outcome Other Serious PT Platelet Count Decreased Hyperuricaemia Intravascular Haemolysis Menometrorrhagia Liver Function Test Abnormal Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:24 YR Route
Gender:Female Dose
Date:04/24/01ISR Number: 3711028-9Report Type:Expedited (15-DaCompany Report #246098 Outcome Other Serious PT Paranoia Anxiety Aphasia Speech Disorder Visual Impairment Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration 28 YR
Date:04/25/01ISR Number: 3710150-0Report Type:Expedited (15-DaCompany Report #258981 Outcome Other Serious PT Drug Interaction Hypersensitivity Report Source Product Lariam Tablets Multivitamins Indinavir Zerit Ddi Hydrocortisone Nevirapine Sudafed Tylenol Nizoral Motrin Proleukin Role PS C C C C C C C C C C I Manufacturer Roche
Age:53 YR Route
Gender:Unknown Dose
Roche
124
DAY
Age:56 YR
Gender:Male
I/FU:I
PT Tremor Depression Insomnia
Report Source
Product Mefloquine Hydrochloride Avaxim
Role PS C
Manufacturer Roche
Route
Dose
Duration 10 1 DAY DAY
03-Apr-2012
09:37 AM
Page: 326
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/01ISR Number: 3711519-0Report Type:Expedited (15-DaCompany Report #242380 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Hyperuricaemia Platelet Count Decreased Menometrorrhagia Intravascular Haemolysis Pregnancy Hepatic Function Abnormal Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:24 YR Route ORAL Gender:Female Dose ORAL I/FU:I Duration 28 DAY
Date:04/26/01ISR Number: 3711060-5Report Type:Expedited (15-DaCompany Report #252788 Outcome Other Serious PT Abnormal Behaviour Delusion Report Source Product Lariam Tablets Toco Xatral Aricept Tanakan Role PS C C C C Manufacturer Roche
Age:74 YR Route
Gender:Male Dose
Date:04/26/01ISR Number: 3711849-2Report Type:Expedited (15-DaCompany Report #258834 Outcome Other Serious PT Depression Tremor Insomnia Report Source Foreign Other Product Lariam Avaxim (Hepatitis A Vaccine) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:04/26/01ISR Number: 3711913-8Report Type:Expedited (15-DaCompany Report #258981 Outcome Other Serious PT Erythema Swelling Injection Site Oedema Dermatitis Injection Site Reaction Hypersensitivity Injection Site Inflammation Rash Pruritic Urticaria Drug Interaction Injection Site Pain Report Source Health Professional Other Product Lariam Proleukin (Aldeslukin) Ddi (Didanosine) Hydrocortizone (Hydrocortizone) Nevirapine (Nevirapine) Sudafed (Pseudophedrine Hydrochloride) Tylenol (Acetaminophen) Role PS SS C C C C C Manufacturer Hoffmann La Roche Inc
Age:53 YR Route ORAL SUBCUTANEOUS
Gender: Dose ORAL 4.5 MILLIONIU 2 PER 1 DAY SUBCUTANEOUS
I/FU:I Duration
Nizoral (Ketoconazole) Motrin (Ibuprofen) Zerit (Stavudine) Indinavir (Indinavir) Multivitamins (Multivitamin Nos) 03-Apr-2012 09:37 AM
C C C C C Page: 327
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/01ISR Number: 3713509-0Report Type:Expedited (15-DaCompany Report #252788 Outcome Other Serious PT Delusion Abnormal Behaviour Report Source Foreign Consumer Product Lariam Toco (Vitamin E) Xatral (Alfuzosin Hydrochloride) Aricept (Donepezil) Tanakan (Ginkgo) Role PS C C C C Manufacturer Hoffmann La Roche Inc Age:74 YR Route ORAL Gender:Male Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:F Duration
Date:05/02/01ISR Number: 3714650-9Report Type:Expedited (15-DaCompany Report #220210 Outcome Hospitalization Initial or Prolonged PT Accommodation Disorder Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:17 YR Route
Gender:Male Dose
Date:05/02/01ISR Number: 3714658-3Report Type:Expedited (15-DaCompany Report #259221 Outcome Congenital Anomaly PT Dysmorphism Congenital Foot Malformation Limb Reduction Defect Congenital Hand Malformation Congenital Central Nervous System Anomaly Thymus Disorder Report Source Product Lariam Tablets Arilvax Vivotif "Berna" Role PS SS SS Manufacturer Roche
Age: Route
Gender:Female Dose
Date:05/03/01ISR Number: 3716049-8Report Type:Expedited (15-DaCompany Report #259450 Outcome Hospitalization Initial or Prolonged PT Urticaria Face Oedema Dyspnoea Laryngeal Oedema Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:53 YR Route
Gender:Male Dose
Date:05/03/01ISR Number: 3717035-4Report Type:Expedited (15-DaCompany Report #259221 Outcome Congenital Anomaly PT Thymus Disorder Congenital Central Nervous System Anomaly
Age:
Gender:Female
I/FU:I
Dysmorphism Congenital Hand Malformation Localised Oedema Limb Reduction Defect Congenital Foot Malformation Tricuspid Valve Disease 03-Apr-2012 09:37 AM Page: 328
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abortion Induced Maternal Drugs Affecting Foetus Congenital Cardiovascular Anomaly
Product Lariam
Role PS
Route ORAL
Dose 250 MG 1 PER WEEK ORAL 1 PER ONE DOSE
Duration
Arilvax (Yellow Fever Vaccine) Vivotif "Berna" (Typhoid Vaccines)
SS SS ORAL
1 PER ONE DOSE ORAL
Date:05/03/01ISR Number: 3717038-XReport Type:Expedited (15-DaCompany Report #220210 Outcome Hospitalization Initial or Prolonged PT Refraction Disorder Diplopia Hypertension Antinuclear Antibody Positive Vision Blurred Platelet Count Decreased Herpes Zoster Weight Increased Neuritis Lipids Increased Headache Thrombocytosis Pupillary Disorder Binocular Eye Movement Disorder Nuclear Magnetic Resonance Imaging Abnormal Laboratory Test Abnormal Csf Test Abnormal Nervous System Disorder Infectious Mononucleosis Chlamydial Infection Visual Acuity Reduced Accommodation Disorder Herpes Simplex Folate Deficiency Measles Inflammation Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Age:72 YR
Gender:Female
I/FU:I
Outcome Death
PT Haemorrhagic Stroke Drug Interaction Circulatory Collapse International Normalised Ratio Increased 09:37 AM
Report Source
Product Lariam Tablets Cozaar Comp Warfarin
Role PS C I
Manufacturer Roche
Route
Dose
Duration 37 DAY 285 DAY
03-Apr-2012
Page: 329
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/01ISR Number: 3717913-6Report Type:Expedited (15-DaCompany Report #259450 Outcome Hospitalization Initial or Prolonged PT Urticaria Pruritus Pain Face Oedema Dyspnoea Laryngeal Oedema Erythema Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:53 YR Route ORAL Gender:Male Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Date:05/07/01ISR Number: 3717719-8Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability Congenital Anomaly Other Serious PT Asthenia Blood Pressure Increased Dizziness Hyperventilation Disorientation Dyspnoea Tinnitus
Company Report # Report Source Product Lariam / 250 Mg. / Laroche Laboritorys, Role PS Manufacturer
Age:68 YR Route
Gender:Female Dose 250 MG ONCE A WK 6 WKS
I/FU:I Duration
Date:05/07/01ISR Number: 3718783-2Report Type:Expedited (15-DaCompany Report #259699 Outcome Death PT International Normalised Ratio Increased Haemorrhagic Stroke Circulatory Collapse Drug Interaction Report Source Foreign Other Product Lariam Warfarin (Warfarin Sodium) Cozaar Comp (Hydrochlorothiazide /Losartan Potassium) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
SS
Date:05/08/01ISR Number: 3718309-3Report Type:Expedited (15-DaCompany Report #235171 Outcome Other Serious PT Abnormal Labour Pregnancy Caesarean Section Maternal Drugs Affecting Foetus Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female
I/FU:F
Age:
Gender:Not SpecifiI/FU:F
PT Limb Reduction Defect
Report Source
Role PS
Manufacturer Roche
Route
Dose
Duration
03-Apr-2012
09:37 AM
Page: 330
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/01ISR Number: 3719121-1Report Type:Expedited (15-DaCompany Report #259776 Outcome Other Serious PT Gamma-Glutamyltransferase Increased Blood Thyroid Stimulating Hormone Increased Sleep Disorder Blood Cholesterol Increased Blood Triglycerides Increased Alanine Aminotransferase Increased Blood Pressure Increased Malaise Muscle Spasms Thyroxine Decreased Xanthelasma Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:49 YR Route Gender:Male Dose I/FU:I Duration 1 DAY
Date:05/09/01ISR Number: 3719124-7Report Type:Expedited (15-DaCompany Report #259784 Outcome Hospitalization Initial or Prolonged PT Asthenia Nausea Pyelonephritis Vomiting Gastritis Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Not SpecifiI/FU:I Dose Duration THE PATIENT HAD RECEIVED THREE DOSE FORMS IN TOTAL. 14 DAY
Date:05/09/01ISR Number: 3721171-6Report Type:Expedited (15-DaCompany Report #235171 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Caesarean Section Abnormal Labour Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:05/10/01ISR Number: 3720252-0Report Type:Expedited (15-DaCompany Report #259927 Outcome Hospitalization Initial or Prolonged PT Drug Interaction Haematochezia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female
I/FU:I
Dose Duration THE PATIENT TOOK 3 DOSES OF LARIAM BEFORE DATE OF ONSET.
Marcumar
Roche
Date:05/10/01ISR Number: 3721537-4Report Type:Expedited (15-DaCompany Report #259776 Outcome Other Serious PT Thyroxine Decreased Muscle Spasms Blood Pressure Increased 09:37 AM
Age:49 YR
Gender:Male
I/FU:I
03-Apr-2012
Page: 331
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Triglycerides Increased Blood Thyroid Stimulating Hormone Increased Lipids Increased Gamma-Glutamyltransferase Increased Alanine Aminotransferase Increased Malaise Sleep Disorder Blood Cholesterol Increased Xanthelasma
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
Date:05/10/01ISR Number: 3721538-6Report Type:Expedited (15-DaCompany Report #259784 Outcome Hospitalization Initial or Prolonged PT Pyelonephritis Vomiting Gastritis Asthenia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Gender:Unknown Dose 1 DOSE FORM 1 PER WEEK ORAL
I/FU:I Duration
Date:05/10/01ISR Number: 3721539-8Report Type:Expedited (15-DaCompany Report #251328 Outcome Congenital Anomaly PT Pregnancy Limb Malformation Maternal Drugs Affecting Foetus Limb Reduction Defect Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:05/11/01ISR Number: 3720799-7Report Type:Expedited (15-DaCompany Report #260010 Outcome Hospitalization Initial or Prolonged PT Anxiety Hallucination Suffocation Feeling Report Source Product Lariam Role PS Manufacturer Roche
Age:20 YR Route
Gender:Male Dose
Date:05/11/01ISR Number: 3720804-8Report Type:Expedited (15-DaCompany Report #259933 Outcome Other Serious PT Hypertension Panic Attack Fatigue Report Source Product Lariam Role PS Manufacturer Roche
Age:62 YR Route
Gender:Female Dose
Asthenia
03-Apr-2012
09:37 AM
Page: 332
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/01ISR Number: 3720906-6Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability Congenital Anomaly Other Serious PT Hyperventilation Asthenia Disorientation Dyspnoea Blood Pressure Increased Tinnitus Dizziness Company Report # Report Source Product Lariam / 250 Mg. / Laroche Laboritorys, Role PS Manufacturer Laroche Laboritorys Age:68 YR Route Gender:Female Dose 250 MG. ONE A WK. 6 WKS I/FU:I Duration
Date:05/14/01ISR Number: 3721765-8Report Type:Expedited (15-DaCompany Report #259776 Outcome Other Serious PT Thyroid Function Test Abnormal Malaise Blood Pressure Increased Xanthelasma Sleep Disorder Alanine Aminotransferase Increased Lipids Increased Gamma-Glutamyltransferase Increased Muscle Spasms Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:49 YR Route
Gender:Male Dose
Date:05/15/01ISR Number: 3723039-8Report Type:Expedited (15-DaCompany Report #259927 Outcome Hospitalization Initial or Prolonged PT Haematochezia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Female
I/FU:F
Dose Duration THE PATIENT TOOK 3 DOSES OF LARIAM BEFORE DATE OF ONSET.
Marcumar
Date:05/16/01ISR Number: 3724398-2Report Type:Direct Outcome Other Serious PT Nightmare Coordination Abnormal Fatigue Photophobia Nausea Insomnia Disturbance In Attention
Company Report # Report Source Product Lariam 250 Mg Tablet Roche Labs I.G. Shot Role PS C Manufacturer Roche Labs
Age:37 YR Route
Gender:Female Dose 1 TABLET PER WEEK
I/FU:I Duration
Hearing Impaired Sensation Of Pressure Headache Dizziness Sedation Memory Impairment Burning Sensation Speech Disorder 03-Apr-2012 09:37 AM Page: 333
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/16/01ISR Number: 3724861-4Report Type:Expedited (15-DaCompany Report #259933 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Asthenia Dyspnoea Hypertension Disorientation Panic Attack Myocardial Infarction Dizziness Emotional Disorder Bronchitis Fatigue Pneumonia Mycoplasmal Chest Pain Anxiety Blood Pressure Increased Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:62 YR Route ORAL Gender:Female Dose 1 PER WEEK ORAL I/FU:I Duration
Date:05/16/01ISR Number: 3725229-7Report Type:Expedited (15-DaCompany Report #260010 Outcome Hospitalization Initial or Prolonged PT Hallucination Anxiety Suffocation Feeling Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:05/17/01ISR Number: 3724379-9Report Type:Direct Outcome Other Serious PT Medication Error
Company Report #USP 54068 Report Source Product Lariam Monograph For Mefloquine Hydrochloride Role PS SS Manufacturer Roche Micromedex
Age: Route
Gender: Dose
I/FU:I Duration
Date:05/17/01ISR Number: 3724772-4Report Type:Expedited (15-DaCompany Report #259927 Outcome Hospitalization Initial or Prolonged PT International Normalised Ratio Increased Haematochezia Report Source Foreign Consumer Product Lariam Marcumar (Phenprocoumon) Role PS C Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:05/18/01ISR Number: 3724986-3Report Type:Expedited (15-DaCompany Report #259784 Outcome Hospitalization PT Pyelonephritis Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route
Gender:Not SpecifiI/FU:I Dose THE PATIENT Duration
Vomiting Nausea Asthenia Gastritis
HAD RECEIVED THREE DOSE FORMS IN TOTAL.
14
DAY
03-Apr-2012
09:37 AM
Page: 334
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/01ISR Number: 3725008-0Report Type:Expedited (15-DaCompany Report #260506 Outcome Hospitalization Initial or Prolonged PT Abdominal Pain Gastritis Asthenia Vomiting Pyelonephritis Nausea Report Source Product Lariam Stamaril Unidose Role PS C Manufacturer Roche Age:33 YR Route Gender:Female I/FU:I
Dose Duration THREE TABLETS TAKEN IN TOTAL. 14 DAY 1 DAY
Date:05/18/01ISR Number: 3725014-6Report Type:Expedited (15-DaCompany Report #247738 Outcome Other Serious PT Pregnancy Uterine Hypertonus Report Source Product Lariam Stamaril Unidose Role PS C Manufacturer Roche
Age: Route
Gender:Not SpecifiI/FU:F Dose Duration THREE TABLETS TAKEN IN TOTAL. 14 DAY 1 DAY
Date:05/21/01ISR Number: 3725705-7Report Type:Expedited (15-DaCompany Report #203837 Outcome Death Hospitalization Initial or Prolonged PT Hallucinations, Mixed Flushing Nervous System Disorder Delirium Anxiety Musculoskeletal Stiffness Decreased Appetite Adjustment Disorder Amnesia Pyrexia Petit Mal Epilepsy Blood Lactate Dehydrogenase Increased Delusional Disorder, Persecutory Type Cognitive Disorder Chills Blood Cortisol Increased Depression Urinary Hesitation Headache Weight Decreased Photopsia Erythema Claustrophobia Hepatic Steatosis Hyperhidrosis Erectile Dysfunction
Age:54 YR
Gender:Male
I/FU:F
Completed Suicide Agitation Insomnia Fatigue Liver Function Test Abnormal Obsessive-Compulsive Disorder 03-Apr-2012 09:37 AM Page: 335
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polydipsia Abnormal Dreams Report Source Product Lariam Tablets Role PS Manufacturer Roche Route Dose Duration 49 DAY
Date:05/21/01ISR Number: 3726835-6Report Type:Expedited (15-DaCompany Report #260506 Outcome Hospitalization Initial or Prolonged PT Abdominal Pain Vomiting Nausea Pyelonephritis Asthenia Uterine Contractions During Pregnancy Gastritis Report Source Foreign Health Professional Product Lariam Stamaril Unidose Role PS C Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:05/21/01ISR Number: 3726836-8Report Type:Expedited (15-DaCompany Report #247738 Outcome Other Serious PT Breech Presentation Pyelonephritis Uterine Hypertonus Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Stamaril Unidose (Yellow Fever Vaccine)
Date:05/21/01ISR Number: 3726936-2Report Type:Expedited (15-DaCompany Report #259784 Outcome Hospitalization Initial or Prolonged PT Pyelonephritis Gastritis Breech Presentation Vomiting Maternal Drugs Affecting Foetus Asthenia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:05/22/01ISR Number: 3726521-2Report Type:Expedited (15-DaCompany Report #260569 Outcome Hospitalization Initial or Prolonged PT Weight Decreased Vomiting Report Source Product Lariam Role PS Manufacturer Roche
Age:29 YR Route
Gender:Female Dose
Date:05/23/01ISR Number: 3727977-1Report Type:Expedited (15-DaCompany Report #203837 Outcome Death Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Urinary Hesitation Hepatic Steatosis Photopsia
Age:54 YR
Gender:Male
I/FU:F
Page: 336
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erythema Abnormal Dreams Polydipsia Petit Mal Epilepsy Hallucinations, Mixed Amnesia Blood Cortisol Increased Delirium Stress Pyrexia Erectile Dysfunction Adjustment Disorder Agitation Nervous System Disorder Cognitive Disorder Claustrophobia Musculoskeletal Stiffness Hyperhidrosis Flushing Delusional Disorder, Persecutory Type Headache Blood Lactate Dehydrogenase Increased Completed Suicide Depression Obsessive-Compulsive Disorder Liver Function Test Abnormal
Product Lariam
Role PS
Route ORAL
Duration
49
DAY
Date:05/23/01ISR Number: 3728418-0Report Type:Direct Outcome Disability PT Claustrophobia Anxiety Paranoia Hallucination
Company Report # Report Source Product Larium Roche Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male
I/FU:I
Date:05/24/01ISR Number: 3728060-1Report Type:Direct Outcome PT Hypersensitivity
Gender:Female Dose 1 TABLET ORALLY
I/FU:I Duration
Age:29 YR
Gender:Female
I/FU:I
PT Vomiting Weight Decreased
Product Lariam
Role PS
Route ORAL
Duration
03-Apr-2012
09:37 AM
Page: 337
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3728985-7Report Type:Expedited (15-DaCompany Report #259927 Outcome Hospitalization Initial or Prolonged PT Haematochezia Diverticulitis Report Source Product Lariam Tablets Aspirin Protect 100 Marcumar Role PS C C Manufacturer Roche Age:73 YR Route Gender:Female Dose I/FU:F Duration 36 DAY 584 DAY
Date:05/29/01ISR Number: 3728990-0Report Type:Expedited (15-DaCompany Report #260569 Outcome Hospitalization Initial or Prolonged PT Vomiting Weight Decreased Report Source Product Lariam Role PS Manufacturer Roche
Age:29 YR Route
Gender:Female Dose
Date:05/29/01ISR Number: 3728996-1Report Type:Expedited (15-DaCompany Report #260745 Outcome Other Serious PT Nerve Root Lesion Report Source Product Lariam Role PS Manufacturer Roche
Age:52 YR Route
Gender:Male
I/FU:I
Dose Duration FOUR TIMES IN TOTAL. 29 DAY
Date:05/29/01ISR Number: 3729002-5Report Type:Expedited (15-DaCompany Report #260795 Outcome Other Serious PT Extrasystoles Transient Ischaemic Attack Atrial Fibrillation Report Source Product Lariam Aspirin Mvi Role PS C C Manufacturer Roche
Age:65 YR Route
Gender:Male Dose
Date:05/30/01ISR Number: 3729600-9Report Type:Expedited (15-DaCompany Report #257983 Outcome Other Serious PT Cystitis Myalgia Influenza Like Illness Insomnia Arthralgia Prostatic Specific Antigen Increased Neuritis Back Pain Pyrexia Prostatic Disorder Anxiety Urinary Retention Fatigue Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:55 YR Route
Gender:Male Dose
Date:05/31/01ISR Number: 3731355-9Report Type:Expedited (15-DaCompany Report #260795 Outcome Other Serious PT Atrial Fibrillation Transient Ischaemic Attack 09:37 AM
Age:65 YR
Gender:Male
I/FU:I
03-Apr-2012
Page: 338
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Extrasystoles Report Source Health Professional Product Lariam Aspirin (Aspirin) Mvi (Multivitamin Nos) Role PS C C Manufacturer Hoffmann La Roche Inc Route ORAL Dose 250 MG 1 PER ONE DOSE;ORAL Duration
Date:05/31/01ISR Number: 3731408-5Report Type:Expedited (15-DaCompany Report #259927 Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Arthralgia Faeces Discoloured Haematochezia Diverticulitis Haemoglobin Decreased Report Source Foreign Consumer Product Lariam Aspirin Protect 100 (Aspirin) Marcumar (Phenprocoumon) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
C C
Date:05/31/01ISR Number: 3731786-7Report Type:Expedited (15-DaCompany Report #257983 Outcome Other Serious PT Pyrexia Prostatic Disorder Neuritis Bladder Disorder Urinary Incontinence Cystitis Arthralgia Insomnia Urinary Retention Influenza Like Illness Urinary Tract Infection Vestibular Disorder Prostatic Specific Antigen Increased Hyperhidrosis Back Pain Fatigue Myalgia Anxiety Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Age:52 YR Route
Gender:Male Dose
I/FU:I Duration
Other Serious
Paraesthesia Coordination Abnormal Nerve Root Lesion
Foreign Other
Lariam
PS
ORAL
1 DOSE FORM 1 PER WEEK ORAL
03-Apr-2012
09:37 AM
Page: 339
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/01ISR Number: 3731790-9Report Type:Expedited (15-DaCompany Report #260569 Outcome Hospitalization Initial or Prolonged PT Vomiting Weight Decreased Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:29 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
Date:06/01/01ISR Number: 3731768-5Report Type:Expedited (15-DaCompany Report #260852 Outcome Other Serious PT Hypoaesthesia Tremor Mental Disorder Insomnia Restlessness Pneumonia Anxiety Hyperhidrosis Report Source Product Lariam Diovan Roxibion Role PS C C Manufacturer Roche
Age: Route
Gender:Female Dose
Date:06/04/01ISR Number: 3733157-6Report Type:Expedited (15-DaCompany Report #260852 Outcome Other Serious PT Anxiety Hyperhidrosis Pneumonia Mental Disorder Tremor Insomnia Restlessness Hypoaesthesia Report Source Foreign Health Professional Product Lariam Diovan (Valsartan) Roxibion (Roxithromycin) Role PS C C Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:06/04/01ISR Number: 3733741-XReport Type:Direct Outcome PT Blood Pressure Increased Dizziness Anxiety
Age:22 YR Route OROPHARINGEAL
Gender:Female
I/FU:I
Dose Duration 1 WEEK OROPHARINGEAL
Date:06/05/01ISR Number: 3733342-3Report Type:Expedited (15-DaCompany Report #247738 Outcome Other Serious PT Uterine Hypertonus Delivery Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Female
I/FU:F
Dose Duration THREE TABLETS TAKEN IN TOTAL. 14 DAY
Stamaril Unidose
DAY
03-Apr-2012
09:37 AM
Page: 340
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3733356-3Report Type:Expedited (15-DaCompany Report #259776 Outcome Other Serious PT Xanthelasma Sleep Disorder Malaise Blood Pressure Increased Muscle Spasms Thyroid Function Test Abnormal Alanine Aminotransferase Increased Gamma-Glutamyltransferase Increased Lipids Increased Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:49 YR Route Gender:Male Dose I/FU:F Duration 1 DAY
Date:06/05/01ISR Number: 3733358-7Report Type:Expedited (15-DaCompany Report #260506 Outcome Hospitalization Initial or Prolonged PT Drug Interaction Asthenia Sedation Abdominal Pain Balance Disorder Uterine Contractions During Pregnancy Gastritis Vertigo Vomiting In Pregnancy Caesarean Section Pyelonephritis Nausea Report Source Product Lariam Stamaril Unidose Role PS I Manufacturer Roche
Age:33 YR Route
Gender:Female
I/FU:F
Dose Duration THREE TABLETS TAKEN IN TOTAL. 14 DAY 1 DAY
Date:06/05/01ISR Number: 3733365-4Report Type:Expedited (15-DaCompany Report #261224 Outcome Hospitalization Initial or Prolonged PT Arrhythmia Vertigo Tremor Dysarthria Myalgia Agitation Pyrexia Headache Arthralgia Report Source Product Lariam Nivaquine Paludrine Role PS SS C Manufacturer Roche
Age:35 YR Route
Gender:Male Dose
Age:58 YR
Gender:Female
I/FU:I
PT Chest Pain Feeling Hot
Product Lariam Calcium (Calcium Nos) Prempro (Estrogens Conjugated/Medroxypr
Role PS C
Route ORAL
Dose ORAL
Duration
03-Apr-2012
09:37 AM
Page: 341
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ogesterone Acetate) C
Date:06/05/01ISR Number: 3734385-6Report Type:Periodic Outcome Disability PT Asthenia Disorientation Nausea Fatigue Paraesthesia Depression
Company Report #113216 Report Source Health Professional Product Lariam Lamisil(Terbinafene) Role PS C Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 250 MG DAILY, ORAL
I/FU:F Duration
Date:06/05/01ISR Number: 3734386-8Report Type:Periodic Outcome Other Serious PT Blood Pressure Diastolic Increased Tachycardia Dizziness Pyrexia Sputum Discoloured Decreased Appetite Anxiety Disorder Body Temperature Increased Dyspnoea Nasopharyngitis Fatigue Oropharyngeal Pain Urinary Tract Infection
I/FU:I Duration
Date:06/05/01ISR Number: 3734387-XReport Type:Periodic Outcome Disability PT Weight Decreased Insomnia Hallucination Depression Depersonalisation
Company Report #910200285001 Report Source Health Professional Product Lariam Methotrexate (Methotrexate) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/05/01ISR Number: 3734388-1Report Type:Periodic Outcome Other Serious PT Tinnitus Ear Infection
Gender:Female Dose 250MG 1 PER WEEK ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734391-1Report Type:Periodic Outcome Other Serious 03-Apr-2012 09:37 AM PT Restlessness Insomnia
Age:21 YR
Gender:Male
I/FU:I
Page: 342
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Asthma Anxiety Fatigue Feeling Abnormal Vertigo Panic Attack
Product Lariam
Role PS
Route ORAL
Duration
Date:06/05/01ISR Number: 3734395-9Report Type:Periodic Outcome Other Serious PT Muscle Contractions Involuntary
I/FU:I Duration
Date:06/05/01ISR Number: 3734397-2Report Type:Periodic Outcome Other Serious PT Nasopharyngitis Oropharyngeal Pain
Company Report #248729 Report Source Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734399-6Report Type:Periodic Outcome Other Serious PT Chest Pain Sensory Disturbance Insomnia Dizziness
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734400-XReport Type:Periodic Outcome Other Serious PT Nausea Dyspepsia Disturbance In Attention Dizziness Hearing Impaired
I/FU:I Duration
Date:06/05/01ISR Number: 3734401-1Report Type:Periodic Outcome Other Serious PT Vomiting
Company Report #253140 Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche
Age:32 YR Route
Gender:Female Dose
I/FU:I Duration
Nausea Vaginal Haemorrhage Diarrhoea
Inc
ORAL
03-Apr-2012
09:37 AM
Page: 343
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3734402-3Report Type:Periodic Outcome Other Serious PT Vision Blurred Electrocardiogram Abnormal Blood Potassium Decreased Hypoaesthesia Palpitations Dizziness Company Report #253766 Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:34 YR Route ORAL Gender:Female Dose 500 MG DAILY, ORAL I/FU:I Duration 6 DAY
Date:06/05/01ISR Number: 3734405-9Report Type:Periodic Outcome Other Serious PT Blepharitis Eyelid Oedema Rash Erythematous
Age: Route ORAL
Gender:Male Dose 1 PER WEEK, ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734407-2Report Type:Periodic Outcome Other Serious PT Agitation Dysarthria Confusional State Anxiety Coordination Abnormal Feeling Jittery Dyspnoea Headache
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734408-4Report Type:Periodic Outcome Other Serious PT Anxiety Vertigo Tremor Agitation
I/FU:I Duration
Date:06/05/01ISR Number: 3734409-6Report Type:Periodic Outcome Other Serious PT Insomnia Abnormal Dreams Blood Triglycerides Increased
I/FU:I Duration
Date:06/05/01ISR Number: 3734410-2Report Type:Periodic Outcome Other Serious 03-Apr-2012 09:37 AM PT Constipation Headache
Age:
Gender:Male
I/FU:I
Page: 344
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Malaise Dizziness
Product Lariam
Role PS
Route ORAL
Dose ORAL
Duration
Date:06/05/01ISR Number: 3734411-4Report Type:Periodic Outcome Other Serious PT Viral Infection Pruritus Asthenia Fatigue Amnesia
Gender:Male Dose 250MG, 1 PER WEEK ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734412-6Report Type:Periodic Outcome Other Serious PT Chest Pain Abnormal Dreams
Company Report #243594 Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Date:06/05/01ISR Number: 3734413-8Report Type:Periodic Outcome Other Serious PT Dizziness Headache Lethargy Migraine Nasopharyngitis
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734414-XReport Type:Periodic Outcome Other Serious PT Visual Impairment Jaundice Abnormal Dreams Panic Attack Asthenia Anger Paranoia
Age: Route ORAL
I/FU:I Duration
Age:
Gender:
I/FU:I
PT Headache Depression Lethargy Paraesthesia Feeling Abnormal Dizziness Nausea 09:37 AM Page: 345
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Epistaxis Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Route ORAL Dose ORAL Duration
Date:06/05/01ISR Number: 3734416-3Report Type:Periodic Outcome Other Serious PT Nervous System Disorder
Age: Route ORAL
Gender: Dose ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734417-5Report Type:Periodic Outcome Other Serious PT Abnormal Dreams Anxiety Emotional Disorder
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734418-7Report Type:Periodic Outcome Other Serious PT Lethargy Diarrhoea Dizziness Constipation Pyrexia Abnormal Faeces Headache Haematochezia Abdominal Pain Upper Fatigue Visual Field Defect Hallucination Nausea Feeling Abnormal Decreased Appetite
Company Report #243646 Report Source Consumer Other Product Lariam Tinidazole 1 Concomitant Drug(Generic Components Unknown) Cipro (Ciprofloxacin Hydrochloride) Role PS C C C Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734419-9Report Type:Periodic Outcome Other Serious PT Jaundice Panic Attack Nausea Asthenia
Age: Route ORAL
I/FU:I Duration
Visual Impairment Abnormal Dreams Anger Paranoia
03-Apr-2012
09:37 AM
Page: 346
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3734423-0Report Type:Periodic Outcome Other Serious PT Hyperhidrosis Dermatitis Diarrhoea Pruritus Sleep Disorder Nightmare Abnormal Faeces Company Report #236092 Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:57 YR Route ORAL Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Date:06/05/01ISR Number: 3734429-1Report Type:Periodic Outcome Other Serious PT Aspartate Aminotransferase Increased Blood Bilirubin Increased Alanine Aminotransferase Increased
I/FU:I Duration
Date:06/05/01ISR Number: 3734432-1Report Type:Periodic Outcome Other Serious PT Joint Swelling
Company Report #238874 Report Source Health Professional Product Lariam Oral Contraceptive Nos (Oral Contraceptive Nos) Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 250 MG 1 WEEK 1 PER ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734434-5Report Type:Periodic Outcome Other Serious PT Cardiac Disorder
Company Report #239398 Report Source Health Professional Product Lariam Probenecid 500 Mg Amoxicillin 875mg Role PS SS SS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 750MG 1 PER ONE DOSE ORAL 500 MG 1 PER 12 HOUR ORAL 2625 MG 1 PER 12 HOUR ORAL
I/FU:I Duration
Age:29 YR Route
Gender:Male Dose
I/FU:I Duration
Other Serious
Rectal Haemorrhage
Consumer
Lariam Antibiotics Nos
PS C
ORAL
03-Apr-2012
09:37 AM
Page: 347
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3734441-2Report Type:Periodic Outcome Other Serious PT Upper Respiratory Tract Infection Company Report #240270 Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Female Dose ORAL I/FU:I Duration
Date:06/05/01ISR Number: 3734446-1Report Type:Periodic Outcome Other Serious PT Dizziness Decreased Appetite Speech Disorder
I/FU:I Duration
Date:06/05/01ISR Number: 3734447-3Report Type:Periodic Outcome Other Serious PT Pruritus Urticaria
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734448-5Report Type:Periodic Outcome Other Serious PT Influenza Like Illness
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734449-7Report Type:Periodic Outcome Other Serious PT Hyperkeratosis Dermatitis
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734460-6Report Type:Periodic Outcome Other Serious PT Nausea Dissociation Hallucination Headache Coordination Abnormal Abnormal Dreams Malaise Abdominal Pain Dermatitis
Age: Route ORAL
Gender: Dose ORAL
I/FU:I Duration
Flushing Dizziness Chills Decreased Appetite Disturbance In Attention Urticaria
03-Apr-2012
09:37 AM
Page: 348
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3734461-8Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Pyrexia Headache Psychotic Disorder Dermatitis Abdominal Pain Agitation White Blood Cell Count Decreased Hepatic Enzyme Increased Sinusitis Hallucination Nasopharyngitis Confusional State Company Report #247060 Report Source Health Professional Product Lariam Dimetapp Necon Oral Contraceptions Pepto Bismol Role PS C C C C Manufacturer Hoffmann La Roche Inc Age:25 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:06/05/01ISR Number: 3734465-5Report Type:Periodic Outcome Other Serious PT Dizziness Nausea
I/FU:I Duration
Date:06/05/01ISR Number: 3734469-2Report Type:Periodic Outcome Other Serious PT Nightmare Fear Insomnia Disturbance In Attention
Age: Route ORAL
I/FU:I Duration
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734475-8Report Type:Periodic Outcome Life-Threatening Hospitalization Initial or Prolonged PT Hyperventilation Chest Pain Suicidal Ideation Hallucination
I/FU:I Duration
Insomnia Bipolar I Disorder Psychomotor Hyperactivity Emotional Disorder
03-Apr-2012
09:37 AM
Page: 349
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3734478-3Report Type:Periodic Outcome Other Serious PT Thinking Abnormal Hypomania Paranoia Inappropriate Affect Company Report #254302 Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:63 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:06/05/01ISR Number: 3734482-5Report Type:Periodic Outcome Disability PT Peripheral Nerve Injury Diarrhoea Panic Attack Weight Decreased Muscular Weakness Balance Disorder Anxiety Nausea
I/FU:I Duration
Date:06/05/01ISR Number: 3734485-0Report Type:Periodic Outcome Other Serious PT Convulsion Psychiatric Symptom
Age: Route ORAL
Gender: Dose ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734488-6Report Type:Periodic Outcome Other Serious PT Malaria Drug Ineffective
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734490-4Report Type:Periodic Outcome Other Serious PT Motion Sickness Balance Disorder Vision Blurred
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734493-XReport Type:Periodic Outcome PT
Age:18 YR Route
Gender:Unknown Dose
I/FU:I Duration
Delusion Paranoia Psychotic Disorder Agitation
Health Professional
Lariam
PS
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 350
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3734495-3Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Asthenia Circulatory Collapse Headache Insomnia Tearfulness Feeling Abnormal Decreased Appetite Amnesia Paraesthesia Dizziness Company Report #2433584 Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Female Dose ORAL I/FU:I Duration
Date:06/05/01ISR Number: 3734497-7Report Type:Periodic Outcome Other Serious PT Anxiety
Age: Route ORAL
Date:06/05/01ISR Number: 3734499-0Report Type:Periodic Outcome Other Serious PT Emotional Disorder Dizziness Decreased Appetite Lethargy Weight Decreased Abnormal Dreams Hallucination
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734502-8Report Type:Periodic Outcome Other Serious PT Anxiety Dyspnoea
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734504-1Report Type:Periodic Outcome Other Serious PT Nausea Paranoia Diarrhoea Insomnia Hyperhidrosis
Age: Route ORAL
Movement Disorder Nightmare Loss Of Consciousness Depression Fatigue Gastroenteritis Visual Impairment Panic Attack 03-Apr-2012 09:37 AM Page: 351
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3734507-7Report Type:Periodic Outcome Other Serious PT Pyrexia Malaria Chills Hyperhidrosis Company Report #243636 Report Source Consumer Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age: Route ORAL Gender:Unknown Dose ORAL I/FU:I Duration
Date:06/05/01ISR Number: 3734508-9Report Type:Periodic Outcome Other Serious PT Convulsion Dizziness
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3734509-0Report Type:Periodic Outcome Other Serious PT Depression Hallucination Headache Paraesthesia Panic Attack Tremor Vomiting Diarrhoea
Age: Route ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3735154-3Report Type:Periodic Outcome Other Serious PT Crying Hallucination, Auditory Amnesia Thinking Abnormal Hallucination, Tactile Hallucination, Visual Suicidal Ideation Hyperglycaemia Hyperventilation Jamais Vu Blood Urea Increased Anxiety Psychotic Disorder Tremor
I/FU:I Duration
Age:26 YR
Gender:Female
I/FU:I
Outcome Disability
PT Depression Tachycardia Psychotic Disorder Sleep Terror Anxiety 09:37 AM
Product Lariam Ortho-Cyclen (Ethinyl Estradiol/Norgestima
Role PS
Route ORAL
Duration
03-Apr-2012
Page: 352
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report te) C
Date:06/05/01ISR Number: 3735160-9Report Type:Periodic Outcome Other Serious PT Confusional State Tremor Hallucination Depression Amnesia Abnormal Dreams Psychotic Disorder Crying Anxiety
I/FU:I Duration
Date:06/05/01ISR Number: 3735161-0Report Type:Periodic Outcome Life-Threatening PT Hypoaesthesia
Company Report #238170 Report Source Consumer Product Lariam Vitamin E Role PS C Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/05/01ISR Number: 3735163-4Report Type:Periodic Outcome Other Serious PT Depression Paranoia
I/FU:I Duration
Date:06/05/01ISR Number: 3735166-XReport Type:Periodic Outcome Disability PT Asthenia Vomiting Headache Malaria Pyrexia Tremor Dysgraphia Diarrhoea Hallucination Nausea
Gender:Female Dose 1250 MG DAILY, ORAL
I/FU:I Duration
Date:06/05/01ISR Number: 3735169-5Report Type:Periodic Outcome Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM PT Dissociation Depression Anxiety Hallucination
I/FU:I Duration
Page: 353
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3735171-3Report Type:Periodic Outcome Disability PT Anxiety Hallucination Confusional State Diarrhoea Depression Insomnia Delirium Company Report #241282 Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:26 YR Route ORAL Gender:Female Dose 250 MG 1 PER ONE DOSE ORAL I/FU:I Duration
Date:06/05/01ISR Number: 3735172-5Report Type:Periodic Outcome Other Serious PT Hypertension
I/FU:I Duration
Date:06/05/01ISR Number: 3735173-7Report Type:Periodic Outcome Other Serious PT Abnormal Dreams Amnesia Fear Road Traffic Accident Feeling Of Despair Chest Discomfort Lethargy Palpitations Photophobia Skin Disorder Visual Acuity Reduced Depression
Age: Route ORAL
I/FU:I Duration
Date:06/06/01ISR Number: 3733847-5Report Type:Expedited (15-DaCompany Report #261363 Outcome Other Serious PT Onycholysis Report Source Product Lariam Hepatitis Vaccination Vivotif "Berna" Role PS C C Manufacturer Roche
Age:10 YR Route
Gender:Female Dose
Date:06/08/01ISR Number: 3736478-6Report Type:Expedited (15-DaCompany Report #261224 Outcome Hospitalization PT Agitation Report Source Foreign Product Lariam Role PS Manufacturer Hoffmann La Roche
Age:35 YR Route
Gender:Male Dose
I/FU:I Duration
Myalgia Vertigo Arrhythmia Headache Pyrexia Arthralgia Dysarthria Tremor
Other Nivaquine (Chloroquine Sulfate) Paludrine (Chloroguanide Hydrochloride) SS C
Inc
ORAL ORAL
1.5 GRAM ORAL ORAL
03-Apr-2012
09:37 AM
Page: 354
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/01ISR Number: 3736491-9Report Type:Expedited (15-DaCompany Report #260506 Outcome Hospitalization Initial or Prolonged PT Vomiting Infectious Peritonitis Asthenia Abdominal Pain Pregnancy Sedation Gastritis Nausea Vertigo Abscess Caesarean Section Arterial Occlusive Disease Pyelonephritis Balance Disorder Post Procedural Complication Uterine Hypertonus Report Source Foreign Health Professional Other Product Lariam Stamaril Unidose (Yellow Fever Vaccination) Role PS Manufacturer Hoffmann La Roche Inc Age:33 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
SS
Date:06/08/01ISR Number: 3736492-0Report Type:Expedited (15-DaCompany Report #259776 Outcome Other Serious PT Thyroid Function Test Abnormal Xanthelasma Sleep Disorder Muscle Spasms Alanine Aminotransferase Increased Lipids Increased Malaise Gamma-Glutamyltransferase Increased Blood Pressure Increased Report Source Foreign Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:06/08/01ISR Number: 3736494-4Report Type:Expedited (15-DaCompany Report #247738 Outcome Other Serious PT Pyelonephritis Uterine Hypertonus Breech Presentation Premature Rupture Of Membranes Maternal Drugs Affecting Foetus Caesarean Section Report Source Foreign Health Professional Other Product Lariam Stamaril Unidose (Yellow Fever Vaccine) Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:06/08/01ISR Number: 3736496-8Report Type:Expedited (15-DaCompany Report #261363 Outcome Other Serious 03-Apr-2012 09:37 AM PT Onycholysis Report Source Foreign Health
Age:10 YR
Gender:Female
I/FU:I
Page: 355
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Lariam Hepatitis Vaccinatioin (Hepatitis Vaccine) Vivotif "Berna" (Typhoid Vaccines) Role PS Manufacturer Hoffmann La Roche Inc Route ORAL Dose ORAL Duration 385 DAY
C C
Date:06/08/01ISR Number: 3736661-XReport Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Eyelid Oedema Burning Sensation Face Oedema Medication Error Liver Disorder Skin Disorder
Company Report # Report Source Product Larium Depakote Role PS SS Manufacturer
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:06/11/01ISR Number: 3736292-1Report Type:Expedited (15-DaCompany Report #247340 Outcome Disability PT Motor Dysfunction Nightmare Vertigo Positional Dizziness Vomiting Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:42 YR Route
Gender:Male Dose FOR MANY YEARS.
I/FU:F Duration
Date:06/11/01ISR Number: 3736334-3Report Type:Expedited (15-DaCompany Report #261664 Outcome Other Serious PT Vaginal Haemorrhage Report Source Product Lariam Role PS Manufacturer Roche
Age:27 YR Route
Gender:Female Dose
Date:06/11/01ISR Number: 3736338-0Report Type:Expedited (15-DaCompany Report #261561 Outcome Hospitalization Initial or Prolonged PT Placenta Praevia Report Source Product Lariam Role PS Manufacturer Roche
Age:30 YR Route
Gender:Female Dose
Age:72 YR
Gender:Female
I/FU:I
Outcome Death
PT International Normalised Ratio Increased Drug Interaction Haemorrhagic Stroke
Report Source
Product Lariam Cozaar Comp Warfarin
Role PS C I
Manufacturer Roche
Route
Dose VARYING DOSES AS PER INR.
03-Apr-2012
09:37 AM
Page: 356
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/01ISR Number: 3736693-1Report Type:Direct Outcome Disability PT Palpitations Panic Attack Anxiety Muscle Spasms Nightmare Company Report # Report Source Product Larium Loratadine Role PS C Manufacturer Age:45 YR Route BUCCAL Gender:Male I/FU:I
Dose Duration 1 TABLE WEEKLY BUCCAL
Date:06/12/01ISR Number: 3738728-9Report Type:Expedited (15-DaCompany Report #261561 Outcome Hospitalization Initial or Prolonged PT Placenta Praevia Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/12/01ISR Number: 3738880-5Report Type:Expedited (15-DaCompany Report #261664 Outcome Other Serious PT Vaginal Haemorrhage Report Source Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:06/12/01ISR Number: 3738885-4Report Type:Expedited (15-DaCompany Report #247340 Outcome Disability PT Nightmare Vomiting Gait Disturbance Vertigo Positional Dizziness Motor Dysfunction Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Date:06/13/01ISR Number: 3738150-5Report Type:Direct Outcome Disability PT Anxiety Fatigue Disorientation Hypertension Dizziness Panic Attack Dyspnoea Chest Pain
Company Report # Report Source Product Lariam 250mg Roche Ambien Cardizem Biaxin Premarin Provera Captopril Role PS C C C C C C Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration 1 TABLET PER WEEK BY MOUTH
Cipro
03-Apr-2012
09:37 AM
Page: 357
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/01ISR Number: 3738958-6Report Type:Expedited (15-DaCompany Report #261498 Outcome Death PT Haemorrhagic Stroke Drug Interaction International Normalised Ratio Increased Report Source Foreign Other Product Lariam Warfarin (Warfarin Sodium) Cozaar Comp (Hydrochlorothiazide /Losartan Potassium) Role PS Manufacturer Hoffmann La Roche Inc Age:72 YR Route ORAL ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL ORAL I/FU:I Duration
SS C
Date:06/15/01ISR Number: 3740168-3Report Type:Expedited (15-DaCompany Report #259927 Outcome Hospitalization Initial or Prolonged PT Diverticulitis Gastrointestinal Haemorrhage Report Source Product Lariam Tablets Aspirin Protect 100 Marcumar Role PS SS SS Manufacturer Roche Roche
Age:73 YR Route
Gender:Female Dose
Date:06/15/01ISR Number: 3740171-3Report Type:Expedited (15-DaCompany Report #260569 Outcome Hospitalization Initial or Prolonged PT Vomiting Weight Decreased Report Source Product Lariam Role PS Manufacturer Roche
Age:29 YR Route
Gender:Female Dose
Date:06/18/01ISR Number: 3740645-5Report Type:Expedited (15-DaCompany Report #259750 Outcome Other Serious PT Staring Inappropriate Affect Panic Reaction Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:94 DY Route
Gender:Male Dose
Date:06/18/01ISR Number: 3741496-8Report Type:Expedited (15-DaCompany Report #259927 Outcome Hospitalization Initial or Prolonged PT Haemoglobin Decreased Diverticulitis Arthralgia Gastrointestinal Haemorrhage Report Source Foreign Consumer Health Professional Product Lariam Aspirin Protect 100 (Aspirin) Marcumar (Phenprocoumon) Role PS Manufacturer Hoffmann La Roche Inc
Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL 100 MG DAILY ORAL 0.5 DOSE FORM DAILY ORAL
I/FU:F Duration
SS SS
Date:06/18/01ISR Number: 3741720-1Report Type:Expedited (15-DaCompany Report #260569 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Vomiting Pregnancy Weight Decreased Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
Page: 358
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/01ISR Number: 3742310-7Report Type:Expedited (15-DaCompany Report #259933 Outcome Other Serious PT Asthenia Hypertension Fatigue Panic Attack Report Source Product Lariam Ambien Biaxin Premarin Medroxyprogesterone Cipro Captopril Cardizem Role PS C C C C C C C Manufacturer Roche Age:62 YR Route Gender:Female Dose AT NIGHT. TAKEN FOR 1 WEEK. TAKEN FOR 1 WEEK I/FU:F Duration 74 DAY 7 DAY
7 34
DAY DAY
Date:06/20/01ISR Number: 3743711-3Report Type:Expedited (15-DaCompany Report #259750 Outcome Other Serious PT Inappropriate Affect Panic Reaction Staring Hallucination Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age:94 DY Route ORAL
I/FU:I Duration
Date:06/21/01ISR Number: 3743483-2Report Type:Expedited (15-DaCompany Report #261561 Outcome Hospitalization Initial or Prolonged PT Placenta Praevia Report Source Product Lariam Role PS Manufacturer Roche
Age:30 YR Route
Gender:Female Dose
Date:06/21/01ISR Number: 3743490-XReport Type:Expedited (15-DaCompany Report #260121 Outcome Other Serious PT Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Asthenia Report Source Product Lariam Voltarene Apranax Role PS C C Manufacturer Roche
Age:51 YR Route
Gender:Male Dose
Date:06/21/01ISR Number: 3743545-XReport Type:Direct Outcome Disability PT Paraesthesia Insomnia Chest Pain Hypoaesthesia Anxiety
I/FU:I Duration
Date:06/22/01ISR Number: 3745665-2Report Type:Expedited (15-DaCompany Report #259933 Outcome Required Intervention to 03-Apr-2012 09:37 AM
Age:62 YR
Gender:Female
I/FU:F
Page: 359
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Pneumonia Mycoplasmal Chest Pain Dizziness Asthenia Disorientation Emotional Disorder Blood Pressure Increased Anxiety Fatigue Hypertension Bronchitis Fear Panic Attack Dyspnoea Report Source Consumer Product Lariam Ambien (Zolpidem Tartrate) Biaxin (Clarithromycin) Premarin (Estrogens, Conjugated) Medroxyprogesterone (Medroxyprogesterone Acetate) Cipro (Ciprofloxacin Hydrochloride) Captopril Cardizem (Diltiazem Hydrochloride) Role PS Manufacturer Hoffmann La Roche Inc Route ORAL Dose 1 PER WEEK ORAL Duration
C C C C C C C
Date:06/25/01ISR Number: 3745221-6Report Type:Expedited (15-DaCompany Report #244451 Outcome Congenital Anomaly PT Intra-Uterine Death Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Not SpecifiI/FU:F Dose Duration 50 DAY
Date:06/25/01ISR Number: 3745817-1Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Sleep Disorder Influenza Like Illness Nervousness Oropharyngeal Pain Anxiety Nasal Congestion Ear Pain Malaise
Gender:Female Dose 6/13/2001 10/4/2001 ORAL
I/FU:I Duration
Date:06/25/01ISR Number: 3746822-1Report Type:Expedited (15-DaCompany Report #261561 Outcome Hospitalization Initial or Prolonged PT Placenta Praevia Caesarean Section Pregnancy Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Hoffmann La Roche Inc
Age:30 YR Route
Gender:Female Dose
I/FU:F Duration
ORAL
Date:06/25/01ISR Number: 3746823-3Report Type:Expedited (15-DaCompany Report #260121 Outcome Other Serious PT Blood Lactate Dehydrogenase Increased Asthenia 09:37 AM
Age:51 YR
Gender:Male
I/FU:I
03-Apr-2012
Page: 360
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Creatine Phosphokinase Increased Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Voltarene (Diclofenac Sodium) Apranax (Naproxen Sodium) Role PS Manufacturer Hoffmann La Roche Inc Route Dose Duration
ORAL
C C
Date:06/26/01ISR Number: 3746273-XReport Type:Expedited (15-DaCompany Report #262670 Outcome Other Serious PT Drug Ineffective Malaria Bacterial Infection Report Source Product Lariam Role PS Manufacturer Roche
Age:23 YR Route
Gender:Female Dose
Date:06/26/01ISR Number: 3748077-0Report Type:Expedited (15-DaCompany Report #244451 Outcome Congenital Anomaly PT Maternal Drugs Affecting Foetus Pregnancy Intra-Uterine Death Congenital Anomaly Abortion Missed Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
Gender:Unknown Dose 250 MG, 1 PER WEEK ORAL
I/FU:I Duration
Date:06/27/01ISR Number: 3748407-XReport Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Psychotic Disorder Anxiety Hallucination Depression Nightmare Paraesthesia Heart Rate Irregular Respiratory Arrest Heart Rate Increased Convulsion Hallucination, Auditory
Company Report # Report Source Product Lariam -(Mefloquine) Role PS Manufacturer Hoffman-Laroche
Age:25 YR Route
Gender:Female
I/FU:I
Dose Duration 1 X WEEK FOR 3 WKS (3 PILLS) 3 WK
Date:06/28/01ISR Number: 3748646-8Report Type:Expedited (15-DaCompany Report #261500 Outcome Hospitalization Initial or Prolonged PT Malaria Asthenia Gastric Ulcer Irritability Nausea
Age:30 YR
Gender:Male
I/FU:F
03-Apr-2012
09:37 AM
Page: 361
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Report Source Product Lariam Role PS Manufacturer Roche Route Dose Duration THE PATIENT RECEIVED 3 TABLETS, THEN TWO TABLETS AND LATER ONE 2 DAY
Lariam Quinine Mopral
SS C C
Roche
Date:06/28/01ISR Number: 3749664-6Report Type:Expedited (15-DaCompany Report #262670 Outcome Other Serious PT Bacterial Infection Ill-Defined Disorder Drug Ineffective Malaria Diarrhoea Report Source Foreign Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Date:07/02/01ISR Number: 3751059-6Report Type:Expedited (15-DaCompany Report #261500 Outcome Hospitalization Initial or Prolonged PT Irritability Drug Effect Decreased Malaria Hepatic Function Abnormal Gastric Ulcer Ileus Paralytic Insomnia Nausea Asthenia Report Source Foreign Health Professional Product Lariam Lariam (Mefloquine Hydrochloride) Quinine Mopral (Oemprazole) Role PS SS C C Manufacturer Hoffmann La Roche Inc
Gender:Male Dose ORAL ORAL
I/FU:I Duration
Date:07/05/01ISR Number: 3751625-8Report Type:Expedited (15-DaCompany Report #260745 Outcome Hospitalization Initial or Prolonged PT Guillain-Barre Syndrome Report Source Product Lariam Tetanus Vaccine Yellow Fever Vaccine Cholera Vaccine Poliomyelitis Vaccine Hepatitis Vaccine Role PS C C C C C Manufacturer Roche
Age:52 YR Route
Gender:Male
I/FU:F
Dose Duration FOUR TABLETS IN TOTAL. 29 DAY
Date:07/05/01ISR Number: 3751630-1Report Type:Expedited (15-DaCompany Report #259147 Outcome Other Serious PT Polymyalgia Rheumatica Nausea Erythema Infectiosum 09:37 AM Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
I/FU:F Duration
03-Apr-2012
Page: 362
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/01ISR Number: 3751640-4Report Type:Expedited (15-DaCompany Report #261224 Outcome Hospitalization Initial or Prolonged PT Dysarthria Tremor Vertigo Asthenia Myalgia Arthralgia Headache Pyrexia Agitation Vestibular Disorder Arrhythmia Report Source Consumer Product Lariam Nivaquine Paludrine Role PS SS C Manufacturer Roche Age:35 YR Route Gender:Male Dose I/FU:F Duration 2 DAY 50 DAY
Date:07/05/01ISR Number: 3751672-6Report Type:Expedited (15-DaCompany Report #259147 Outcome Other Serious PT Erythema Infectiosum Polymyalgia Rheumatica Nausea Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
I/FU:F Duration
Date:07/05/01ISR Number: 3751687-8Report Type:Expedited (15-DaCompany Report #260745 Outcome Hospitalization Initial or Prolonged PT Guillain-Barre Syndrome Report Source Consumer Product Lariam Tetanus Vaccine Yellow Fever Vaccine Cholera Vaccine Poliomyelitis Vaccine Hepatitis Vaccine Role PS C C C C C Manufacturer Roche
Age:52 YR Route
Gender:Male
I/FU:F
Dose Duration FOUR TABLETS IN TOTAL. 29 DAY
Date:07/05/01ISR Number: 3751701-XReport Type:Expedited (15-DaCompany Report #261224 Outcome Hospitalization Initial or Prolonged PT Dysarthria Asthenia Headache Arthralgia Vestibular Disorder Pyrexia Agitation Tremor Myalgia Vertigo Report Source Consumer Product Lariam Nivaquine Paludrine Role PS SS C Manufacturer Roche
Age:35 YR Route
Gender:Male Dose
Arrhythmia
03-Apr-2012
09:37 AM
Page: 363
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/01ISR Number: 3751721-5Report Type:Expedited (15-DaCompany Report #263420 Outcome Disability PT Amnesia Confusional State Report Source Product Lariam Edecrin Naprosyn Asa Role PS C C C Manufacturer Roche Age:66 YR Route Gender:Male Dose I/FU:I Duration 36 DAY
Date:07/10/01ISR Number: 3754734-2Report Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability PT Depression Vertigo Headache Anxiety Panic Attack Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:24 YR Route
Date:07/10/01ISR Number: 3754747-0Report Type:Expedited (15-DaCompany Report #261469 Outcome Other Serious PT Decreased Appetite Anxiety Coordination Abnormal Night Sweats Hepatitis A Antibody Positive Depression Panic Attack Liver Function Test Abnormal Memory Impairment Flushing Dizziness Chills Nausea Diarrhoea Report Source Product Lariam Leios Role PS C Manufacturer Roche
Age:32 YR Route
Gender:Female Dose
Date:07/10/01ISR Number: 3755913-0Report Type:Expedited (15-DaCompany Report #263420 Outcome Disability PT Confusional State Amnesia Report Source Consumer Product Lariam Edecrin (Ethacrynate Sodium Or Ethacrynic Acid) Naprosyn (Naproxen) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
C C
Asa (Aspirin)
03-Apr-2012
09:37 AM
Page: 364
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/01ISR Number: 3756155-5Report Type:Expedited (15-DaCompany Report #261224 Outcome Hospitalization Initial or Prolonged PT Electroencephalogram Abnormal Malaria Agitation Myalgia Headache Dysarthria Asthenia Arrhythmia Arthralgia Tremor Vestibular Disorder Vertigo Pyrexia Report Source Foreign Other Product Lariam Nivaquine (Chloroquine Sulfate) Paludrine (Chloroguanide Hydrochloride) Role PS Manufacturer Hoffmann La Roche Inc Age:35 YR Route ORAL ORAL Gender:Male Dose 1.5 GRAM ORAL ORAL I/FU:F Duration
SS C
Date:07/10/01ISR Number: 3756157-9Report Type:Expedited (15-DaCompany Report #260745 Outcome Hospitalization Initial or Prolonged PT Mumps Bacterial Infection Guillain-Barre Syndrome Report Source Foreign Other Product Lariam Tetanus Vaccine (Tetanus Toxoid) Yellow Fever Vaccine Cholera Vaccine (Cholera Vaccine) Poliomyelitis Vaccine (Poliomyelitis Vaccines) Hepatitis Vaccine (Hepatitis Vaccine) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
C C C
C C
Date:07/10/01ISR Number: 3756283-4Report Type:Expedited (15-DaCompany Report #259147 Outcome Other Serious PT Polymyalgia Rheumatica Erythema Infectiosum Nausea Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:07/11/01ISR Number: 3755609-5Report Type:Expedited (15-DaCompany Report #262670 Outcome Hospitalization PT Drug Ineffective Report Source Product Lariam Role PS Manufacturer Roche
Age:23 YR Route
Gender:Female Dose
Bacterial Infection Ill-Defined Disorder Diarrhoea Malaria
03-Apr-2012
09:37 AM
Page: 365
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/01ISR Number: 3755616-2Report Type:Expedited (15-DaCompany Report #263822 Outcome Life-Threatening PT Cardiac Arrest Grand Mal Convulsion Report Source Product Lariam Role PS Manufacturer Roche Age:62 YR Route Gender:Male Dose I/FU:I Duration 15 DAY
Date:07/12/01ISR Number: 3756377-3Report Type:Expedited (15-DaCompany Report #249874 Outcome Disability PT Musculoskeletal Pain Aphasia Nightmare Headache Amnesia Insomnia Sensory Loss Dyspnoea Muscular Weakness Abnormal Dreams Weight Decreased Dizziness Palpitations Hyperventilation Nuclear Magnetic Resonance Imaging Abnormal Alcoholism Thirst Influenza Like Illness Injury Blood Pressure Decreased Anhedonia Encephalopathy Psychotic Disorder Emotional Distress Paraesthesia Mental Disorder Educational Problem Electroencephalogram Abnormal Agitation Visual Impairment Balance Disorder Sleep Disorder Tinnitus Hypophagia Cold Sweat Emotional Disorder Report Source Product Lariam Claritin-D Biaxin Role PS C C Manufacturer Roche
Age:14 YR Route
Gender:Male
I/FU:F
Dose Duration TOTAL OF 5 WEEKLY DOSES. 29 DAY
Date:07/12/01ISR Number: 3757198-8Report Type:Expedited (15-DaCompany Report #241365 Outcome Hospitalization Initial or Prolonged Disability PT Vertigo Panic Attack Depression Headache Anxiety
Age:24 YR
Gender:Female
I/FU:F
03-Apr-2012
09:37 AM
Page: 366
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Report Source Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Route ORAL Dose 250MG 1 PER WEEK ORAL Duration
Date:07/12/01ISR Number: 3757293-3Report Type:Expedited (15-DaCompany Report #261469 Outcome Other Serious PT Dizziness Panic Attack Nausea Diarrhoea Depression Hepatitis A Chills Coordination Abnormal Agitation Memory Impairment Night Sweats Abnormal Faeces Anxiety Decreased Appetite Flushing Report Source Foreign Consumer Health Professional Product Lariam Leios (Ethinyl Estradiol/Levonorges trel) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:07/13/01ISR Number: 3757307-0Report Type:Expedited (15-DaCompany Report #263895 Outcome Hospitalization Initial or Prolonged PT Rhabdomyolysis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:07/13/01ISR Number: 3758782-8Report Type:Expedited (15-DaCompany Report #263822 Outcome Life-Threatening PT Grand Mal Convulsion Cardiac Arrest Report Source Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose 250 MG 1 WEEK 1 PER ORAL
I/FU:I Duration
Date:07/13/01ISR Number: 3758798-1Report Type:Expedited (15-DaCompany Report #262670 Outcome Hospitalization Initial or Prolonged Required PT Ill-Defined Disorder Diarrhoea Malaria Report Source Foreign Consumer Health Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Bacterial Infection Drug Ineffective
Professional
03-Apr-2012
09:37 AM
Page: 367
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/01ISR Number: 3759497-2Report Type:Expedited (15-DaCompany Report #249874 Outcome Disability PT Palpitations Headache Encephalopathy Emotional Distress Educational Problem Hyperventilation Blood Pressure Decreased Cognitive Disorder Influenza Like Illness Musculoskeletal Pain Insomnia Dyspnoea Weight Decreased Dizziness Visual Impairment Muscular Weakness Cold Sweat Hypophagia Nightmare Thirst Electroencephalogram Abnormal Paraesthesia Sensory Loss Hypoaesthesia Agitation Balance Disorder Dysarthria Amnesia Abnormal Dreams Psychotic Disorder Emotional Disorder Injury Nuclear Magnetic Resonance Imaging Abnormal Mental Disorder Coordination Abnormal Report Source Other Product Lariam Claritin-D (Loratadine/Pseudoep hedrine Sulfate) Biaxin (Clarithromycin) Role PS Manufacturer Hoffmann La Roche Inc Age:14 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
C C
Date:07/17/01ISR Number: 3760015-3Report Type:Direct Outcome Disability Other Serious PT Hypophagia Lethargy Anxiety Hallucination Fear
Gender:Female Dose 1 PILL/ 4 DAYS/ ORAL
I/FU:I Duration
Date:07/17/01ISR Number: 3760208-5Report Type:Expedited (15-DaCompany Report #263895 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Rhabdomyolysis Report Source Foreign Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Page: 368
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/01ISR Number: 3760951-8Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Amnesia Abnormal Dreams Sleep Disorder Hallucinations, Mixed Chills Depression Anxiety Headache Disturbance In Attention Paraesthesia Gastrointestinal Disorder Confusional State Balance Disorder Dizziness Memory Impairment Company Report # Report Source Product Lariam (250 Mg) (Mefloquine Hcl) (Hoffmann-Laroche Inc.) Role Manufacturer Age:30 YR Route Gender:Female Dose I/FU:I Duration
PS
Hoffman-Laroche Inc
ORAL
1 250 MG TABLET TAKEN OARLLY
Date:07/19/01ISR Number: 3761240-8Report Type:Expedited (15-DaCompany Report #264097 Outcome Other Serious PT Retinal Pigmentation Angiogram Abnormal Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age:19 YR Route
Gender:Male Dose
Date:07/19/01ISR Number: 3764530-8Report Type:Periodic Outcome Other Serious PT Suicide Attempt Apathy Paranoia Intentional Overdose
Company Report #1409764A Report Source Foreign Other Product Tylenol Pseudoephedrine Lariam (Meloquine) 250 Mg Role PS SS SS ORAL Manufacturer Mcneil Consumer Products Co Div Mcneilab Inc
Age:18 YR Route
Gender:Male Dose UNKNOWN DOSE UNKNOWN DOSE, PO
I/FU:I Duration
Date:07/23/01ISR Number: 3762418-XReport Type:Direct Outcome Other Serious PT Depression Paraesthesia Syncope Dizziness Insomnia Anxiety Muscle Spasms Paranoia
Company Report # Report Source Product Larium/Mefloquine 250 Mg Roche Orthocept Role PS C Manufacturer Roche
Age: Route ORAL
Gender:Female Dose 250 MG ONCE A WEEK ORAL
I/FU:I Duration
Date:07/23/01ISR Number: 3763556-8Report Type:Expedited (15-DaCompany Report #264097 Outcome Other Serious 03-Apr-2012 09:37 AM PT Eye Disorder Report Source Foreign Health
Age:19 YR
Gender:Male
I/FU:I
Page: 369
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Route ORAL Dose ORAL Duration
Date:07/23/01ISR Number: 3763734-8Report Type:Expedited (15-DaCompany Report #256731 Outcome Death PT Drug Interaction Malaria Circulatory Collapse Bronchopneumonia Electrocardiogram Qt Prolonged Sudden Death Arrhythmia Hypertrophic Cardiomyopathy Report Source Literature Health Professional Product Lariam Halofantrine (Halofantrine Hydrochloride) Dirithromycin (Dirithromycin) Acetylcysteine Role PS Manufacturer Hoffmann La Roche Inc
Gender:Male Dose ORAL ORAL ORAL
I/FU:I Duration
SS C C
Date:07/23/01ISR Number: 3764087-1Report Type:Expedited (15-DaCompany Report #249748 Outcome Hospitalization Initial or Prolonged PT Confusional State Acute Psychosis Hypertonia Report Source Foreign Literature Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age:55 YR Route
Gender:Male Dose
I/FU:F Duration
Date:07/24/01ISR Number: 3763645-8Report Type:Expedited (15-DaCompany Report #260795 Outcome Other Serious PT Extrasystoles Transient Ischaemic Attack Atrial Fibrillation Report Source Health Professional Product Lariam Aspirin Mvi Role PS C C Manufacturer Roche
Age:65 YR Route
Gender:Male Dose
Date:07/24/01ISR Number: 3763650-1Report Type:Expedited (15-DaCompany Report #263895 Outcome Hospitalization Initial or Prolonged PT Rhabdomyolysis Headache Dizziness Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Age:28 YR Route
Gender:Male Dose
Date:07/24/01ISR Number: 3763651-3Report Type:Expedited (15-DaCompany Report #263420 Outcome Disability PT Fatigue Confusional State Amnesia Depression 09:37 AM Report Source Health Professional Product Lariam Edecrin Naprosyn Asa Role PS C C C Manufacturer Roche
Age:66 YR Route
Gender:Male Dose
03-Apr-2012
Page: 370
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/01ISR Number: 3764221-3Report Type:Expedited (15-DaCompany Report #264611 Outcome Hospitalization Initial or Prolonged PT Insomnia Confusional State Automatism Hypochondriasis Agitation Persecutory Delusion Anxiety Aggression Amnesia Report Source Health Professional Product Lariam Role PS Manufacturer Roche Age:23 YR Route Gender:Male Dose A TOTAL OF THREE DOSES WERE RECEIVED. I/FU:I Duration
DAY
Date:07/25/01ISR Number: 3764225-0Report Type:Expedited (15-DaCompany Report #264612 Outcome Other Serious PT Insomnia Anxiety Depression Suicidal Ideation Obsessive-Compulsive Disorder Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age:45 YR Route
Gender:Male Dose MEFLOQUINE WAS GIVEN DURING A PREVIOUS TRIP ABOUT SIX
I/FU:I Duration
Date:07/25/01ISR Number: 3765689-9Report Type:Expedited (15-DaCompany Report #264219 Outcome Death Hospitalization Initial or Prolonged PT International Normalised Ratio Increased Pupils Unequal Haemorrhagic Stroke Hypothermia Bradycardia Precerebral Artery Occlusion Corneal Reflex Decreased Arteriosclerosis Hypotension Hyporeflexia Brain Oedema Brain Scan Abnormal Tachycardia Drug Interaction Respiratory Arrest Report Source Foreign Other Product Lariam Warfarin Sodium (Warfarin Sodium) 5 Mg Cozaar (Losartan Potassium) Role PS Manufacturer Hoffmann La Roche Inc
Age:72 YR Route
Gender:Female Dose 1 PER WEEK 4 MG 1 PER 2 DAY
I/FU:I Duration
SS C
Age:35 YR Route
Gender:Male Dose
I/FU:I Duration
Hospitalization Initial or Prolonged Disability
Thyroiditis Arthralgia Psoriasis Drug Interaction
Lariam
PS
ORAL ORAL ORAL
Lexomil Effexor 03-Apr-2012 09:37 AM
SS SS
1 DOSE FORM 1 PER ONE DOSE ORAL 2 PER DAY ORAL 2 DOSE FORM DAILY ORAL Page: 371
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Teralithe Seropram Havlane Plaquenil SS SS C C ORAL ORAL 400 MG 3 PER DAY ORAL 2 DOSE FORM DAILY ORAL
Date:07/26/01ISR Number: 3765431-1Report Type:Expedited (15-DaCompany Report #256317 Outcome Disability PT Sleep Disorder Mood Swings Diarrhoea Mental Impairment Myalgia Nightmare Anxiety Fatigue Depression Weight Decreased Alopecia Report Source Product Lariam Tablets Unknown Medication Role PS C Manufacturer Roche
Age:54 YR Route
Doxycycline
Date:07/26/01ISR Number: 3765442-6Report Type:Expedited (15-DaCompany Report #264404 Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Paranoia Flushing Delusion Confusional State Report Source Product Lariam Proguanil Chloroquine Role PS C C Manufacturer Roche
Age:22 YR Route
Gender:Female Dose
Date:07/26/01ISR Number: 3766229-0Report Type:Expedited (15-DaCompany Report #263420 Outcome Disability PT Depression Confusional State Amnesia Fatigue Report Source Consumer Product Lariam Edecrin (Ethacrynate Sodium Or Ethacrynic Acid) Asa (Aspirin) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:F Duration
C C
Age:65 YR Route
Gender:Male Dose
I/FU:F Duration
Other Serious
Atrial Fibrillation Heart Rate Irregular Transient Ischaemic Attack Extrasystoles Speech Disorder
Health Professional
Lariam Aspirin Mvi (Multivitamin Nos)
PS C C
ORAL
250 MG, 1 PER DOSE; ORAL
03-Apr-2012
09:37 AM
Page: 372
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/01ISR Number: 3766523-3Report Type:Expedited (15-DaCompany Report #263895 Outcome Hospitalization Initial or Prolonged PT Hypoaesthesia Chest Pain Dizziness Rhabdomyolysis Dyspnoea Headache Report Source Foreign Consumer Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc Age:28 YR Route ORAL Gender:Male Dose I/FU:F Duration
Date:07/27/01ISR Number: 3767003-1Report Type:Expedited (15-DaCompany Report #264611 Outcome Hospitalization Initial or Prolonged PT Confusional State Persecutory Delusion Automatism Amnesia Agitation Aggression Hypochondriasis Insomnia Anxiety Drug Level Above Therapeutic Pyrexia Report Source Foreign Literature Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Date:07/27/01ISR Number: 3767008-0Report Type:Expedited (15-DaCompany Report #264612 Outcome Other Serious PT Anxiety Suicidal Ideation Insomnia Obsessive-Compulsive Disorder Feeling Abnormal Depression Report Source Foreign Literature Health Professional Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:07/30/01ISR Number: 3766773-6Report Type:Expedited (15-DaCompany Report #264705 Outcome Other Serious PT Bipolar Disorder Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age:50 YR Route
Gender:Male Dose THE PATIENT TOOK A TOTAL OF 1750MG.
I/FU:I Duration
Date:07/30/01ISR Number: 3766776-1Report Type:Expedited (15-DaCompany Report #203837 Outcome Death Hospitalization Initial or Prolonged PT Delirium Agitation Depression Nervous System Disorder Abnormal Dreams
Age:53 YR
Gender:Male
I/FU:F
03-Apr-2012
09:37 AM
Page: 373
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polydipsia Photopsia Delusional Disorder, Persecutory Type Hepatic Steatosis Erectile Dysfunction Weight Decreased Cognitive Disorder Chills Musculoskeletal Stiffness Erythema Blood Lactate Dehydrogenase Increased Blood Cortisol Increased Claustrophobia Obsessive-Compulsive Disorder Hallucinations, Mixed Hyperhidrosis Amnesia Anxiety Liver Function Test Abnormal Pyrexia Completed Suicide Flushing Urinary Hesitation Insomnia Headache Adjustment Disorder Fatigue Decreased Appetite Petit Mal Epilepsy
Report Source
Role PS
Manufacturer Roche
Route
Dose Duration THE PATIENT RECEIVED A TOTAL OF NINE TABLETS OF LARIAM. 67 DAY
Date:07/30/01ISR Number: 3766777-3Report Type:Expedited (15-DaCompany Report #264819 Outcome Hospitalization Initial or Prolonged PT Malaria Drug Ineffective Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
Date:07/30/01ISR Number: 3768298-0Report Type:Expedited (15-DaCompany Report #256317 Outcome Disability PT Irritability Memory Impairment Diarrhoea Nightmare Alopecia Personality Disorder
Age:54 YR
Gender:Male
I/FU:F
Weight Decreased Tension Mood Swings Obsessive-Compulsive Disorder Sleep Disorder Mental Impairment Muscular Weakness 03-Apr-2012 09:37 AM Page: 374
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Anxiety Stress Disturbance In Attention Myalgia Malaise Fatigue Depression Judgement Impaired
Report Source Other
Product Lariam Unknown Medication (Generic Component(S) Unknown) Doxycycline (Doxycycline)
Role PS
Route
Dose
Duration
C C
Date:07/30/01ISR Number: 3769075-7Report Type:Expedited (15-DaCompany Report #264404 Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Flushing Paranoia Delusion Confusional State Report Source Foreign Health Professional Product Lariam Proguanil (Chloroguanide Hydrochloride) Chloroquine Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
C C
Date:08/01/01ISR Number: 3769118-0Report Type:Expedited (15-DaCompany Report #203837 Outcome Death Hospitalization Initial or Prolonged PT Insomnia Blood Lactate Dehydrogenase Increased Arterial Injury Erythema Obsessive-Compulsive Disorder Cognitive Disorder Weight Decreased Adjustment Disorder Anxiety Petit Mal Epilepsy Nervous System Disorder Headache Chills Hepatic Fibrosis Spinal Cord Injury Cervical Subarachnoid Haemorrhage Hepatic Function Abnormal Fatigue Polydipsia Flushing Urinary Hesitation
Age:53 YR
Gender:Male
I/FU:F
Agitation Claustrophobia Delusional Disorder, Persecutory Type Hepatic Necrosis Completed Suicide Delirium Hallucinations, Mixed 03-Apr-2012 09:37 AM Page: 375
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatitis Hepatic Steatosis Erectile Dysfunction Decreased Appetite Blood Cortisol Increased Injury Cardiomegaly Amnesia Hyperhidrosis Abnormal Dreams Depression Respiratory Disorder Spinal Fracture Laceration Musculoskeletal Stiffness Pyrexia Photopsia
Product Lariam
Role PS
Route ORAL
Duration
Date:08/01/01ISR Number: 3769201-XReport Type:Expedited (15-DaCompany Report #264705 Outcome Other Serious PT Suicidal Ideation Delusion Bipolar Disorder Electrocardiogram Qt Prolonged Report Source Foreign Literature Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age:50 YR Route
Gender:Male Dose 250 MG
I/FU:I Duration
Date:08/01/01ISR Number: 3769641-9Report Type:Expedited (15-DaCompany Report #264819 Outcome Hospitalization Initial or Prolonged PT Vomiting Weight Decreased Hyperhidrosis Malaise Spinal Fracture Fatigue Malaria Drug Ineffective Report Source Foreign Consumer Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:I Duration
Date:08/02/01ISR Number: 3769264-1Report Type:Expedited (15-DaCompany Report #265424 Outcome Life-Threatening PT Leukopenia Report Source Product Lariam Role PS Manufacturer Roche
Age:32 YR Route
Gender:Female Dose
Age:62 YR
Gender:Male
I/FU:I
PT Grand Mal Convulsion Dizziness Tinnitus Cardiac Arrest
Product Lariam Malarone
Role PS SS
Manufacturer Roche
Route
Dose
Duration 4 DAY
03-Apr-2012
09:37 AM
Page: 376
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/01ISR Number: 3770939-9Report Type:Expedited (15-DaCompany Report #265419 Outcome Disability PT Abnormal Behaviour Emotional Disorder Irritability Hallucination Report Source Product Lariam Role PS Manufacturer Roche Age:38 YR Route Gender:Female Dose I/FU:I Duration 411 DAY
Date:08/07/01ISR Number: 3771367-2Report Type:Expedited (15-DaCompany Report #265329 Outcome Disability PT Illusion Dysarthria Hallucination Panic Attack Disturbance In Attention Report Source Product Lariam Role PS Manufacturer Roche
Age:42 YR Route
Gender:Male Dose
I/FU:I Duration
Date:08/07/01ISR Number: 3771784-0Report Type:Expedited (15-DaCompany Report #265284 Outcome Other Serious PT Grand Mal Convulsion Dizziness Tinnitus Cardiac Arrest Report Source Health Professional Other Product Lariam Malarone (Atovaquone/Chlorogu anide Hydrochloride) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
SS
Date:08/07/01ISR Number: 3771899-7Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Personality Change Abnormal Behaviour Confusional State Insomnia Feeling Abnormal Disorientation
Company Report # Report Source Product Lariam (Mefloquine) 250mg Role PS Manufacturer
Gender:Male Dose 250 MG PO + TAB QID
I/FU:I Duration
Date:08/07/01ISR Number: 3772128-0Report Type:Expedited (15-DaCompany Report #265424 Outcome Life-Threatening PT Dyspnoea Pneumococcal Infection Leukopenia Pneumothorax Cough Blood Culture Positive Report Source Foreign Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Pneumonia
03-Apr-2012
09:37 AM
Page: 377
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/01ISR Number: 3771798-0Report Type:Expedited (15-DaCompany Report #252574 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Mental Disorder Agitation Pyrexia Hyperventilation Coma Respiratory Failure Convulsion Influenza Like Illness Report Source Health Professional Product Lariam Tablets Role PS Manufacturer Roche Age:21 YR Route Gender:Female Dose 4 TABLETS TAKEN IN TOTAL. I/FU:F Duration 21 DAY
Date:08/08/01ISR Number: 3772873-7Report Type:Expedited (15-DaCompany Report #265419 Outcome Disability PT Hallucination Irritability Abnormal Behaviour Emotional Disorder Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:08/09/01ISR Number: 3773720-XReport Type:Direct Outcome Disability PT Neuropathy Peripheral Convulsion Visual Acuity Reduced Insomnia Disorientation Tremor Vertigo Fatigue Balance Disorder Headache
Company Report # Report Source Product Mefloquin Role PS Manufacturer
Age:32 YR Route
Gender:Male Dose 1 DAY
I/FU:I Duration
Date:08/09/01ISR Number: 3775106-0Report Type:Expedited (15-DaCompany Report #252574 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Malaise Depressed Level Of Consciousness Autonomic Nervous System Imbalance Fear Muscle Spasms Hyperventilation Agitation Respiratory Arrest
Age:21 YR
Gender:Female
I/FU:F
Anxiety Dyspnoea Nausea Respiratory Disorder Convulsion Pyrexia Blood Ph Increased Depression 03-Apr-2012 09:37 AM Page: 378
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pco2 Increased Mental Disorder Cyanosis Respiratory Failure Fatigue Apnoea Coma Loss Of Consciousness Stress Influenza Like Illness Restlessness Arthralgia
Product Lariam
Role PS
Route ORAL
Duration
Date:08/13/01ISR Number: 3774908-4Report Type:Expedited (15-DaCompany Report #64270 Outcome Disability PT Tremor Anxiety Circulatory Collapse Chronic Fatigue Syndrome Hyperhidrosis Bradycardia Muscle Spasms Dizziness Headache Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
Date:08/13/01ISR Number: 3774917-5Report Type:Expedited (15-DaCompany Report #264404 Outcome Hospitalization Initial or Prolonged PT Paranoia Psychotic Disorder Flushing Confusional State Delusion Report Source Product Lariam Proguanil Chloroquine Role PS C C Manufacturer Roche
Age:22 YR Route
Gender:Female Dose
I/FU:F Duration 2 DAY 1 DAY 1 DAY
Date:08/15/01ISR Number: 3778531-7Report Type:Expedited (15-DaCompany Report #64270 Outcome Disability PT Chronic Fatigue Syndrome Dizziness Anxiety Headache Bradycardia Hyperhidrosis Tremor Muscle Spasms Circulatory Collapse Report Source Foreign Literature Other Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
Age: Route ORAL
I/FU:F Duration
Date:08/15/01ISR Number: 3778546-9Report Type:Expedited (15-DaCompany Report #264404 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Psychotic Disorder Delusion
Age:22 YR
Gender:Female
I/FU:F
Page: 379
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Paranoia Confusional State Flushing
Product Lariam Proguanil (Chloroguanide Hydrochloride) Chloroquine (Chloroquine)
Role PS
Route ORAL
Dose 250 MG ORAL
Duration
C C
Date:08/17/01ISR Number: 3778887-5Report Type:Expedited (15-DaCompany Report #265854 Outcome Life-Threatening PT Bronchospasm Report Source Product Lariam Role PS Manufacturer Roche
Age:17 YR Route
Gender:Female Dose
Date:08/17/01ISR Number: 3779696-3Report Type:Direct Outcome Other Serious PT Nightmare Insomnia Nausea
Company Report # Report Source Product Larium 25o Mg Roche Typhoid Vi Ipol Role PS C C Manufacturer Roche
Gender:Female Dose PO
I/FU:I Duration
Date:08/21/01ISR Number: 3781466-7Report Type:Expedited (15-DaCompany Report #265854 Outcome Life-Threatening PT Bronchospasm Report Source Foreign Health Professional Product Lariam Role PS Manufacturer Hoffmann La Roche Inc
I/FU:I Duration
Date:08/21/01ISR Number: 3781711-8Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Insomnia Depression Abnormal Dreams Psychomotor Hyperactivity Nervousness Nausea Panic Attack Anxiety Dizziness Flatulence Cold Sweat
Company Report # Report Source Product Lariam / 250 / La Roche/Hoffman Role PS Manufacturer La Roche/Hoffman
Age:24 YR Route SUBLINGUAL
Gender:Male Dose 1 TABLE / ONCE A WEEK / SUBLINGUAL
I/FU:I Duration
Date:08/23/01ISR Number: 3782314-1Report Type:Direct Outcome Life-Threatening Required Intervention to 03-Apr-2012 09:37 AM
Company Report #
Age:18 YR
Gender:Male
I/FU:I
Page: 380
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Ecchymosis Grand Mal Convulsion Fall Report Source Product Lariam Role PS Manufacturer Route Dose Duration 1 TAB 250MG EACH WK FOR 156 WKS PATIENT TOOK 1 DOSE ON
Date:08/23/01ISR Number: 3782498-5Report Type:Direct Outcome Other Serious PT Hallucination Paranoia Depression
Gender:Female Dose ONCE WEEK ORAL
I/FU:I Duration
Date:08/28/01ISR Number: 3783549-4Report Type:Expedited (15-DaCompany Report #266589 Outcome Hospitalization Initial or Prolonged PT Feeling Jittery Paraesthesia Panic Attack Toxicity To Various Agents Anxiety Palpitations Confusional State Report Source Product Lariam Alcohol Role PS C Manufacturer Roche
Age:30 YR Route
Gender:Male Dose
Date:08/28/01ISR Number: 3783984-4Report Type:Direct Outcome PT Panic Attack Abnormal Dreams Palpitations Muscle Spasms Abdominal Pain Fatigue Insomnia Convulsion
Company Report # Report Source Product Larium 228.0 Mg Of Free Base/ Roche Role PS Manufacturer Roche
Gender:Male Dose 1 TABLE/ PER WEEK/ ORAL
I/FU:I Duration
Date:08/30/01ISR Number: 3785111-6Report Type:Expedited (15-DaCompany Report #264819 Outcome Hospitalization Initial or Prolonged PT Drug Ineffective Malaria Report Source Product Lariam Role PS Manufacturer Roche
Age:31 YR Route
Gender:Female Dose
Company Report #
Age:
Gender:Male
I/FU:I
Page: 381
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Anxiety Panic Attack Dizziness Fatigue Paraesthesia Vision Blurred Movement Disorder Eye Pain Abnormal Dreams Dyspnoea Report Source Product Mefloquine / Larium Role PS Manufacturer Route Dose ONE PILL WEEKLY Duration
Date:08/30/01ISR Number: 3786101-XReport Type:Expedited (15-DaCompany Report #266589 Outcome Hospitalization Initial or Prolonged PT Palpitations Anxiety Toxicity To Various Agents Feeling Jittery Paraesthesia Confusional State Panic Attack Report Source Consumer Product Lariam (Mefloquine Hydrochloride) 250 Mg Alcohol (Alcohol) Role PS C Manufacturer
I/FU:I Duration
Date:09/03/01ISR Number: 3787527-0Report Type:Expedited (15-DaCompany Report #264819 Outcome Hospitalization Initial or Prolonged PT Hyperhidrosis Meningitis Viral Back Injury Spinal Fracture Weight Decreased Malaria Drug Ineffective Report Source Foreign Consumer Health Professional Product Lariam (Mefloquine Hydrochloride ) 250 Mg Role PS Manufacturer
I/FU:F Duration
Date:09/04/01ISR Number: 3786713-3Report Type:Expedited (15-DaCompany Report #267025 Outcome Disability PT Dementia Report Source Product Lariam Chloroquine Role PS C Manufacturer Roche
Age:55 YR Route
Gender:Female Dose
Company Report #
Age:28 YR
Gender:Female
I/FU:I
Outcome Disability
PT Nightmare Vertigo Mental Disorder
Report Source
Product Lariam Claritin
Role PS C
Manufacturer
Route ORAL
Dose Duration 1PILL WEEKLY ORAL
03-Apr-2012
09:37 AM
Page: 382
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/01ISR Number: 3788705-7Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Headache Affective Disorder Psychotic Disorder Disturbance In Attention Insomnia Anxiety Hyperhidrosis Pyrexia Hallucination Neurotoxicity Diarrhoea Panic Attack Dizziness Tinnitus Company Report # Report Source Product Lariam 250 Mg (Mefloquine Hcl) (Roche Laboratories) Halofentrine Role PS C Manufacturer Roche Laboratories Age:26 YR Route Gender:Male Dose 250 MG 1 X WEEK I/FU:I Duration
Date:09/06/01ISR Number: 3789407-3Report Type:Expedited (15-DaCompany Report #267025 Outcome Disability PT Cerebral Atrophy Report Source Foreign Health Professional Product Lariam Chloroquine (Chloroquine) Role PS C Manufacturer
Age:55 YR Route
Gender:Female Dose
I/FU:I Duration
Date:09/10/01ISR Number: 3789468-1Report Type:Expedited (15-DaCompany Report #203837 Outcome Death Hospitalization Initial or Prolonged PT Hyperhidrosis Hepatic Steatosis Abnormal Dreams Amnesia Photopsia Blood Cortisol Increased Nervous System Disorder Urinary Hesitation Agitation Weight Decreased Adjustment Disorder Erythema Delusional Disorder, Persecutory Type Flushing Insomnia Petit Mal Epilepsy Completed Suicide Polydipsia Delirium Fatigue
Age:53 YR
Gender:Male
I/FU:F
Musculoskeletal Stiffness Blood Lactate Dehydrogenase Increased Obsessive-Compulsive Disorder Depression Headache Anxiety 03-Apr-2012 09:37 AM Page: 383
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Appetite Liver Function Test Abnormal Pyrexia Chills Hallucinations, Mixed Cognitive Disorder Erectile Dysfunction Claustrophobia
Report Source
Role PS
Manufacturer Roche
Route
Date:09/10/01ISR Number: 3789481-4Report Type:Expedited (15-DaCompany Report #265469 Outcome Disability PT Loss Of Libido Sensory Loss Anorgasmia Report Source Product Lariam Mirtazapine Prempak-C Role PS C C Manufacturer Roche
Age:48 YR Route
Gender:Female Dose DOSE DESCRIBED AS 0.125 ONCE PER DAY. NO UNITS OF
Fluoxetine
1462 DAY
Date:09/13/01ISR Number: 3792786-4Report Type:Expedited (15-DaCompany Report #265469 Outcome Disability PT Sexual Dysfunction Loss Of Libido Sensory Loss Anorgasmia Local Swelling Report Source Foreign Health Professional Product Lariam (Melfloquine Hydrochloride) Mirtazapine Prempak-C (Estrogens, Conjugated/Norgestre l) Fluoxetine Role PS C Manufacturer
I/FU:I Duration
C C
Date:09/13/01ISR Number: 3793046-8Report Type:Expedited (15-DaCompany Report #203837 Outcome Death Hospitalization Initial or Prolonged PT Adjustment Disorder Polydipsia Anxiety Delirium Musculoskeletal Stiffness Delusional Disorder, Persecutory Type Decreased Appetite Abnormal Dreams Dermatitis
Age:53 YR
Gender:Male
I/FU:F
Amnesia Hyperkeratosis Blood Cortisol Increased Petit Mal Epilepsy Weight Decreased Hallucinations, Mixed Hepatic Necrosis Erectile Dysfunction 03-Apr-2012 09:37 AM Page: 384
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Agitation Fatigue Flushing Liver Disorder Urinary Hesitation Hepatic Function Abnormal Headache Insomnia Hyperhidrosis Depression Injury Claustrophobia Arteriosclerosis Pyrexia Hepatic Steatosis Photopsia Neoplasm Obsessive-Compulsive Disorder Cognitive Disorder Cardiomegaly Chills Completed Suicide Inflammation Nervous System Disorder Rash Erythematous
Product Lariam Tablets (Melfloquine Hydrochloride) 250 Mg
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
Date:09/17/01ISR Number: 3793857-9Report Type:Direct Outcome Other Serious PT Abnormal Dreams Panic Attack Anxiety Paraesthesia Paranoia Suicidal Ideation Depression Heart Rate Increased Hallucination Hypoaesthesia
Company Report # Report Source Product Lariam 250 Mg Hoffman-Laroche Sudafed Role PS C Manufacturer Hoffman-Laroche
Gender:Female Dose 1 250 WEEK ORAL
I/FU:I Duration
Date:09/17/01ISR Number: 3793869-5Report Type:Direct Outcome Other Serious PT Hyperhidrosis Tremor Respiratory Disorder Tachycardia Panic Attack
Company Report # Report Source Product Larium Role PS Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration 250 MG/ 1X/WEEK/ ORAL
Date:09/21/01ISR Number: 3796268-5Report Type:Expedited (15-DaCompany Report #252449 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Ventricular Septal Defect Congenital Pneumonia Report Source Product Lariam Tablets Typhoral Role PS C Manufacturer Roche
Age: Route
Gender:Female Dose
I/FU:F Duration 60 DAY Page: 385
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Yellow Fever Vaccine C 1 DAY
Date:09/24/01ISR Number: 3797262-0Report Type:Expedited (15-DaCompany Report #267335 Outcome Hospitalization Initial or Prolonged PT Tremor Hallucination Sleep Disorder Confusional State Anxiety Report Source Product Lariam Role PS Manufacturer Roche
Age:59 YR Route
Gender:Male Dose
Date:09/24/01ISR Number: 3797270-XReport Type:Expedited (15-DaCompany Report #268058 Outcome Hospitalization Initial or Prolonged PT Brain Oedema Depression Headache Pyrexia Influenza Like Illness Liver Function Test Abnormal Report Source Product Lariam Aspirin Soluble Role PS C Manufacturer Roche
Age:32 YR Route
Gender:Male Dose
I/FU:I Duration
Date:09/24/01ISR Number: 3797282-6Report Type:Expedited (15-DaCompany Report #268319 Outcome Other Serious PT Brain Neoplasm Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:09/24/01ISR Number: 3797771-4Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability PT Throat Tightness Respiratory Rate Increased Panic Attack Ear Pain Emotional Disorder Paraesthesia Insomnia Heart Rate Increased Vertigo Dyspnoea Hypoaesthesia Tremor Burning Sensation Feeling Abnormal
Company Report # Report Source Product Lariam Role PS Manufacturer Roche Pharmaceuticals
Age: Route ORAL
Gender:Male Dose ONE PILL/ PER WEEK/ ORAL
I/FU:I Duration
Anxiety Palpitations
03-Apr-2012
09:37 AM
Page: 386
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3797740-4Report Type:Expedited (15-DaCompany Report #259147 Outcome Other Serious PT Polymyalgia Rheumatica Erythema Infectiosum Dengue Fever Nausea Report Source Product Lariam Role PS Manufacturer Roche Age: Route Gender:Female Dose I/FU:F Duration
Date:09/25/01ISR Number: 3797747-7Report Type:Expedited (15-DaCompany Report #268381 Outcome Other Serious PT Thrombocytopenia Haematoma Report Source Product Lariam Role PS Manufacturer Roche
Age:62 YR Route
Gender:Male Dose
I/FU:I Duration
Date:09/26/01ISR Number: 3798430-4Report Type:Expedited (15-DaCompany Report #265854 Outcome Life-Threatening PT Bronchospasm Report Source Product Lariam Role PS Manufacturer Roche
Age:17 YR Route
Gender:Female Dose
Date:09/26/01ISR Number: 3799276-3Report Type:Direct Outcome Disability PT Syncope Gastrooesophageal Reflux Disease Abdominal Distension Heart Rate Increased Discomfort Dizziness Myalgia Fatigue Anxiety Muscle Spasms Headache
Gender:Male Dose WEEKLY ORAL
I/FU:I Duration
Date:09/27/01ISR Number: 3799042-9Report Type:Expedited (15-DaCompany Report #267025 Outcome Disability PT Dementia Report Source Product Lariam Chloroquine Role PS C Manufacturer Roche
Age:55 YR Route
Gender:Female Dose
Age:
Gender:Female
I/FU:I
PT Chlamydial Infection Pregnancy Cyanosis Ventricular Septal Defect Acquired Congenital Pneumonia Neonatal Respiratory Page: 387
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Distress Syndrome Maternal Drugs Affecting Foetus Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Typhoral (Typhoid Vaccines) Yellow Fever Vaccine (Yellow Feve Vaccine) Role PS C C Manufacturer Route ORAL Dose ORAL Duration
Date:09/28/01ISR Number: 3800344-8Report Type:Expedited (15-DaCompany Report #268717 Outcome Disability PT Asthenia Palpitations Dry Mouth Agitation Anxiety Tinnitus Report Source Product Lariam Role PS Manufacturer Roche
Age:53 YR Route
Gender:Female Dose
I/FU:I Duration
Date:09/28/01ISR Number: 3800349-7Report Type:Expedited (15-DaCompany Report #268666 Outcome Hospitalization Initial or Prolonged PT Blood Alkaline Phosphatase Increased Jaundice Aspartate Aminotransferase Increased Report Source Product Lariam Role PS Manufacturer Roche
Age:23 YR Route
Gender:Male Dose
I/FU:I Duration
Date:09/28/01ISR Number: 3802046-0Report Type:Direct Outcome Disability Other Serious PT Disturbance In Attention Pain Influenza Like Illness Insomnia Dizziness Headache Arthralgia
Company Report # Report Source Product Lariam 250 Mg Tablet Role PS Manufacturer
Gender:Female
I/FU:I
Age:2 YR
Gender:Male
I/FU:I
PT Blood Bilirubin Increased Aspartate Aminotransferase Increased
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route
Dose
Duration
03-Apr-2012
09:37 AM
Page: 388
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/01ISR Number: 3803270-3Report Type:Expedited (15-DaCompany Report #267335 Outcome Hospitalization Initial or Prolonged PT Anxiety Sleep Disorder Tremor Hallucination Confusional State Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Age:59 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:10/01/01ISR Number: 3803271-5Report Type:Expedited (15-DaCompany Report #268058 Outcome Hospitalization Initial or Prolonged PT Liver Function Test Abnormal Brain Oedema Influenza Like Illness Pyrexia Hepatocellular Injury Headache Depression Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Aspirin Soluble (Aspirin) Role PS C Manufacturer
I/FU:I Duration
Date:10/01/01ISR Number: 3804291-7Report Type:Expedited (15-DaCompany Report #268319 Outcome Other Serious PT Brain Neoplasm Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:10/02/01ISR Number: 3802203-3Report Type:Expedited (15-DaCompany Report #268857 Outcome Disability PT Diabetes Mellitus Inadequate Control Report Source Product Mefloquine Hydrochloride Insulin Role PS C Manufacturer Roche
Age:45 YR Route
Gender:Male Dose
Date:10/02/01ISR Number: 3802214-8Report Type:Expedited (15-DaCompany Report #268799 Outcome Hospitalization Initial or Prolonged PT Mania Faecal Incontinence Nightmare Insomnia Urinary Incontinence Paranoia Tachycardia Hallucination Report Source Product Lariam Role PS Manufacturer Roche
Age:41 YR Route
Gender:Female
I/FU:I
Dose Duration THE PATIENT WAS REPORTED TO HAVE TAKEN TWO DOSES. 8 DAY
Prozac
Date:10/02/01ISR Number: 3804021-9Report Type:Expedited (15-DaCompany Report #268381 Outcome Other Serious 03-Apr-2012 09:37 AM PT Haematoma Thrombocytopenia Report Source Foreign Health
Age:62 YR
Gender:Male
I/FU:I
Page: 389
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Route Dose Duration
Date:10/02/01ISR Number: 3804064-5Report Type:Expedited (15-DaCompany Report #259147 Outcome Other Serious PT Polymyalgia Rheumatica Asthenia Joint Effusion Arthralgia Decreased Appetite Dengue Fever Erythema Infectiosum Bone Pain Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:F Duration
Date:10/03/01ISR Number: 3803283-1Report Type:Expedited (15-DaCompany Report #268895 Outcome Other Serious PT Melaena Report Source Product Lariam Ziac Lipitor Role PS C C Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:10/03/01ISR Number: 3805396-7Report Type:Expedited (15-DaCompany Report #268622 Outcome Other Serious PT Blood Bilirubin Increased Aspartate Aminotransferase Increased Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:2 YR Route ORAL
I/FU:I Duration
Date:10/03/01ISR Number: 3805674-1Report Type:Expedited (15-DaCompany Report #265854 Outcome Life-Threatening PT Bronchospasm Choking Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:F Duration
Age:23 YR Route
Gender:Male Dose
I/FU:I Duration
Jaundice Blood Albumin Increased Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased
Lariam (Mefloquine Hydrochloride)
PS
ORAL
03-Apr-2012
09:37 AM
Page: 390
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/01ISR Number: 3804838-0Report Type:Expedited (15-DaCompany Report #268717 Outcome Disability PT Dry Mouth Anxiety Agitation Tinnitus Palpitations Asthenia Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age:53 YR Route ORAL Gender:Female Dose ORAL I/FU:I Duration
Date:10/04/01ISR Number: 3804840-9Report Type:Expedited (15-DaCompany Report #267025 Outcome Disability PT Cerebral Atrophy Cognitive Disorder Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Chloroquine (Chloroquine) Role PS C Manufacturer
Age:55 YR Route
Gender:Female Dose
I/FU:F Duration
Date:10/04/01ISR Number: 3805279-2Report Type:Expedited (15-DaCompany Report #268857 Outcome Disability PT Decreased Activity Hypoglycaemia Diabetes Mellitus Inadequate Control Report Source Foreign Health Professional Other Product Mefloquine Hydrochloride Insulin (Insulin) Role PS C Manufacturer
Gender:Male Dose 250 MG 1 PER DAY ORAL
I/FU:I Duration
Date:10/04/01ISR Number: 3805297-4Report Type:Expedited (15-DaCompany Report #268799 Outcome Hospitalization Initial or Prolonged PT Palpitations Hallucination Paranoia Faecal Incontinence Insomnia Urinary Incontinence Mania Tachycardia Nightmare Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Prozac (Fluoxetine Hydrochloride) Role PS C Manufacturer
I/FU:I Duration
Date:10/05/01ISR Number: 3806709-2Report Type:Expedited (15-DaCompany Report #268895 Outcome Other Serious PT Melaena Faeces Discoloured Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Ziac (Bisoprolol Fumarate/Hydrochloro thiazide) Lipitor (Atorvastatin Calcium)
C C
03-Apr-2012
09:37 AM
Page: 391
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/01ISR Number: 3806216-7Report Type:Direct Outcome Disability PT Fatigue Decreased Appetite Weight Decreased Tremor Vision Blurred Ill-Defined Disorder Disturbance In Attention Lethargy Frequent Bowel Movements Myalgia Company Report # Report Source Product Mefoquine 250mg La Roche Role PS Manufacturer La Roche Age:31 YR Route ORAL Gender:Male Dose 250MG WEEKLY ORAL I/FU:I Duration
Date:10/11/01ISR Number: 3806934-0Report Type:Expedited (15-DaCompany Report #203837 Outcome Death Hospitalization Initial or Prolonged PT Polydipsia Decreased Appetite Photopsia Claustrophobia Hyperhidrosis Abnormal Dreams Cognitive Disorder Agitation Completed Suicide Anxiety Petit Mal Epilepsy Erythema Fatigue Liver Function Test Abnormal Obsessive-Compulsive Disorder Weight Decreased Headache Urinary Hesitation Amnesia Insomnia Hallucinations, Mixed Depression Flushing Delirium Adjustment Disorder Delusional Disorder, Persecutory Type Hepatic Steatosis Nervous System Disorder Chills Musculoskeletal Stiffness Pyrexia Report Source Consumer Product Lariam Tablets Role PS Manufacturer Roche
Age:53 YR Route
Gender:Male
I/FU:F
Erectile Dysfunction Blood Lactate Dehydrogenase Increased Blood Cortisol Increased
03-Apr-2012
09:37 AM
Page: 392
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/01ISR Number: 3806935-2Report Type:Expedited (15-DaCompany Report #263895 Outcome Hospitalization Initial or Prolonged PT Dizziness Headache Rhabdomyolysis Report Source Health Professional Product Lariam Role PS Manufacturer Roche Age:28 YR Route Gender:Male Dose I/FU:F Duration 22 DAY
Date:10/12/01ISR Number: 3807758-0Report Type:Expedited (15-DaCompany Report #269202 Outcome Life-Threatening PT Haemorrhage Skin Necrosis Drug Interaction Report Source Product Lariam Metformin Hcl Marcumar Role PS C I Manufacturer Roche Roche
Age:63 YR Route
Gender:Male Dose
I/FU:I Duration
Date:10/15/01ISR Number: 3809502-XReport Type:Expedited (15-DaCompany Report #203837 Outcome Death Hospitalization Initial or Prolonged PT Chills Anxiety Petit Mal Epilepsy Weight Decreased Pyrexia Cardiomegaly Spinal Cord Injury Hepatic Necrosis Amnesia Fatigue Delirium Musculoskeletal Stiffness Hepatic Steatosis Delusional Disorder, Persecutory Type Liver Function Test Abnormal Spinal Cord Injury Cervical Blood Lactate Dehydrogenase Increased Blood Cortisol Increased Depression Laceration Arterial Injury Injury Hyperhidrosis Decreased Appetite Flushing Headache Dermatitis Erectile Dysfunction
Age:53 YR
Gender:Male
I/FU:F
Hyperkeratosis Abnormal Dreams Agitation Completed Suicide Urinary Hesitation Adjustment Disorder Insomnia Cyst 03-Apr-2012 09:37 AM Page: 393
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Subarachnoid Haemorrhage Claustrophobia Nervous System Disorder Spinal Fracture Arteriosclerosis Coronary Artery Polydipsia Obsessive-Compulsive Disorder Cognitive Disorder Hallucinations, Mixed Photopsia Erythema Hepatitis Brain Scan Abnormal
Role
Manufacturer
Route
Dose
Duration
PS
Hoffman-La Roche
ORAL
Date:10/15/01ISR Number: 3809714-5Report Type:Expedited (15-DaCompany Report #263895 Outcome Hospitalization Initial or Prolonged PT Iris Adhesions Headache Rhabdomyolysis Antibody Test Positive Chest Pain Dizziness Dyspnoea Astigmatism Muscle Atrophy Report Source Foreign Consumer Health Professional Product Lariam (Melfloquine Hydrochloride) Role PS Manufacturer
I/FU:F Duration
Date:10/16/01ISR Number: 3809077-5Report Type:Expedited (15-DaCompany Report #263420 Outcome Disability PT Fatigue Confusional State Depression Amnesia Report Source Product Lariam Edecrin Naprosyn Asa Role PS C C C Manufacturer Roche
Age:66 YR Route
Gender:Male Dose
Date:10/16/01ISR Number: 3809095-7Report Type:Expedited (15-DaCompany Report #269729 Outcome Other Serious PT Viith Nerve Paralysis Paraesthesia Report Source Product Lariam Role PS Manufacturer Roche
Age:29 YR Route
Gender:Female Dose
Age:63 YR
Gender:Male
I/FU:I
Outcome Life-Threatening
PT Ulcer Drug Interaction Skin Necrosis Haemorrhage Subcutaneous
Product Lariam (Mefloquine Hydrochloride) 250 Mg Marcumar (Phenprocoumon) 3 Mg
Role PS SS
Manufacturer
Route ORAL ORAL
Dose 250 MG 1 PER WEEK ORAL 1.5 MG DAILY ORAL
Duration
03-Apr-2012
09:37 AM
Page: 394
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metformin Hcl (Metformin Hydrochloride)
Date:10/17/01ISR Number: 3809774-1Report Type:Expedited (15-DaCompany Report #268895 Outcome Other Serious PT Gastric Haemorrhage Report Source Product Lariam Ziac Lipitor Role PS C C Manufacturer Roche
Age:60 YR Route
Gender:Male Dose
Date:10/18/01ISR Number: 3811130-7Report Type:Direct Outcome Other Serious PT Insomnia Nightmare
Company Report # Report Source Product Mephaquin (Mepha Ltd) Alsch-Basil, Switzerland Role PS Manufacturer Mepha Ltd
Age:35 YR Route
Gender:Female Dose ONE TABLET Q WEEK
I/FU:I Duration
Date:10/18/01ISR Number: 3811971-6Report Type:Expedited (15-DaCompany Report #263420 Outcome Disability PT Hypoxia Depression Confusional State Fatigue Amnesia Report Source Consumer Product Lariam (Mefloquine Hydrochloride) 250 Mg Edecrin (Ethacrynate Sodium Or Ethacrynic Acid) Naprosyn (Naproxen) Asa (Aspirin) Role PS Manufacturer
I/FU:F Duration
C C C
Date:10/18/01ISR Number: 3812046-2Report Type:Expedited (15-DaCompany Report #269729 Outcome Other Serious PT Eye Irritation Hypoaesthesia Paraesthesia Viith Nerve Paralysis Report Source Foreign Other Product Lariam Role PS Manufacturer
Gender:Female
I/FU:I
Age:60 YR Route
Gender:Male Dose
I/FU:F Duration
Other Serious
Melaena Haematemesis Gastrointestinal Haemorrhage
Consumer
Lariam (Mefloquine Hydrochloride) Ziac (Bisoprolol Fumarate/Hydrochloro thiazide) Lipitor (Atorvastatin Calcium)
PS C C
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 395
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/22/01ISR Number: 3813829-5Report Type:Expedited (15-DaCompany Report #253217 Outcome Hospitalization Initial or Prolonged PT Placental Insufficiency Placental Disorder Premature Labour Oligohydramnios Report Source Product Lariam Tablets Role PS Manufacturer Roche Age: Route Gender:Male I/FU:F
Ass-Ratiopharm Codein Gelsemium Cimicifuga Paracetamol Acc Brausetabletten Superpep
C C C C C C C
Dose Duration 3 DOSES TAKEN IN TOTAL ON 28 DEC 2000, 04 JAN 2001 AND 11 JAN 15 DAY 5 DAY 1 DAY 29 DAY 29 DAY 29 DAY 5 DAY 1 DAY
Date:10/22/01ISR Number: 3813843-XReport Type:Expedited (15-DaCompany Report #263895 Outcome Hospitalization Initial or Prolonged PT Headache Rhabdomyolysis Dizziness Report Source Product Lariam Role PS Manufacturer Roche
Age:28 YR Route
Gender:Male Dose
Date:10/22/01ISR Number: 3813867-2Report Type:Expedited (15-DaCompany Report #268622 Outcome Other Serious PT Blood Bilirubin Increased Aspartate Aminotransferase Increased Report Source Product Lariam Role PS Manufacturer Roche
Age:2 YR Route
Gender:Male Dose
I/FU:F Duration
Date:10/23/01ISR Number: 3811978-9Report Type:Expedited (15-DaCompany Report #237587 Outcome Other Serious PT Intra-Uterine Death Accidental Exposure Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
Date:10/24/01ISR Number: 3812634-3Report Type:Expedited (15-DaCompany Report #242880 Outcome Disability PT Panic Reaction Alopecia Anxiety Depression Neurological Symptom
Age:42 YR
Gender:Female
I/FU:F
Thinking Abnormal Demyelination Hemiparesis Vision Blurred Nausea Dysgraphia Optic Neuritis Memory Impairment 03-Apr-2012 09:37 AM Page: 396
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abdominal Pain Delusion Amnesia Diarrhoea Abdominal Distension Nightmare Dizziness
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route
Dose
Duration 15 DAY
Date:10/24/01ISR Number: 3813739-3Report Type:Expedited (15-DaCompany Report #268622 Outcome Other Serious PT Blood Bilirubin Increased Aspartate Aminotransferase Increased Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Age:2 YR Route ORAL
I/FU:F Duration
Date:10/24/01ISR Number: 3813743-5Report Type:Expedited (15-DaCompany Report #253217 Outcome Hospitalization Initial or Prolonged PT Placental Insufficiency Foetal Growth Restriction Placental Disorder Premature Labour Maternal Drugs Affecting Foetus Oligohydramnios Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Ass-Ratiopharm (Aspirin) Codein (Codeine) Gelsemium (Gelsemium) Cimicifuga (Cimicifuga) Paracetamol (Acetaminophen) Acc Brausetabletten (Acetylcysteine) Superpep (Dimenhydrinate) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
C C C C C C C
Date:10/24/01ISR Number: 3813776-9Report Type:Expedited (15-DaCompany Report #263895 Outcome Hospitalization Initial or Prolonged PT Iris Adhesions Rhabdomyolysis Paraesthesia Dyspnoea Chest Pain Dizziness Report Source Foreign Consumer Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:F Duration
Eye Injury Astigmatism Headache Pulmonary Embolism Pupillary Reflex Impaired
03-Apr-2012
09:37 AM
Page: 397
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/01ISR Number: 3815531-2Report Type:Expedited (15-DaCompany Report #237587 Outcome Other Serious PT Accidental Exposure Maternal Drugs Affecting Foetus Intra-Uterine Death Pregnancy Report Source Foreign Consumer Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age: Route ORAL Gender:Female Dose ORAL I/FU:F Duration
Date:10/26/01ISR Number: 3815722-0Report Type:Expedited (15-DaCompany Report #242880 Outcome Disability PT Nausea Toxicity To Various Agents Delusion Neuralgia Abdominal Pain Depression Amnesia Hypoaesthesia Thinking Abnormal Optic Neuritis Herpes Zoster Headache Hemiparesis Antinuclear Antibody Positive Panic Reaction Dizziness Paraesthesia Abdominal Distension Memory Impairment Demyelination Pain Alopecia Dysgraphia Vision Blurred Anxiety Diarrhoea Nightmare Report Source Health Professional Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:F Duration
Date:10/30/01ISR Number: 3816587-3Report Type:Expedited (15-DaCompany Report #257525 Outcome Hospitalization Initial or Prolonged PT Depressed Level Of Consciousness Aphasia Amnesia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:63 YR Route
Gender:Female
I/FU:F
Dose Duration ONLY ONE DOSE TAKEN. 1 DAY
Date:10/30/01ISR Number: 3816590-3Report Type:Expedited (15-DaCompany Report #253217 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Placental Disorder Premature Labour
Age:
Gender:Male
I/FU:F
Page: 398
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Placental Insufficiency Oligohydramnios Report Source Product Lariam Tablets Role PS Manufacturer Roche Route Dose Duration 3 DOSES TAKEN IN TOTAL ON 28 DEC 2000, 04 JAN 2001 AND 11 JAN 15 DAY 5 DAY 1 DAY 29 DAY 29 DAY 29 DAY 5 DAY 1 DAY
Ass-Ratiopharm Codein Gelsemium Cimicifuga Paracetamol Acc Brausetabletten Superpep
C C C C C C C
Date:10/30/01ISR Number: 3817332-8Report Type:Direct Outcome Other Serious PT Suicidal Ideation Depression
Age:34 YR Route
Gender:Male Dose 1 TABLE WEEKLY
I/FU:I Duration
Date:10/31/01ISR Number: 3817244-XReport Type:Expedited (15-DaCompany Report #256317 Outcome Disability PT Weight Decreased Diarrhoea Nightmare Fatigue Anxiety Myalgia Bipolar Disorder Depression Alopecia Mental Impairment Mood Swings Sleep Disorder Report Source Product Lariam Unknown Medication Role PS C Manufacturer Roche
Age:54 YR Route
Doxycycline
Date:11/01/01ISR Number: 3819874-8Report Type:Direct Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage PT Feeling Abnormal Palpitations Ventricular Extrasystoles Panic Attack Dissociation Hyperhidrosis
Company Report # Report Source Product Lariam 250 Mg Roche Role PS Manufacturer Roche
Gender:Male
I/FU:I
Dose Duration 1 TABLE WEEK ORAL
Dyspnoea Anxiety
03-Apr-2012
09:37 AM
Page: 399
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/01ISR Number: 3818568-2Report Type:Expedited (15-DaCompany Report #300688 Outcome Disability PT Coordination Abnormal Disturbance In Attention Dizziness Report Source Product Lariam Role PS Manufacturer Roche Age:20 YR Route Gender:Male Dose I/FU:I Duration
Date:11/02/01ISR Number: 3819609-9Report Type:Expedited (15-DaCompany Report #253217 Outcome Hospitalization Initial or Prolonged PT Placental Disorder Foetal Growth Restriction Maternal Drugs Affecting Foetus Oligohydramnios Premature Labour Calcinosis Placental Insufficiency Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Ass-Ratiopharm (Aspirin) Codein (Codeine) Gelsemium (Gelsemium) Cimicifuga (Cimicifuga) Paracetamol (Acetaminophen) Acc Brausetabletten (Acetylcysteine) Superpep (Dimenhydrinate) Role PS C C C C C C C Manufacturer
I/FU:F Duration
Date:11/02/01ISR Number: 3819610-5Report Type:Expedited (15-DaCompany Report #257525 Outcome Hospitalization Initial or Prolonged PT Aphasia Speech Disorder Depressed Level Of Consciousness Amnesia Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride)250 Mg Role PS Manufacturer
I/FU:I Duration
Date:11/02/01ISR Number: 3819850-5Report Type:Expedited (15-DaCompany Report #256317 Outcome Disability PT Disturbance In Attention Memory Impairment Cognitive Disorder Judgement Impaired Bipolar Disorder Mood Swings Alopecia
Age:54 YR
Gender:Male
I/FU:F
Depression Anxiety Diarrhoea Myalgia Fatigue Sleep Disorder Mental Impairment Muscular Weakness 03-Apr-2012 09:37 AM Page: 400
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Obsessive-Compulsive Disorder Nightmare
Report Source Other
Product Lariam (Mefloquine Hydrochloride) Doxycycline (Doxycycline)
Role PS C
Manufacturer
Route
Dose
Duration
Date:11/06/01ISR Number: 3820350-7Report Type:Direct Outcome Disability PT Nausea Fatigue Disturbance In Attention Dizziness Feeling Abnormal Pyrexia
Company Report # Report Source Product Lariam (Mefloquine) 250 Mg Tablets Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:11/08/01ISR Number: 3821839-7Report Type:Direct Outcome Other Serious PT Insomnia Psychotic Disorder Depression
Age:39 YR Route
Gender:Male Dose
I/FU:I Duration
Date:11/15/01ISR Number: 3824467-2Report Type:Expedited (15-DaCompany Report #263822 Outcome Life-Threatening PT Grand Mal Convulsion Movement Disorder Tinnitus Vision Blurred Cardiac Arrest Hearing Impaired Dizziness Report Source Product Lariam Role PS Manufacturer Roche
Age:62 YR Route
Gender:Male Dose
Date:11/19/01ISR Number: 3825625-3Report Type:Expedited (15-DaCompany Report #251768 Outcome Congenital Anomaly PT Limb Malformation Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:F Duration
Age:62 YR
Gender:Male
I/FU:F
PT Dizziness Pulse Absent Tinnitus Thinking Abnormal Headache Muscle Twitching Vision Blurred Page: 401
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Memory Impairment Cardiac Arrest Grand Mal Convulsion Deafness
Product Lariam (Mefloquine Hydrochloride) 250 Mg
Role PS
Manufacturer
Route ORAL
Duration
Date:11/21/01ISR Number: 3829085-8Report Type:Expedited (15-DaCompany Report #251768 Outcome Congenital Anomaly PT Pregnancy Maternal Drugs Affecting Foetus Limb Reduction Defect Abortion Induced Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:F Duration
Date:11/21/01ISR Number: 3829480-7Report Type:Direct Outcome Other Serious PT Coordination Abnormal Dizziness
Company Report # Report Source Product Lariam 250 Mg Role PS Manufacturer
Gender:Female Dose 1 ORAL
I/FU:I Duration
Date:11/26/01ISR Number: 3828569-6Report Type:Expedited (15-DaCompany Report #203837 Outcome Death Hospitalization Initial or Prolonged PT Abnormal Dreams Fatigue Delusional Disorder, Persecutory Type Insomnia Erythema Depression Hepatic Steatosis Weight Decreased Cognitive Disorder Polydipsia Amnesia Chills Petit Mal Epilepsy Hyperhidrosis Flushing Nervous System Disorder Decreased Appetite Claustrophobia Headache Adjustment Disorder
Age:53 YR
Gender:Male
I/FU:F
Anxiety Musculoskeletal Stiffness Liver Function Test Abnormal Erectile Dysfunction Completed Suicide Pyrexia Agitation 03-Apr-2012 09:37 AM Page: 402
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Lactate Dehydrogenase Increased Blood Cortisol Increased Obsessive-Compulsive Disorder Hallucinations, Mixed Urinary Hesitation Delirium Photopsia
Report Source
Role PS
Manufacturer Roche
Route
Cyproheptadine
Dose Duration THE PATIENT RECEIVED A TOTAL OF NINE TABLETS OF LARIAM. 67 DAY AT BEDTIME.
Date:11/26/01ISR Number: 3828570-2Report Type:Expedited (15-DaCompany Report #215428 Outcome Hospitalization Initial or Prolonged Disability PT Urinary Retention Panic Disorder Without Agoraphobia Nightmare Urinary Tract Infection Dehydration Anxiety Schizophrenia Agitation Insomnia Report Source Product Lariam Tablets Tamoxifen Fosamax Role PS C C Manufacturer Roche
Age:66 YR Route
Gender:Female Dose
Date:11/26/01ISR Number: 3828571-4Report Type:Expedited (15-DaCompany Report #86887 Outcome Disability PT Peripheral Sensory Neuropathy Ill-Defined Disorder Suicidal Ideation Myalgia Tinnitus Epistaxis Sleep Disorder Csf Protein Abnormal Flushing Pain Asthenia Malaise Convulsion Nervousness Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age:43 YR Route
Gender:Female Dose
Date:11/26/01ISR Number: 3828603-3Report Type:Expedited (15-DaCompany Report #301583 Outcome Hospitalization PT Nervous System Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age:37 YR Route
Gender:Male Dose 8 TABLETS
I/FU:I Duration
Gastrointestinal Disorder
TAKEN OVER 2 DAYS.
03-Apr-2012
09:37 AM
Page: 403
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/01ISR Number: 3828607-0Report Type:Expedited (15-DaCompany Report #302003 Outcome Other Serious PT Anxiety Paraesthesia Demyelination Asthenia Report Source Product Lariam Role PS Manufacturer Roche Age:43 YR Route Gender:Male Dose I/FU:I Duration 46 DAY
Date:11/28/01ISR Number: 3831370-0Report Type:Expedited (15-DaCompany Report #215428 Outcome Hospitalization Initial or Prolonged Disability PT Insomnia Panic Reaction Schizophrenia Agitation Anxiety Nightmare Urinary Retention Emotional Disorder Circadian Rhythm Sleep Disorder Oliguria Dehydration Report Source Consumer Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Tamoxifen (Tamoxifen Citrate) Fosamax (Alendronate Sodium) Role Manufacturer
Age:66 YR Route
Gender:Female Dose
I/FU:F Duration
PS C C
ORAL
Date:11/28/01ISR Number: 3831775-8Report Type:Expedited (15-DaCompany Report #203837 Outcome Death Hospitalization Initial or Prolonged PT Decreased Appetite Arterial Injury Erectile Dysfunction Insomnia Blood Lactate Dehydrogenase Increased Respiratory Disorder Hepatic Fibrosis Weight Decreased Hallucinations, Mixed Nervous System Disorder Subarachnoid Haemorrhage Photopsia Abnormal Dreams Obsessive-Compulsive Disorder Claustrophobia Ventricular Hypertrophy Musculoskeletal Stiffness Delusional Disorder, Persecutory Type Chills
Age:53 YR
Gender:Male
I/FU:F
Completed Suicide Blood Cortisol Increased Depression Arteriosclerosis Hepatic Function Abnormal Amnesia Anxiety Delirium 03-Apr-2012 09:37 AM Page: 404
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Hepatic Steatosis Headache Hyperhidrosis Agitation Flushing Petit Mal Epilepsy Urinary Hesitation Rash Erythematous Fatigue Polydipsia Injury Erythema Cognitive Disorder Spinal Fracture Adjustment Disorder
Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Cyproheptadine (Cyproheptadine Hydrochloride)
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
Date:11/28/01ISR Number: 3831847-8Report Type:Expedited (15-DaCompany Report #86887 Outcome Disability PT Fatigue Flushing Blood Immunoglobulin G Increased Sleep Disorder Convulsion Herpes Simplex Myalgia Skin Atrophy Antinuclear Antibody Positive Malaise Laboratory Test Abnormal Tinnitus Suicidal Ideation Asthenia Muscular Weakness Norepinephrine Increased Peripheral Sensory Neuropathy Feeling Of Body Temperature Change Infectious Mononucleosis Nervousness Chest Pain Blood Albumin Decreased Epistaxis Herpes Zoster Report Source Foreign Consumer Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Date:11/28/01ISR Number: 3831980-0Report Type:Expedited (15-DaCompany Report #301583 Outcome Hospitalization Initial or Prolonged PT Abdominal Pain Affective Disorder Hallucination Paranoia Headache
Age:37 YR
Gender:Male
I/FU:I
03-Apr-2012
09:37 AM
Page: 405
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Dizziness Agitation Nausea Gastrointestinal Disorder Anxiety Mental Disorder Confusional State Constipation
Product Lariam (Mefloquine Hydrocloride)
Role PS
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:11/28/01ISR Number: 3832228-3Report Type:Expedited (15-DaCompany Report #302003 Outcome Other Serious PT Electromyogram Abnormal Demyelination Neuropathy Peripheral Asthenia Muscle Contractions Involuntary Anxiety Paraesthesia Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:12/04/01ISR Number: 3833485-XReport Type:Expedited (15-DaCompany Report #302763 Outcome Other Serious PT Haematuria Report Source Product Lariam Role PS Manufacturer Roche
Age:21 YR Route
Gender:Male Dose
I/FU:I Duration
Date:12/05/01ISR Number: 3836429-XReport Type:Direct Outcome Hospitalization Initial or Prolonged PT Atrioventricular Block Second Degree
Company Report # Report Source Product Mefloquine Claritin Motrin Role PS C C Manufacturer
Age:53 YR Route
Gender:Male Dose
I/FU:I Duration
Date:12/07/01ISR Number: 3836514-2Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Nervous System Disorder
Company Report # Report Source Product Lariam Hoffman-Laroche Role PS Manufacturer Hoffman-Laroche
Age:40 YR Route
Gender:Male Dose 1 PILL 1 TIME
I/FU:I Duration
Age:21 YR
Gender:Male
I/FU:I
PT Haematuria
Role PS
Manufacturer
Route
Dose 1 DOSE FORM 1 PER WEEK
Duration
03-Apr-2012
09:37 AM
Page: 406
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/01ISR Number: 3836508-7Report Type:Expedited (15-DaCompany Report #252788 Outcome Other Serious PT Abnormal Behaviour Delusion Report Source Product Lariam Tablets Tanakan Ludiomil Toco Aspegic Aricept Xatral Role PS C C C C C C Manufacturer Roche Age:74 YR Route Gender:Male Dose TAKEN AT BEDTIME. TAKEN AT BEDTIME. I/FU:F Duration 8 DAY
Date:12/12/01ISR Number: 3839260-4Report Type:Expedited (15-DaCompany Report #252788 Outcome Other Serious PT Delusion Abnormal Behaviour Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Tanakan (Ginkgo) Ludiomil (Maprotiline Hydrochloride) Toco (Vitamin E) Aspegic (Aspirin Dl-Lysine) Aricept (Donepezil) Xatral (Alfuzosin Hydrochloride) Role PS C C C C C C Manufacturer
I/FU:F Duration
Date:12/18/01ISR Number: 3839742-5Report Type:Expedited (15-DaCompany Report #303413 Outcome Hospitalization Initial or Prolonged PT Convulsions Local Epilepsy Report Source Product Lariam Corticosteroids Role PS C Manufacturer Roche
Age:29 YR Route
Gender:Female Dose
Date:12/18/01ISR Number: 3839747-4Report Type:Expedited (15-DaCompany Report #303343 Outcome Death Hospitalization Initial or Prolonged PT Nausea Cardiac Arrest Fatigue Report Source Product Lariam Role PS Manufacturer Roche
Age:49 YR Route
Gender:Male Dose
I/FU:I Duration
Age:29 YR
Gender:Female
I/FU:F
PT Eye Irritation Headache Fatigue Viith Nerve Paralysis Dizziness Paraesthesia 09:37 AM Page: 407
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diplopia Report Source Product Lariam Role PS Manufacturer Roche Route Dose Duration 1 DAY
Date:12/19/01ISR Number: 3842512-5Report Type:Expedited (15-DaCompany Report #303413 Outcome Hospitalization Initial or Prolonged PT Convulsion Loss Of Consciousness Grand Mal Convulsion Depression Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Corticosteroids (Corticosteroid Nos) Role PS C Manufacturer
Date:12/19/01ISR Number: 3842514-9Report Type:Expedited (15-DaCompany Report #303343 Outcome Death Hospitalization Initial or Prolonged PT Fatigue Meningism Cerebral Ischaemia Loss Of Consciousness Cardiac Arrest Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:12/20/01ISR Number: 3843382-1Report Type:Expedited (15-DaCompany Report #269729 Outcome Other Serious PT Diplopia Dizziness Burning Sensation Fatigue Headache Hypoaesthesia Viith Nerve Paralysis Paraesthesia Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:F Duration
Date:12/21/01ISR Number: 3842639-8Report Type:Expedited (15-DaCompany Report #303685 Outcome Hospitalization Initial or Prolonged PT Catatonia Psychomotor Retardation Confusional State Amnesia Report Source Product Lariam Role PS Manufacturer Roche
Age:23 YR Route
Gender:Male Dose
Age:38 YR
Gender:Male
I/FU:I
PT Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Creatine Page: 408
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Increased Myalgia Report Source Product Lariam Role PS Manufacturer Roche Route Dose Duration 44 DAY
Date:12/27/01ISR Number: 3845437-4Report Type:Expedited (15-DaCompany Report #303614 Outcome Hospitalization Initial or Prolonged PT Alanine Aminotransferase Increased Oedema Muscle Disorder Inflammation Myalgia Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Back Pain Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:12/27/01ISR Number: 3845439-8Report Type:Expedited (15-DaCompany Report #303685 Outcome Hospitalization Initial or Prolonged PT Confusional State Catatonia Amnesia Psychomotor Retardation Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Male Dose 5 DOSE FORM DAILY ORAL
I/FU:I Duration
Date:12/31/01ISR Number: 3845986-9Report Type:Direct Outcome Other Serious PT Emotional Disorder Fatigue Dizziness Headache Chills Confusional State Depression Insomnia Nightmare Anxiety
Company Report #CTU 157943 Report Source Product Mefloquine Role PS Manufacturer
Age:31 YR Route
Gender:Female
I/FU:I
Dose Duration 1 TAB Q WEEK
Age:43 YR
Gender:Female
I/FU:F
Outcome Disability
PT Convulsion Malaise Nervousness Sleep Disorder Pain Asthenia Tinnitus 09:37 AM Page: 409
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscular Weakness Peripheral Sensory Neuropathy Suicidal Ideation Csf Protein Abnormal Flushing Epistaxis Myalgia Ill-Defined Disorder
Report Source
Role PS
Manufacturer Roche
Route
Dose
Duration 49 DAY
Date:01/04/02ISR Number: 3849007-3Report Type:Expedited (15-DaCompany Report #86887 Outcome Disability PT Feeling Hot Loss Of Consciousness Peripheral Sensory Neuropathy Decreased Activity Epistaxis Nervousness Tinnitus Hepatitis B Surface Antigen Positive Asthenia Pain Arthropod Bite Back Pain Lipoatrophy Convulsion Csf Oligoclonal Band Present Neck Pain Sleep Disorder Angina Pectoris Antibody Test Positive Fatigue Malaise Myalgia Suicidal Ideation Csf Protein Abnormal Muscular Weakness Paraesthesia Epstein-Barr Virus Antibody Positive Feeling Cold Hypoaesthesia Report Source Foreign Consumer Health Professional Other Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer
Age:43 YR Route
Gender:Female Dose
I/FU:F Duration
PS
ORAL
ORAL
49
DAY
Age:25 YR
Gender:Female
I/FU:F
PT Convulsions Local Epilepsy
Report Source
Product Lariam Corticosteroids
Role PS C
Manufacturer Roche
Route
Dose
Duration 11 DAY
03-Apr-2012
09:37 AM
Page: 410
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/02ISR Number: 3848564-0Report Type:Expedited (15-DaCompany Report #303976 Outcome Life-Threatening PT Headache Extrasystoles Convulsion Cardiac Arrest Bradycardia Visual Impairment Report Source Product Lariam Role PS Manufacturer Roche Age:48 YR Route Gender:Male Dose I/FU:I Duration 21 DAY
Date:01/07/02ISR Number: 3849817-2Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Arrhythmia Ventricular Tachycardia
Company Report #CTU 158576 Report Source Product Lariam Roche Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male
I/FU:I
Date:01/08/02ISR Number: 3849126-1Report Type:Expedited (15-DaCompany Report #304340 Outcome Hospitalization Initial or Prolonged Disability PT Depressed Level Of Consciousness Visual Acuity Reduced Suicidal Ideation Macular Oedema Myalgia Hemiparesis Hypoaesthesia Hallucination Headache Report Source Product Lariam Role PS Manufacturer Roche
Age:15 YR Route
Gender:Female Dose
Date:01/09/02ISR Number: 3849476-9Report Type:Expedited (15-DaCompany Report #302003 Outcome Other Serious PT Anxiety Asthenia Report Source Product Lariam Role PS Manufacturer Roche
Age:42 YR Route
Gender:Male Dose
Date:01/09/02ISR Number: 3849479-4Report Type:Expedited (15-DaCompany Report #304145 Outcome Other Serious PT Guillain-Barre Syndrome Report Source Product Lariam Role PS Manufacturer Roche
Age:32 YR Route
Gender:Male Dose
I/FU:I Duration
Age:48 YR
Gender:Male
I/FU:I
PT Cardiac Arrest Extrasystoles Eye Pain Grand Mal Convulsion Bradycardia Headache Page: 411
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Visual Impairment Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Route ORAL Dose 1 DOSE FORM 1 PER WEEK ORAL Duration
Date:01/09/02ISR Number: 3850225-9Report Type:Expedited (15-DaCompany Report #303413 Outcome Hospitalization Initial or Prolonged PT Epilepsy Grand Mal Convulsion Depression Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Corticosteroids (Corticosteroids Nos) Role PS Manufacturer
I/FU:F Duration
Date:01/10/02ISR Number: 3850029-7Report Type:Expedited (15-DaCompany Report #263822 Outcome Life-Threatening PT Grand Mal Convulsion Hearing Impaired Movement Disorder Tinnitus Vision Blurred Cardiac Arrest Report Source Product Lariam Role PS Manufacturer Roche
Age:62 YR Route
Gender:Male Dose
Date:01/10/02ISR Number: 3851407-2Report Type:Expedited (15-DaCompany Report #304340 Outcome Hospitalization Initial or Prolonged Disability PT Depressed Level Of Consciousness Myalgia Hypoaesthesia Paraesthesia Hemiparesis Hemiplegia Hallucination Headache Suicidal Ideation Depression Eye Swelling Blindness Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:I Duration
Age:
Gender:Not SpecifiI/FU:F
PT Abortion Induced Anencephaly
Report Source
Role PS
Manufacturer Roche
Route
Dose
Duration 8 DAY
03-Apr-2012
09:37 AM
Page: 412
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/02ISR Number: 3852084-7Report Type:Expedited (15-DaCompany Report #304145 Outcome Other Serious PT Guillain-Barre Syndrome Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age:32 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:01/11/02ISR Number: 3852090-2Report Type:Expedited (15-DaCompany Report #302003 Outcome Other Serious PT Electromyogram Abnormal Affective Disorder Dysaesthesia Muscle Contractions Involuntary Anxiety Demyelinating Polyneuropathy Asthenia Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:F Duration
Date:01/14/02ISR Number: 3852358-XReport Type:Expedited (15-DaCompany Report #263822 Outcome Life-Threatening PT Cardiac Arrest Grand Mal Convulsion Headache Memory Impairment Deafness Obstructive Airways Disorder Pulse Absent Dizziness Thinking Abnormal Movement Disorder Vision Blurred Tinnitus Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:F Duration
Date:01/14/02ISR Number: 3852926-5Report Type:Expedited (15-DaCompany Report #259087 Outcome Congenital Anomaly PT Abortion Induced Maternal Drugs Affecting Foetus Anencephaly Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:01/17/02ISR Number: 3854155-8Report Type:Expedited (15-DaCompany Report #304615 Outcome Congenital Anomaly PT Ear Malformation Hydrocephalus Dysmorphism Maternal Exposure During
Age:
Gender:Male
I/FU:I
03-Apr-2012
09:37 AM
Page: 413
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pregnancy Abortion Induced Pregnancy Maternal Drugs Affecting Foetus Haemorrhage Deformity Of Orbit Thrombocytopenia
Product Lariam (Mefloquine Hydrochloride)
Role PS
Manufacturer
Route ORAL
Dose 1 DOSE FORM 1 PER WEEK ORAL
Duration
Date:01/21/02ISR Number: 3854428-9Report Type:Expedited (15-DaCompany Report #304615 Outcome Congenital Anomaly PT Multiple Congenital Abnormalities Maternal Drugs Affecting Foetus Hydrocephalus Chondromatosis Ear Malformation Dysmorphism Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
Date:01/21/02ISR Number: 3854429-0Report Type:Expedited (15-DaCompany Report #305025 Outcome Other Serious PT Drug Withdrawal Syndrome Panic Disorder Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age:54 YR Route
Gender:Male Dose
Date:01/21/02ISR Number: 3854469-1Report Type:Expedited (15-DaCompany Report #305014 Outcome Hospitalization Initial or Prolonged PT Chronic Myeloid Leukaemia Report Source Product Lariam Role PS Manufacturer Roche
Age:36 YR Route
Gender:Male Dose
Date:01/22/02ISR Number: 3855316-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11660594 Outcome Hospitalization Initial or Prolonged PT Malaria Liver Function Test Abnormal Pyrexia Report Source Product Aprovel Tabs Lariam Hepatitis B Virus Vaccine Hepatitis A Virus Vaccine Typhoid Vaccine Yellow Fever Vaccine Role PS SS C C C C Manufacturer Bristol-Myers Squibb Company
Gender:Female Dose
I/FU:I Duration 3 6 MON WK
Date:01/22/02ISR Number: 3857526-9Report Type:Expedited (15-DaCompany Report #305025 Outcome Required Intervention to Prevent Permanent 03-Apr-2012 09:37 AM
Age:54 YR
Gender:Male
I/FU:I
Page: 414
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Drug Withdrawal Syndrome Panic Disorder Report Source Foreign Other Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Role Manufacturer Route Dose Duration
PS
ORAL
1 PER DAY ORAL
Date:01/22/02ISR Number: 3857527-0Report Type:Expedited (15-DaCompany Report #304615 Outcome Congenital Anomaly PT Amniotic Cavity Disorder Abortion Induced Dysmorphism Foetal Disorder Deformity Of Orbit Hydrocephalus Thrombocytopenia Maternal Drugs Affecting Foetus Cerebral Haemorrhage Foetal Report Source Foreign Other Product Lariam (Melfloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
Gender:Male Dose DOSE FORM 1 PER WEEK ORAL
Date:01/23/02ISR Number: 3856157-4Report Type:Expedited (15-DaCompany Report #301407 Outcome Other Serious PT Vision Blurred Disturbance In Attention Vertigo Insomnia Tremor Dry Mouth Hyperhidrosis Energy Increased Report Source Product Lariam Zyban Trinordiol Role PS SS C Manufacturer Roche
Age:23 YR Route
Gender:Female Dose
Date:01/23/02ISR Number: 3859719-3Report Type:Expedited (15-DaCompany Report #305014 Outcome Hospitalization Initial or Prolonged PT Chronic Myeloid Leukaemia Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Company Report #CTU 159881
Age:59 YR
Gender:Female
I/FU:I
PT Hearing Impaired
Report Source
Product Lariam -Mefloquine250 Mg Roch Tri-Estrogen + Progesterone
Role PS C
Manufacturer Roch
Route ORAL
Dose 250 MG WEEKLY ORAL
Duration
03-Apr-2012
09:37 AM
Page: 415
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3860023-8Report Type:Direct Outcome Disability PT Nausea Insomnia Memory Impairment Panic Attack Decreased Appetite Anxiety Depression Disturbance In Attention Nervousness Fatigue Company Report #CTU 159878 Report Source Product Lariam 250mg Roche Role PS Manufacturer Roche Age:27 YR Route ORAL Gender:Female I/FU:I
Date:01/24/02ISR Number: 3860046-9Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Insomnia Paranoia Panic Disorder Dizziness Fatigue Hallucination Abnormal Dreams Heart Rate Increased Nausea
Company Report #CTU 159858 Report Source Product Lariam (250 Mg) (Tablets (Ud),Roche Labs) Role PS Manufacturer Roche Labs
Age: Route ORAL
Gender:Male Dose 250MG 1 TABLET ORALLY WEEKLY
I/FU:I Duration
Date:01/25/02ISR Number: 3860071-8Report Type:Expedited (15-DaCompany Report #301407 Outcome Other Serious PT Tremor Dry Mouth Hyperhidrosis Vertigo Vision Blurred Energy Increased Insomnia Disturbance In Attention Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Zyban (Bupropion Hydrochloride) Trinordiol (Ethinyl Estradiol/Levonorges trel) Role PS SS Manufacturer
Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL 1 DOSE FORM DAILY ORAL
I/FU:I Duration
Date:01/28/02ISR Number: 3861035-0Report Type:Expedited (15-DaCompany Report #305169 Outcome Other Serious PT Asthenia Shock Weight Decreased Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Gender:Female Dose 1 DOSE FORM
I/FU:I Duration
Confusional State Nausea Decreased Appetite Fatigue Apathy
DAILY ORAL
03-Apr-2012
09:37 AM
Page: 416
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/02ISR Number: 3860653-3Report Type:Expedited (15-DaCompany Report #256017 Outcome Congenital Anomaly PT Kidney Malformation Report Source Product Lariam Tablets Role PS Manufacturer Roche Age: Route Gender:Female Dose I/FU:F Duration
Date:01/31/02ISR Number: 3861555-9Report Type:Direct Outcome Disability PT Disturbance In Attention Malaise Night Sweats Palpitations Headache Fatigue
Company Report #CTU 160493 Report Source Product Lariam (Mefloquine)(250 Mg / Roche Laboratories) Role Manufacturer
Age:48 YR Route
Gender:Female Dose
I/FU:I Duration
PS
Roche Laboratories
ORAL
250MG PO Q WEEK X 7 WEEKS
Date:01/31/02ISR Number: 3862951-6Report Type:Expedited (15-DaCompany Report #256017 Outcome Congenital Anomaly PT Maternal Drugs Affecting Foetus Pregnancy Congenital Genitourinary Abnormality Report Source Foreign Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose 1 DOSEFORM 1 PER WEEK ORAL
I/FU:I Duration
Date:02/04/02ISR Number: 3862342-8Report Type:Expedited (15-DaCompany Report #302003 Outcome Other Serious PT Asthenia Anxiety Report Source Product Lariam Role PS Manufacturer Roche
Age:42 YR Route
Gender:Male Dose
Date:02/04/02ISR Number: 3862356-8Report Type:Expedited (15-DaCompany Report #305855 Outcome Other Serious PT Mouth Ulceration Erythema Multiforme Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age:40 YR Route
Gender:Male Dose
Date:02/05/02ISR Number: 3863086-9Report Type:Expedited (15-DaCompany Report #305877 Outcome Other Serious PT Pulmonary Congestion Dyspnoea Report Source Product Lariam Role PS Manufacturer Roche
Age:42 YR Route
Gender:Not SpecifiI/FU:I Dose Duration DESCRIBED AS 3 TABLETS IN THE MORNING, 2 IN THE
MIDDLE OF THE
DAY
03-Apr-2012
09:37 AM
Page: 417
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/02ISR Number: 3865088-5Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Thinking Abnormal Dissociation Fear Anxiety Hypothyroidism Dysentery Feeling Abnormal Paranoia Stress Company Report #CTU 160910 Report Source Product Lariam Role PS Manufacturer Age:20 YR Route ORAL Gender:Female I/FU:I
Dose Duration 1 PILL EVERYDAY/2MN ORAL
Date:02/06/02ISR Number: 3866167-9Report Type:Expedited (15-DaCompany Report #305855 Outcome Other Serious PT Mouth Ulceration Weight Decreased Erythema Multiforme Report Source Foreign Other Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Role Manufacturer
Age:40 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
250 MG ORAL
Date:02/07/02ISR Number: 3865776-0Report Type:Direct Outcome Other Serious PT Aphasia
Company Report #CTU 161186 Report Source Product Larium Role PS Manufacturer
Gender:Female Dose ONE PILL ONCE A WEEK ORAL
I/FU:I Duration
Date:02/07/02ISR Number: 3866397-6Report Type:Direct Outcome Other Serious PT Memory Impairment Hallucination Disorientation Confusional State
Company Report #CTU 161175 Report Source Product Mefloquine (Larium) Role PS Manufacturer
Gender:Male
I/FU:I
Date:02/07/02ISR Number: 3866467-2Report Type:Direct Outcome Other Serious PT Fear Anxiety
Company Report #CTU 161208 Report Source Product Lariam Hoffmann-La Roche Role PS Manufacturer Hoffmann-La Roche
Gender:Female Dose ONE 250 MG ONCE A WEEK ORAL
I/FU:I Duration
Date:02/07/02ISR Number: 3867764-7Report Type:Expedited (15-DaCompany Report #305877 Outcome Other Serious PT Lung Infiltration Dyspnoea Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Gender: Dose 250 MG ORAL
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 418
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/02ISR Number: 3866762-7Report Type:Direct Outcome Other Serious PT Anxiety Headache Diarrhoea Vertigo Abdominal Pain Decreased Appetite Nausea Visual Impairment Company Report #CTU 161353 Report Source Product Larium (?Standard For Malaria) Role PS Manufacturer Age: Route ORAL Gender:Female Dose 1 TABLE WEEKLY ORAL I/FU:I Duration
Date:02/08/02ISR Number: 3866871-2Report Type:Direct Outcome Life-Threatening Required Intervention to Prevent Permanent Impairment/Damage PT Insomnia Anxiety Suicidal Ideation Delusion Depression Nightmare
Company Report #CTU 161327 Report Source Product Larium 250mg Roche Pharacuticals Role PS Manufacturer Roche Pharacuticals
Gender:Male Dose 250MG ONE A WEEK ORAL
I/FU:I Duration
Date:02/08/02ISR Number: 3866875-XReport Type:Direct Outcome Other Serious PT Initial Insomnia Nervousness Fear Agitation
Company Report #CTU 161331 Report Source Product Lariam 250mg Roche Echinacea Topical Insect Spray Multi-Vitamin Role PS C C C Manufacturer Roche
Age:46 YR Route
Gender:Female Dose 1/WEEK
I/FU:I Duration
Date:02/12/02ISR Number: 3866799-8Report Type:Expedited (15-DaCompany Report #261498 Outcome Death PT International Normalised Ratio Increased Haemorrhagic Stroke Drug Interaction Report Source Consumer Product Lariam Cozaar Comp Warfarin Role PS C I Manufacturer Roche
Age:72 YR Route
Gender:Female Dose VARYING DOSES AS PER INR.
Date:02/12/02ISR Number: 3866804-9Report Type:Expedited (15-DaCompany Report #251768 Outcome Congenital Anomaly PT Limb Reduction Defect Pregnancy Abortion Induced Maternal Drugs Affecting Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:F Duration
Foetus Maternal Exposure During Pregnancy
03-Apr-2012
09:37 AM
Page: 419
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/02ISR Number: 3867634-4Report Type:Direct Outcome Other Serious PT Depression Panic Attack Company Report #CTU 161443 Report Source Product Larium Role PS Manufacturer Age:25 YR Route Gender:Female I/FU:I
Dose Duration ONCE A TABLET
Date:02/12/02ISR Number: 3867716-7Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Pyrexia Malaise Chest Pain Paranoia Chest Discomfort Panic Attack
Company Report #CTU 161424 Report Source Product Larium Xanax Role PS C Manufacturer
Gender:Female Dose 1 WEEK ORAL
I/FU:I Duration
Date:02/12/02ISR Number: 3867740-4Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Paranoia Blood Pressure Increased Pyrexia Heart Rate Increased Tongue Disorder Hallucination Hypersensitivity
Company Report #CTU 161427 Report Source Product Mefloquine Hci 250 Mg Hoffman-Laroche Cephalexin Valium Role PS C C Manufacturer Hoffman-Laroche
I/FU:I Duration
Date:02/12/02ISR Number: 3868199-3Report Type:Direct Outcome Disability PT Menstrual Disorder Paranoia Depression Nightmare Insomnia Personality Change Hallucination Dizziness
Company Report #CTU 161515 Report Source Product Lariam Role PS Manufacturer
Age:28 YR Route
Gender:Female Dose 1 WEEK
I/FU:I Duration
Date:02/14/02ISR Number: 3869224-6Report Type:Direct Outcome Disability PT Insomnia Nightmare Panic Attack
Gender:Male
I/FU:I
Dose Duration ONE WEEK ORAL
Phobia Of Flying
03-Apr-2012
09:37 AM
Page: 420
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/02ISR Number: 3869307-0Report Type:Direct Outcome Other Serious PT Abnormal Behaviour Malaise Conversion Disorder Confusional State Depression Palpitations Panic Attack Anxiety Claustrophobia Crying Mental Disorder Company Report #CTU 161585 Report Source Product Lariam Role PS Manufacturer Age:25 YR Route ORAL Gender:Female Dose 1 PILL ORAL I/FU:I Duration
Date:02/14/02ISR Number: 3870022-8Report Type:Direct Outcome Other Serious PT Depression Obsessive-Compulsive Disorder Nightmare
Age: Route
Gender:Male Dose ONE TABLE ONCE A WEEK
I/FU:I Duration
Date:02/15/02ISR Number: 3869297-0Report Type:Expedited (15-DaCompany Report #264219 Outcome Death Hospitalization Initial or Prolonged PT Drug Interaction Speech Disorder Brain Oedema Brain Death Pupils Unequal Bradycardia Aphasia Hemiplegia International Normalised Ratio Increased Tachycardia Haemorrhagic Stroke Blood Pressure Systolic Increased Hypotension Report Source Product Lariam Cozaar Warfarin Sodium Role PS C I Manufacturer Roche
Age:72 YR Route
Gender:Female Dose
I/FU:I Duration
Date:02/15/02ISR Number: 3869736-5Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Headache Dehydration
Gender:Female
I/FU:I
Dose Duration STANDARD ONCE A WEEK ORAL
Dizziness Pain Depression Photosensitivity Reaction Vomiting
03-Apr-2012
09:37 AM
Page: 421
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/15/02ISR Number: 3871175-8Report Type:Expedited (15-DaCompany Report #259699 Outcome Death PT Drug Interaction International Normalised Ratio Increased Circulatory Collapse Cerebral Haemorrhage Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Warfarin (Warfarin Sodium) Cozaar Comp (Hydrochlorothiazide /Losartan Potassium) Role PS SS Manufacturer Age:72 YR Route ORAL ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL 4 MG 1 PER 2 DAY ORAL I/FU:F Duration
Date:02/15/02ISR Number: 3871379-4Report Type:Expedited (15-DaCompany Report #261498 Outcome Death PT Potentiating Drug Interaction Cerebral Haemorrhage International Normalised Ratio Increased Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Warfarin (Warfarin Sodium) Cozaar Comp (Hydrochlorothiazide /Losartan Potassium) Role PS SS C Manufacturer
I/FU:F Duration
Date:02/15/02ISR Number: 3871385-XReport Type:Expedited (15-DaCompany Report #261498 Outcome Death PT Cerebral Haemorrhage International Normalised Ratio Increased Potentiating Drug Interaction Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Warfarin (Warfarin Sodium) Cozaar Comp (Hydrochlorothiazide /Losartan Potassium) Role PS SS C Manufacturer
I/FU:F Duration
Date:02/18/02ISR Number: 3869837-1Report Type:Expedited (15-DaCompany Report #263822 Outcome Life-Threatening PT Grand Mal Convulsion Movement Disorder Tinnitus Vision Blurred Cardiac Arrest Hearing Impaired Report Source Product Lariam Malarone Role PS SS Manufacturer Roche
Age:62 YR Route
Gender:Male Dose
Date:02/18/02ISR Number: 3869840-1Report Type:Expedited (15-DaCompany Report #303413 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Epilepsy Convulsions Local Report Source Product Lariam Epitomax Diane Role PS C C Manufacturer Roche
Age:24 YR Route
Gender:Female Dose
I/FU:F Duration 12 DAY 1590 DAY Page: 422
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Corticosteroids Erythromycine C C
Date:02/18/02ISR Number: 3869843-7Report Type:Expedited (15-DaCompany Report #265284 Outcome Other Serious PT Cardiac Arrest Grand Mal Convulsion Tinnitus Report Source Product Lariam Malarone Role PS SS Manufacturer Roche
Age:62 YR Route
Gender:Male Dose
Date:02/19/02ISR Number: 3870399-3Report Type:Expedited (15-DaCompany Report #259699 Outcome Death Hospitalization Initial or Prolonged PT Drug Interaction Haemorrhagic Stroke International Normalised Ratio Increased Report Source Product Lariam Cozaar Comp Warfarin Role PS C I Manufacturer Roche
Age:72 YR Route
Gender:Female Dose
Date:02/19/02ISR Number: 3871276-4Report Type:Direct Outcome Other Serious PT Diarrhoea Vomiting Malaise Panic Attack
Company Report #CTU 161854 Report Source Product Larium 250mg Hoffmann-La Roche Role PS Manufacturer Hoffmann-La Roche
Gender:Male Dose 1 TABLE PER WEEK ORAL
I/FU:I Duration
Date:02/19/02ISR Number: 3872467-9Report Type:Expedited (15-DaCompany Report #264219 Outcome Death Hospitalization Initial or Prolonged PT Brain Oedema Drug Interaction Aphasia Facial Paresis Haemorrhagic Stroke Hypotension Blood Pressure Systolic Increased Bradycardia Hemiparesis Hypothermia Papilloedema International Normalised Ratio Increased Hyporeflexia Pupils Unequal Report Source Foreign Other Product Lariam (Melfoquine Hydrochloride) 250 Mg Warfarin Sodium (Warfarin Sodium) 5 Mg Cozaar (Losartan Potassium) Role PS SS C Manufacturer
Age:72 YR Route
Gender:Female Dose 1 PER WEEK 4 MG 1 PER 2 DAY
I/FU:F Duration
Tachycardia
03-Apr-2012
09:37 AM
Page: 423
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/02ISR Number: 3873797-7Report Type:Expedited (15-DaCompany Report #263822 Outcome Life-Threatening PT Grand Mal Convulsion Dizziness Deafness Memory Impairment Muscle Twitching Tinnitus Obstructive Airways Disorder Headache Cardiac Arrest Confusional State Vision Blurred Report Source Health Professional Other Product Lariam (Mefloquine Hydrochloride)250 Mg Malarone (Atovawuone/Chlorogu ande Hydrochloride) Role PS Manufacturer Age:62 YR Route ORAL Gender:Male Dose 250 MG 1 PER 1 WEEK ORAL ORAL I/FU:F Duration
SS
ORAL
Date:02/20/02ISR Number: 3873798-9Report Type:Expedited (15-DaCompany Report #265284 Outcome Other Serious PT Grand Mal Convulsion Dizziness Tinnitus Cardiac Arrest Report Source Health Professional Other Product Lariam (Mefloquine Hydrochloride) Malarone (Atovaquone/Chlorogu anide Hydrochloride) Role PS SS Manufacturer
I/FU:F Duration
Date:02/20/02ISR Number: 3873922-8Report Type:Expedited (15-DaCompany Report #303413 Outcome Hospitalization Initial or Prolonged PT Nervous System Disorder Convulsion Weight Increased Antinuclear Antibody Positive Dystonia Epilepsy Loss Of Consciousness Rash Erythematous Tremor Aphthous Stomatitis Arthralgia Depression Electroencephalogram Abnormal Joint Ankylosis Carpal Tunnel Syndrome Hypersensitivity Inflammation Sinusitis Sensation Of Heaviness
Age:24 YR
Gender:Female
I/FU:F
Feeling Abnormal Drug Tolerance Decreased Anaemia Gastrointestinal Disorder Peroneal Nerve Palsy Skin Disorder Bronchitis Nuclear Magnetic 03-Apr-2012 09:37 AM Page: 424
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Resonance Imaging Brain Abnormal Paraesthesia Partial Seizures Sensory Disturbance Clonic Convulsion
Product Lariam (Mefloquine Hydrochloride) Epitomax (Topiramate) Diane (Cyproterone Acetate/Ethinyl Estradiol) Corticosteriods Nos (Corticosteroid Nos) Erythromycine (Erythromycin)
Role PS C C C C
Manufacturer
Route ORAL
Duration
Date:02/21/02ISR Number: 3872711-8Report Type:Direct Outcome Other Serious PT Headache Dizziness Influenza Like Illness Pyrexia Nausea Pain Hyperhidrosis Malaise Oropharyngeal Pain Chills
Age:50 YR Route
Gender:Male Dose ONE PER
I/FU:I Duration
Date:02/21/02ISR Number: 3873492-4Report Type:Expedited (15-DaCompany Report #259699 Outcome Death Hospitalization Initial or Prolonged PT Hemiplegia Brain Oedema Pupils Unequal Cerebral Haemorrhage Extensor Plantar Response Hemiparesis Tachycardia Bradycardia Drug Interaction Aphasia Coma Papilloedema Hypertension Hyporeflexia Hypotension International Normalised Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Warfarin (Warfarin Sodium) Cozaar Comp (Hydrochlorothiazide /Losartan Potassium) Role PS SS Manufacturer
I/FU:F Duration
Ratio Increased
03-Apr-2012
09:37 AM
Page: 425
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/02ISR Number: 3871938-9Report Type:Expedited (15-DaCompany Report #307365 Outcome Disability PT Headache Fear Depression Dry Mouth Paraesthesia Dizziness Anxiety Report Source Product Lariam Role PS Manufacturer Roche Age: Route Gender:Female Dose I/FU:I Duration 8 DAY
Date:02/26/02ISR Number: 3875863-9Report Type:Expedited (15-DaCompany Report #307365 Outcome Disability PT Dry Mouth Dizziness Paraesthesia Anxiety Depression Headache Hypoaesthesia Report Source Foreign Consumer Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:02/27/02ISR Number: 3874072-7Report Type:Expedited (15-DaCompany Report #303413 Outcome Hospitalization Initial or Prolonged PT Hypersensitivity Feeling Abnormal Partial Seizures Epilepsy Brain Scan Abnormal Clonic Convulsion Mouth Ulceration Bronchitis Convulsions Local Sinusitis Carpal Tunnel Syndrome Report Source Product Lariam Epitomax Diane Corticosteroids Erythromycine Role PS C C C C Manufacturer Roche
Age:24 YR Route
Gender:Female Dose
Date:02/27/02ISR Number: 3874950-9Report Type:Direct Outcome Other Serious PT Nausea Abnormal Dreams Dizziness Mood Swings
Company Report #CTU 162354 Report Source Product Lariam 250mg Roche Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:02/28/02ISR Number: 3877137-9Report Type:Direct Outcome Other Serious PT Disturbance In Attention Myalgia Dizziness Sensation Of Heaviness Decreased Appetite 09:37 AM
Age:36 YR
Gender:Female
I/FU:I
03-Apr-2012
Page: 426
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuralgia Sleep Disorder Vision Blurred Asthenia Weight Decreased Medication Error Diarrhoea Ventricular Extrasystoles
Report Source
Product Mefloquine (Lariam) Vit C Vit E Calcium Carbonate Levothyroxin B Vits
Role PS C C C C C
Manufacturer
Route ORAL
Dose 250 MG PO Q WEEK
Duration
Date:02/28/02ISR Number: 3878070-9Report Type:Expedited (15-DaCompany Report #303413 Outcome Hospitalization Initial or Prolonged PT Arrhythmia Depression Joint Ankylosis Sensory Loss Sinusitis Clonic Convulsion Dystonia Paraesthesia Partial Seizures Systemic Inflammatory Response Syndrome Bronchitis Condition Aggravated Hypersensitivity Tremor Feeling Abnormal Rash Erythematous Epigastric Discomfort Aphthous Stomatitis Carpal Tunnel Syndrome Loss Of Consciousness Nuclear Magnetic Resonance Imaging Abnormal Sensation Of Heaviness Convulsion Epilepsy Skin Disorder Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Epitomax (Topiramate) Diane (Cyproterone Acetate/Ethinyl Estradiol) Corticosteroids (Corticosteroid Nos) Erythromycine (Erythromycin) Role PS C C C C Manufacturer
I/FU:F Duration
Date:03/01/02ISR Number: 3877283-XReport Type:Direct Outcome Other Serious PT Nightmare Mental Disorder Memory Impairment
Gender:Male Dose ONE PILL WEEKLY ORAL
I/FU:I Duration
Date:03/01/02ISR Number: 3877309-3Report Type:Direct Outcome Disability 03-Apr-2012 09:37 AM PT Tremor Anxiety Disorder
Age:30 YR
Gender:Female
I/FU:I
Page: 427
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperventilation Panic Attack Depression
Report Source
Product Mefloquine
Role PS
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:03/01/02ISR Number: 3878265-4Report Type:Direct Outcome Other Serious PT Anxiety Hallucination Irritability Insomnia Nightmare
Gender:Male
I/FU:I
Dose Duration DON''T ONCE A WEEK ORAL
Date:03/01/02ISR Number: 3878287-3Report Type:Direct Outcome Other Serious PT Nightmare Decreased Appetite Psychotic Disorder Muscle Spasms Pyrexia Night Sweats Vomiting Weight Decreased
Company Report #CTU 162674 Report Source Product Lariam Xalatan Allese Role PS C C Manufacturer
Age: Route ORAL
Gender:Female Dose 1 PILL WEEK ORAL
I/FU:I Duration
Date:03/04/02ISR Number: 3877211-7Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Malaise Heart Rate Increased
Company Report #CTU 162600 Report Source Product Lariam 4oz 5 Weeks Role Took For PS Manufacturer
Age:56 YR Route
Gender:Female Dose 1 PER WEEK FOR 6 WEEKS
I/FU:I Duration
Date:03/04/02ISR Number: 3878268-XReport Type:Direct Outcome Other Serious PT Anxiety Psychotic Disorder Toothache Nightmare Panic Disorder Paranoia Screaming Convulsion Crying
Company Report #CTU 162647 Report Source Product Lariam Erythromycin Flagyl Ponstan Forte Mefanamic Acid Ibuprofen Role PS C C C C Manufacturer Hoffman La Roche
Gender:Male
I/FU:I
Dose Duration 250 MG WEEKLY ORAL
Date:03/06/02ISR Number: 3879593-9Report Type:Direct Outcome PT Anxiety Insomnia 09:37 AM
Age:30 YR
Gender:Male
I/FU:I
03-Apr-2012
Page: 428
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Nightmare Panic Reaction Memory Impairment Mental Disorder Disturbance In Attention Feeling Of Body Temperature Change Nervousness
Report Source
Product Lariam 250mg Roche
Role PS
Manufacturer Roche
Route BUCCAL
Dose 1 WEEKS BUCCAL
Duration
Date:03/07/02ISR Number: 3881201-8Report Type:Direct Outcome PT Feeling Abnormal Vomiting Eyelid Ptosis Lid Lag Headache Eyelid Function Disorder Speech Disorder Fall Vertigo
Company Report #CTU 162987 Report Source Product Mefloquine -Lariam250 Mg Role PS Manufacturer
Age:38 YR Route
Gender:Female Dose `
I/FU:I Duration
Date:03/08/02ISR Number: 3879919-6Report Type:Expedited (15-DaCompany Report #308528 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Prothrombin Time Prolonged Drug Interaction Report Source Product Mefloquine Hydrochloride Carvedilol Betoptic Captopril Digoxin Warfarin Role PS C C C C I Manufacturer Roche
Age:66 YR Route
Gender:Male Dose
I/FU:I Duration
Date:03/11/02ISR Number: 3880623-9Report Type:Expedited (15-DaCompany Report #308514 Outcome Congenital Anomaly PT Moderate Mental Retardation Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:03/12/02ISR Number: 3881606-5Report Type:Direct Outcome Other Serious PT Anxiety Sinusitis
Company Report #CTU 163184 Report Source Product Lariam 1 Pill Per Week Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose 1 WEEKLY
I/FU:I Duration
Hyperventilation Disorientation Claustrophobia
ORAL Vit E Anti-Biotic Multi-Herbal Med C C C
03-Apr-2012
09:37 AM
Page: 429
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/02ISR Number: 3882986-7Report Type:Expedited (15-DaCompany Report #308514 Outcome Congenital Anomaly PT Congenital Neurological Degeneration Maternal Drugs Affecting Foetus Mental Retardation Pregnancy Neonatal Disorder Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Age: Route Gender:Female Dose 250 MG 1 PER WEEK I/FU:I Duration
Date:03/13/02ISR Number: 3882388-3Report Type:Direct Outcome Other Serious PT Confusional State Mental Impairment Convulsion Abnormal Behaviour
Company Report #CTU 163302 Report Source Product Lariam 250mg Role PS Manufacturer
Age:71 YR Route
Gender:Male
I/FU:I
Dose Duration 1 PILL ONCE A WEEK
Date:03/13/02ISR Number: 3882791-1Report Type:Expedited (15-DaCompany Report #308528 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Abdominal Distension Cardiomegaly Gallop Rhythm Present Blood Pressure Decreased Computerised Tomogram Abnormal Anaemia Drug Interaction Haemorrhage Infectious Peritonitis Congestive Cardiomyopathy Melaena Tachycardia Ejection Fraction Decreased Ascites Ileus Paralytic Abdominal Tenderness Prothrombin Time Prolonged Report Source Foreign Health Professional Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Warfarin (Warfarin Sodium) Digoxin (Digoxin) Captopril (Captopril) Betoptic (Betaxolol Hydrochloride) Carvedilol (Carvedilol) Role Manufacturer
Age:66 YR Route
Gender:Male Dose
I/FU:I Duration
PS SS C C C C
250 MG 1 PER WEEK
Date:03/14/02ISR Number: 3882692-9Report Type:Direct Outcome Life-Threatening PT Hallucination
Age:7 YR Route
Gender:Male Dose
I/FU:I Duration
Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage
Dyspnoea
03-Apr-2012
09:37 AM
Page: 430
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/02ISR Number: 3882716-9Report Type:Direct Outcome Other Serious PT Myalgia Anxiety Depression Headache Palpitations Insomnia Dizziness Paranoia Vision Blurred Angina Pectoris Arthralgia Company Report #CTU 163401 Report Source Product Lariam Role PS Manufacturer Age: Route ORAL Gender:Female Dose 1 TABLE WEEKLY ORAL I/FU:I Duration
Date:03/15/02ISR Number: 3883529-4Report Type:Direct Outcome Other Serious PT Paranoia Disorientation Panic Disorder Flashback Delusion Fear
Gender:Male Dose ONCE WEEK ORAL
I/FU:I Duration
Date:03/19/02ISR Number: 3884395-3Report Type:Expedited (15-DaCompany Report #308974 Outcome Hospitalization Initial or Prolonged PT Pulmonary Toxicity Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age:53 YR Route
Gender:Male Dose
I/FU:I Duration
Date:03/19/02ISR Number: 3886232-XReport Type:Direct Outcome Other Serious PT Anxiety Palpitations Chest Pain Confusional State Nightmare Insomnia
Company Report #CTU 163734 Report Source Product Lariam -Mefloquin Hci- 250 Mg Roche Laboratories Role PS Manufacturer Roche Laboratories
I/FU:I Duration
Date:03/19/02ISR Number: 3886246-XReport Type:Direct Outcome Other Serious PT Depression
Company Report #CTU 163742 Report Source Product Lariam Role Manufacturer
Age:55 YR Route
Gender:Female Dose
I/FU:I Duration
Dizziness Palpitations Anxiety Nightmare
Hoffmann-Laroche
PS
Hoffmann-Laroche
ORAL
1 TABLE ONCE A WEEK ORAL
03-Apr-2012
09:37 AM
Page: 431
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/02ISR Number: 3886508-6Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Hypoaesthesia Chest Pain Arrhythmia Company Report #CTU 163886 Report Source Product Lariam 250mg Roche Role PS Manufacturer Roche Age:58 YR Route ORAL Gender:Female I/FU:I
Dose Duration ONE TABLET WK / ORAL
Date:03/21/02ISR Number: 3886963-1Report Type:Expedited (15-DaCompany Report #308974 Outcome Hospitalization Initial or Prolonged PT Hypoxia Lung Disorder Cough White Blood Cell Count Increased Tachypnoea Biopsy Lung Abnormal Dyspnoea Rales C-Reactive Protein Increased Lung Infiltration Blood Lactate Dehydrogenase Increased Haematocrit Decreased Blood Pressure Diastolic Decreased Diarrhoea Haemoglobin Decreased Pulmonary Toxicity Report Source Foreign Literature Health Professional Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Role Manufacturer
Age:53 YR Route
Gender:Male Dose
I/FU:I Duration
PS
Date:03/22/02ISR Number: 3886649-3Report Type:Expedited (15-DaCompany Report #262856 Outcome Congenital Anomaly PT Multiple Congenital Abnormalities Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
Date:03/22/02ISR Number: 3886657-2Report Type:Expedited (15-DaCompany Report #308521 Outcome Hospitalization Initial or Prolonged PT Abdominal Pain Sleep Disorder Headache Muscle Twitching Malaise Vomiting Balance Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age:12 YR Route
Gender:Male Dose
I/FU:F Duration
Date:03/26/02ISR Number: 3888125-0Report Type:Expedited (15-DaCompany Report #308521 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Malaise Sleep Disorder
Age:12 YR
Gender:Male
I/FU:F
Page: 432
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Headache Abdominal Pain Balance Disorder Muscle Twitching Vomiting
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route
Dose
Duration 23 DAY
Date:03/26/02ISR Number: 3889699-6Report Type:Expedited (15-DaCompany Report #262856 Outcome Congenital Anomaly PT Breech Presentation Pregnancy Caesarean Section Low Set Ears Premature Baby Maternal Drugs Affecting Foetus Congenital Hand Malformation Skull Malformation Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:03/26/02ISR Number: 3889700-XReport Type:Expedited (15-DaCompany Report #308521 Outcome Hospitalization Initial or Prolonged PT Muscle Twitching Sleep Disorder Abdominal Pain Headache Vomiting Asthenia Gait Disturbance Malaise Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:12 YR Route
Gender:Male Dose
I/FU:I Duration
Date:03/27/02ISR Number: 3890784-3Report Type:Direct Outcome PT Depression Sleep Disorder Headache Abnormal Dreams Paraesthesia Anxiety
Age:46 YR Route
Gender:Male
I/FU:I
Dose Duration 250MG WEEKLY
Age:12 YR
Gender:Male
I/FU:F
PT Balance Disorder Headache Sleep Disorder Malaise Pyrexia Vomiting Muscle Twitching Page: 433
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asthenia Abdominal Pain Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Route ORAL Dose ORAL Duration
Date:03/29/02ISR Number: 3891942-4Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Other Serious PT Nervousness Overdose Anxiety Depression Suicidal Ideation Suicide Attempt Condition Aggravated Mania Agitation Bipolar Disorder
Age: Route ORAL
Gender:Female Dose ONE CAPSUL WEEKLY ORAL
I/FU:I Duration
Date:03/29/02ISR Number: 3891958-8Report Type:Direct Outcome Other Serious PT Nightmare Fear
Company Report #CTU 164480 Report Source Product Larium Estrogen Progesterone Synthroid Role PS C C C Manufacturer
Gender:Female Dose ONE PILL WEEKLY ORAL
I/FU:I Duration
Date:03/29/02ISR Number: 3891961-8Report Type:Direct Outcome Disability Other Serious PT Fibromyalgia Depression Suicidal Ideation
Company Report #CTU 164482 Report Source Product Lariam/Mefloquin Role PS Manufacturer
Gender:Female Dose WEEKLY ORAL
I/FU:I Duration
Date:04/01/02ISR Number: 3892044-3Report Type:Expedited (15-DaCompany Report #309830 Outcome Hospitalization Initial or Prolonged PT Cerebellar Ataxia Report Source Product Lariam Nivaquine Paludrine Artemether Role PS SS SS C Manufacturer Roche
Age:52 YR Route
Gender:Male Dose
I/FU:I Duration
PO.
DAY
Date:04/03/02ISR Number: 3895454-3Report Type:Expedited (15-DaCompany Report #309830 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Muscular Weakness Plasmodium Falciparum
Age:52 YR
Gender:Male
I/FU:I
Page: 434
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Tachypnoea Blood Pressure Decreased Heart Rate Increased Confusional State Aggression Dehydration Loss Of Consciousness Asthenia Cerebellar Ataxia Diarrhoea
Product Lariam (Mefloquine Hydrochloride) Paludrine (Chloroguanide Hydrochloride) 100 Mg Artemether (Artemether)
Role PS
Manufacturer
Route ORAL
Dose ARTEMETHER (ARTEMETHER)
Duration
SS SS
ORAL
1 DOSE FORM DAILY ORAL 200 MG MULTIPLE
Date:04/08/02ISR Number: 3895865-6Report Type:Expedited (15-DaCompany Report #309830 Outcome Hospitalization Initial or Prolonged PT Cerebellar Ataxia Report Source Product Lariam Paludrine Nivaquine Artemether Role PS SS SS SS Manufacturer Roche
Age:52 YR Route
Gender:Male Dose
I/FU:F Duration
PO.
DAY
Date:04/08/02ISR Number: 3898379-2Report Type:Direct Outcome Other Serious PT Dizziness
Gender:Female Dose 1 PER WK/5 ORAL
I/FU:I Duration
Date:04/09/02ISR Number: 3896411-3Report Type:Expedited (15-DaCompany Report #310770 Outcome Other Serious PT Ankle Fracture Palpitations Chest Pain Ventricular Extrasystoles Anxiety Electrocardiogram Qt Prolonged Report Source Product Lariam Fragmin Role PS C Manufacturer Roche
Age:33 YR Route
Gender:Female Dose DAILY DOSE REPORTED AS 2500 IE.
I/FU:I Duration
Date:04/10/02ISR Number: 3897120-7Report Type:Expedited (15-DaCompany Report #310741 Outcome Other Serious PT Abortion Spontaneous Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Date:04/10/02ISR Number: 3898007-6Report Type:Expedited (15-DaCompany Report #309830 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Diarrhoea Muscular Weakness Cerebellar Ataxia
Age:52 YR
Gender:Male
I/FU:F
Page: 435
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Loss Of Consciousness Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Paludrine (Chloroguanide Hydrochloride) Nivaquine (Chloroquine Sulfate) Artemether (Artemether) Role PS SS Manufacturer Route ORAL ORAL Dose ORAL 1 DOSE FORM DAILY ORAL ORAL 200 MG MULTIPLE Duration
SS SS
ORAL
Date:04/10/02ISR Number: 3899376-3Report Type:Direct Outcome Other Serious PT Headache Discomfort Dizziness Nausea Anxiety Eye Pain Mood Swings
Company Report #CTU 165430 Report Source Product Lariam 250 Mg Flagyl Zithromax Prilosec Supplements Librax Elavil Biaxin Vitamins, Role PS C C C C C C C C Manufacturer
Age:40 YR Route
Gender:Female Dose
I/FU:I Duration
Date:04/11/02ISR Number: 3899398-2Report Type:Expedited (15-DaCompany Report #310770 Outcome Other Serious PT Electrocardiogram Qt Prolonged Anxiety Chest Pain Palpitations Ventricular Extrasystoles Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Fragmin (Dalteparin Sodium) Role PS C Manufacturer
Gender:Female Dose
I/FU:I Duration
Date:04/12/02ISR Number: 3899745-1Report Type:Expedited (15-DaCompany Report #310741 Outcome Other Serious PT Pregnancy Maternal Drugs Affecting Foetus Abortion Spontaneous Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:04/12/02ISR Number: 3900290-5Report Type:Direct Outcome PT Nightmare Disorientation Fear 09:37 AM
Age:53 YR Route
Gender:Male Dose 1 PER
I/FU:I Duration
03-Apr-2012
Page: 436
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/02ISR Number: 3900029-3Report Type:Direct Outcome PT Insomnia Nervousness Panic Attack Flushing Bladder Disorder Company Report #CTU 165643 Report Source Product Lariam Role PS Manufacturer Age: Route Gender:Female I/FU:I
Dose Duration 1 DOSE PER WEEK X 6 WKS
Date:04/17/02ISR Number: 3900592-2Report Type:Expedited (15-DaCompany Report #310850 Outcome Hospitalization Initial or Prolonged PT Neutropenia Haemoglobin Decreased Pyrexia Leukopenia Report Source Product Lariam Kinin Role PS C Manufacturer Roche
Age:20 YR Route
Gender:Female Dose
Date:04/17/02ISR Number: 3900596-XReport Type:Expedited (15-DaCompany Report #310913 Outcome Other Serious PT Pollakiuria Abnormal Dreams Report Source Product Lariam Role PS Manufacturer Roche
Age:28 YR Route
Gender:Female Dose
Date:04/22/02ISR Number: 3904484-4Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Paranoia Delusion Confusional State Agitation Pressure Of Speech
Company Report #CTU 166347 Report Source Product Mefloquine 250mg Bisoprolol Estradiol Role PS C C Manufacturer
Gender:Female
I/FU:I
Dose Duration 250MG WEEKLY ORAL
Date:04/23/02ISR Number: 3904592-8Report Type:Expedited (15-DaCompany Report #311417 Outcome Other Serious PT Thrombocytopenia Neutropenia Report Source Product Lariam Aspirine Efferalgan Role PS C C Manufacturer Roche
Age:29 YR Route
Gender:Male Dose
Date:04/24/02ISR Number: 3905788-1Report Type:Expedited (15-DaCompany Report #311387 Outcome Hospitalization PT Coordination Abnormal Report Source Product Lariam Role PS Manufacturer Roche
Age:48 YR Route
Gender:Male Dose
Dizziness Diplopia Vomiting
03-Apr-2012
09:37 AM
Page: 437
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/02ISR Number: 3906283-6Report Type:Direct Outcome Other Serious PT Influenza Depression Decreased Activity Company Report #CTU 166528 Report Source Product Lariam Role PS Manufacturer Age:19 YR Route Gender:Female I/FU:I
Dose Duration ONCE A WEEK, 8 DOSES
Date:04/25/02ISR Number: 3906132-6Report Type:Expedited (15-DaCompany Report #310913 Outcome Other Serious PT Pollakiuria Abnormal Dreams Report Source Product Lariam Role PS Manufacturer Roche
Age:28 YR Route
Gender:Female Dose
Date:04/26/02ISR Number: 3906880-8Report Type:Expedited (15-DaCompany Report #269045 Outcome Disability PT Rash Abdominal Pain Hyperaesthesia Arthralgia Diarrhoea Liver Function Test Abnormal Vomiting Report Source Product Lariam Role PS Manufacturer Roche
Age:25 YR Route
Gender:Female Dose
Date:04/26/02ISR Number: 3907842-7Report Type:Expedited (15-DaCompany Report #311417 Outcome Other Serious PT Febrile Convulsion Thrombocytopenia Neutropenia Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Aspirine (Aspirin) Efferalgan (Acetaminophen) Role PS C C Manufacturer
I/FU:I Duration
Date:04/26/02ISR Number: 3907914-7Report Type:Expedited (15-DaCompany Report #311387 Outcome Hospitalization Initial or Prolonged PT Dizziness Diplopia Encephalitis Coordination Abnormal Vomiting Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:04/29/02ISR Number: 3907812-9Report Type:Expedited (15-DaCompany Report #309533 Outcome Other Serious PT Cardiac Failure Ventricular Hypokinesia Report Source Product Lariam Role PS Manufacturer Roche
Age:33 YR Route
Gender:Male Dose
03-Apr-2012
09:37 AM
Page: 438
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/02ISR Number: 3907824-5Report Type:Expedited (15-DaCompany Report #311417 Outcome Other Serious PT Neutropenia Thrombocytopenia Report Source Product Lariam Aspirine Efferalgan Role PS C C Manufacturer Roche Age:29 YR Route Gender:Male Dose I/FU:F Duration 1 DAY
Date:05/01/02ISR Number: 3909145-3Report Type:Expedited (15-DaCompany Report #310913 Outcome Other Serious PT Pollakiuria Abnormal Dreams Report Source Product Lariam Role PS Manufacturer Roche
Age:28 YR Route
Gender:Female Dose
Date:05/01/02ISR Number: 3911255-1Report Type:Expedited (15-DaCompany Report #269045 Outcome Disability PT Diarrhoea Rash Arthralgia Liver Function Test Abnormal Vomiting Abdominal Pain Hyperaesthesia Report Source Foreign Health Professional Other Product Lariam(Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:I Duration
Date:05/01/02ISR Number: 3911290-3Report Type:Expedited (15-DaCompany Report #311417 Outcome Other Serious PT Thrombocytopenia Neutropenia Febrile Convulsion Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Aspirine (Aspirin) Efferalgan (Acetaminophen) Role PS C C Manufacturer
I/FU:F Duration
Date:05/01/02ISR Number: 3911292-7Report Type:Expedited (15-DaCompany Report #309533 Outcome Other Serious PT Cardiac Failure Dilatation Ventricular Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Age:50 YR
Gender:Female
I/FU:I
PT Burning Sensation Anxiety Insomnia Feeling Cold Dizziness Dyspnoea 09:37 AM Page: 439
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Jittery Pain Chills Tremor Paraesthesia Palpitations
Report Source
Product Lariam 250 -Mg Tablets Roche
Role PS
Manufacturer Roche
Route ORAL
Dose 1 TABLE 1 PER WEEK ORAL
Duration
Date:05/02/02ISR Number: 3909837-6Report Type:Expedited (15-DaCompany Report #311387 Outcome Death Hospitalization Initial or Prolonged PT Dizziness Coordination Abnormal Vomiting Diplopia Encephalitis Viral Immune System Disorder Report Source Consumer Product Lariam Role PS Manufacturer Roche
Age:48 YR Route
Gender:Male Dose
Date:05/02/02ISR Number: 3909838-8Report Type:Expedited (15-DaCompany Report #312383 Outcome Other Serious PT Vith Nerve Paralysis Report Source Product Lariam Role PS Manufacturer Roche
Age:51 YR Route
Gender:Male Dose
Date:05/03/02ISR Number: 3910667-XReport Type:Expedited (15-DaCompany Report #312383 Outcome Other Serious PT Vith Nerve Paralysis Report Source Product Lariam Role PS Manufacturer Roche
Age:51 YR Route
Gender:Male Dose
Date:05/03/02ISR Number: 3912167-XReport Type:Direct Outcome Life-Threatening Other Serious PT Dyspnoea Heart Rate Decreased Palpitations Arrhythmia Mental Disorder Nightmare Panic Attack Dizziness Paranoia Hyperhidrosis Anxiety Nervousness
Company Report #CTU 167303 Report Source Product Larium Aspirin Birth Control Pills Role PS C C Manufacturer
Gender:Female Dose 1 PILL 1X WEEK ORAL
I/FU:I Duration
Date:05/06/02ISR Number: 3912508-3Report Type:Direct Outcome Disability PT Suicidal Ideation Anxiety Panic Attack 09:37 AM
Company Report #CTU 167374 Report Source Product Mefloquine (Lariam) Role PS Manufacturer
Gender:Male Dose 1 DAY ORAL
I/FU:I Duration
03-Apr-2012
Page: 440
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/02ISR Number: 3912580-0Report Type:Expedited (15-DaCompany Report #311387 Outcome Death Hospitalization Initial or Prolonged PT Coordination Abnormal Vomiting Diplopia Encephalitis Viral Dizziness Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Age:48 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:F Duration
Date:05/07/02ISR Number: 3912581-2Report Type:Expedited (15-DaCompany Report #312383 Outcome Other Serious PT Vith Nerve Paralysis Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:05/07/02ISR Number: 3912886-5Report Type:Expedited (15-DaCompany Report #312383 Outcome Other Serious PT Vith Nerve Paralysis Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:F Duration
Date:05/10/02ISR Number: 3913789-2Report Type:Expedited (15-DaCompany Report #312621 Outcome Other Serious PT Hypoaesthesia Oral Viith Nerve Paralysis Paraesthesia Oral Report Source Product Lariam Role PS Manufacturer Roche
Age:30 YR Route
Gender:Male Dose
Date:05/14/02ISR Number: 3915583-5Report Type:Expedited (15-DaCompany Report #264418 Outcome Other Serious PT Premature Baby Premature Separation Of Placenta Report Source Product Lariam Quinine Sulfate Role PS C Manufacturer Roche
Age: Route
Gender:Female Dose 24 HOUR PERIODS EVERY 8 HOURS, 10 MG/KG. TREATED 03 TO
I/FU:F Duration
25
DAY
Age:49 YR
Gender:Female
I/FU:F
Outcome Disability
PT Deafness Tinnitus Ear Discomfort
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route
Dose
Duration 36 DAY
03-Apr-2012
09:37 AM
Page: 441
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/02ISR Number: 3915609-9Report Type:Expedited (15-DaCompany Report #311320 Outcome Other Serious PT Visual Field Defect Report Source Product Lariam Role PS Manufacturer Roche Age:41 YR Route Gender:Male Dose I/FU:F Duration 363 DAY
Date:05/14/02ISR Number: 3916964-6Report Type:Expedited (15-DaCompany Report #312621 Outcome Other Serious PT Nuclear Magnetic Resonance Imaging Abnormal Hypoaesthesia Oral Paraesthesia Oral Viith Nerve Paralysis Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:I Duration
Date:05/15/02ISR Number: 3916379-0Report Type:Direct Outcome Other Serious PT Abnormal Behaviour Anger
Age:50 YR Route
Gender:Male
I/FU:I
Dose Duration ONE TABLET A WEEK
Date:05/16/02ISR Number: 3916689-7Report Type:Expedited (15-DaCompany Report #312628 Outcome Other Serious PT Influenza Like Illness Report Source Product Lariam Role PS Manufacturer Roche
Age:25 YR Route
Gender:Male Dose
I/FU:F Duration
Date:05/16/02ISR Number: 3917735-7Report Type:Direct Outcome Disability PT Arthralgia Nausea Neck Pain Pyrexia Myalgia Headache Muscle Spasms Pain Movement Disorder Back Pain Gait Disturbance Chills
Age: Route
Gender:Female Dose ONCE A
I/FU:I Duration
Age:
Gender:Female
I/FU:I
Outcome Disability
PT Balance Disorder Dysstasia Gait Disturbance Feeling Abnormal
Report Source
Product Lariam
Role PS
Manufacturer
Route
Dose ONCE A
Duration
03-Apr-2012
09:37 AM
Page: 442
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/02ISR Number: 3917198-1Report Type:Expedited (15-DaCompany Report #313299 Outcome Other Serious PT Gastrointestinal Haemorrhage Report Source Product Lariam Role PS Manufacturer Roche Age:70 YR Route Gender:Female Dose I/FU:I Duration 77 DAY
Date:05/17/02ISR Number: 3917205-6Report Type:Expedited (15-DaCompany Report #313197 Outcome Hospitalization Initial or Prolonged Disability PT Agitation Psychotic Disorder Hallucination, Auditory Dependent Personality Disorder Paranoia Report Source Product Mefloquine Hydrochloride Cannabis Sativa Role PS C Manufacturer Roche
Age:32 YR Route
Gender:Male Dose
Date:05/20/02ISR Number: 3919404-6Report Type:Expedited (15-DaCompany Report #312628 Outcome Other Serious PT Chills Pain Influenza Like Illness Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:25 YR Route
Gender:Male Dose 250 MG 1 PER WEEK
I/FU:I Duration
Date:05/20/02ISR Number: 3919494-0Report Type:Expedited (15-DaCompany Report #311320 Outcome Other Serious PT Visual Field Defect Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:I Duration
Date:05/20/02ISR Number: 3919569-6Report Type:Expedited (15-DaCompany Report #264418 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Apgar Score Low Pregnancy Caesarean Section Maternal Drugs Affecting Foetus Premature Baby Premature Separation Of Placenta Report Source Consumer Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:05/20/02ISR Number: 3919652-5Report Type:Expedited (15-DaCompany Report #311132 Outcome Disability PT Ear Discomfort Deafness Tinnitus Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 443
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/02ISR Number: 3920502-1Report Type:Direct Outcome Disability PT Major Depression Suicidal Ideation Company Report #CTU 168520 Report Source Product Lariam Role PS Manufacturer Age:16 YR Route Gender:Female Dose 250 MG/WK I/FU:I Duration
Date:05/22/02ISR Number: 3922870-3Report Type:Expedited (15-DaCompany Report #313197 Outcome Hospitalization Initial or Prolonged Disability PT Psychotic Disorder Agitation Dependent Personality Disorder Hallucination, Auditory Paranoia Report Source Foreign Other Product Mefloquine Hydrochloride(Mefloq uine Hydrochloride) Cannabis Sativa(Cannabis) Role PS C Manufacturer
Gender:Male Dose DOSE FORM E DAILY ORAL
I/FU:I Duration
Date:05/22/02ISR Number: 3922872-7Report Type:Expedited (15-DaCompany Report #313299 Outcome Other Serious PT Gastrointestinal Haemorrhage Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:I Duration
Date:05/23/02ISR Number: 3920961-4Report Type:Direct Outcome Life-Threatening Disability Required Intervention to Prevent Permanent Impairment/Damage PT Depression Palpitations Paranoia Pyrexia Vertigo Suicidal Ideation Heart Rate Increased Panic Reaction Fatigue Sleep Disorder Headache Mood Swings
Company Report #CTU 168739 Report Source Product Lariam Ortho-Tricyclen Role PS C Manufacturer Roche
Age: Route ORAL
I/FU:I Duration
Date:05/23/02ISR Number: 3920972-9Report Type:Direct Outcome Other Serious PT Headache Feeling Abnormal
Company Report #CTU 168747 Report Source Product Mefloguine Roche Role PS Manufacturer Roche
Gender:Male
I/FU:I
Dose Duration NOT SURE 1 WEEKLY ORAL
Dizziness Palpitations Visual Impairment Panic Attack
Cipro
03-Apr-2012
09:37 AM
Page: 444
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/02ISR Number: 3924251-5Report Type:Expedited (15-DaCompany Report #304145 Outcome Other Serious PT Pyrexia Respiratory Disorder Rash Guillain-Barre Syndrome Report Source Health Professional Product Lariam Role PS Manufacturer Roche Age:32 YR Route Gender:Male Dose I/FU:F Duration
Date:05/29/02ISR Number: 3924280-1Report Type:Expedited (15-DaCompany Report #313979 Outcome Disability PT Drug Withdrawal Syndrome Mood Altered Depression Anxiety Report Source Product Lariam Role PS Manufacturer Roche
Age:32 YR Route
Gender:Male Dose
Date:05/29/02ISR Number: 3924281-3Report Type:Expedited (15-DaCompany Report #313825 Outcome Death PT Paranoia Death Mood Altered Report Source Product Lariam Role PS Manufacturer Roche
Age:27 YR Route
Gender:Male Dose
I/FU:I Duration
Date:05/31/02ISR Number: 3927273-3Report Type:Expedited (15-DaCompany Report #313825 Outcome Death PT Personality Change Asphyxia Fear Feeling Abnormal Paranoia Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:27 YR Route
Gender:Male Dose
I/FU:I Duration
Date:05/31/02ISR Number: 3927275-7Report Type:Expedited (15-DaCompany Report #304145 Outcome Other Serious PT Rash Guillain-Barre Syndrome Pyrexia Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride)250mg Role PS Manufacturer
I/FU:F Duration
Date:05/31/02ISR Number: 3927276-9Report Type:Expedited (15-DaCompany Report #313979 Outcome Disability PT Depression Report Source Foreign Product Lariam (Mefloquine Role Manufacturer
Age:32 YR Route
Gender:Male Dose
I/FU:I Duration
Mood Altered Drug Withdrawal Syndrome Anxiety
Other
Hydrochloride)
PS
ORAL
250 MG DAILY ORAL
03-Apr-2012
09:37 AM
Page: 445
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/02ISR Number: 3932755-4Report Type:Periodic Outcome Other Serious PT Malaria Company Report #258485 Report Source Health Professional Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Role Manufacturer Age:20 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
1 DOSE FORM 1 PER WEEK ORAL
Date:06/04/02ISR Number: 3932756-6Report Type:Periodic Outcome Death PT Completed Suicide Hallucination
Age: Route ORAL
Gender: Dose ORAL
I/FU:I Duration
Date:06/04/02ISR Number: 3932757-8Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Depression Diplopia Hallucination Balance Disorder Coordination Abnormal Nightmare Insomnia Mental Disorder
Company Report #258950 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Mg Doxycycline (Doxycyline) Prempro (Estrogens, Conjugated/Medroypro gesterone Acetate) Cardizem (Diltiazem Hydrochloride) Cipro (Ciprofloxacin Hydrochloride) Lasix (Furosemide) Role Manufacturer
Age:62 YR Route
Gender:Female Dose
I/FU:I Duration
PS C C C C C
ORAL
Date:06/04/02ISR Number: 3932758-XReport Type:Periodic Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Anxiety Decreased Appetite Depression Hypomania Agitation Insomnia Disturbance In Attention Hyperaesthesia
Age:26 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/04/02ISR Number: 3932759-1Report Type:Periodic Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Fatigue Haemoglobin Decreased Malaria
Company Report #259529 Report Source Consumer Product Lariam Tablets (Mefloquine Hydrochloride) 250 Role Manufacturer
Age:50 YR Route
Gender:Male Dose
I/FU:I Duration
Page: 446
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mg Centrum (Ascorbic/Cholecalci ferol/Cr./Cu./Folic Acid/Iodine/Iron/Iv PS ORAL 250 MG 1 PER WEEK ORAL
SS
ORAL
1 DOSE FORM 1 PER DAY ORAL
Date:06/04/02ISR Number: 3932760-8Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Bradycardia Dysarthria Arrhythmia Insomnia
Age:63 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/04/02ISR Number: 3932761-XReport Type:Periodic Outcome Other Serious PT Aggression Lethargy Psychotic Disorder Hallucination
Age:19 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Date:06/04/02ISR Number: 3932762-1Report Type:Periodic Outcome Other Serious PT Malaria
Age:20 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Age:20 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
Age:20 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/02ISR Number: 3943960-5Report Type:Periodic Outcome Other Serious PT Malaria Company Report #266440 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age:21 YR Route ORAL Gender:Male Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:06/04/02ISR Number: 3943961-7Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Palpitations Dizziness
Company Report #266772 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Allegra (Fexofenadne Hydrochloride) Premarin (Estrogens) Role PS C C Manufacturer
I/FU:I Duration
Date:06/04/02ISR Number: 3943962-9Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Hallucination, Visual Paranoia Depression Confusional State Anxiety Cognitive Disorder
Company Report #269411 Report Source Literature Other Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Role Manufacturer
Age:52 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
21
DAY
Date:06/04/02ISR Number: 3943963-0Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Insomnia Heart Rate Increased Anxiety Malaria Tremor
Company Report #304961 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) Birth Control Pill (Oral Contractptive Nos) Luvox (Fluvoxamine) Role PS Manufacturer
Gender:Female Dose 1 PER ORAL WEEK
I/FU:I Duration
C C
Date:06/04/02ISR Number: 3943964-2Report Type:Periodic Outcome Required Intervention to PT Hyperventilation Psychotic Disorder
Age:25 YR
Gender:Female
I/FU:F
Anxiety Hallucination, Auditory Crying Hallucination, Visual Jamais Vu Thinking Abnormal Tremor Dissociation Page: 448
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Hyperglycaemia Suicidal Ideation Depression Hallucination Abnormal Dreams Confusional State Feeling Abnormal
Product Lariam (Mefloquine Hydrochloride) 250 Mg Risperdal (Risperidone) Zyprexa (Olanzapine) Valium (Diazepam)
Role PS SS SS SS
Manufacturer
Route ORAL
Duration
Date:06/04/02ISR Number: 3943965-4Report Type:Periodic Outcome Disability PT Muscular Weakness Diarrhoea Weight Decreased Balance Disorder Panic Attack Dizziness Nerve Injury Anxiety Nausea
I/FU:F Duration
Date:06/04/02ISR Number: 3946386-3Report Type:Periodic Outcome Other Serious PT Fatigue Hallucination Dysgeusia Lethargy Insomnia Depression Suicidal Ideation
Company Report #268911 Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Prempro (Estrogens Conjugagted/Medroxyp rogesterone Acetate) Fosamax (Alendronate Sodium) Role PS Manufacturer
I/FU:I Duration
C C
Date:06/10/02ISR Number: 3930038-XReport Type:Expedited (15-DaCompany Report #304145 Outcome Other Serious PT Guillain-Barre Syndrome Dyspnoea Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Age:32 YR Route
Gender:Male Dose 4 TABLETS TAKEN IN TOTAL.
Date:06/10/02ISR Number: 3930229-8Report Type:Direct Outcome Other Serious PT Abnormal Behaviour Mania
Company Report #CTU 169778 Report Source Product Lariam 250mg Roche Laboratories Role PS Manufacturer Roche Laboratories
Gender:Female Dose 62.5MG WEEK ORAL
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 449
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/02ISR Number: 3931023-4Report Type:Expedited (15-DaCompany Report #314691 Outcome Life-Threatening PT Nightmare Bipolar Disorder Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche Age:38 YR Route Gender:Male Dose WEEKLY I/FU:I Duration 8 DAY
Date:06/12/02ISR Number: 3931889-8Report Type:Expedited (15-DaCompany Report #269729 Outcome Other Serious PT Viith Nerve Paralysis Paraesthesia Report Source Product Lariam Role PS Manufacturer Roche
Age:29 YR Route
Gender:Female Dose
Date:06/13/02ISR Number: 3934018-XReport Type:Expedited (15-DaCompany Report #314691 Outcome Life-Threatening PT Paranoia Mania Nightmare Bipolar Disorder Report Source Foreign Other Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Role Manufacturer
Age:38 YR Route
Gender:Male Dose
I/FU:I Duration
PS
ORAL
ORAL
Date:06/13/02ISR Number: 3934164-0Report Type:Expedited (15-DaCompany Report #304145 Outcome Other Serious PT Respiratory Disorder Pyrexia Guillain-Barre Syndrome Rash Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:F Duration
Date:06/17/02ISR Number: 3934814-9Report Type:Direct Outcome Life-Threatening PT Insomnia
Company Report #CTU 170287 Report Source Product Lariam/Mefloquine Hcl 250 Milligram Tablets Hoffman La Roche Role Manufacturer
Age:40 YR Route
Gender:Male Dose
I/FU:I Duration
PS
Hoffman La Roche
ORAL
1 TABLE WEEK ORAL
Date:06/17/02ISR Number: 3935025-3Report Type:Expedited (15-DaCompany Report #269729 Outcome Other Serious PT Fatigue Dizziness Facial Nerve Disorder
Age:29 YR
Gender:Female
I/FU:F
Eye Irritation Hypoaesthesia Arteriosclerosis Coronary Artery Paraesthesia Viith Nerve Paralysis Diplopia Headache 03-Apr-2012 09:37 AM Page: 450
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trigeminal Nerve Disorder Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Route ORAL Dose 250 MG 1 PER WEEK ORAL Duration
Date:06/18/02ISR Number: 3934117-2Report Type:Expedited (15-DaCompany Report #314691 Outcome Life-Threatening PT Nightmare Bipolar Disorder Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age:38 YR Route
Gender:Male Dose WEEKLY
Date:06/18/02ISR Number: 3934122-6Report Type:Expedited (15-DaCompany Report #314899 Outcome Hospitalization Initial or Prolonged Disability PT Disorientation Speech Disorder Incontinence Convulsion Agitation Drug Ineffective Hallucination Depression Headache Fatigue Memory Impairment Psychotic Disorder Loss Of Libido Paranoia Hostility Aggression Gait Disturbance Antisocial Behaviour Report Source Product Lariam Valium Role PS SS Manufacturer Roche Roche
Age: Route
Gender:Female Dose EVERY WEEK.
Date:06/20/02ISR Number: 3935868-6Report Type:Expedited (15-DaCompany Report #313825 Outcome Death PT Respiratory Failure Abnormal Behaviour Fear Asphyxia Report Source Consumer Product Lariam Role PS Manufacturer Roche
Age:27 YR Route
Gender:Male Dose
I/FU:F Duration
Age:38 YR
Gender:Male
I/FU:F
PT Bipolar Disorder Nightmare Paranoia
Product Mefloquine Hydrochloride (Mefloquine Hydrochloride)
Role
Manufacturer
Route
Dose
Duration
PS
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 451
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/02ISR Number: 3937925-7Report Type:Expedited (15-DaCompany Report #314899 Outcome Hospitalization Initial or Prolonged Disability PT Convulsion Gait Disturbance Incoherent Abnormal Behaviour Drug Ineffective Memory Impairment Speech Disorder Circulatory Collapse Hallucination Incontinence Fatigue Psychotic Disorder Aggression Antisocial Behaviour Hypersomnia Headache Loss Of Libido Paranoia Agitation Depression Disorientation Hostility Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Valium (Diazepam) Role PS SS Manufacturer Age: Route ORAL INTRAVENOUS Gender:Female Dose 250 MG ORAL 2 PER ONE DOSE INTRAVENOUS I/FU:I Duration
Date:06/20/02ISR Number: 3938627-3Report Type:Expedited (15-DaCompany Report #314899 Outcome Hospitalization Initial or Prolonged Disability PT Disorientation Drug Ineffective Headache Psychotic Disorder Agitation Speech Disorder Memory Impairment Hostility Loss Of Libido Circulatory Collapse Hypersomnia Paranoia Gait Disturbance Convulsion Antisocial Behaviour Incontinence Hallucination Fatigue Depression Aggression Incoherent Report Source Consumer Product Lariam Valium Role PS SS Manufacturer Roche Roche
Age: Route
Date:06/24/02ISR Number: 3937485-0Report Type:Expedited (15-DaCompany Report #315549 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Anxiety Delirium Aggression
Age:52 YR
Gender:Male
I/FU:I
Page: 452
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Agitation Report Source Product Lariam Role PS Manufacturer Roche Route Dose Duration 2 DAY
Date:06/24/02ISR Number: 3938733-3Report Type:Expedited (15-DaCompany Report #314899 Outcome Hospitalization Initial or Prolonged Disability PT Gait Disturbance Fatigue Loss Of Libido Psychotic Disorder Incontinence Cognitive Disorder Depression Aggression Speech Disorder Antisocial Behaviour Hypersomnia Abnormal Behaviour Drug Ineffective Paranoia Agitation Communication Disorder Disorientation Hallucination Headache Hostility Memory Impairment Convulsion Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Valium (Diazepam) Role PS SS Manufacturer
Age: Route ORAL INTRAVENOUS
Gender:Female Dose 250 MG ORAL 2 PER ONE DOSE INTRAVENOUS
I/FU:F Duration
Date:06/24/02ISR Number: 3939023-5Report Type:Expedited (15-DaCompany Report #313825 Outcome Death PT Fear Abnormal Behaviour Respiratory Failure Asphyxia Personality Change Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:27 YR Route
Gender:Male Dose
I/FU:F Duration
Date:06/26/02ISR Number: 3940478-0Report Type:Expedited (15-DaCompany Report #315549 Outcome Hospitalization Initial or Prolonged PT Delirium Anxiety Agitation Aggression Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Gender:Male Dose 1 DOSE FORM 3 PER DAY ; ORAL
I/FU:I Duration
Date:07/01/02ISR Number: 3941764-0Report Type:Expedited (15-DaCompany Report #312685 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Nervous System Disorder Loss Of Consciousness Report Source Product Lariam Role PS Manufacturer Roche
Age:52 YR Route
Gender:Male Dose
I/FU:F Duration
Page: 453
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/02ISR Number: 3943540-1Report Type:Direct Outcome Disability PT Nausea Thinking Abnormal Hallucinations, Mixed Diarrhoea Decreased Appetite Insomnia Anxiety Panic Attack Tinnitus Nightmare Paraesthesia Company Report #CTU 171531 Report Source Product Lariam, 250 Mg, Roche Role PS Manufacturer Roche Age: Route Gender:Female Dose 1 TABLET/WEEK I/FU:I Duration
Date:07/03/02ISR Number: 3942894-XReport Type:Expedited (15-DaCompany Report #316199 Outcome Other Serious PT Papilloedema Report Source Product Lariam Role PS Manufacturer Roche
Age:31 YR Route
Gender:Male Dose
I/FU:I Duration
Date:07/03/02ISR Number: 3942896-3Report Type:Expedited (15-DaCompany Report #316127 Outcome Other Serious PT Oedema Report Source Product Lariam Prozac Role PS C Manufacturer Roche
Age:32 YR Route
Gender:Male Dose 1/2 TABLET Q.
Date:07/03/02ISR Number: 3944277-5Report Type:Expedited (15-DaCompany Report #312685 Outcome Hospitalization Initial or Prolonged PT Nervous System Disorder Hunger Loss Of Consciousness Malaise Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:07/08/02ISR Number: 3944365-3Report Type:Expedited (15-DaCompany Report #316149 Outcome Disability PT Optic Ischaemic Neuropathy Report Source Product Lariam Role PS Manufacturer Roche
Age:50 YR Route
Gender:Male Dose
Date:07/08/02ISR Number: 3945803-2Report Type:Direct Outcome PT
Company Report #CTU 171760 Report Source Product Role Manufacturer
Age:26 YR Route
Gender:Female Dose
I/FU:I Duration
Other Serious
Fatigue Panic Attack Confusional State Abnormal Dreams Paranoia Anxiety Insomnia 09:37 AM
Lariam 250 Mg Roche Laboratories Inc.
PS
Roche Laboratories Inc.
ORAL
1 WEEK ORAL
03-Apr-2012
Page: 454
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/02ISR Number: 3945975-XReport Type:Expedited (15-DaCompany Report #313891 Outcome Other Serious PT Abortion Spontaneous Report Source Product Lariam Role PS Manufacturer Roche Age: Route Gender:Not SpecifiI/FU:I Dose Duration 1 DAY
Date:07/11/02ISR Number: 3946728-9Report Type:Expedited (15-DaCompany Report #316885 Outcome Other Serious PT Transient Ischaemic Attack Report Source Product Lariam Role PS Manufacturer Roche
Age:36 YR Route
Gender:Male Dose
I/FU:I Duration
Date:07/11/02ISR Number: 3946741-1Report Type:Direct Outcome Other Serious PT Headache Dizziness
Gender:Male
I/FU:I
Date:07/12/02ISR Number: 3947476-1Report Type:Expedited (15-DaCompany Report #313825 Outcome Death PT Asphyxia Mood Altered Fear Death Report Source Product Lariam Role PS Manufacturer Roche
Age:27 YR Route
Gender:Male Dose
I/FU:F Duration
Date:07/17/02ISR Number: 3949407-7Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Headache Feeling Of Body Temperature Change Palpitations Influenza Like Illness Paraesthesia Hyperhidrosis Fatigue Disorientation Eye Pain Neck Pain Tinnitus
Company Report #CTU 172441 Report Source Product Mefloquin 250mg Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration 250MG ONE PER ORAL
Age:23 YR
Gender:Female
I/FU:I
PT Insomnia Nightmare Sleep Disorder Pain Suicidal Ideation
Report Source
Product Lariam 250mg Hoffman Roche
Role PS
Manufacturer Hoffman Roche
Route
Dose 2TAB ONCE PER
Duration
03-Apr-2012
09:37 AM
Page: 455
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/02ISR Number: 3952731-5Report Type:Expedited (15-DaCompany Report #317246 Outcome Other Serious PT Obsessive-Compulsive Disorder Restlessness Anxiety Delusional Disorder, Persecutory Type Report Source Product Lariam Role PS Manufacturer Roche Age:21 YR Route Gender:Unknown Dose WEEKLY DOSING. I/FU:I Duration 15 DAY
Date:07/25/02ISR Number: 3953195-8Report Type:Expedited (15-DaCompany Report #317246 Outcome Other Serious PT Delusional Disorder, Persecutory Type Obsessive-Compulsive Disorder Restlessness Anxiety Report Source Product Lariam Role PS Manufacturer Roche
Age:21 YR Route
Gender:Male Dose WEEKLY DOSING.
Date:07/26/02ISR Number: 3953701-3Report Type:Expedited (15-DaCompany Report #312621 Outcome Other Serious PT Viith Nerve Paralysis Paraesthesia Oral Hypoaesthesia Oral Neuritis Report Source Product Lariam Role PS Manufacturer Roche
Age:30 YR Route
Gender:Male Dose
Date:07/26/02ISR Number: 3953703-7Report Type:Expedited (15-DaCompany Report #316035 Outcome Disability PT Depression Irritability Fatigue Hallucination, Visual Flashback Nightmare Report Source Product Lariam Contraceptive Pill Role PS C Manufacturer Roche
Age:17 YR Route
Gender:Female Dose
Date:07/30/02ISR Number: 3955307-9Report Type:Expedited (15-DaCompany Report #316127 Outcome Other Serious PT Oedema Report Source Product Lariam Prozac Role PS C Manufacturer Roche
Age:32 YR Route
Date:07/30/02ISR Number: 3955636-9Report Type:Direct Outcome PT Fear Anxiety Insomnia Paranoia 09:37 AM
Age:22 YR
Gender:Female
I/FU:I
03-Apr-2012
Page: 456
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Euphoric Mood Energy Increased Report Source Product Mefloquine 250 Mg Hepatitis A Vaccine Yellow Fever Vaccine Role PS C C Manufacturer Geneva Pharm Tech Corp Route Dose 250 MG X 1 Duration
Date:07/31/02ISR Number: 3955740-5Report Type:Expedited (15-DaCompany Report #263822 Outcome Life-Threatening PT Vision Blurred Cardiac Arrest Tinnitus Movement Disorder Grand Mal Convulsion Dizziness Deafness Report Source Health Professional Product Lariam Malarone Role PS SS Manufacturer Roche
Age:62 YR Route
Gender:Male Dose
Date:07/31/02ISR Number: 3956338-5Report Type:Direct Outcome Other Serious PT Grand Mal Convulsion Epilepsy
Company Report #CTU 173279 Report Source Product Mefloquine ( Lariam) Acetaminophen Aspirin Role PS C C Manufacturer
Gender:Male Dose WEEKLY ORAL
I/FU:I Duration 3 YR
Date:08/02/02ISR Number: 3956916-3Report Type:Expedited (15-DaCompany Report #316127 Outcome Other Serious PT Pruritus Oedema Peripheral Report Source Product Lariam Prozac Role PS C Manufacturer Roche
Age:32 YR Route
Date:08/05/02ISR Number: 3957894-3Report Type:Direct Outcome Other Serious PT Insomnia
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:08/07/02ISR Number: 3959487-0Report Type:Direct Outcome PT Blood Pressure Increased Depression Suicidal Ideation
Age:
Gender:Male
I/FU:I
Thinking Abnormal Anxiety Chest Pain Confusional State Heart Rate Increased Panic Attack Fatigue Feeling Abnormal 03-Apr-2012 09:37 AM Page: 457
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mood Swings Agitation Cold Sweat Disorientation Feeling Hot Headache Paranoia Disturbance In Attention Insomnia Memory Impairment Psychotic Disorder
Report Source
Product Lariam
Role PS
Manufacturer
Route
Dose 1 SERIES
Duration
Date:08/08/02ISR Number: 3959678-9Report Type:Expedited (15-DaCompany Report #318504 Outcome Hospitalization Initial or Prolonged PT Gastrointestinal Haemorrhage Report Source Product Lariam Role PS Manufacturer Roche
Age:52 YR Route
Gender:Female
I/FU:I
Dose Duration PATIENT RECEIVED 6 OR 7 TABLETS IN TOTAL.
Date:08/12/02ISR Number: 3960866-6Report Type:Expedited (15-DaCompany Report #316035 Outcome Disability PT Irritability Depression Nightmare Flashback Hallucination, Visual Fatigue Report Source Product Lariam Contraceptive Pill Role PS C Manufacturer Roche
Age:17 YR Route
Gender:Female Dose
Date:08/19/02ISR Number: 3963568-5Report Type:Expedited (15-DaCompany Report #319090 Outcome Other Serious PT Suicide Attempt Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:08/19/02ISR Number: 3963569-7Report Type:Expedited (15-DaCompany Report #319098 Outcome Hospitalization Initial or Prolonged PT Chills Crying Vomiting Hallucination Asthenia Chest Pain Anxiety Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
I/FU:I Duration
Suicidal Ideation
03-Apr-2012
09:37 AM
Page: 458
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/02ISR Number: 3963579-XReport Type:Expedited (15-DaCompany Report #319480 Outcome Life-Threatening PT Homicide Suicide Attempt Physical Assault Hypoxic-Ischaemic Encephalopathy Report Source Product Lariam Role PS Manufacturer Roche Age: Route Gender:Male Dose I/FU:I Duration
Date:08/20/02ISR Number: 3964267-6Report Type:Direct Outcome Other Serious PT Emotional Distress Anxiety Mental Disorder
Company Report #CTU 174573 Report Source Product Larium/Mefloquin Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 1 PER FOR TWO ORAL
Date:08/20/02ISR Number: 3964533-4Report Type:Direct Outcome Other Serious PT Vision Blurred
Company Report #CTU 174624 Report Source Product Lariam Tab 250 Mg Ud Nitrostat Role PS C Manufacturer
Age:70 YR Route
Gender:Male Dose 250 MG Q WK
Date:08/21/02ISR Number: 3964552-8Report Type:Expedited (15-DaCompany Report #319597 Outcome Other Serious PT Asphyxia Homicide Feeling Abnormal Aggression Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:08/23/02ISR Number: 3965918-2Report Type:Direct Outcome Other Serious PT Anxiety Depression Panic Attack Malaria Mental Disorder
Company Report #CTU 174896 Report Source Product Mefloquine Roche Role 250mg PS Roche ORAL Manufacturer
Age:22 YR Route
Gender:Male Dose 250MG QWEEK ORAL
I/FU:I Duration
Date:08/23/02ISR Number: 3965956-XReport Type:Direct Outcome Disability PT Depression
Company Report #CTU 174911 Report Source Product Lariam Standard Role PS Manufacturer
Age:25 YR Route
Gender:Female Dose
I/FU:I Duration
Bipolar Disorder Psychomotor Hyperactivity Insomnia Mania
03-Apr-2012
09:37 AM
Page: 459
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/02ISR Number: 3966695-1Report Type:Direct Outcome Life-Threatening Disability Required Intervention to Prevent Permanent Impairment/Damage PT Hypersensitivity Muscle Spasticity Tremor Anaphylactic Reaction Company Report #CTU 175006 Report Source Product Lariam Roche Role PS Manufacturer Roche Age:53 YR Route ORAL Gender:Female I/FU:I
Dose Duration 1 Q WEEK ORAL
Date:08/26/02ISR Number: 3966696-3Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Asthenia Disorientation Insomnia Dyspnoea Headache Vertigo Vision Blurred Anxiety Dizziness
Age:32 YR Route AURICULAR (OTIC)
Gender:Female Dose 1 WEEKLY AURICULAR
I/FU:I Duration
Date:08/26/02ISR Number: 3966794-4Report Type:Direct Outcome Disability PT Emotional Disorder Confusional State Crying Mania Panic Attack Stress Suicidal Ideation Anxiety Depression Paranoia
Age:30 YR Route
Gender:Female Dose 1X/WK
I/FU:I Duration
Date:08/26/02ISR Number: 3966896-2Report Type:Direct Outcome Other Serious PT Disorientation Paranoia Hypoaesthesia Panic Attack Confusional State
I/FU:I Duration
Date:08/26/02ISR Number: 3966913-XReport Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Psychomotor Skills Impaired Memory Impairment Suicidal Ideation
Age:
Gender:Male
I/FU:I
Page: 460
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Disorientation Report Source Product Larium Role PS Manufacturer Route Dose Duration
Date:08/27/02ISR Number: 3967147-5Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Screaming Fear Hallucination Nervous System Disorder Hyperhidrosis Feeling Cold Nervousness Poisoning Depression Crying Anxiety Flatulence Panic Attack Feeling Abnormal
Company Report #CTU 175112 Report Source Product Lariam 250 Mg Roche Role PS Manufacturer Roche
Gender:Male
I/FU:I
Date:08/27/02ISR Number: 3967173-6Report Type:Direct Outcome Disability PT Depression Anxiety Paranoia
Company Report #CTU 175102 Report Source Product Lariam Hoffman-Laroche Role PS Manufacturer Hoffman-Laroche
Gender:Female Dose 250MG WEEKLY ORAL
I/FU:I Duration
Date:08/28/02ISR Number: 3967043-3Report Type:Expedited (15-DaCompany Report #264418 Outcome Other Serious PT Pregnancy Apgar Score Low Premature Separation Of Placenta Caesarean Section Premature Baby Maternal Drugs Affecting Foetus Report Source Product Lariam Quinine Sulfate Role PS C Manufacturer Roche
Age: Route
Gender:Female Dose 24 HOUR PERIODS EVERY 8 HOURS, 10 MG/KG. TREATED 03 TO
I/FU:F Duration
25
DAY
Age:32 YR Route
Gender:Male Dose
I/FU:I Duration
Other Serious
Paranoia Panic Reaction
Lariam Roche
PS
Roche
ORAL
1/WEEK ORAL
03-Apr-2012
09:37 AM
Page: 461
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/02ISR Number: 3970033-8Report Type:Direct Outcome Disability PT Depression Paranoia Insomnia Hallucination Activities Of Daily Living Impaired Company Report #CTU 175541 Report Source Product Mefloquine Laroche Role Hoffman PS Hoffman Laroche BUCCAL 250 MG ONCE A WEEK BUCCAL Manufacturer Age:37 YR Route Gender:Female Dose I/FU:I Duration
Date:09/05/02ISR Number: 3970808-5Report Type:Expedited (15-DaCompany Report #320492 Outcome Death PT Depression Overdose Completed Suicide Report Source Product Lariam Role PS Manufacturer Roche
Age:22 YR Route
Gender:Female Dose
I/FU:I Duration
Date:09/05/02ISR Number: 3970809-7Report Type:Expedited (15-DaCompany Report #311320 Outcome Other Serious PT Blindness Visual Field Defect Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Age:41 YR Route
Gender:Male Dose
Date:09/05/02ISR Number: 3970849-8Report Type:Direct Outcome Life-Threatening Other Serious PT Abnormal Dreams Suicidal Ideation
Company Report #CTU 175737 Report Source Product Mefloquone Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose STANDARD WEEKLY ORAL
I/FU:I Duration
Date:09/05/02ISR Number: 3971375-2Report Type:Direct Outcome PT Disturbance In Attention Abnormal Behaviour Fatigue Insomnia Psychomotor Hyperactivity Nightmare
Company Report #CTU 175736 Report Source Product Larium 250 Mg Role PS Manufacturer
Age:49 YR Route
Gender:Female Dose
I/FU:I Duration
Date:09/06/02ISR Number: 3971323-5Report Type:Expedited (15-DaCompany Report #A0379543A Outcome Other Serious PT Diarrhoea Report Source Health Product Malarone Role PS Manufacturer Glaxo Wellcome
Gender:Male Dose
Tinnitus
Professional
Mefloquine
SS
ORAL
DAY
03-Apr-2012
09:37 AM
Page: 462
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/02ISR Number: 3971398-3Report Type:Expedited (15-DaCompany Report #316149 Outcome Disability PT Optic Ischaemic Neuropathy Report Source Health Professional Product Lariam Role PS Manufacturer Roche Age:50 YR Route Gender:Male Dose I/FU:F Duration 48 DAY
Date:09/06/02ISR Number: 3971399-5Report Type:Expedited (15-DaCompany Report #319597 Outcome Other Serious PT Anger Social Avoidant Behaviour Nervousness Homicide Communication Disorder Tremor Incoherent Aggression Feeling Abnormal Report Source Consumer Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:F Duration
Date:09/06/02ISR Number: 3971407-1Report Type:Expedited (15-DaCompany Report #320484 Outcome Other Serious PT Suicidal Ideation Anger Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:09/09/02ISR Number: 3974309-XReport Type:Expedited (15-DaCompany Report #02P-056-0198998-00 Outcome Hospitalization Initial or Prolonged PT Myalgia Amyotrophy Red Blood Cell Sedimentation Rate Increased Pain Systemic Inflammatory Response Syndrome Report Source Foreign Health Professional Product Isoptine (Verapamil) (Verapamil) Insuline Humalog Mefloquine Perindopril Simvastatin Insuline "Umuline" Acetylsalicylic Acid Role PS SS SS SS SS SS SS Manufacturer
Age:56 YR Route ORAL ORAL ORAL ORAL SUBCUTANEOUS ORAL
Gender:Male Dose 240 MG, PER ORAL 250 MG, 1 IN 1 WK, PER ORAL 2 MG, PER ORAL PER ORAL SUBCUTANEOUS PER ORAL
I/FU:I Duration
Date:09/10/02ISR Number: 3974021-7Report Type:Direct Outcome Disability PT Paranoia
Age:37 YR
Gender:Male
I/FU:I
Fatigue Hyperventilation Agitation Dizziness Hallucination Insomnia Fear Nightmare 03-Apr-2012 09:37 AM Page: 463
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Panic Disorder Report Source Product Lariam 250mg Roche Role PS Manufacturer Roche Route ORAL Dose Duration 1 TABLE ONCE PER ORAL
Date:09/10/02ISR Number: 3974116-8Report Type:Direct Outcome Other Serious PT Unevaluable Event
Company Report #CTU 176039 Report Source Product Lariam 250mg F Hoffman-Laroche Role PS Manufacturer F Hoffman-Laroche
Gender:Female Dose 1 TABLE ONCE A WEEK ORAL
I/FU:I Duration
Date:09/11/02ISR Number: 3974266-6Report Type:Expedited (15-DaCompany Report #PERI00202002217 Outcome Hospitalization Initial or Prolonged PT Red Blood Cell Sedimentation Rate Increased Myalgia Pain In Extremity Report Source Foreign Health Professional Other Product Coversyl (Perindopril) Lariam (Mefloquine) Kardegic (Acetylsalicylate Lysine) Umuline (Insulin Human Zinc Suspension) Humalog (Insulin Lispro) Lodales (Simvastatin) Isoptin (Verapamil Hydrochloride) Role PS SS Manufacturer
Gender:Male Dose 2 MG QD PO 250 MG DAILY PO DAILY PO DAILY SC DAILY SC DAILY
I/FU:I Duration
SS SS SS SS SS
ORAL SUBCUTANEOUS SUBCUTANEOUS
ORAL
DAILY PO
Date:09/12/02ISR Number: 3975274-1Report Type:Direct Outcome Other Serious PT Dizziness Fatigue Vertigo Tinnitus Dysgraphia
Company Report #CTU 176271 Report Source Product Lariam -Mefloaquin250 Mg. Roche Role PS Manufacturer Roche
Gender:Male Dose 250MG WEEKLY ORAL
I/FU:I Duration
Age:52 YR Route
Gender:Female Dose
I/FU:I Duration
Other Serious Required Intervention to Prevent Permanent Impairment/Damage
Insomnia Anxiety Paranoia Nervousness
Larium Plaquenil Ambien Biaxin
PS C C C
ORAL
ONCE WEEK ORAL
03-Apr-2012
09:37 AM
Page: 464
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/02ISR Number: 3975606-4Report Type:Expedited (15-DaCompany Report #321059 Outcome Hospitalization Initial or Prolonged PT Inflammation Amyotrophy Pain Pain In Extremity Myalgia Red Blood Cell Sedimentation Rate Increased Report Source Product Lariam Lodales Coversyl Kardegic Umuline Isoptine Humalog Role PS SS SS SS SS SS C Manufacturer Roche Age:56 YR Route Gender:Male Dose I/FU:I Duration 29 DAY
FORMULATION LYOPHILISED.
Date:09/16/02ISR Number: 3976184-6Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Aggression Suicidal Ideation Homicidal Ideation Hallucination Toxicity To Various Agents Psychotic Disorder
Company Report #CTU 176452 Report Source Product Mefloquine Hoffman La Roche Role PS Manufacturer Hoffman La Roche
Gender:Male Dose BI-WEEKLY ORAL
I/FU:I Duration
Date:09/17/02ISR Number: 3977060-5Report Type:Direct Outcome Disability PT Alopecia Dry Skin Vision Blurred Feeling Abnormal Headache Dizziness Swelling
Gender:Female Dose ONCE WEEKLY ORAL
I/FU:I Duration
Date:09/17/02ISR Number: 3977073-3Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Palpitations Illusion Dyspnoea Vertigo Dizziness Disorientation Visual Impairment Dysphagia Headache
Company Report #CTU 176590 Report Source Product Lariam 250mg Roche Lab Role PS Manufacturer Roche Lab
Gender:Male Dose ONCE WEEKLY ORAL
I/FU:I Duration
Anxiety
03-Apr-2012
09:37 AM
Page: 465
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/02ISR Number: 3977706-1Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Hallucination Neurosis Panic Attack Suicidal Ideation Night Sweats Tachycardia Insomnia Muscle Spasms Paranoia Decreased Appetite Psychotic Disorder Thirst Company Report #CTU 176752 Report Source Product Lariam Role PS Manufacturer Roche Pharmaceuticals Age:52 YR Route Gender:Male Dose ONE PER I/FU:I Duration
Date:09/23/02ISR Number: 3978040-6Report Type:Expedited (15-DaCompany Report #320927 Outcome Disability PT Dizziness Nausea Headache Vision Blurred Sedation Report Source Product Lariam Amlodipine Bendrofluazide Role PS C C Manufacturer Roche
Age:58 YR Route
Gender:Female Dose
Date:09/23/02ISR Number: 3978044-3Report Type:Expedited (15-DaCompany Report #320902 Outcome Hospitalization Initial or Prolonged PT Feeling Abnormal Cold Sweat Hallucination Aggression Disorientation Report Source Product Lariam Role PS Manufacturer Roche
Age:45 YR Route
Gender:Male Dose
I/FU:I Duration
Date:09/23/02ISR Number: 3979340-6Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability Other Serious PT Delusion Performance Status Decreased Anxiety Mental Disorder Blood Pressure Increased Suicidal Ideation Abnormal Behaviour Aggression Anger
Company Report #CTU 176999 Report Source Product Lariam Laroche Role PS Manufacturer Laroche
Age:32 YR Route
Gender:Male Dose
I/FU:I Duration
Divorced Hallucination Depression Palpitations
03-Apr-2012
09:37 AM
Page: 466
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/02ISR Number: 3978154-0Report Type:Expedited (15-DaCompany Report #321488 Outcome Other Serious PT Night Sweats Delirium Nightmare Heart Rate Increased Report Source Product Lariam Role PS Manufacturer Roche Age: Route Gender:Female Dose I/FU:I Duration 43 DAY
Date:09/26/02ISR Number: 3981417-6Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Agitation Depression Paraesthesia Palpitations Toxicity To Various Agents Anxiety Hypertension Nausea
Company Report #CTU 177370 Report Source Product Larium - Roche Role PS Manufacturer Roche
Age:55 YR Route
Gender:Female Dose 1 TABLET WEEKLY
I/FU:I Duration
Date:09/27/02ISR Number: 3982056-3Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Chills Paraesthesia Renal Pain Pollakiuria Morbid Thoughts Feeling Of Despair Panic Attack Insomnia Sleep Disorder
Company Report #CTU 177430 Report Source Product Lariam Doxycycline Bactrim Ciprofloxacin Role PS C C C Manufacturer Roche
Gender:Male Dose 250MG WEEK ORAL
I/FU:I Duration
Date:09/27/02ISR Number: 3985386-4Report Type:Expedited (15-DaCompany Report #321488 Outcome Other Serious PT Nightmare Heart Rate Increased Night Sweats Delirium Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Age: Route
Gender:Female Dose
I/FU:I Duration
Other Serious
Facial Pain Dizziness Nightmare Disorientation
Lariam Microgestin-Birth Control-
PS C
ORAL
WEEKLY ORAL
03-Apr-2012
09:37 AM
Page: 467
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/02ISR Number: 3985611-XReport Type:Direct Outcome Other Serious PT Disorientation Depression Mood Altered Company Report #CTU 177838 Report Source Product Mefloquine Role PS Manufacturer Age:21 YR Route Gender:Male Dose 1 PILL WEEK I/FU:I Duration
Date:10/07/02ISR Number: 3984410-2Report Type:Expedited (15-DaCompany Report #A0379543A Outcome Other Serious PT Tinnitus Diarrhoea Irritability Report Source Product Malarone Mefloquine Mvi Role PS SS C Manufacturer Glaxo Wellcome
Gender:Male Dose
Date:10/07/02ISR Number: 3984911-7Report Type:Expedited (15-DaCompany Report #305877 Outcome Other Serious PT Lung Infiltration Dyspnoea Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Age:42 YR Route
Gender:Male
I/FU:F
Dose Duration DESCRIBED AS 3 TABLETS IN THE MORNING, 2 IN THE MIDDLE OF THE 1 DAY
Date:10/07/02ISR Number: 3984914-2Report Type:Expedited (15-DaCompany Report #321938 Outcome Other Serious PT Vomiting Nausea Disturbance In Attention Abnormal Dreams Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age:29 YR Route
Gender:Male Dose
I/FU:I Duration
Date:10/07/02ISR Number: 3984952-XReport Type:Expedited (15-DaCompany Report #316199 Outcome Other Serious PT Optic Neuritis Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Age:32 YR Route
Gender:Male Dose
Date:10/07/02ISR Number: 3984973-7Report Type:Expedited (15-DaCompany Report #319597 Outcome Other Serious PT Homicide Social Avoidant Behaviour Dysphemia Report Source Consumer Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:F Duration
Tremor Aggression Feeling Abnormal Nervousness Abnormal Behaviour Incoherent Anger 03-Apr-2012 09:37 AM Page: 468
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/02ISR Number: 3987080-2Report Type:Direct Outcome Other Serious PT Tinnitus Myalgia Fibromyalgia Company Report #CTU 178124 Report Source Product Lariam- Roche Labs Role PS Manufacturer Roche Labs Age:60 YR Route ORAL Gender:Female Dose WEEKLY- 136 WKS ORAL I/FU:I Duration
Date:10/07/02ISR Number: 3987117-0Report Type:Direct Outcome Other Serious PT Abdominal Pain Tinnitus Depression Headache Abnormal Dreams Anxiety Pruritus
Company Report #CTU 178129 Report Source Product Lariam -Roche Labs Role PS Manufacturer Roche Labs
Gender:Male
I/FU:I
Dose Duration WEEKLY -150WKS ORAL
Date:10/07/02ISR Number: 3990430-4Report Type:Direct Outcome Disability PT Headache Panic Disorder Abnormal Behaviour Abdominal Pain Confusional State Mood Swings Emotional Disorder Insomnia Anxiety Decreased Appetite
Company Report #CTU 178059 Report Source Product Mefloquine Hydrochloride 250mg Geneva Pharm Tech Role PS Manufacturer Geneva Pharm Tech
Age:44 YR Route
Gender:Female Dose ONCE WEEKL
I/FU:I Duration
Date:10/08/02ISR Number: 3990489-4Report Type:Direct Outcome Other Serious PT Aggression Vomiting Abnormal Behaviour Malaise Mood Swings
Age:40 YR Route
Gender:Male
I/FU:I
Dose Duration 2 TABLETS 10 DAYS
Date:10/09/02ISR Number: 3987337-5Report Type:Direct Outcome Disability PT Mood Swings
Age:41 YR
Gender:Female
I/FU:I
Pulmonary Embolism Back Pain Chest Pain Dyspepsia Aggression Dizziness Stress Depression 03-Apr-2012 09:37 AM Page: 469
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Abnormal Headache Sleep Disorder Panic Attack
Report Source
Product Larium Oral Ulcer-Type Products Cimetidine Warfarin
Role PS C C C
Manufacturer
Route ORAL
Date:10/10/02ISR Number: 3987531-3Report Type:Expedited (15-DaCompany Report #320484 Outcome Hospitalization Initial or Prolonged PT Extrasystoles Panic Attack Insomnia Vestibular Disorder Hallucination Suicidal Ideation Cognitive Disorder Depression Toxicity To Various Agents Brain Injury Tremor Illusion Nervous System Disorder Hyperacusis Anger Report Source Consumer Product Lariam Role PS Manufacturer Roche
Age:52 YR Route
Gender:Male Dose
Date:10/11/02ISR Number: 3988282-1Report Type:Expedited (15-DaCompany Report #322910 Outcome Other Serious PT Dyspnoea Gastrointestinal Haemorrhage Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:10/14/02ISR Number: 3989477-3Report Type:Expedited (15-DaCompany Report #265329 Outcome Disability PT Illusion Hallucination Disturbance In Attention Dysarthria Panic Attack Report Source Product Lariam Role PS Manufacturer Roche
Age:42 YR Route
Gender:Male Dose
I/FU:I Duration
Date:10/15/02ISR Number: 3989917-XReport Type:Expedited (15-DaCompany Report #323150 Outcome Hospitalization Initial or Prolonged PT Drug Interaction Psoas Sign Coagulopathy Haematoma Report Source Health Professional Product Lariam Previscan Role PS I Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:F Duration
03-Apr-2012
09:37 AM
Page: 470
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/02ISR Number: 3991717-1Report Type:Direct Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage PT Contusion Decreased Appetite Heart Rate Increased Tremor Chills Syncope Nausea Hypertension Hyperhidrosis Company Report #CTU 178703 Report Source Product Lariam Hoffman La Roche Cardizem Cd Vioxx Centrum Silver Role PS C C C Manufacturer Hoffman La Roche Age: Route ORAL Gender:Female Dose STANDARD ONCE A WEEK ORAL I/FU:I Duration
Date:10/16/02ISR Number: 3990823-5Report Type:Expedited (15-DaCompany Report #86887 Outcome Disability PT Pain Suicidal Ideation Myalgia Arthropod Bite Csf Protein Abnormal Malaise Angina Pectoris Atrophy Feeling Of Body Temperature Change Asthenia Flushing Convulsion Tinnitus Nervousness Muscular Weakness Sleep Disorder Neck Pain Peripheral Sensory Neuropathy Epistaxis Fatigue Report Source Consumer Product Lariam Tablets Role PS Manufacturer Roche
Age:43 YR Route
Gender:Female Dose
Date:10/17/02ISR Number: 3991243-XReport Type:Expedited (15-DaCompany Report #323291 Outcome Death PT Respiratory Failure Maternal Drugs Affecting Foetus Microcephaly Pregnancy Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
Date:10/17/02ISR Number: 3997443-7Report Type:Expedited (15-DaCompany Report #323150 Outcome Hospitalization Initial or Prolonged PT Coagulopathy Drug Interaction Muscle Haemorrhage Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Previscan (Fluindione) Role PS SS Manufacturer
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 471
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/02ISR Number: 3992136-4Report Type:Expedited (15-DaCompany Report #200841 Outcome Hospitalization Initial or Prolonged Disability PT Accommodation Disorder Speech Disorder Dry Mouth Dysphagia Paraesthesia Emotional Disorder Panic Attack Asthenia Movement Disorder Tinnitus Vision Blurred Gait Disturbance Feeling Drunk Malaise Fall Heterophoria Tremor Balance Disorder Hallucination, Visual Diarrhoea Diplopia Hydrocephalus Arrhythmia Somnolence Fatigue Hyperventilation Nausea Dyspnoea Disturbance In Attention Report Source Health Professional Product Lariam Meningococcal Vaccine Flu Vaccine Role PS Manufacturer Roche Age:42 YR Route Gender:Male Dose CUMULATIVE DOSAGE= 750 MG I/FU:F Duration 380 1 1 DAY DAY DAY
C C
Date:10/21/02ISR Number: 3993095-0Report Type:Expedited (15-DaCompany Report #305230 Outcome Other Serious PT Congenital Tongue Anomaly Cryptorchism Maternal Drugs Affecting Foetus Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
Date:10/22/02ISR Number: 3994346-9Report Type:Expedited (15-DaCompany Report #314899 Outcome Hospitalization Initial or Prolonged Disability PT Incontinence Paranoia Speech Disorder Antisocial Behaviour Loss Of Libido
Age:
Gender:Female
I/FU:F
Communication Disorder Reading Disorder Depression Memory Impairment Incoherent Circulatory Collapse Hallucination Disorientation 03-Apr-2012 09:37 AM Page: 472
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Gait Disturbance Agitation Convulsion Hostility Drug Ineffective Aggression Headache Delusion Fatigue Mania Confusional State
Report Source
Product Lariam Valium
Role PS SS
Route
Dose EVERY WEEK.
Date:10/22/02ISR Number: 3994559-6Report Type:Expedited (15-DaCompany Report #323614 Outcome Hospitalization Initial or Prolonged PT Lung Infection Hypoxia Lung Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:10/22/02ISR Number: 3994562-6Report Type:Expedited (15-DaCompany Report #323551 Outcome Other Serious PT Diarrhoea Haemorrhagic Report Source Product Lariam Role PS Manufacturer Roche
Age:13 YR Route
Gender:Male Dose
I/FU:I Duration
Date:10/23/02ISR Number: 3995061-8Report Type:Expedited (15-DaCompany Report #265329 Outcome Disability PT Balance Disorder Hallucinations, Mixed Panic Attack Illusion Disturbance In Attention Hallucination, Olfactory Dysarthria Report Source Product Lariam Role PS Manufacturer Roche
Age:42 YR Route
Gender:Male Dose
I/FU:I Duration
Date:10/24/02ISR Number: 3996343-6Report Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Feeling Abnormal Insomnia Amnesia Crying Anger Vertigo
Company Report #CTU 179445 Report Source Product Lariam 250 Mg Mephaquin Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose 1 PILL ONCE A WEEK ORAL
I/FU:I Duration
Mood Swings
03-Apr-2012
09:37 AM
Page: 473
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/02ISR Number: 3998338-5Report Type:Direct Outcome Other Serious PT Dyspepsia Depression Company Report #CTU 179642 Report Source Product Lariam 250 Mg Mefloquin Mfr -Hoffman La Roche Role PS Manufacturer Hoffman La Roche Age:50 YR Route Gender:Male Dose 250 MG EVERY WEEK (ONE'S A WEEK) I/FU:I Duration
WK
Date:10/25/02ISR Number: 4000382-9Report Type:Direct Outcome Disability Other Serious PT Feeling Abnormal Stress Depression Anxiety
Gender:Female
I/FU:I
Date:10/29/02ISR Number: 3998705-XReport Type:Expedited (15-DaCompany Report #323614 Outcome Hospitalization Initial or Prolonged PT Hypoxia Infection Lung Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:F Duration
Date:10/31/02ISR Number: 4000596-8Report Type:Expedited (15-DaCompany Report #323900 Outcome Other Serious PT Maternal Drugs Affecting Foetus Abortion Spontaneous Paternal Drugs Affecting Foetus Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Date:11/01/02ISR Number: 4003334-8Report Type:Direct Outcome PT Nervousness Nightmare Weight Decreased Anxiety
Company Report #CTU 180174 Report Source Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route
Gender:Male Dose ONCE A WEEK
I/FU:I Duration
Age:36 YR
Gender:Male
I/FU:I
PT Dizziness Nausea
Report Source
Product Larium
Role PS
Manufacturer
Route ORAL
Dose 1 PILL WEEK ORAL
Duration
03-Apr-2012
09:37 AM
Page: 474
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/02ISR Number: 4002692-8Report Type:Expedited (15-DaCompany Report #324511 Outcome Hospitalization Initial or Prolonged PT Haemolytic Anaemia Report Source Product Lariam Role PS Manufacturer Roche Age:25 YR Route Gender:Female Dose I/FU:I Duration
Date:11/06/02ISR Number: 4004677-4Report Type:Expedited (15-DaCompany Report #324735 Outcome Disability PT Gait Disturbance Visual Impairment Tinnitus Report Source Product Lariam Role PS Manufacturer Roche
Age:39 YR Route
Gender:Male Dose
Date:11/07/02ISR Number: 4005549-1Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Paranoia Psychotic Disorder Delusion Hallucination Thinking Abnormal
Company Report #CTU 180546 Report Source Product Lariam La Roche Role PS Manufacturer La Roche
Gender:Male
I/FU:I
Dose Duration 1 TABLE ONCE A WEEK ORAL
Date:11/13/02ISR Number: 4012180-0Report Type:Expedited (15-DaCompany Report #321428 Outcome Other Serious PT Maternal Drugs Affecting Foetus Abortion Spontaneous Pregnancy Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Age: Route ORAL
Gender: Dose 250 MG 1 PER ONE DOSE ORAL
I/FU:I Duration
Date:11/13/02ISR Number: 4012181-2Report Type:Expedited (15-DaCompany Report #324511 Outcome Hospitalization Initial or Prolonged PT Haemorrhage Haemolytic Anaemia Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:25 YR Route
Gender:Female Dose
I/FU:F Duration
Date:11/13/02ISR Number: 4012182-4Report Type:Expedited (15-DaCompany Report #323150 Outcome Hospitalization PT Muscle Haemorrhage Report Source Foreign Product Lariam (Mefloquine Role Manufacturer
Age:48 YR Route
Gender:Male Dose
I/FU:F Duration
Pain Flatulence Constipation Drug Interaction Hypocoagulable State
Health Professional
Hydrochloride) Previscan (Fluindione) Lovenox (Enoxaparin Sodium)
PS SS C
ORAL ORAL
ORAL 1 DOSE FORM DAILY ORAL
03-Apr-2012
09:37 AM
Page: 475
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/02ISR Number: 4012183-6Report Type:Expedited (15-DaCompany Report #324949 Outcome Hospitalization Initial or Prolonged PT Headache Multiple Sclerosis Optic Neuritis Report Source Foreign Health Professional Product Lariam(Mefloquine Hydrochloride) Role PS Manufacturer Age:29 YR Route ORAL Gender:Male Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Date:11/15/02ISR Number: 4011394-3Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Congenital Anomaly Required Intervention to Prevent Permanent Impairment/Damage PT Asthenia Anxiety Blood Pressure Decreased Psychotic Disorder Dizziness Chills Headache Suicidal Ideation
Company Report #CTU 181033 Report Source Product Lariam (Mefloquin) Role PS Manufacturer
Age: Route ORAL
Gender:Female
I/FU:I
Dose Duration 1X WK 1 WK BEFOR ORAL; 1 X WK 4WKS AFT ORAL
Prozac Fludrocortizone
C C
Date:11/18/02ISR Number: 4013350-8Report Type:Expedited (15-DaCompany Report #324949 Outcome Hospitalization Initial or Prolonged PT Headache Optic Neuritis Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:F Duration
Date:11/18/02ISR Number: 4013366-1Report Type:Expedited (15-DaCompany Report #321428 Outcome Hospitalization Initial or Prolonged PT Maternal Drugs Affecting Foetus Abortion Spontaneous Pregnancy Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Age: Route ORAL
Gender:Unknown Dose 250 MG 1 PER ONE DOSE ORAL
I/FU:F Duration
Date:11/19/02ISR Number: 4014667-3Report Type:Expedited (15-DaCompany Report #325394 Outcome Other Serious PT Suicide Attempt Suicidal Ideation Homicidal Ideation Paranoia Confusional State Depression Hallucination Report Source Other Product Lariam Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:11/19/02ISR Number: 4014668-5Report Type:Expedited (15-DaCompany Report #325416 Outcome Other Serious 03-Apr-2012 09:37 AM PT Hallucination Confusional State
Age:27 YR
Gender:Male
I/FU:I
Page: 476
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delusion Anger Loss Of Consciousness Tremor
Report Source Other
Role PS
Manufacturer
Route
Dose
Duration
Date:11/20/02ISR Number: 4012638-4Report Type:Direct Outcome Disability Other Serious PT Hallucination, Auditory Homicidal Ideation Hypoaesthesia Anxiety Schizophrenia, Paranoid Type Suicidal Ideation Depression Psychotic Disorder Restlessness Depersonalisation
Company Report #CTU 181421 Report Source Product Mefloquine (Lariam) (Roche Pharm) Role PS Manufacturer Roche Pharm
Age:22 YR Route
Gender:Male Dose 2 DOSES OVER 2 WEEKS
I/FU:I Duration
Date:11/20/02ISR Number: 4012681-5Report Type:Direct Outcome Other Serious PT Abnormal Dreams Fear Disorientation Hallucination
Age:50 YR Route
Gender:Male Dose
I/FU:I Duration
Date:11/26/02ISR Number: 4017612-XReport Type:Expedited (15-DaCompany Report #324855 Outcome Life-Threatening PT Aspartate Aminotransferase Increased Pneumonitis Cerebral Atrophy Gamma-Glutamyltransferase Increased Prothrombin Time Prolonged Alcohol Withdrawal Syndrome Haemoglobin Abnormal Platelet Count Abnormal Alanine Aminotransferase Increased Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Hyperhidrosis Blood Potassium Abnormal Blood Sodium Abnormal Livedo Reticularis Nosocomial Infection Encephalopathy Respiratory Alkalosis Peripheral Coldness 03-Apr-2012 09:37 AM Page: 477
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/02ISR Number: 4018662-XReport Type:Expedited (15-DaCompany Report #325725 Outcome Other Serious PT Multiple Sclerosis Optic Neuritis Report Source Foreign Health Professional Product Lariam (Meloquine Hydrochloride) Yellow Fever Vaccine (Yellow Fever Vaccine) Role PS Manufacturer Age:43 YR Route ORAL Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Date:11/26/02ISR Number: 4018664-3Report Type:Expedited (15-DaCompany Report #323150 Outcome Hospitalization Initial or Prolonged PT Gastrointestinal Motility Disorder Hypocoagulable State Flatulence Pain Drug Interaction Muscle Haemorrhage Report Source Foreign Health Professional Product Lariam(Mefloquine Hydrochloride) Previsan (Fluindione) Role PS SS Manufacturer
Gender:Male Dose ORAL DOSE FORM DAILY ORAL
I/FU:F Duration
Date:11/27/02ISR Number: 4019178-7Report Type:Expedited (15-DaCompany Report #304340 Outcome Hospitalization Initial or Prolonged Disability PT Bipolar Disorder Hallucination Hemiparesis Myalgia Blindness Depression Paraesthesia Depressed Level Of Consciousness Headache Paranoia Eye Swelling Hypoaesthesia Suicidal Ideation Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:F Duration
Date:11/27/02ISR Number: 4019228-8Report Type:Expedited (15-DaCompany Report #325881 Outcome Other Serious PT Jaundice Erythema Multiforme Arthralgia Report Source Foreign Other Product Lariam (Mefloquine Hydrochloride) Havrix (Hepatitis A Vaccine) Role PS C Manufacturer
I/FU:I Duration
Date:12/06/02ISR Number: 4022746-XReport Type:Expedited (15-DaCompany Report #324949 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Multiple Sclerosis Headache
Age:29 YR
Gender:Male
I/FU:F
Page: 478
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Optic Neuritis Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Route ORAL Dose 1 DOSE FORM 1 PER WEEK ORAL Duration
Date:12/09/02ISR Number: 4020858-8Report Type:Direct Outcome Other Serious PT Personality Change Pain Abnormal Behaviour
Company Report #CTU 182353 Report Source Product Lariam - MefloquineRole PS Manufacturer
Age:42 YR Route
Gender:Male Dose
I/FU:I Duration
Date:12/09/02ISR Number: 4020882-5Report Type:Direct Outcome Other Serious PT Grand Mal Convulsion
Gender:Male
I/FU:I
Date:12/16/02ISR Number: 4027039-2Report Type:Expedited (15-DaCompany Report #319597 Outcome Other Serious PT Aggression Homicide Anger Social Avoidant Behaviour Tremor Speech Disorder Feeling Abnormal Nervousness Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Age: Route ORAL
I/FU:F Duration
Date:12/16/02ISR Number: 4027400-6Report Type:Expedited (15-DaCompany Report #324949 Outcome Hospitalization Initial or Prolonged PT Headache Multiple Sclerosis Optic Neuritis Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:F Duration
Date:12/23/02ISR Number: 4028551-2Report Type:Direct Outcome Other Serious PT Anxiety
Company Report #CTU 183235 Report Source Product Lariam 250mg Role Roche Manufacturer
Age:37 YR Route
Gender:Male Dose
I/FU:I Duration
Panic Reaction Toxicity To Various Agents Confusional State Irritability
Labs.
PS
Roche Labs
1 TABLE WEEKLY
03-Apr-2012
09:37 AM
Page: 479
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/02ISR Number: 4028552-4Report Type:Direct Outcome Other Serious PT Depression Anxiety Dizziness Nausea Paranoia Tinnitus Vision Blurred Toxicity To Various Agents Muscle Twitching Muscle Spasms Company Report #CTU 183236 Report Source Product Lariam (Mefloqune) 250gm Roche Labs. Role PS Manufacturer Roche Labs Age:30 YR Route Gender:Female Dose ONE TABLE PER WEEK I/FU:I Duration
Date:12/23/02ISR Number: 4028553-6Report Type:Direct Outcome Life-Threatening Required Intervention to Prevent Permanent Impairment/Damage PT Cerebral Atrophy Nausea Balance Disorder Dizziness Syncope
Company Report #CTU 183237 Report Source Product Larium 250 Mg Roche Lab Role PS Manufacturer Roche Lab
Gender:Female Dose 1 PER 7 WEEKS ORAL
I/FU:I Duration
Date:12/23/02ISR Number: 4033084-3Report Type:Expedited (15-DaCompany Report #327602 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Anticholinergic Syndrome Report Source Literature Health Professional Product Mefloquine Hydrochloride Role PS Manufacturer
Age:47 YR Route
Gender: Dose
I/FU:I Duration
Date:12/23/02ISR Number: 4033392-6Report Type:Expedited (15-DaCompany Report #324949 Outcome Hospitalization Initial or Prolonged PT Headache Optic Neuritis Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:F Duration
Date:12/26/02ISR Number: 4030737-8Report Type:Direct Outcome Disability Required Intervention to PT Anxiety Disorder Visual Impairment Diarrhoea
Company Report #CTU 183365 Report Source Product Larium Unsure-Gov.'T Issue Role PS Manufacturer
Age: Route
I/FU:I Duration
Vomiting Dizziness Insomnia Nausea Panic Attack Anxiety Hallucination Skin Ulcer
Furamide Metronidozol Bactrim Fazygen
C C C C
03-Apr-2012
09:37 AM
Page: 480
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/03ISR Number: 4039907-6Report Type:Expedited (15-DaCompany Report #323965 Outcome Disability PT Nightmare Paraesthesia Electrocardiogram T Wave Abnormal Agitation Electrocardiogram Abnormal Fear Hypotension Panic Attack Gastrointestinal Disorder Abnormal Dreams Convulsion Diarrhoea Anxiety Conduction Disorder Supraventricular Tachycardia Dyspepsia Constipation Dizziness Gastrooesophageal Reflux Disease Insomnia Restlessness Chills Tremor Mental Disorder Atrioventricular Block First Degree Choking Sensation Nausea Sensory Loss Hypertension Night Sweats Vision Blurred Eructation Flushing Palpitations Supraventricular Extrasystoles Weight Decreased Dysphagia Report Source Consumer Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age:30 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:01/08/03ISR Number: 4040684-3Report Type:Expedited (15-DaCompany Report #328238 Outcome Other Serious PT Paresis Report Source Foreign Product Lariam (Mefloquine Role Manufacturer
Age:40 YR Route
Gender:Female Dose
I/FU:I Duration
PS
03-Apr-2012
09:37 AM
Page: 481
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/03ISR Number: 4042880-8Report Type:Expedited (15-DaCompany Report #328748 Outcome Other Serious PT Labyrinthitis Bradyphrenia Headache Hypercholesterolaemia Clonic Convulsion Report Source Foreign Literature Health Professional Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Cerivastatin (Cerivastatin Sodium) Role Manufacturer Age:54 YR Route Gender:Female Dose I/FU:I Duration
PS
250 MG 1 PER WEEK
Date:01/14/03ISR Number: 4043507-1Report Type:Expedited (15-DaCompany Report #303888 Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage PT Panic Attack Visual Impairment Agoraphobia Psychotic Disorder Nervousness Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) Chloroquine (Chloroquine) Role PS C Manufacturer
I/FU:I Duration
Date:01/16/03ISR Number: 4042779-7Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Psychotic Disorder Aggression
Age: Route
Gender:Male Dose 2 TABLE
I/FU:I Duration
Date:01/17/03ISR Number: 4043730-6Report Type:Direct Outcome Disability PT Panic Attack Paraesthesia Eustachian Tube Disorder Feeling Abnormal Hearing Impaired Insomnia Decreased Appetite Dissociation Tinnitus Disturbance In Attention Loss Of Consciousness Anxiety
Company Report #CTU 184788 Report Source Product Lariam 250mg.#7 Roche? Not On Label I Have Left Role PS Manufacturer Roche?
Gender:Male Dose 1-250 ORAL WEEK
I/FU:I Duration
Fatigue Suicidal Ideation Asthenia
03-Apr-2012
09:37 AM
Page: 482
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/03ISR Number: 4045508-6Report Type:Expedited (15-DaCompany Report #328238 Outcome Other Serious PT Viith Nerve Paralysis Paresis Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Havrix (Hepatitis A Vaccine) Role PS C Manufacturer Age:39 YR Route ORAL Gender:Female Dose 250 MG ORAL I/FU:F Duration
Date:01/21/03ISR Number: 4045971-0Report Type:Expedited (15-DaCompany Report #328238 Outcome Other Serious PT Paresis Viith Nerve Paralysis Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Havrix (Hepatitis A Vaccine) Role PS C Manufacturer
I/FU:F Duration
Date:01/23/03ISR Number: 4046538-0Report Type:Expedited (15-DaCompany Report #329521 Outcome Other Serious PT Thrombocytopenia Somnolence Haemolysis Renal Disorder Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:01/23/03ISR Number: 4046936-5Report Type:Expedited (15-DaCompany Report #325725 Outcome Hospitalization Initial or Prolonged PT Optic Neuritis Multiple Sclerosis Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Yellow Fever Vaccine (Yellow Fever Vaccine) Role PS Manufacturer
I/FU:F Duration
Date:01/23/03ISR Number: 4046940-7Report Type:Expedited (15-DaCompany Report #312331 Outcome Other Serious PT Maternal Drugs Affecting Foetus Intra-Uterine Death Antepartum Haemorrhage Umbilical Cord Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Trandate (Labetalol Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Abnormality
Hydrochloride)
03-Apr-2012
09:37 AM
Page: 483
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/03ISR Number: 4046951-1Report Type:Expedited (15-DaCompany Report #329423 Outcome Hospitalization Initial or Prolonged PT Renal Failure Hypertension Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Trandate (Labetalol Hydrochloride) Role PS Manufacturer Age:35 YR Route ORAL Gender:Female Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Date:01/23/03ISR Number: 4046976-6Report Type:Expedited (15-DaCompany Report #329220 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Carpal Tunnel Syndrome Diarrhoea Insomnia Depression Post-Traumatic Stress Disorder Disturbance In Social Behaviour Muscle Twitching Chills Vomiting Hyperacusis Disturbance In Attention Fatigue Memory Impairment Nervousness Restless Legs Syndrome Paranoia Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Adderall (Amphetamine Aspartate/Amphetamin e Sulfate/Dextroamphet Role PS Manufacturer
I/FU:I Duration
Date:01/26/03ISR Number: 4050195-7Report Type:Expedited (15-DaCompany Report #328612 Outcome Other Serious PT Cyanosis Fatigue Convulsion Urinary Incontinence Disease Recurrence Muscle Rigidity Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Bcg Vaccine (Bcg Vaccine) Role PS C Manufacturer
I/FU:F Duration
Date:01/27/03ISR Number: 4047938-5Report Type:Expedited (15-DaCompany Report #329220 Outcome Required Intervention to PT Diarrhoea Vomiting
Age:47 YR
Gender:Male
I/FU:F
Fatigue Paranoia Depression Disturbance In Attention Hyperacusis Muscle Twitching Memory Impairment Post-Traumatic Stress Page: 484
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorder Restless Legs Syndrome Chills Insomnia Nervousness Carpal Tunnel Syndrome
Product Lariam (Mefloquine Hydrochloride) (Amphetamine Aspartate/Amphetamin e Sulfate/Dextroamphet amine Adderall
Role PS
Manufacturer
Route ORAL
Duration
C C
Date:01/27/03ISR Number: 4048136-1Report Type:Expedited (15-DaCompany Report #328612 Outcome Other Serious PT Urinary Incontinence Convulsion Syncope Muscle Rigidity Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Bcg Vaccine (Bcg Vaccine) Role PS C Manufacturer
I/FU:I Duration
Date:01/27/03ISR Number: 4048137-3Report Type:Expedited (15-DaCompany Report #329947 Outcome Hospitalization Initial or Prolonged PT Myoglobin Blood Increased Heat Stroke Hepatocellular Injury Blood Creatine Phosphokinase Increased Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
Gender:Male Dose 1 DOSE FORM 1 PER ONE DOSE ORAL
I/FU:I Duration
Date:01/27/03ISR Number: 4048138-5Report Type:Expedited (15-DaCompany Report #329796 Outcome Hospitalization Initial or Prolonged PT Erythema Burning Sensation Facial Pain Mental Disorder Tenderness Emotional Disorder Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:19 YR Route
Gender:Male Dose
I/FU:I Duration
Age:25 YR Route
Gender:Female Dose
I/FU:F Duration
Convulsion Headache Transfusion Reaction Anaemia Haemolytic Autoimmune Splenomegaly
Lariam (Mefloquine Hydrochloride) Propecia (Finasteride)
PS C
ORAL
03-Apr-2012
09:37 AM
Page: 485
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/03ISR Number: 4050369-5Report Type:Expedited (15-DaCompany Report #309389 Outcome Hospitalization Initial or Prolonged PT Maternal Drugs Affecting Foetus Pregnancy Abortion Spontaneous Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) Zinnat (Cefuroxime Axetil Or Cefuroxime Sodium/*Lidocaine Hydrochloride) Role PS Manufacturer Age: Route ORAL Gender:Unknown Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:01/30/03ISR Number: 4049529-9Report Type:Direct Outcome Disability PT Paranoia Psychotic Disorder
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:02/03/03ISR Number: 4053696-0Report Type:Expedited (15-DaCompany Report #2003-102650-NL B0006-2003 Outcome PT Syncope Convulsion Report Source Product Bcg Vaccine Mefloquine Role PS SS Manufacturer
Age:18 YR Route
I/FU:I Duration
Date:02/05/03ISR Number: 4052084-0Report Type:Direct Outcome PT Syncope Convulsion Urinary Incontinence
Company Report #CTU 185987 Report Source Product Mefloquine Bacillus Calmette Guerin Vaccine Role PS C Manufacturer
Age:18 YR Route
Gender:Female Dose
I/FU:I Duration
Date:02/06/03ISR Number: 4055962-1Report Type:Expedited (15-DaCompany Report #329796 Outcome Hospitalization Initial or Prolonged PT Emotional Disorder Burning Sensation Facial Pain Mental Disorder Erythema Sensation Of Pressure Tenderness Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:19 YR Route
Gender:Male Dose
I/FU:F Duration
Age:29 YR
Gender:Male
I/FU:F
PT Multiple Sclerosis Blood Immunoglobulin G Increased Headache Optic Neuritis Measles
Role PS
Manufacturer
Route ORAL
Duration
03-Apr-2012
09:37 AM
Page: 486
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/03ISR Number: 4056506-0Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Suicide Attempt Overdose Company Report #CTU 186611 Report Source Product Mefloquine 250 Mg Geneva Doxycycline Role PS C Manufacturer Geneva Age:33 YR Route ORAL Gender:Male Dose ONE WEEKLY ORAL I/FU:I Duration
Date:02/13/03ISR Number: 4057400-1Report Type:Expedited (15-DaCompany Report #328238 Outcome Disability PT Viith Nerve Paralysis Paresis Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Havrix (Hepatitis A Vaccine) Role PS C Manufacturer
I/FU:F Duration
Date:02/13/03ISR Number: 4057959-4Report Type:Expedited (15-DaCompany Report #329220 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Depression Fatigue Insomnia Skin Discolouration Carpal Tunnel Syndrome Disturbance In Attention Emotional Disorder Stress Suicidal Ideation Nightmare Pollakiuria Weight Decreased Hypersensitivity Blood Cholesterol Increased Nausea Nervousness Pain In Extremity Chills Vomiting Diarrhoea Paranoia Post-Traumatic Stress Disorder Vision Blurred Anxiety Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Tramadol (Tramadol Hydrochloride) Indomethacin (Indomethacine) Adderall (Amphetamine Aspartate/Amphetamin e Sulfate/Dextroamphen Role PS C C Manufacturer
Age:47 YR Route
I/FU:F Duration
Headache Memory Impairment Muscle Twitching Restless Legs Syndrome
03-Apr-2012
09:37 AM
Page: 487
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/03ISR Number: 4056675-2Report Type:Direct Outcome Other Serious PT Malaise Treatment Noncompliance Depression Crying Nightmare Company Report #CTU 186682 Report Source Product Larium Role PS Manufacturer Age:25 YR Route ORAL Gender:Female I/FU:I
Dose Duration 1/2 TABLE TWICE A WEEK ORAL
Date:02/14/03ISR Number: 4060284-9Report Type:Expedited (15-DaCompany Report #329220 Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Stress Vision Blurred Insomnia Depression Headache Nausea Nervousness Chills Delusional Disorder, Persecutory Type Post-Traumatic Stress Disorder Suicidal Ideation Emotional Disorder Restless Legs Syndrome Skin Disorder Skin Papilloma Blood Cholesterol Increased Diarrhoea Paranoia Memory Impairment Pollakiuria Disturbance In Attention Anxiety Carpal Tunnel Syndrome Hyperacusis Muscle Twitching Nightmare Pain In Extremity Vomiting Weight Decreased Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Tramadol (Tramadol Hydrochloride) Indomethacin (Indomethacin) Adderall (Amphetamine Aspartate/Amphetamin e Sulfate/Dextroamphet Role PS C C Manufacturer
I/FU:F Duration
Date:02/19/03ISR Number: 4059353-9Report Type:Expedited (15-DaCompany Report #329799 Outcome Hospitalization PT Headache
Age:16 YR
Gender:Female
I/FU:I
Initial or Prolonged Disability
Nausea Abdominal Distension Middle Insomnia Visual Impairment Diarrhoea Disorientation Disturbance In Attention Haemorrhage Page: 488
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Influenza Like Illness Initial Insomnia Oropharyngeal Pain Pyrexia Constipation Musculoskeletal Disorder Dizziness Thinking Abnormal Dry Mouth Dry Skin Insomnia Amnesia Tinnitus Abdominal Pain Depression Nervous System Disorder Pruritus Skin Depigmentation Chronic Fatigue Syndrome Orthostatic Hypotension
Product Lariam (Mefloquine Hydrochloride) 250 Mg Hepatitis A Vaccine (Hepatitis A Vaccine)
Role PS
Manufacturer
Route ORAL
Dose 1 DOSE FORM ORAL
Duration
Date:02/20/03ISR Number: 4061246-8Report Type:Expedited (15-DaCompany Report #2003005986 Outcome Death PT Drug Interaction Arrhythmia Myocardial Infarction Report Source Foreign Health Professional Company Representative Product Atorvastatin (Atorvastatin) Mefloquine Role PS SS Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:02/24/03ISR Number: 4059792-6Report Type:Direct Outcome Other Serious PT Diarrhoea Chapped Lips Abnormal Dreams Feeling Of Body Temperature Change Influenza Like Illness Rash Flushing Nightmare
Company Report #CTU 187215 Report Source Product Mefloquine Larium Role PS Manufacturer
Gender:Male Dose 1 PILL ONCE A ORAL
I/FU:I Duration
Date:02/24/03ISR Number: 4064761-6Report Type:Expedited (15-DaCompany Report #2003005986 Outcome Death PT Arrhythmia Report Source Foreign Product Atorvastatin Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:F Duration
Drug Interaction Myocardial Infarction
Health Professional Company Representative
(Atorvastatin) Mefloquine
PS SS
03-Apr-2012
09:37 AM
Page: 489
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/03ISR Number: 4062009-XReport Type:Direct Outcome PT Bipolar Disorder Depression Mental Impairment Abnormal Behaviour Anxiety Company Report #CTU 187388 Report Source Product Lariam Role PS Manufacturer Age:17 YR Route Gender:Female Dose I/FU:I Duration
Date:02/25/03ISR Number: 4065847-2Report Type:Expedited (15-DaCompany Report #267379 Outcome Other Serious PT Abortion Spontaneous Maternal Drugs Affecting Foetus Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
Gender:Unknown Dose 250 MG ORAL
I/FU:I Duration
Date:02/25/03ISR Number: 4066502-5Report Type:Expedited (15-DaCompany Report #329799 Outcome Hospitalization Initial or Prolonged Disability PT Chronic Fatigue Syndrome Depression Dry Skin Tinnitus Exercise Tolerance Decreased Abdominal Pain Disorientation Dry Mouth Skin Depigmentation Nervous System Disorder Amnesia Disturbance In Attention Nausea Abdominal Distension Oropharyngeal Pain Constipation Fatigue Pyrexia Syncope Mental Impairment Middle Insomnia Diarrhoea Headache Insomnia Orthostatic Hypotension Pruritus Heart Rate Decreased Influenza Like Illness Report Source Consumer Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Hepatitis A Vaccine (Hepatitis A Vaccine) Role PS Manufacturer
Gender:Female Dose 1 DOSE FORM ORAL
I/FU:F Duration
Initial Insomnia Haemorrhage
03-Apr-2012
09:37 AM
Page: 490
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/03ISR Number: 4061186-4Report Type:Direct Outcome Disability PT Depression Dyspepsia Influenza Like Illness Suicidal Ideation Insomnia Anxiety Company Report #CTU 187477 Report Source Product Lariam Roche Role PS Manufacturer Roche Age: Route ORAL Gender:Male Dose WEEK ORAL I/FU:I Duration
Date:02/27/03ISR Number: 4067619-1Report Type:Expedited (15-DaCompany Report #329799 Outcome Hospitalization Initial or Prolonged Disability PT Headache Memory Impairment Nausea Skin Depigmentation Dry Mouth Dry Skin Insomnia Orthostatic Hypotension Oropharyngeal Pain Fatigue Constipation Diarrhoea Influenza Like Illness Abdominal Pain Dizziness Syncope Tinnitus Nervous System Disorder Sleep Disorder Chronic Fatigue Syndrome Depression Abdominal Distension Disorientation Disturbance In Attention Menorrhagia Pruritus Report Source Consumer Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Hepatitis A Vaccine (Hepatitis A Vaccine) Role PS Manufacturer
Gender:Female Dose 1 DOSE FORM ORAL
I/FU:F Duration
Date:03/06/03ISR Number: 4071806-6Report Type:Expedited (15-DaCompany Report #332282 Outcome Other Serious PT Memory Impairment Viith Nerve Paralysis Visual Impairment Hypoaesthesia Report Source Consumer Product Lariam (Mefloquine Hydrochloride) 240 Mg Role PS Manufacturer
I/FU:I Duration
Date:03/11/03ISR Number: 4069555-3Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0398888A Outcome Other Serious PT Homicide Report Source Consumer Product Paxil Lariam Role PS SS Manufacturer Glaxosmithkline
Age: Route
Gender:Male Dose
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 491
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/03ISR Number: 4074039-2Report Type:Expedited (15-DaCompany Report #324511 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Chromaturia Decreased Appetite Heart Rate Increased Pallor Asthenia Anaemia Haemolytic Autoimmune Coombs Positive Haemolytic Anaemia Headache Convulsion Fatigue Jaundice Pyrexia Splenomegaly Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) Propecia (Finasteride) Role PS C Manufacturer Age:24 YR Route Gender:Female Dose I/FU:F Duration
Date:03/11/03ISR Number: 4074044-6Report Type:Expedited (15-DaCompany Report #328238 Outcome Disability PT Viith Nerve Paralysis Paresis Report Source Foreign Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Havrix (Hepatitis A Vaccine) Role PS C Manufacturer
I/FU:F Duration
Date:03/13/03ISR Number: 4074065-3Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability PT Convulsion Toxicity To Various Agents Suicidal Ideation Aggression Abnormal Behaviour Paranoia Hallucination Psychotic Disorder Confusional State
Gender:Male Dose 250 MG WEEK ORAL
I/FU:I Duration
Date:03/14/03ISR Number: 4076565-9Report Type:Expedited (15-DaCompany Report #304340 Outcome Hospitalization Initial or Prolonged PT Crying Depression
Age:15 YR
Gender:Female
I/FU:F
Disability
Diplopia Eye Swelling Hemiplegia Encephalitis Mental Disorder Due To A General Medical Condition Sleep Disorder Visual Field Defect 09:37 AM Page: 492
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination Memory Impairment Tinnitus Bipolar I Disorder Blindness Paranoia Intentional Self-Injury Vitreous Floaters Papilloedema Suicidal Ideation Suicide Attempt Arthralgia Cognitive Disorder Depressed Level Of Consciousness Mood Swings Nervous System Disorder Obsessive-Compulsive Disorder
Report Source Other
Role PS
Manufacturer
Route ORAL
Duration
Date:03/14/03ISR Number: 4076957-8Report Type:Expedited (15-DaCompany Report #333205 Outcome Hospitalization Initial or Prolonged PT Hallucination Insomnia Bipolar I Disorder Agitation Crying Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:03/17/03ISR Number: 4074480-8Report Type:Direct Outcome Other Serious PT Eye Disorder Panic Attack Fear Muscle Twitching Blepharospasm Food Allergy Hyperventilation Dyskinesia Fatigue Feeling Abnormal Grimacing Vertigo
Company Report #CTU 188872 Report Source Product Lariam Peace Corps Standard In Doxycyline Role PS C Manufacturer
Age: Route ORAL
I/FU:I Duration
Age:
Gender:Female
I/FU:I
PT Dizziness Myalgia Fatigue Hallucination Tinnitus Tremor Sleep Terror 09:37 AM Page: 493
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Depression Nausea Paranoia Nightmare Hyperhidrosis
Report Source
Product Mefloquin Generic For Hoffman-La Roche
Role PS
Manufacturer Hoffmann- La Roche
Route ORAL
Dose 1 TABLE PER WEEK ORAL
Duration
Date:03/19/03ISR Number: 4078912-0Report Type:Expedited (15-DaCompany Report #329521 Outcome Hospitalization Initial or Prolonged PT Somnolence General Physical Health Deterioration Renal Disorder Haemolytic Anaemia Thrombocytopenia Report Source Foreign Health Professional Product Lariam (Mefloquine Hydrochloride) Riamet (Coartem) (Artemether/Lumefant rine) Role PS Manufacturer
Gender:Male Dose 3 DOSE FORM DAILY ORAL 6 DOSE FORM 1 PER 8 HOUR ORAL
I/FU:F Duration
SS
ORAL
Date:03/21/03ISR Number: 4082093-7Report Type:Expedited (15-DaCompany Report #328748 Outcome Other Serious PT Dizziness Dyskinesia Headache Hypercholesterolaemia Clonic Convulsion Bradyphrenia Shock Report Source Foreign Literature Health Professional Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Cerivastatin (Cerivastatin Sodium) Role Manufacturer
Age:54 YR Route
Gender:Female Dose
I/FU:F Duration
PS
250 MG 1 PER WEEK
Date:04/01/03ISR Number: 4082569-2Report Type:Expedited (15-DaCompany Report #CA-ROCHE-334734 Outcome Other Serious PT Electrocardiogram Qt Prolonged Hallucination Suicidal Ideation Paranoia Toxicity To Various Agents Coordination Abnormal Decreased Appetite Report Source Product Lariam Chloroquine Phosphate Role PS Manufacturer Roche
Age:23 YR Route UNKNOWN
Gender:Male
I/FU:I
Dose Duration THREE DOSES WERE TAKEN BY THE PATIENT.
SS
UNKNOWN
Date:04/01/03ISR Number: 4082624-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-328127 Outcome Other Serious PT Abortion Spontaneous Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender: Dose
03-Apr-2012
09:37 AM
Page: 494
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/03ISR Number: 4088082-0Report Type:Expedited (15-DaCompany Report #328127 Outcome Other Serious PT Pregnancy Abortion Spontaneous Maternal Drugs Affecting Foetus Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Age: Route ORAL Gender: Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:04/04/03ISR Number: 4085178-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-320492 Outcome Death PT Completed Suicide Personality Change Loss Of Consciousness Intentional Overdose Depression Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:04/07/03ISR Number: 4088101-1Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability PT Chest Pain Anxiety Palpitations Dizziness Malaise Chills
Company Report #CTU 190308 Report Source Product Larium 250mg Tablets Roche Products Ventolin Becotide Role PS C C Manufacturer Roche Products
Age: Route ORAL
I/FU:I Duration
Date:04/14/03ISR Number: 4090106-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-305025 Outcome Other Serious PT Panic Disorder Drug Withdrawal Syndrome Drug Dependence Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
Date:04/14/03ISR Number: 4090111-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-313979 Outcome Disability PT Depression Anxiety Drug Withdrawal Syndrome Mood Altered Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Age:24 YR
Gender:Female
I/FU:I
Outcome Life-Threatening Hospitalization Initial or Prolonged Disability
PT Suicidal Ideation Depression
Report Source
Product Larium
Role PS
Manufacturer
Route
Dose WEEKLY
Duration
03-Apr-2012
09:37 AM
Page: 495
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/03ISR Number: 4092995-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-336048 Outcome Hospitalization Initial or Prolonged PT Vomiting Gastrointestinal Infection Weight Decreased Diarrhoea Report Source Product Lariam Role PS Manufacturer Roche Age:6 YR Route ORAL Gender:Male Dose I/FU:I Duration
Date:04/22/03ISR Number: 4094866-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-333205 Outcome Hospitalization Initial or Prolonged PT Insomnia Agitation Bipolar I Disorder Hallucination Crying Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:04/28/03ISR Number: 4098493-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-329220 Outcome Other Serious PT Diarrhoea Post-Traumatic Stress Disorder Tenosynovitis Insomnia Surgical Procedure Repeated Paranoia Disturbance In Attention Memory Impairment Vomiting Muscle Twitching Blood Cholesterol Increased Suicidal Ideation Nausea Restless Legs Syndrome Libido Decreased Skin Papilloma Carpal Tunnel Syndrome Nervousness Chills Nightmare Hyperacusis Headache Pollakiuria Migraine Pain In Extremity Report Source Product Lariam Tramadol Indomethacin Adderall Role PS C C C Manufacturer Roche
Age:46 YR Route ORAL ORAL ORAL ORAL
Gender:Male Dose
I/FU:I Duration
Loss Of Employment Fatigue Weight Decreased Skin Discolouration Visual Impairment Stress Depression Vision Blurred 03-Apr-2012 09:37 AM Page: 496
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/03ISR Number: 4105493-5Report Type:Direct Outcome Other Serious PT Depression Palpitations Supraventricular Extrasystoles Mood Altered Company Report #CTU 192075 Report Source Product Mefloquine 250 Mg Geneva Pharm Tech Corporation Role PS Manufacturer Geneva Pharm Tech Corporation Age:26 YR Route Gender:Male Dose I/FU:I Duration
PARENTERAL
250 MG Q WEEK PARENTERAL
Date:05/02/03ISR Number: 4102404-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-336087 Outcome Other Serious PT Anosmia Ageusia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:05/06/03ISR Number: 4106524-9Report Type:Direct Outcome PT Sinus Disorder Dysphagia Oropharyngeal Pain
Age:27 YR Route
Gender:Male Dose
I/FU:I Duration
Date:05/06/03ISR Number: 4106525-0Report Type:Direct Outcome Other Serious PT Depression Loss Of Consciousness Affect Lability
Company Report #CTU 192354 Report Source Product Mefloquine 250mg Role PS Manufacturer
Gender:Male Dose 250 MG PO WEEKLY
I/FU:I Duration
Date:05/08/03ISR Number: 4105846-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-336087 Outcome Other Serious PT Anosmia Ageusia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:05/12/03ISR Number: 4107655-XReport Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Outcome Other Serious PT Homicide Paranoia Hallucination, Auditory Condition Aggravated Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Hallucination, Olfactory Mental Disorder
03-Apr-2012
09:37 AM
Page: 497
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/03ISR Number: 4110899-4Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Other Serious PT Anxiety Fatigue Suicidal Ideation Night Sweats Nightmare Depression Hallucination Company Report #CTU 192740 Report Source Product Lariam 250 Mg Per Week Roche Usa Role PS Manufacturer Roche Usa Age:30 YR Route ORAL Gender:Male Dose 250 MG PER WEEK ORAL I/FU:I Duration
Date:05/19/03ISR Number: 4111056-8Report Type:Expedited (15-DaCompany Report #SE-ROCHE-328238 Outcome Disability PT Viith Nerve Paralysis Report Source Product Lariam Havrix Role PS C Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration 1 TABLET ONLY TAKEN. 1 DAY
Date:05/19/03ISR Number: 4111080-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-337777 Outcome Death PT Tachycardia Insomnia Drowning Anxiety Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:05/19/03ISR Number: 4114514-5Report Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Insomnia Panic Attack Anxiety Paranoia Hallucination Decreased Appetite Emotional Disorder
Company Report #CTU 193224 Report Source Product Lariam Mefloquine Hydrochloride 250mg Tabs Omeprazole Magnesium Losec Role PS C C Manufacturer
Age:60 YR Route
Gender:Female Dose SEE IMAGE
I/FU:I Duration
Date:05/21/03ISR Number: 4113122-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-337388 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Hepatic Enzyme Increased Psychotic Disorder Report Source Consumer Product Lariam Lariam Clont Lariam Role PS SS SS SS Manufacturer Roche Roche Roche
Gender:Female Dose
Date:05/28/03ISR Number: 4117382-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-329799 Outcome Hospitalization Initial or Prolonged Disability 03-Apr-2012 09:37 AM PT Psychotic Disorder Abdominal Pain Cognitive Disorder
Age:16 YR
Gender:Female
I/FU:F
Page: 498
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Diarrhoea Dry Mouth Pruritus Mania Influenza Like Illness Nausea Constipation Headache Disorientation Initial Insomnia Nervous System Disorder Chronic Fatigue Syndrome Menstruation Irregular Dry Skin Disturbance In Attention Orthostatic Hypotension Abdominal Distension Amnesia Heart Rate Decreased Tinnitus Skin Depigmentation Exercise Tolerance Decreased
Report Source
Product Lariam Hepatitis A Vaccine
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:05/30/03ISR Number: 4187487-7Report Type:Periodic Outcome Disability PT Nerve Injury Dizziness Weight Decreased Nausea Anxiety Balance Disorder Diarrhoea Panic Attack Vertigo Muscular Weakness
Company Report #255796 Report Source Consumer Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:I Duration
Date:05/30/03ISR Number: 4187488-9Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Blood Pressure Abnormal Blood Pressure Increased Weight Decreased Decreased Appetite Depression Tachycardia Anxiety
Company Report #312535 Report Source Consumer Product Lariam (Mefloquine Hydrochloride) 250 Mg Trandate (Labetalol Hydrochloride) Role PS C Manufacturer
I/FU:I Duration
Suicidal Ideation Bradycardia Syncope
03-Apr-2012
09:37 AM
Page: 499
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/03ISR Number: 4187489-0Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Hallucination Company Report #317591 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age:44 YR Route ORAL Gender:Female Dose 250 MG 1 PER WEEK ORAL I/FU:I Duration
Date:05/30/03ISR Number: 4187490-7Report Type:Periodic Outcome Death Disability PT Delusion Depression Anxiety Delusional Disorder, Persecutory Type Completed Suicide Mood Swings Confusional State Headache
Company Report #322558 Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:I Duration
Date:05/30/03ISR Number: 4187491-9Report Type:Periodic Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Feeling Cold Confusional State Nausea Diarrhoea Medication Error
Company Report #322574 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
I/FU:I Duration
Date:05/30/03ISR Number: 4187492-0Report Type:Periodic Outcome Other Serious PT Headache Weight Decreased Suicidal Ideation
Company Report #324697 Report Source Consumer Product Lariam (Mefloquine Hydrochloride) 240 Mg Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:05/30/03ISR Number: 4187493-2Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Anxiety Hallucination Depression
Company Report #325385 Report Source Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Date:05/30/03ISR Number: 4187494-4Report Type:Periodic Outcome Disability PT Asthenia
Company Report #327591 Report Source Literature Health Professional Product Mefloquine Hydrochloride (Mefloquine Role Manufacturer
Age:37 YR Route
Gender:Female Dose
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 500
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) Pyridostigmine (Pyridostigmine Bromide) PS C
Date:05/30/03ISR Number: 4187495-6Report Type:Periodic Outcome Disability PT Asthenia
Company Report #327601 Report Source Literature Health Professional Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Role Manufacturer
Age:52 YR Route
Gender:Female Dose
I/FU:I Duration
PS
Date:05/30/03ISR Number: 4187496-8Report Type:Periodic Outcome Other Serious PT Convulsion
Company Report #329345 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:05/30/03ISR Number: 4188986-4Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Eye Irritation Hallucination Heart Rate Increased Insomnia Nervousness Nightmare Dizziness Dry Mouth Dyspnoea Headache Psychotic Disorder Tremor Claustrophobia Panic Attack Depression Agitation
Company Report #329978 Report Source Consumer Health Professional Product Lariam (Mefloquine Hydrochloride) Ultran (Phenaglycodol) Lorazepam (Lorazepam) Oxycontin (Oxycodone) Unspecified Immunizations (Immunisation) Effexor (Venlafaxine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
C C C C C
Date:05/30/03ISR Number: 4188987-6Report Type:Periodic Outcome Other Serious PT Self Esteem Decreased Anxiety Insomnia Dyspnoea
Age: Route ORAL
Chest Pain Mood Swings Suicide Attempt Nervousness Depression
03-Apr-2012
09:37 AM
Page: 501
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/03ISR Number: 4188988-8Report Type:Periodic Outcome Other Serious PT Petit Mal Epilepsy Convulsion Company Report #332637 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age:2 YR Route ORAL Gender:Male Dose 0.25 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Date:05/30/03ISR Number: 4188989-XReport Type:Periodic Outcome Hospitalization Initial or Prolonged PT Acute Psychosis
Age:59 YR Route
Gender:Male Dose
I/FU:I Duration
Date:05/30/03ISR Number: 4188990-6Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Malaria Abnormal Dreams Hypotension
I/FU:I Duration
Date:06/02/03ISR Number: 4120310-5Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Outcome Other Serious PT Homicide Hallucination, Olfactory Flashback Paranoia Hallucination, Auditory Report Source Health Professional Product Lariam Antidepressants Nos Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:F Duration 3 MON
Date:06/03/03ISR Number: 4121733-0Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Nausea Aggression Paranoia Headache Anxiety Hallucination Oropharyngeal Pain Tinnitus Fatigue Syncope
Company Report #CTU 194609 Report Source Product Mefloquine 250 Mg Geneva Role PS Manufacturer Geneva
Age:16 YR Route
Gender:Female Dose 1 TABLET PER WEEK BEGINNING 1 WK B/F DEPARTURE AND
I/FU:I Duration
Skin Disorder Confusional State Dizziness Mood Altered Orthostatic Hypotension Depression Psychotic Disorder Insomnia 03-Apr-2012 09:37 AM Page: 502
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/03ISR Number: 4122087-6Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041072A Outcome Hospitalization Initial or Prolonged PT Intentional Overdose Alcohol Poisoning Suicide Attempt Vomiting Report Source Product Halfan Alcohol Lariam Role PS SS SS Manufacturer Glaxosmithkline Age:39 YR Route ORAL ORAL ORAL Gender:Male I/FU:I
Dose Duration 3000MG Single dose 1 DAY 1 DAY 1500MG Single dose 1 DAY
Date:06/04/03ISR Number: 4122521-1Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Outcome Other Serious PT Hallucination, Auditory Hallucination, Olfactory Paranoia Flashback Homicide Report Source Product Lariam Antidepressants Nos Role PS C Manufacturer Roche
Gender:Male Dose
Date:06/04/03ISR Number: 4122561-2Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0299754A Outcome Hospitalization Initial or Prolonged PT Condition Aggravated Overdose Anxiety Fear Hallucination Insomnia Suicide Attempt Depression Nightmare Report Source Product Deroxat Lariam Prozac Lysanxia Xanax Role PS SS SS SS SS Manufacturer Glaxosmithkline
Age:19 YR Route ORAL ORAL ORAL ORAL ORAL
Gender:Female
I/FU:I
Dose Duration 20MG Twice per day 250MG Unknown 36 DAY 36 DAY
Date:06/04/03ISR Number: 4123059-8Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Anxiety Depression Disturbance In Attention Memory Impairment Night Sweats Suicidal Ideation Insomnia
Company Report #CTU 194940 Report Source Product Larium Roche Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male
I/FU:I
Date:06/05/03ISR Number: 4123097-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-339395 Outcome PT Report Source Product Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
Other Serious
Atrioventricular Block Complete
Lariam Beta Blocker Nos
PS C
Roche
ORAL ORAL
03-Apr-2012
09:37 AM
Page: 503
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/03ISR Number: 4123733-3Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Panic Disorder With Agoraphobia Depression Company Report #CTU 195063 Report Source Product Larium 250mg Roche Role PS Manufacturer Roche Age:29 YR Route ORAL Gender:Male Dose 250MG 1 PER WEEK ORAL I/FU:I Duration
Date:06/06/03ISR Number: 4123954-XReport Type:Expedited (15-DaCompany Report #CA-ROCHE-339135 Outcome Other Serious PT Kawasaki'S Disease Cholestasis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:06/10/03ISR Number: 4125466-6Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Outcome Other Serious PT Hallucination, Auditory Paranoia Homicide Hallucination, Olfactory Flashback Report Source Health Professional Product Lariam Flagyl Unknown Medication Antidepressants Nos Role PS C C C Manufacturer Roche
Gender:Male Dose
I/FU:F Duration 3 MON 8 DAY
Date:06/10/03ISR Number: 4125480-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-339481 Outcome Hospitalization Initial or Prolonged PT Meningism Hepatitis Report Source Consumer Product Lariam Ibuprofene Doliprane Adepal Role PS SS SS C Manufacturer Roche
Gender:Female Dose
RECEIVED TREATMENT FOR SEVERAL MONTHS
Date:06/10/03ISR Number: 4126187-6Report Type:Direct Outcome Other Serious PT Panic Reaction Anxiety Paraesthesia Depression Dizziness Distractibility Neurotoxicity Fatigue
Company Report #CTU 195411 Report Source Product Larium Laroche Role PS Manufacturer Laroche
I/FU:I Duration
Date:06/11/03ISR Number: 4126537-0Report Type:Expedited (15-DaCompany Report #SE-ROCHE-328238 Outcome Disability PT Viith Nerve Paralysis Report Source Consumer Product Lariam Havrix 03-Apr-2012 09:37 AM Role PS SS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration 1 TABLET ONLY TAKEN. 1 DAY 1 DAY Page: 504
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/03ISR Number: 4128467-7Report Type:Direct Outcome Death Life-Threatening Disability Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Depression Asthenia Sleep Apnoea Syndrome Weight Increased Panic Disorder Completed Suicide Company Report #CTU 195725 Report Source Product Lariam 250 Mg Hoffman-Laroche, Inc. Phen/Fen Role PS SS Manufacturer Hoffman-Laroche, Inc. Age:50 YR Route Gender:Male Dose I/FU:I Duration
ORAL ORAL
250 MG OVER 5 ORAL OVER 9 ORAL
Date:06/23/03ISR Number: 4134248-0Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Feeling Abnormal Mental Disorder Activities Of Daily Living Impaired
Gender:Male
I/FU:I
Dose Duration 1 TABLE ONCE A WEEK ORAL
Date:06/24/03ISR Number: 4133560-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-336087 Outcome Other Serious PT Ageusia Viral Infection Anosmia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:06/26/03ISR Number: 4135803-4Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041072A Outcome Hospitalization Initial or Prolonged PT Suicide Attempt Alcohol Poisoning Intentional Overdose Vomiting Report Source Health Professional Product Halfan Alcohol Lariam Role PS SS SS Manufacturer Glaxosmithkline
Gender:Male
I/FU:F
Dose Duration 3000MG Single dose 1 DAY 1 DAY 1500MG Single dose 1 DAY
Date:06/27/03ISR Number: 4136538-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-329799 Outcome Hospitalization Initial or Prolonged PT Fatigue Tinnitus
Age:16 YR
Gender:Female
I/FU:F
Disability
Diarrhoea Dry Skin Skin Depigmentation Insomnia Abdominal Distension Nausea Laboratory Test Abnormal Disturbance In Attention 09:37 AM Page: 505
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Malaise Haemorrhage Psychotic Disorder Depression Headache Red Blood Cell Sedimentation Rate Increased Amnesia Exercise Tolerance Decreased Mania C-Reactive Protein Increased Immunology Test Abnormal Bipolar Disorder Constipation Abdominal Pain Nervous System Disorder Influenza Like Illness Syncope Heart Rate Decreased Brain Scan Normal Orthostatic Hypotension Dry Mouth Pyrexia Initial Insomnia
Report Source
Product Lariam Hepatitis A Vaccine
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:06/27/03ISR Number: 4137636-1Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability PT Speech Disorder Ear Pain Weight Decreased Feeling Abnormal Diplopia Cerebrovascular Accident Balance Disorder Headache Migraine Nausea Pain In Extremity Vertigo Vision Blurred Lupus-Like Syndrome Decreased Appetite Asthenia Confusional State Gait Disturbance Dizziness
Company Report #CTU 196820 Report Source Product Lariam 250 Mg Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 1 TABLET BY MOUTH WEEKLY
Eye Disorder Vomiting Dysphemia Arterial Occlusive Disease Arthralgia
03-Apr-2012
09:37 AM
Page: 506
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/03ISR Number: 4138763-5Report Type:Expedited (15-DaCompany Report #KE-ROCHE-340706 Outcome Hospitalization Initial or Prolonged PT Prothrombin Time Prolonged Abdominal Distension Ascites Blood Pressure Decreased Drug Interaction Tachycardia Infectious Peritonitis Cardiomegaly Abdominal Rebound Tenderness Anaemia Gallop Rhythm Present Report Source Product Mefloquine Hydrochloride Carvedilol Betoptic Eye Drops Captoril Digoxin Warfarin Role PS C C C C I Manufacturer Roche Age:66 YR Route UNKNOWN Gender:Male Dose DOSE REPORTED AS 250MG PER WEEK. I/FU:I Duration
UNKNOWN
Date:07/01/03ISR Number: 4138771-4Report Type:Expedited (15-DaCompany Report #KE-ROCHE-340709 Outcome Hospitalization Initial or Prolonged PT Prothrombin Time Prolonged Oedema Peripheral Injury Muscle Twitching Confusional State Hypoglycaemia Aggression Haemorrhage Blood Glucose Fluctuation Cellulitis Drug Interaction Dermatitis Exfoliative Blister Retrograde Amnesia Report Source Product Mefloquine Hydrochloride Sotalol Frusemide Digoxin Glibenclamide Chlorpropamide Role PS C C C I I Manufacturer Roche
Gender:Male Dose DOSE REPORTED AS 250MG WEEKLY. REPORTED AS GIVEN OCASIONALLY.
I/FU:I Duration
Roche
UNKNOWN UNKNOWN
Date:07/03/03ISR Number: 4140824-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-339743 Outcome Other Serious PT Platelet Disorder Contusion Menorrhagia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration THE PATIENT WAS REPORTED TO HAVE RECEIVED MEFLOQUINE
Lariam Lariam
SS SS
Roche Roche
ORAL ORAL
Date:07/07/03ISR Number: 4142181-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-341198 Outcome Disability PT C-Reactive Protein Increased Arthropathy Muscle Disorder 09:37 AM Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
03-Apr-2012
Page: 507
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/03ISR Number: 4142198-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-341603 Outcome Other Serious PT Retinitis Pigmentosa Report Source Product Lariam Role PS Manufacturer Roche Age: Route UNKNOWN Gender:Male Dose I/FU:I Duration
Date:07/07/03ISR Number: 4142200-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-341571 Outcome Other Serious PT Groin Pain Quadriplegia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
Date:07/07/03ISR Number: 4142985-7Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Convulsion Road Traffic Accident Lethargy Depression
Company Report #CTU 197286 Report Source Product Mefloquine 250 Lariam Role PS Manufacturer
I/FU:I Duration
Date:07/07/03ISR Number: 4144312-8Report Type:Expedited (15-DaCompany Report #FRWYE193930JUN03 Outcome Hospitalization Initial or Prolonged PT Hepatitis Cytolytic Hepatitis Antinuclear Antibody Positive Report Source Health Professional Other Product Adepal (Levonorgestrel/Ethi nyl Estradiol, Tablet, O) Lariam (Mefloquine, 0) Doliprane (Paracetamol) Ibuprofen (Ibuprofen) Role Manufacturer
Age:42 YR Route
Gender:Female Dose
I/FU:I Duration
PS SS C C
ORAL ORAL
ORAL/SEVERAL MONTHS 250 MG 1X PER 1 WK, ORAL 53 DAY
Date:07/10/03ISR Number: 4144762-XReport Type:Direct Outcome Disability PT Viith Nerve Paralysis
Company Report #CTU 197662 Report Source Product Mefloquine Hepatitis A Vaccine Role PS C Manufacturer
Gender:Female Dose 250MG ORAL
I/FU:I Duration
Date:07/10/03ISR Number: 4147062-7Report Type:Expedited (15-DaCompany Report #FRWYE193930JUN03
Age:42 YR
Gender:Female
I/FU:F
PT Diarrhoea Myalgia Arthralgia Hepatitis Headache Cytolytic Hepatitis Antinuclear Antibody Page: 508
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Positive Report Source Health Professional Other Product Adepal (Levonorgestrel/Ethi nyl Estradiol, Tablet, 0) Lariam (Mefloquine, , 0) Role Manufacturer Route Dose Duration
PS SS
ORAL ORAL 250 MG 1X PER 1 WK 53 DAY
Date:07/11/03ISR Number: 4145359-8Report Type:Expedited (15-DaCompany Report #KE-ROCHE-340706 Outcome Hospitalization Initial or Prolonged PT Peritoneal Haemorrhage Ascites Infectious Peritonitis Blood Pressure Decreased Prothrombin Time Prolonged Cardiomegaly Anaemia Gallop Rhythm Present Gastrointestinal Haemorrhage Drug Interaction Tachycardia Melaena Report Source Product Mefloquine Hydrochloride Carvedilol Betoptic Eye Drops Captoril Digoxin Warfarin Role PS C C C C I Manufacturer Roche
Gender:Male Dose DOSE REPORTED AS 250MG PER WEEK.
I/FU:I Duration
UNKNOWN
Date:07/14/03ISR Number: 4146493-9Report Type:Direct Outcome Other Serious PT Delusion Memory Impairment Social Avoidant Behaviour Sensory Loss Panic Attack Visual Impairment Speech Disorder Crying Depression Poisoning Hearing Impaired Flat Affect Emotional Disorder Bipolar Disorder
Age:22 YR Route
Gender:Male Dose
I/FU:I Duration
Date:07/14/03ISR Number: 4148525-0Report Type:Expedited (15-DaCompany Report #200316652GDDC Outcome Hospitalization Initial or Prolonged PT Drug Interaction Aggression Hyperhidrosis Confusional State Depressed Level Of
Age:63 YR
Gender:Male
I/FU:I
03-Apr-2012
09:37 AM
Page: 509
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Hunger Hypoglycaemia Cellulitis Fatigue Haemorrhage Irritability Oedema Peripheral Muscle Twitching Prothrombin Time Prolonged Mental Disorder Blister Retrograde Amnesia Blood Glucose Fluctuation Skin Graft Injury Dermatitis Exfoliative
Report Source Foreign Literature Health Professional Other
Product Glibenclamide Mefloquine Hydrochloride Frusemide Sotalol Digoxin
Role PS SS C C C
Manufacturer
Route
Dose 250 MG
Duration
Date:07/15/03ISR Number: 4147230-4Report Type:Direct Outcome Life-Threatening PT Chest Pain Dyspnoea Hypoaesthesia Conversion Disorder Speech Disorder Anxiety Costochondritis
Gender:Male Dose 250MG Q7D ORAL
I/FU:I Duration
Date:07/15/03ISR Number: 4147241-9Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Diarrhoea Eyelid Oedema Local Swelling Chest Discomfort Nausea Feeling Abnormal Vision Blurred Abdominal Discomfort Abdominal Pain Oedema Peripheral Decreased Appetite Rash Swollen Tongue Swelling Face
Gender:Female
I/FU:I
Date:07/15/03ISR Number: 4147253-5Report Type:Expedited (15-DaCompany Report #KE-ROCHE-308528 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Drug Interaction Prothrombin Time Prolonged Gallop Rhythm Present Abdominal Rebound
Age:66 YR
Gender:Male
I/FU:I
03-Apr-2012
09:37 AM
Page: 510
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tenderness Blood Pressure Decreased Gastrointestinal Haemorrhage Ejection Fraction Decreased Infectious Peritonitis Anaemia Congestive Cardiomyopathy Peritoneal Haemorrhage Tachycardia Gastrointestinal Sounds Abnormal Abdominal Distension Ascites Cardiomegaly Ileus
Report Source
Product Mefloquine Hydrochloride Carvedilol Betoptic Eye Drops Captopril Digoxin Warfarin
Role PS C C C C I
Manufacturer Roche
Route UNKNOWN
Dose
Duration
UNKNOWN
Date:07/16/03ISR Number: 4148165-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-339481 Outcome Hospitalization Initial or Prolonged PT Antinuclear Antibody Positive Hepatitis Report Source Consumer Product Lariam Doliprane Adepal Role PS C C Manufacturer Roche
Gender:Female Dose RECEIVED TREATMENT FOR SEVERAL MONTHS
Ibuprofene
ORAL
DAY
Date:07/17/03ISR Number: 4148786-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-342147 Outcome Hospitalization Initial or Prolonged PT Cerebrovascular Accident Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male
I/FU:I
Dose Duration REPORTED AS THREE-QUARTER S OF A TABLET.
Date:07/21/03ISR Number: 4150523-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-342003 Outcome Congenital Anomaly PT Pregnancy Maternal Drugs Affecting Foetus Abortion Induced Foetal Disorder Congenital Hydrocephalus Report Source Product Lariam Stamaril Unidose Librax Role PS SS SS Manufacturer Roche Roche
Age:29 YR Route UNKNOWN UNKNOWN UNKNOWN
Gender:Female Dose TAKEN OCCASIONALLY.
Date:07/22/03ISR Number: 4151451-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-336087 Outcome Disability PT Cardiac Failure Hyperlipidaemia Viral Infection Anosmia 09:37 AM
Age:71 YR
Gender:Male
I/FU:F
03-Apr-2012
Page: 511
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ageusia Hypothyroidism Report Source Product Lariam Role PS Manufacturer Roche Route ORAL Dose Duration
Date:07/22/03ISR Number: 4151460-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-342003 Outcome Congenital Anomaly PT Foetal Disorder Lung Disorder Maternal Drugs Affecting Foetus Nervous System Disorder Abortion Induced Congenital Hydrocephalus Metrorrhagia Pregnancy Dysplasia Report Source Product Lariam Stamaril Unidose Librax Role PS SS SS Manufacturer Roche Roche
Age:29 YR Route UNKNOWN UNKNOWN UNKNOWN
Gender:Female Dose TAKEN OCCASIONALLY.
Date:07/23/03ISR Number: 4152252-3Report Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Impaired Work Ability Confusional State Arthritis Anxiety Night Sweats Hyperhidrosis Insomnia Depression Hallucination, Auditory Impaired Driving Ability
Company Report #CTU 198498 Report Source Product Mefloquine Roche Role 250 Mg PS Roche Manufacturer
Age:62 YR Route
Gender:Female Dose 1@ WEEK 10 WEEKS
I/FU:I Duration
Date:07/24/03ISR Number: 4153323-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-339481 Outcome Hospitalization Initial or Prolonged PT Hepatitis Report Source Product Lariam Adepal Role PS SS Manufacturer Roche
Gender:Female Dose RECEIVED TREATMENT FOR SEVERAL MONTHS 7 7
Ibuprofene Doliprane
C C
ORAL ORAL
DAY DAY
Date:07/25/03ISR Number: 4154030-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-341571
Age:30 YR
Gender:Female
I/FU:F
PT Paralysis Groin Pain
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose
Duration 36 DAY
03-Apr-2012
09:37 AM
Page: 512
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/03ISR Number: 4154884-5Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Restlessness Rash Heart Rate Increased Dizziness Anxiety Confusional State Company Report #CTU 198688 Report Source Product Lariam = Mefloquine 250 Mg Role PS Manufacturer Age:34 YR Route Gender:Male Dose 250MG 7 WEEKS I/FU:I Duration
Date:07/28/03ISR Number: 4155347-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-324511 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Headache Convulsion Pyrexia Heart Rate Increased Splenomegaly Jaundice Circulatory Collapse Anaemia Haemolytic Autoimmune Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration THERAPY DURATION REPORTED AS 5 MONTHS.
Propecia
Date:07/28/03ISR Number: 4155373-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-342738 Outcome Other Serious PT Pain In Extremity Headache Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:07/30/03ISR Number: 4158822-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-329796 Outcome Hospitalization Initial or Prolonged Disability PT Flushing Emotional Distress Facial Pain Burning Sensation Tenderness Erythema Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:07/31/03ISR Number: 4158590-2Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Outcome Other Serious PT Flashback Paranoia Homicide Report Source Product Lariam Flagyl Unknown Medication Role PS C C Manufacturer Roche
Gender:Male Dose
I/FU:F Duration 3 MON 8 DAY
Hallucination, Auditory Hallucination, Olfactory
Antidepressants Nos
03-Apr-2012
09:37 AM
Page: 513
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4158597-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-342869 Outcome Hospitalization Initial or Prolonged PT Lymphocyte Morphology Abnormal Dermatitis Exfoliative Pseudolymphoma Lymphadenopathy Report Source Product Lariam Role PS Manufacturer Roche Age:35 YR Route ORAL Gender:Male Dose I/FU:I Duration 198 DAY
Date:07/31/03ISR Number: 4158599-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-343049 Outcome Hospitalization Initial or Prolonged PT Hepatic Enzyme Increased Diarrhoea Hepatitis Cholestatic Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:I
Di Antalvic Perfalgan
C C
ORAL INTRAVENOUS
Dose Duration REPORTED AS 3 TABLETS EVERY 8 HOURS, THEN 2 EVERY 8 HOURS, THEN 1 3 DAY 1 DAY 2 DAY
Date:08/04/03ISR Number: 4160446-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Anxiety Hallucination, Visual Vestibular Disorder Headache Hypertension Confusional State Depression Memory Impairment Dyspnoea Skin Disorder Gastrointestinal Disorder Chronic Fatigue Syndrome Mitral Valve Prolapse Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:08/07/03ISR Number: 4163376-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-343702 Outcome Other Serious PT Muscle Spasms Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Age:31 YR
Gender:Male
I/FU:I
Other Serious Required Intervention to Prevent Permanent Impairment/Damage
Escherichia Infection Anxiety Disturbance In Attention Paranoia Thinking Abnormal Diarrhoea Insomnia Vision Blurred Page: 514
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Toxicity To Various Agents Headache Vomiting Abdominal Pain Upper Depression
Report Source
Product Lariam 250 Mg Roche Labs Inc. Nj
Role PS
Manufacturer Roche Labs Inc. Nj
Route ORAL
Dose 1 PILL 1 A WEEK ORAL
Duration
Date:08/13/03ISR Number: 4166562-7Report Type:Expedited (15-DaCompany Report #AU-ROCHE-344285 Outcome Hospitalization Initial or Prolonged PT Arrhythmia Supraventricular Sinus Bradycardia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:08/13/03ISR Number: 4166567-6Report Type:Expedited (15-DaCompany Report #DE-ROCHE-341571 Outcome Other Serious PT Asthenia Paraesthesia Groin Pain Paralysis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:08/15/03ISR Number: 4169049-0Report Type:Direct Outcome Life-Threatening PT Anxiety Costochondritis Dyspnoea Speech Disorder Hypoaesthesia Conversion Disorder Chest Pain
Gender:Male Dose 250 MG Q7D ORAL
I/FU:I Duration
Date:08/15/03ISR Number: 4169053-2Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Oedema Peripheral Abdominal Discomfort Diarrhoea Swollen Tongue Eyelid Oedema Feeling Abnormal Nausea Swelling Face
Gender:Female
I/FU:I
Rash Local Swelling Pain Decreased Appetite Chest Discomfort Vision Blurred
03-Apr-2012
09:37 AM
Page: 515
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/03ISR Number: 4171983-2Report Type:Direct Outcome Disability PT Depression Mental Disorder Nervousness Abnormal Behaviour Disturbance In Attention Swollen Tongue Irritability Company Report #CTU 200182 Report Source Product Larium - Mefloquin Roche Role PS Manufacturer Roche Age: Route ORAL Gender:Female Dose 250 MG, ORAL WEEKLY I/FU:I Duration
Date:08/19/03ISR Number: 4169987-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-339743 Outcome Other Serious PT Haemorrhage Von Willebrand'S Disease Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration THE PATIENT WAS REPORTED TO HAVE RECEIVED MEFLOQUINE
Lariam Lariam
SS SS
Roche Roche
ORAL ORAL
Date:08/25/03ISR Number: 4177287-6Report Type:Expedited (15-DaCompany Report #2003034182 Outcome Hospitalization Initial or Prolonged Other Serious PT Drug Ineffective Dyspnoea Nausea Paraesthesia Productive Cough Hyperhidrosis Medication Error Fatigue Pyrexia Myalgia Self-Medication Insomnia Oropharyngeal Pain Sputum Discoloured Malaria Pharyngitis Chills Sleep Disorder Decreased Appetite Arthralgia Headache Lymphadenopathy Report Source Foreign Literature Health Professional Product Doxycycline (Doxycycline) Mefloquine (Mefloquine) Role PS Manufacturer
Age: Route
Gender:Male Dose 100 MG (DAILY), UNKNOWN
I/FU:I Duration
SS
Date:08/27/03ISR Number: 4175954-1Report Type:Direct Outcome Death PT Completed Suicide Drug Abuser
Company Report #CTU 200820 Report Source Product Lariam Marijuana Role PS C Manufacturer
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 516
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/03ISR Number: 4176059-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-345390 Outcome Death PT Fall Hallucination Coordination Abnormal Abnormal Behaviour Balance Disorder Confusional State Report Source Product Lariam Role PS Manufacturer Roche Age:25 YR Route ORAL Gender:Male Dose I/FU:I Duration
Date:09/02/03ISR Number: 4178742-5Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Emotional Disorder Anxiety Disturbance In Attention Thinking Abnormal Suicidal Ideation Obsessive-Compulsive Disorder Confusional State Dysgraphia Attention Deficit/Hyperactivity Disorder Binge Eating Abnormal Dreams Educational Problem Bipolar Disorder
Company Report #CTU 201022 Report Source Product Mefloquin Accutane Role PS C Manufacturer
Gender:Male
I/FU:I
Dose Duration AS DIREC ORAL
Date:09/04/03ISR Number: 4178977-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-343702 Outcome Other Serious PT Overdose Muscle Spasms Poisoning Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:09/05/03ISR Number: 4180293-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-340171 Outcome Hospitalization Initial or Prolonged PT Coordination Abnormal Anxiety Transient Ischaemic Attack Myalgia Paraesthesia Viith Nerve Paralysis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Neuromyopathy
03-Apr-2012
09:37 AM
Page: 517
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/03ISR Number: 4185949-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-344428 Outcome Other Serious PT Diarrhoea Nausea Gastroenteritis Bacterial Infection C-Reactive Protein Increased Decreased Appetite Report Source Product Lariam Trinordiol Role PS C Manufacturer Roche Age:22 YR Route ORAL ORAL Gender:Female Dose I/FU:I Duration 48 DAY
Date:09/22/03ISR Number: 4190417-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-346816 Outcome Hospitalization Initial or Prolonged PT Mental Disorder Condition Aggravated Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:09/22/03ISR Number: 4193952-9Report Type:Direct Outcome Life-Threatening Disability PT Fear Abnormal Dreams Ear Disorder Gastrointestinal Pain Muscle Twitching Panic Attack Balance Disorder Dyspepsia Vestibular Disorder Depressed Mood Insomnia Muscle Spasms Muscular Weakness Nausea Depression Dizziness Motion Sickness Pruritus Somnambulism Heart Rate Increased Anxiety Hypersensitivity Irritable Bowel Syndrome
Company Report #CTU 202092 Report Source Product Lariam 250 Mg Roche Labs Yellow Fever Shot Role PS C Manufacturer Roche Labs
I/FU:I Duration
Age:31 YR Route
Gender:Male Dose
I/FU:I Duration
Life-Threatening
Fear Panic Attack Dyspnoea Thinking Abnormal
Lariam 250 Mg Hoffmann-Laroche Diamox-Acetazolamide
PS C
Hoffmann- Loroche
ORAL
1 PILL WEEK ORAL
03-Apr-2012
09:37 AM
Page: 518
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/03ISR Number: 4196918-8Report Type:Direct Outcome Disability PT Selective Iga Immunodeficiency Sleep Disorder Balance Disorder Mood Swings Vestibular Disorder Post-Traumatic Stress Disorder Activities Of Daily Living Impaired Coordination Abnormal Company Report #CTU 202631 Report Source Product Larium (Mefloquine) Role PS Manufacturer Hoffman-La Roche Age:44 YR Route ORAL Gender:Male Dose 1 TAB WEEK ORAL I/FU:I Duration
Date:09/26/03ISR Number: 4197035-3Report Type:Direct Outcome Disability PT Balance Disorder Activities Of Daily Living Impaired Sleep Disorder Coordination Abnormal Vestibular Neuronitis Mood Swings Vestibular Disorder
Company Report #CTU 202661 Report Source Product Lariam -MefloquineHoffman-La Roche Role PS Manufacturer Hoffman-La Roche
Gender:Male Dose 1 TAB ORAL WEEK
I/FU:I Duration
Date:10/01/03ISR Number: 4199107-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-346816 Outcome Hospitalization Initial or Prolonged PT Mental Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:F Duration
Date:10/02/03ISR Number: 4200052-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-347539 Outcome Disability PT Feeling Abnormal Panic Reaction Tremor Hypoaesthesia Vitreous Floaters Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
Date:10/02/03ISR Number: 4200058-9Report Type:Expedited (15-DaCompany Report #BE-ROCHE-347367 Outcome PT Report Source Product Role Manufacturer
Age:36 YR Route
Gender:Female Dose
I/FU:I Duration
Disability
Dizziness Speech Disorder Coordination Abnormal Nystagmus
Mefloquine Hydrochloride
PS
Roche
ORAL
03-Apr-2012
09:37 AM
Page: 519
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/03ISR Number: 4200060-7Report Type:Expedited (15-DaCompany Report #CA-ROCHE-348024 Outcome Hospitalization Initial or Prolonged PT Blood Creatine Phosphokinase Loss Of Consciousness Vomiting Nausea Diarrhoea Blood Lactate Dehydrogenase Increased Dehydration Hepatic Enzyme Increased Blood Creatine Phosphokinase Increased Myalgia Report Source Product Lariam Echinacea Role PS C Manufacturer Roche Age:40 YR Route ORAL ORAL Gender:Male Dose I/FU:I Duration
Date:10/03/03ISR Number: 4200906-2Report Type:Expedited (15-DaCompany Report #KR-ROCHE-347870 Outcome Hospitalization Initial or Prolonged PT Dizziness Visual Impairment Nasal Congestion Syncope Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:10/08/03ISR Number: 4203837-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-347843 Outcome Hospitalization Initial or Prolonged PT Dehydration Blood Calcium Decreased Blood Magnesium Decreased Blood Parathyroid Hormone Decreased Oligodipsia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:10/10/03ISR Number: 4205951-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-348532 Outcome Other Serious PT Pyrexia Nausea Metrorrhagia Report Source Product Lariam Lariam Microgynon Role PS SS C Manufacturer Roche Roche
Gender:Female Dose
Age:51 YR Route
Gender:Male Dose
I/FU:I Duration
Death
Completed Suicide Physical Assault Abnormal Behaviour Aggression Thinking Abnormal Anxiety
Lariam Roche Prozak
PS C
Roche
ORAL
ORAL
03-Apr-2012
09:37 AM
Page: 520
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/03ISR Number: 4215201-5Report Type:Expedited (15-DaCompany Report #JP-ROCHE-348824 Outcome Hospitalization Initial or Prolonged PT Haemolytic Anaemia Jaundice Systemic Lupus Erythematosus Report Source Product Lariam Role PS Manufacturer Roche Age:71 YR Route UNKNOWN Gender:Female Dose I/FU:I Duration
Date:10/21/03ISR Number: 4215206-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-349152 Outcome Other Serious PT Rhabdomyolysis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:10/22/03ISR Number: 4215411-7Report Type:Direct Outcome PT Diarrhoea Abnormal Dreams Psychiatric Symptom Thinking Abnormal Morbid Thoughts Anxiety
Company Report #CTU 204278 Report Source Product Mephaquin 275 Mg Mefloquine Hydrichloride Mepha Ltd Role Manufacturer
Age:29 YR Route
Gender:Female Dose
I/FU:I Duration
PS
Mepha Ltd
ORAL
1 TABLET 1/ WEEK ORAL
Date:10/23/03ISR Number: 4215803-6Report Type:Direct Outcome Other Serious PT Balance Disorder Nightmare
Age: Route ORAL
Gender:Female
I/FU:I
Dose Duration 250 MG Q WEEK ORAL
Date:10/27/03ISR Number: 4218198-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-320492 Outcome Death PT Hypersomnia Depression Feeling Abnormal Personality Change Loss Of Consciousness Overdose Completed Suicide Weight Increased Sensory Disturbance Tearfulness Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:10/27/03ISR Number: 4218616-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-349710 Outcome Other Serious PT Maternal Drugs Affecting Foetus Abortion Spontaneous Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 521
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/03ISR Number: 4219696-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Outcome Hospitalization Initial or Prolonged Disability PT Antisocial Behaviour Convulsion Headache Mania Psychotic Disorder Speech Disorder Drug Ineffective Blood Potassium Decreased Incontinence Memory Impairment Delusion Hostility Confusional State Hallucination Disorientation Aggression Paranoia Depression Gait Disturbance Agitation Fatigue Loss Of Libido Report Source Product Lariam Valium Prozac Role PS SS C Manufacturer Roche Roche Age:40 YR Route ORAL INTRAVENOUS ORAL Gender:Female Dose EVERY WEEK. I/FU:F Duration 9 DAY 1 DAY
Date:10/30/03ISR Number: 4222386-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-257719 Outcome Disability PT Memory Impairment Suicidal Ideation Hypertension Hallucination Dissociative Disorder Anxiety Paranoia Psychotic Disorder Agoraphobia Dizziness Confusional State Balance Disorder Headache Depression Report Source Product Lariam Tablets Role PS Manufacturer Roche
Gender:Male
I/FU:F
Date:11/05/03ISR Number: 4237482-4Report Type:Expedited (15-DaCompany Report #12424925 Outcome Hospitalization Initial or Prolonged PT Blood Pressure Decreased Infectious Peritonitis Report Source Foreign Literature Product Warfarin Sodium Mefloquine Role PS Manufacturer
I/FU:I Duration
Tachycardia Anaemia Drug Interaction Prothrombin Time Prolonged Ascites
(Mefloquine Hcl) Captopril Tabs (Captopril) Digoxin (Digoxin) Carvedilol (Carvedilol)
SS
250 MILLIGRAM, 1 WEEK
C C C Page: 522
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/03ISR Number: 4233982-1Report Type:Expedited (15-DaCompany Report #IE-ROCHE-350696 Outcome Hospitalization Initial or Prolonged PT Pyrexia Lower Respiratory Tract Infection Report Source Product Lariam Folic Acid Role PS C Manufacturer Roche Age:23 MON Route UNKNOWN Gender:Female Dose 0.25 OF A TABLET. I/FU:I Duration
Date:11/10/03ISR Number: 4233988-2Report Type:Expedited (15-DaCompany Report #IE-ROCHE-350774 Outcome Hospitalization Initial or Prolonged PT Pyrexia Lower Respiratory Tract Infection Report Source Product Lariam Folic Acid Role PS C Manufacturer Roche
Age:23 MON Route UNKNOWN
Gender:Female Dose 0.25 OF A TABLET.
I/FU:I Duration
Date:11/12/03ISR Number: 4233947-XReport Type:Expedited (15-DaCompany Report #CA-ROCHE-348024 Outcome Hospitalization Initial or Prolonged PT Dehydration Blood Creatine Phosphokinase Diarrhoea Nausea Vomiting Blood Lactate Dehydrogenase Increased Loss Of Consciousness Myalgia Hepatitis Hepatitis Viral Report Source Product Lariam Echinacea Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:11/14/03ISR Number: 4235630-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-351227 Outcome Other Serious PT Viith Nerve Paralysis Vision Blurred Dysgeusia Product Quality Issue Corneal Reflex Decreased Eating Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
Date:11/17/03ISR Number: 4236524-XReport Type:Direct Outcome Life-Threatening PT Abdominal Pain Night Sweats
Age:35 YR
Gender:Male
I/FU:I
Depression Suicidal Ideation Nightmare Homicidal Ideation Fatigue Insomnia Overwork Diarrhoea 03-Apr-2012 09:37 AM Page: 523
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Circadian Rhythm Sleep Disorder Report Source Product Lariam Roche 250 Mg Tablets Role PS Manufacturer Roche Route Dose (1) 250 MG TABLET 1X WEEKLY X 5 WKS Duration
Date:11/19/03ISR Number: 4237499-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-351387 Outcome Other Serious PT Abortion Spontaneous Maternal Drugs Affecting Foetus Intra-Uterine Death Report Source Product Lariam Stamaril Unidose Role PS C Manufacturer Roche
Age: Route ORAL SUBCUTANEOUS
Gender:Female Dose
Date:11/21/03ISR Number: 4239347-0Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Abasia Photophobia Visual Field Defect Bladder Disorder Feeling Abnormal Hallucination, Auditory Fall Suicidal Ideation Tremor Anger Anxiety Visual Impairment Insomnia Aphasia Panic Attack
Gender:Male
I/FU:I
Dose Duration 250 MG WEEKLY ORAL
Date:12/01/03ISR Number: 4243237-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-350389 Outcome Other Serious PT Amnesia Disorientation Panic Attack Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration 3 DOSES TAKEN IN TOTAL. 24 DAY
Date:12/01/03ISR Number: 4243240-7Report Type:Expedited (15-DaCompany Report #IE-ROCHE-350696
Age:23 MON
Gender:Female
I/FU:F
PT Pyrexia Malaise Lower Respiratory Tract Infection White Blood Cell Count Increased
Report Source
Product Lariam Penicillin V Cefotaxim Dexamethasone
Role PS C C C
Manufacturer Roche
Route UNKNOWN ORAL INTRAVENOUS INTRAVENOUS
Dose Duration 0.25 OF A TABLET. DOSE INCREASED TO 250MG BD. 6 DAY 4MG TO 1 MG, Page: 524
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report QDS Folic Acid Clarithromycin C C ORAL ORAL 2 8 DAY DAY
Date:12/01/03ISR Number: 4243244-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-350389 Outcome Other Serious PT Disorientation Panic Attack Amnesia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration 3 DOSES TAKEN IN TOTAL. 24 DAY
Date:12/01/03ISR Number: 4243580-1Report Type:Expedited (15-DaCompany Report #IE-ROCHE-350774 Outcome Hospitalization Initial or Prolonged PT Lower Respiratory Tract Infection Malaise Pyrexia White Blood Cell Count Increased Report Source Product Lariam Penicillin V Clarithromycin Folic Acid Cefotaxime Role PS C C C C Manufacturer Roche
Age:23 MON Route ORAL ORAL ORAL ORAL INTRAVENOUS
I/FU:F Duration
8 8
DAY DAY
Date:12/01/03ISR Number: 4243635-1Report Type:Expedited (15-DaCompany Report #IE-ROCHE-350774 Outcome Hospitalization Initial or Prolonged PT Lower Respiratory Tract Infection Pyrexia Malaise White Blood Cell Count Increased Report Source Product Lariam Penicillin V Clarithromycin Folic Acid Cefotaxime Role PS C C C C Manufacturer Roche
Age:23 MON Route ORAL ORAL ORAL ORAL INTRAVENOUS
I/FU:F Duration
8 8
DAY DAY
Date:12/02/03ISR Number: 4244263-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-352392 Outcome Other Serious PT Homicidal Ideation Suicidal Ideation Hallucination Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:12/04/03ISR Number: 4245784-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-331974 Outcome Other Serious PT Abortion Spontaneous Maternal Drugs Affecting Foetus Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration PATIENT TOOK 3 TABLETS IN TOTAL 3 WK
Alcohol Use Pregnancy On Oral Contraceptive
Oral Contraceptive Pill
ORAL
03-Apr-2012
09:37 AM
Page: 525
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4245788-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-352436 Outcome Other Serious PT Dyspnoea Iiird Nerve Disorder Hypoaesthesia Paraesthesia Report Source Product Lariam Role PS Manufacturer Roche Age:30 YR Route UNKNOWN Gender:Female Dose I/FU:I Duration
Date:12/08/03ISR Number: 4248397-XReport Type:Direct Outcome Other Serious PT Decreased Appetite Hyperhidrosis Night Sweats Asthenia Heat Rash Depression Insomnia Lethargy
Gender:Male Dose DAILY ORAL
I/FU:I Duration
Date:12/15/03ISR Number: 4251655-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-353732 Outcome Other Serious PT Abortion Spontaneous Pregnancy Maternal Drugs Affecting Foetus Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
Date:12/15/03ISR Number: 4252145-7Report Type:Direct Outcome Other Serious PT Panic Attack Anxiety
Company Report #CTU 208025 Report Source Product Mefloquine Birth Control Pill Cipro Zovia Role PS C C C Manufacturer
Gender:Female Dose ONCE WEEK ORAL
I/FU:I Duration
Date:12/18/03ISR Number: 4253973-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Outcome Hospitalization Initial or Prolonged Disability PT Paranoia Disorientation Blood Potassium Decreased Vision Blurred Memory Impairment
Age:40 YR
Gender:Female
I/FU:F
Hallucination Psychotic Disorder Incontinence Disturbance In Attention Hostility Disability Somnolence Gait Disturbance 03-Apr-2012 09:37 AM Page: 526
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Circulatory Collapse Delusion Decreased Activity Drug Ineffective Aggression Depression Speech Disorder Agitation Headache Antisocial Behaviour Loss Of Libido Confusional State Mania Convulsion
Product Lariam Valium Prozac
Role PS SS C
Route ORAL INTRAVENOUS ORAL
Dose EVERY WEEK.
Date:12/18/03ISR Number: 4253974-6Report Type:Expedited (15-DaCompany Report #CA-ROCHE-348024 Outcome Hospitalization Initial or Prolonged PT Myalgia Blood Creatine Phosphokinase Dehydration Hepatitis Viral Loss Of Consciousness Vomiting Nausea Hepatitis Syncope Diarrhoea Report Source Health Professional Product Lariam Echinacea Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:12/22/03ISR Number: 4256133-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-354080 Outcome Other Serious PT Convulsion Loss Of Consciousness Respiratory Arrest Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:12/22/03ISR Number: 4256138-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-354423 Outcome Hospitalization Initial or Prolonged PT Biliary Colic Cholecystitis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
Date:12/23/03ISR Number: 4257040-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-352436
Age:30 YR
Gender:Female
I/FU:F
PT Feeling Cold Muscle Rigidity Protein C Increased Iiird Nerve Disorder Nervous System Disorder Gait Disturbance Page: 527
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Injection Site Anaesthesia Dyspnoea Paraesthesia Chest Discomfort Tremor Diplopia Painful Respiration Hypoaesthesia Cerebellar Syndrome
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose
Duration
Date:01/05/04ISR Number: 4263391-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Paranoia Balance Disorder Suicidal Ideation Hallucination Neuropathy Peripheral Viiith Nerve Lesion Visual Impairment Tremor Photophobia Hepatic Failure Panic Attack Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose 23 TABLETS DISPENSED.
I/FU:I Duration
Date:01/07/04ISR Number: 4265742-XReport Type:Expedited (15-DaCompany Report #GB-ROCHE-354080 Outcome Other Serious PT Convulsion Respiratory Arrest Loss Of Consciousness Report Source Consumer Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:01/09/04ISR Number: 4268113-5Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability PT Nightmare Tremor Depression Anxiety Convulsion
Company Report #CTU 209610 Report Source Product Mefloquin 250 Mg Lariam Role PS Manufacturer
I/FU:I Duration
Age:54 YR Route
Gender:Female Dose
I/FU:I Duration
Depression Convulsion Anxiety
Lariam Antibiotic Levaquen Reglan Prevacid
PS C C C C
ORAL
ONE TIME ORAL
03-Apr-2012
09:37 AM
Page: 528
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/04ISR Number: 4271467-7Report Type:Direct Outcome Disability PT Feeling Abnormal Sleep Disorder Hyperacusis Stress Depression Anxiety Emotional Disorder Company Report #CTU 210092 Report Source Product Lariam Mefloquine Roche Role PS Manufacturer Roche Age: Route ORAL Gender:Female Dose 1 WEEK ORAL I/FU:I Duration
Date:01/20/04ISR Number: 4274670-5Report Type:Direct Outcome Other Serious PT Anxiety Panic Attack Nightmare Vertigo
Age:22 YR Route
I/FU:I Duration
Date:01/29/04ISR Number: 4281325-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-351227 Outcome Other Serious PT Dysgeusia Viith Nerve Paralysis Product Quality Issue Vision Blurred Lacrimation Increased Report Source Consumer Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
Date:01/30/04ISR Number: 4282938-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-357211 Outcome Hospitalization Initial or Prolonged PT Amnesia Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose PATIENT TOOK ONLY ONE DOSE OF MEFLOQUINE.
I/FU:I Duration
DAY
Date:02/02/04ISR Number: 4283667-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-357080 Outcome Hospitalization Initial or Prolonged PT Dysphagia Urticaria Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:02/04/04ISR Number: 4285179-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Outcome Hospitalization Initial or Prolonged Disability PT Hallucination Mania Psychotic Disorder Speech Disorder Confusional State
Age:40 YR
Gender:Female
I/FU:F
03-Apr-2012
09:37 AM
Page: 529
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Potassium Decreased Hostility Decreased Activity Gait Disturbance Antisocial Behaviour Loss Of Libido Disturbance In Attention Paranoia Disorientation Convulsion Agitation Fatigue Aggression Vision Blurred Incontinence Drug Ineffective Headache Depression Memory Impairment Delusion
Role PS SS C
Dose EVERY WEEK.
Company Report #CTU 211605 Report Source Product Lariam 125 Mg/5ml. Methlaquine Tabs 250 Mg - Compounded Role PS SS Manufacturer
Age:10 YR Route
Gender:Male Dose 1 TSP ONE TIME PER WK
I/FU:I Duration
Date:02/06/04ISR Number: 4286779-0Report Type:Expedited (15-DaCompany Report #NL-ROCHE-348532 Outcome Other Serious PT Metrorrhagia Pyrexia Nausea Report Source Health Professional Product Lariam Lariam Microgynon 30 Role PS SS C Manufacturer Roche Roche
Gender:Female Dose
Date:02/06/04ISR Number: 4286781-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-355117 Outcome Other Serious PT Muscle Spasms Mucosal Inflammation Throat Irritation Oropharyngeal Blistering Palpitations Dizziness Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:02/12/04ISR Number: 4293681-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Outcome Hospitalization Initial or Prolonged Disability 03-Apr-2012 09:37 AM PT Hallucination Depression Gait Disturbance Blood Potassium Decreased
Age:40 YR
Gender:Female
I/FU:F
Page: 530
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Speech Disorder Fatigue Mania Confusional State Delusion Pyrexia Muscle Rigidity Disorientation Hostility Memory Impairment Aggression Headache Psychotic Disorder Convulsion Loss Of Libido Incontinence Agitation Antisocial Behaviour Drug Ineffective
Role PS SS C
Dose EVERY WEEK.
Date:02/12/04ISR Number: 4293695-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-354080 Outcome Other Serious PT Convulsion Loss Of Consciousness Report Source Consumer Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:02/12/04ISR Number: 4294092-0Report Type:Direct Outcome Congenital Anomaly PT Anger Aggression Psychotic Disorder Imprisonment
Company Report #CTU 212123 Report Source Product Larium 250 Mg Roache Pharmaceuticals Role PS Manufacturer Roache Pharmaceuticals
Gender:Male Dose 250 MG , WEEKLY ORAL
I/FU:I Duration
Date:02/16/04ISR Number: 4295449-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-351227 Outcome Other Serious PT Viith Nerve Paralysis Dysgeusia Report Source Consumer Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
Date:02/16/04ISR Number: 4295459-7Report Type:Expedited (15-DaCompany Report #CA-ROCHE-358463 Outcome Other Serious PT Schizoaffective Disorder Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Mania Psychotic Disorder
03-Apr-2012
09:37 AM
Page: 531
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/04ISR Number: 4303509-4Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Abnormal Dreams Hallucination Anxiety Sleep Disorder Affect Lability Insomnia Decreased Appetite Depression Panic Attack Company Report #CTU 213006 Report Source Product Mefloquine Hcl 250 Mg Tab Geneva Pharm. Tech. Corp Flomax Proscar Role PS C C Manufacturer Geneva Pharm Tech. Corp Age:69 YR Route Gender:Male Dose I/FU:I Duration
ORAL
1 A WEEK ORAL
Date:02/26/04ISR Number: 4307492-7Report Type:Expedited (15-DaCompany Report #2003IC000217 Outcome Death Congenital Anomaly PT Intra-Uterine Death Pregnancy Abortion Induced Foetal Malformation Maternal Drugs Affecting Foetus Hydrocephalus Foetal Disorder Haemorrhage Foetal Malposition Report Source Foreign Health Professional Product Librax (Chlordiazepoxide Hydrochloride/Clidin ium Bromide) Stamaril Amaril Vaccin (Generic Unknown) Lariam (Mefloquine Chlorhydrate) (Generic Unknown) Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
TRANSPLACENTAL
TRANSPLACENTA L 1 FD; TRANSPLACENTA L TRANSPLANCENT AL
SS
TRANSPLACENTAL
SS
TRANSPLACENTAL
Date:03/01/04ISR Number: 4308476-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-359452 Outcome Hospitalization Initial or Prolonged PT Lymphadenopathy Pulmonary Fibrosis Interstitial Lung Disease Report Source Consumer Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:I
Unknown Medication
INTRAVENOUS
Dose Duration DOSAGE REPORTED AS 1.1 AND 1.2 MG/L. DRUG REPORTED AS CLAMOXIL. 3 DAY
Date:03/03/04ISR Number: 4310349-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-355117 Outcome Other Serious PT Muscle Spasms Palpitations Product Quality Issue Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Medication Error Mucosal Inflammation Throat Irritation Oropharyngeal Blistering Dizziness
03-Apr-2012
09:37 AM
Page: 532
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4310471-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-351227 Outcome Other Serious PT Dysgeusia Vision Blurred Face Oedema Corneal Reflex Decreased Viith Nerve Paralysis Report Source Health Professional Product Lariam Role PS Manufacturer Roche Age:55 YR Route ORAL Gender:Female Dose I/FU:F Duration 1 DAY
Date:03/08/04ISR Number: 4313479-0Report Type:Expedited (15-DaCompany Report #CA-ROCHE-358463 Outcome Other Serious PT Mania Psychotic Disorder Schizoaffective Disorder Treatment Noncompliance Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:03/09/04ISR Number: 4314313-5Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Anxiety Panic Attack Malaria Drug Ineffective Major Depression
Company Report #CTU 214091 Report Source Product Lariam 250 Mg Roche Cipro Flagyl Role PS C C Manufacturer Roche
Gender:Male
I/FU:I
Dose Duration 500 MG WEEKLY ORAL, 1500 MG ONE TIME ORAL
Date:03/11/04ISR Number: 4315538-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-351227 Outcome Other Serious PT Vision Blurred Dysgeusia Viith Nerve Paralysis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:03/15/04ISR Number: 4317682-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Mitral Valve Prolapse Depression Viral Infection Arthralgia Constipation Upper-Airway Cough Syndrome
Age:42 YR
Gender:Male
I/FU:F
Hypertension Angina Pectoris Total Lung Capacity Decreased Somnolence Bronchospasm Low Density Lipoprotein Increased 03-Apr-2012 09:37 AM Page: 533
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Exfoliative Rash Dry Skin Chest Discomfort Vestibular Disorder Skin Disorder Bronchitis Sinus Tachycardia Blood Triglycerides Increased Dehydration Blood Creatine Phosphokinase Increased Hallucination, Visual Gastrointestinal Disorder Diastolic Dysfunction Cardiac Murmur Dry Eye Vitiligo Blood Glucose Increased Gastrooesophageal Reflux Disease Amnesia Fatigue Rash Dry Mouth Snoring Anxiety Headache Angiotensin Converting Enzyme Increased Rhinitis Dyspnoea Weight Increased Blood Cholesterol Increased Total Cholesterol/Hdl Ratio Decreased Diarrhoea Oral Disorder Insomnia Confusional State Ventricular Hypertrophy Restrictive Pulmonary Disease Nocturia Acrochordon
Report Source
Product Lariam Zoloft
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:03/16/04ISR Number: 4317812-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Anxiety
Age:42 YR
Gender:Male
I/FU:F
Ventricular Hypertrophy Hypertension Bronchitis Cardiac Murmur Dry Eye Gastrooesophageal Reflux Disease Upper-Airway Cough 03-Apr-2012 09:37 AM Page: 534
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Amnesia Skin Disorder Fatigue Somnolence Rash Weight Increased Total Cholesterol/Hdl Ratio Decreased Dehydration Oral Disorder Vestibular Disorder Angina Pectoris Dry Mouth Constipation Rhinitis Hallucination, Visual Headache Total Lung Capacity Decreased Sinus Tachycardia Low Density Lipoprotein Increased Exfoliative Rash Confusional State Restrictive Pulmonary Disease Nocturia Vitiligo Angiotensin Converting Enzyme Increased Blood Glucose Increased Hypersomnia Mitral Valve Prolapse Depression Diastolic Dysfunction Bronchospasm Blood Cholesterol Increased Blood Triglycerides Increased Dry Skin Chest Discomfort Insomnia Dyspnoea Diarrhoea Blood Creatine Phosphokinase Increased Snoring Gastrointestinal Disorder Viral Infection Arthralgia Acrochordon
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:03/16/04ISR Number: 4317891-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Skin Disorder Viral Infection Bronchitis 09:37 AM
Age:42 YR
Gender:Male
I/FU:F
03-Apr-2012
Page: 535
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chest Discomfort Angiotensin Converting Enzyme Increased Fundoscopy Abnormal Body Temperature Increased Dyspnoea Diastolic Dysfunction Weight Increased Blood Cholesterol Increased Dry Mouth Vitiligo Exercise Tolerance Decreased Nausea Anxiety Hypertension Blood Triglycerides Increased Dehydration Constipation Rhinitis Myalgia Heart Sounds Abnormal Occult Blood Positive Exfoliative Rash Dry Eye Chronic Fatigue Syndrome Hypersomnia Rash Low Density Lipoprotein Increased Upper-Airway Cough Syndrome Pain In Jaw Chills Mitral Valve Prolapse Bronchospasm Cardiac Murmur Blood Glucose Increased Insomnia Tongue Coated Listless Neck Pain Amnesia Hallucination, Visual Gastrointestinal Disorder Fatigue Angina Pectoris Total Lung Capacity Decreased Somnolence
Diarrhoea Dry Skin Snoring Nocturia Oral Disorder Upper Respiratory Tract Infection Impaired Work Ability 03-Apr-2012 09:37 AM Page: 536
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abdominal Tenderness Confusional State Vestibular Disorder Depression Headache Ventricular Hypertrophy Restrictive Pulmonary Disease Arthralgia Sinus Tachycardia Total Cholesterol/Hdl Ratio Decreased Blood Creatine Phosphokinase Increased Acrochordon Gastrooesophageal Reflux Disease Drug Tolerance Decreased Pyrexia Injury
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:03/18/04ISR Number: 4318870-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-321435 Outcome Hospitalization Initial or Prolonged PT Maternal Exposure During Pregnancy Premature Baby Report Source Consumer Product Lariam Nivaquine Quinine Paludrine Role PS SS SS SS Manufacturer Roche
Age: Route
Gender:Female Dose
Date:03/18/04ISR Number: 4318889-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-361697 Outcome Hospitalization Initial or Prolonged PT Premature Baby Twin Pregnancy Report Source Consumer Product Lariam Nivaquine Paludrine Quinine Role PS SS SS SS Manufacturer Roche
Age: Route
Gender:Female Dose
Date:03/23/04ISR Number: 4322410-3Report Type:Direct Outcome Disability PT Impaired Work Ability Activities Of Daily Living Impaired Depression
Company Report #CTU 215048 Report Source Product Larium Standard For Malaria Role PS Manufacturer
Age:26 YR Route
Gender:Female Dose
I/FU:I Duration
Date:03/29/04ISR Number: 4325789-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Fatigue Rash Constipation Oral Disorder Dyspnoea 09:37 AM
Age:42 YR
Gender:Male
I/FU:F
03-Apr-2012
Page: 537
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mitral Valve Prolapse Total Lung Capacity Decreased Bronchospasm Weight Increased Chest Discomfort Major Depression Scratch Chest X-Ray Abnormal Vestibular Disorder Blood Cholesterol Increased Dehydration Blood Creatine Phosphokinase Increased Exfoliative Rash Abnormal Dreams Bipolar Disorder Haemorrhoids Balance Disorder Affective Disorder Confusional State Restrictive Pulmonary Disease Blood Triglycerides Increased Low Density Lipoprotein Increased Diarrhoea Dry Skin Dry Eye Vitiligo Gastrooesophageal Reflux Disease Rhinitis Clumsiness Coordination Abnormal Adjustment Disorder Neck Pain Ventricular Hypertrophy Somnolence Arthralgia Cardiac Murmur Blood Glucose Increased Visual Impairment Asthma Hypersomnia Wheezing Sputum Abnormal Oedema Peripheral Skin Disorder Diastolic Dysfunction Acrochordon
Contusion Upper Respiratory Tract Infection Dyspnoea Exertional Depression Hypertension Angina Pectoris Bronchitis 03-Apr-2012 09:37 AM Page: 538
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinus Tachycardia Total Cholesterol/Hdl Ratio Decreased Snoring Angiotensin Converting Enzyme Increased Adjustment Disorder With Depressed Mood Body Temperature Increased Amnesia Hallucination, Visual Anxiety Gastrointestinal Disorder Headache Viral Infection Dry Mouth Nocturia Upper-Airway Cough Syndrome Insomnia Memory Impairment
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:04/05/04ISR Number: 4332092-2Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-362924 Outcome Disability PT Psoriasis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:04/08/04ISR Number: 4334985-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-360920 Outcome Disability PT Muscular Weakness Myalgia Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Balance Disorder Insomnia Vertigo Hypertension Fall Report Source Product Lariam Lariam Role PS SS Manufacturer Roche Roche
Gender:Female Dose
Date:04/21/04ISR Number: 4343035-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Dyspnoea
Age:42 YR
Gender:Male
I/FU:F
Mitral Valve Prolapse Hypertension Somnolence Cardiac Murmur Blood Cholesterol Increased Blood Triglycerides Increased 03-Apr-2012 09:37 AM Page: 539
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Upper-Airway Cough Syndrome Insomnia Affective Disorder Depression Headache Ventricular Hypertrophy Diastolic Dysfunction Bronchitis Dehydration Dry Skin Bipolar Disorder Major Depression Restrictive Pulmonary Disease Viral Infection Total Cholesterol/Hdl Ratio Decreased Exfoliative Rash Nocturia Vitiligo Visual Impairment Abnormal Dreams Coordination Abnormal Adjustment Disorder With Depressed Mood Adjustment Disorder Hallucination, Visual Gastrointestinal Disorder Fatigue Blood Creatine Phosphokinase Increased Gastrooesophageal Reflux Disease Balance Disorder Hypersomnia Anxiety Bronchospasm Diarrhoea Memory Impairment Angina Pectoris Sleep Apnoea Syndrome Rash Weight Increased Dry Eye Oral Disorder Blood Glucose Increased Rhinitis Contusion Amnesia Vestibular Disorder Arthralgia Low Density Lipoprotein
Increased Constipation Acrochordon Clumsiness Haemorrhoids Scratch Confusional State Skin Disorder 03-Apr-2012 09:37 AM Page: 540
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Total Lung Capacity Decreased Sinus Tachycardia Dry Mouth Snoring Chest Discomfort Angiotensin Converting Enzyme Increased Asthma
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:04/21/04ISR Number: 4344421-4Report Type:Direct Outcome Other Serious PT Anger Headache Myalgia Mood Swings
Company Report #CTU 217021 Report Source Product Mefloquine 250 Mg Role PS Manufacturer
Gender:Male Dose 250 MG Q WK PO
I/FU:I Duration 2 MON
Date:04/26/04ISR Number: 4347305-0Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Tachycardia Heart Rate Irregular Extrasystoles
Company Report #CTU 217365 Report Source Product Mefloquine Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose ONE TAB WEEKLY ORAL
I/FU:I Duration
Date:04/27/04ISR Number: 4348517-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-365129 Outcome Hospitalization Initial or Prolonged PT Mania Psychotic Disorder Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:04/27/04ISR Number: 4349105-4Report Type:Direct Outcome Other Serious PT Gait Disturbance Eating Disorder Muscle Spasms Dizziness
Company Report #CTU 217446 Report Source Product Lariam 250 Mg Hoffmann-La Roche Role PS Manufacturer Hoffmann-La Roche
Gender:Male Dose 1 TABLET WEEKLY ORAL
I/FU:I Duration
Age:60 YR Route
Gender:Male Dose
I/FU:I Duration
Loss Of Consciousness
Mefloquine 250mg Geneva Minocycline 200mg
PS SS
Geneva
1 PER WEEK 200MG FIRST DAY, 100MG AFTER
03-Apr-2012
09:37 AM
Page: 541
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/04ISR Number: 4351449-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-328967 Outcome Congenital Anomaly PT Congenital Anomaly Hypospadias Testicular Atrophy Testicular Disorder Maternal Drugs Affecting Foetus Report Source Product Lariam Role PS Manufacturer Roche Age: Route Gender:Male Dose I/FU:I Duration 1 DAY
Date:05/12/04ISR Number: 4357189-2Report Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Suicidal Ideation Fear Thinking Abnormal Mental Disorder Malaise Feeling Abnormal Confusional State
Age: Route ORAL
Gender:Male
I/FU:I
Dose Duration 1 PILL PER WK ORAL
Date:05/14/04ISR Number: 4358415-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Vestibular Disorder Rash Weight Increased Diarrhoea Chest Discomfort Blood Glucose Increased Clumsiness Haemorrhoids Schizoaffective Disorder Sleep Apnoea Syndrome Bronchospasm Total Cholesterol/Hdl Ratio Decreased Blood Creatine Phosphokinase Increased Exfoliative Rash Angiotensin Converting Enzyme Increased Rhinitis Balance Disorder Psychotic Disorder Anxiety Headache Restrictive Pulmonary Disease
Age:42 YR
Gender:Male
I/FU:F
Viral Infection Arthralgia Bronchitis Sinus Tachycardia Constipation Upper-Airway Cough Syndrome Asthma 03-Apr-2012 09:37 AM Page: 542
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Adjustment Disorder With Depressed Mood Fatigue Total Lung Capacity Decreased Cardiac Murmur Blood Cholesterol Increased Low Density Lipoprotein Increased Oral Disorder Vitiligo Contusion Memory Impairment Confusional State Gastrointestinal Disorder Depression Snoring Bipolar Disorder Major Depression Hypertension Dry Mouth Gastrooesophageal Reflux Disease Visual Impairment Abnormal Dreams Scratch Amnesia Dyspnoea Mitral Valve Prolapse Skin Disorder Angina Pectoris Blood Triglycerides Increased Dry Skin Coordination Abnormal Affective Disorder Ventricular Hypertrophy Diastolic Dysfunction Somnolence Dehydration Dry Eye Nocturia Acrochordon Insomnia
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:05/14/04ISR Number: 4358421-1Report Type:Expedited (15-DaCompany Report #CH-ROCHE-357220 Outcome Hospitalization Initial or Prolonged PT Blindness Unilateral Vitreous Haemorrhage Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose DOSAGE REGIMEN
I/FU:I Duration
REPORTED AS 250 MG. Lariam SS Roche ORAL
03-Apr-2012
09:37 AM
Page: 543
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/04ISR Number: 4358430-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-367059 Outcome Other Serious PT Glaucoma Arrhythmia Report Source Product Lariam Role PS Manufacturer Roche Age:69 YR Route ORAL Gender:Female Dose I/FU:I Duration
Date:05/14/04ISR Number: 4358440-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-367058 Outcome Other Serious PT Glaucoma Silent Myocardial Infarction Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:05/24/04ISR Number: 4363710-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Disorientation Insomnia Vertigo Diarrhoea Vestibular Disorder Chest Pain Night Sweats Agitation Anxiety Disorder Fatigue Psychotic Disorder Nightmare Amnesia Tinnitus Vomiting Memory Impairment Nausea Mood Swings Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:05/27/04ISR Number: 4366518-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Outcome Hospitalization Initial or Prolonged Disability PT Paranoia Depression Delusion Speech Disorder Confusional State Aggression Blood Potassium Decreased Agitation Antisocial Behaviour
Age:40 YR
Gender:Female
I/FU:F
Drug Ineffective Muscle Rigidity Disorientation Convulsion Loss Of Libido Psychotic Disorder Gait Disturbance Incontinence 03-Apr-2012 09:37 AM Page: 544
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Memory Impairment Mania Pyrexia Hallucination Hostility Fatigue Headache
Role PS SS C
Dose EVERY WEEK.
Date:05/27/04ISR Number: 4366535-5Report Type:Expedited (15-DaCompany Report #CA-ROCHE-368340 Outcome Other Serious PT Urinary Incontinence Panic Reaction Dizziness Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:05/27/04ISR Number: 4367724-6Report Type:Periodic Outcome Disability PT Cold Sweat Heart Rate Irregular Depression Tinnitus Abdominal Distension Weight Decreased Acrophobia Heart Rate Increased Diarrhoea Dyspnoea Disturbance In Attention Anxiety Panic Attack Motion Sickness Hypersensitivity Phobia Of Flying Suicidal Ideation Dizziness Self Esteem Decreased Photophobia Burning Sensation Paraesthesia Nausea Abdominal Pain Rash Vestibular Disorder Faeces Discoloured Phobia Claustrophobia Disorientation Balance Disorder
Company Report #262840 Report Source Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Gender:Male Dose 1 DOSE FROM 1 PER WEEK ORAL
I/FU:I Duration
Emotional Distress Flatulence Constipation Insomnia Headache Irritable Bowel Syndrome
03-Apr-2012
09:37 AM
Page: 545
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/04ISR Number: 4367725-8Report Type:Periodic Outcome Disability PT Tinnitus Anxiety Dizziness Psychotic Disorder Insomnia Tremor Confusional State Abnormal Behaviour Head Discomfort Company Report #350185 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age:36 YR Route ORAL Gender:Male Dose 250 MG, 1 PER WEEK ORAL I/FU:I Duration
Date:05/27/04ISR Number: 4367728-3Report Type:Periodic Outcome Death PT Arrhythmia Death Adverse Event
Company Report #354441 Report Source Consumer Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Age: Route ORAL
I/FU:I Duration
Company Report #358251 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Propranolol (Propranolol Hydrochloride) Role PS C Manufacturer
I/FU:I Duration
Date:05/27/04ISR Number: 4367731-3Report Type:Periodic Outcome Other Serious PT Suicidal Ideation Obsessive Thoughts Panic Attack Anxiety
Age: Route ORAL
I/FU:I Duration
Date:05/27/04ISR Number: 4367732-5Report Type:Periodic Outcome Other Serious PT Paranoia Anxiety
I/FU:I Duration
Date:05/27/04ISR Number: 4367733-7Report Type:Periodic Outcome Other Serious PT Social Avoidant Behaviour Anger Paranoia 09:37 AM
I/FU:I Duration
03-Apr-2012
Page: 546
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/04ISR Number: 4367734-9Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Reactive Psychosis Company Report #361644 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Malarone (Atovaquone/Chlorogu anide Hydrochloride) Role PS SS Manufacturer Age:50 YR Route ORAL ORAL Gender:Male Dose 250 MG ORAL ORAL I/FU:I Duration
I/FU:I Duration
Date:05/27/04ISR Number: 4367736-2Report Type:Periodic Outcome Death PT Adverse Event Completed Suicide
Age: Route ORAL
I/FU:I Duration
Date:05/27/04ISR Number: 4367737-4Report Type:Periodic Outcome Hospitalization Initial or Prolonged Disability PT Oral Disorder Toxicity To Various Agents Hyperventilation Dizziness Vision Blurred Insomnia Mood Altered Dyspnoea Abnormal Dreams Heart Rate Increased Panic Attack Hyperhidrosis Fatigue Blood Pressure Increased Adverse Event Headache Paraesthesia Agitation
Age:40 YR
Gender:Male
I/FU:I
Vertigo Decreased Activity Erythema Chest Discomfort Balance Disorder Lichen Planus Disturbance In Attention Nightmare 03-Apr-2012 09:37 AM Page: 547
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Anxiety Panic Disorder Depression
Role PS
Manufacturer
Route ORAL
Dose 250 MG ORAL
Duration
Date:05/27/04ISR Number: 4367738-6Report Type:Periodic Outcome Hospitalization Initial or Prolonged Disability PT Suicidal Ideation Confusional State Night Sweats Adverse Event Anxiety Disturbance In Attention Depression Palpitations
I/FU:I Duration
Date:05/27/04ISR Number: 4367739-8Report Type:Periodic Outcome Other Serious PT Suicidal Ideation
Company Report #339943 Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:15 YR Route
Gender:Male Dose
I/FU:I Duration
Date:05/27/04ISR Number: 4367740-4Report Type:Periodic Outcome Disability PT Tinnitus
I/FU:I Duration
Date:05/27/04ISR Number: 4367741-6Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Adverse Event Psychotic Disorder
Company Report #343641 Report Source Literature Health Professional Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Oral Contraceptive Nos (Oral Contraceptive Nos) Role Manufacturer
Age:25 YR Route
Gender:Female Dose
I/FU:I Duration
PS
250 MG 1 PER WEEK
Date:05/27/04ISR Number: 4367744-1Report Type:Periodic Outcome Other Serious 03-Apr-2012 09:37 AM PT Anxiety Suicidal Ideation
Age:42 YR
Gender:Female
I/FU:I
Page: 548
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Emotional Disorder Insomnia Report Source Consumer Product Lariam (Mefloquine Hydrochloride) 250 Mg Liquibid (Guaifenesin) Flonase (Fluticasone Propionate) Zyrtec (Cetirizine Hydrochloride) Role PS C C C Manufacturer Route ORAL Dose 1 DOSE FOR 1 PER WEEK ORAL Duration
Date:05/27/04ISR Number: 4367745-3Report Type:Periodic Outcome Other Serious PT Chills Suicidal Ideation Weight Decreased Depression Decreased Appetite Fatigue Hyperhidrosis Adverse Event
Company Report #346923 Report Source Consumer Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Date:05/27/04ISR Number: 4367746-5Report Type:Periodic Outcome Other Serious PT Grand Mal Convulsion Vomiting Neuropathy Peripheral Dizziness Headache
Company Report #347625 Report Source Consumer Product Lariam (Mefloquine Hydrochloride) Chloroquine (Chloroquine) Nitroglycerine (Nitroglycerin) Premarin (Estrogens, Conjugated) Fansidar (Pyrimethamine/Sulfa doxine) Role PS C C C C Manufacturer
I/FU:I Duration
Date:05/27/04ISR Number: 4367747-7Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Abdominal Discomfort Insomnia Hallucination
I/FU:I Duration
Fatigue Dyspepsia Myalgia
03-Apr-2012
09:37 AM
Page: 549
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/04ISR Number: 4367748-9Report Type:Periodic Outcome Other Serious PT Tremor Fatigue Convulsion Muscle Twitching Dizziness Adverse Event Company Report #350183 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Age: Route ORAL Gender:Male Dose ORAL I/FU:I Duration
Date:06/01/04ISR Number: 4367871-9Report Type:Direct Outcome Life-Threatening Disability Required Intervention to Prevent Permanent Impairment/Damage PT Suicide Attempt Abnormal Behaviour Depression Fall Vision Blurred Suicidal Ideation Amnesia Balance Disorder
Company Report #CTU 219805 Report Source Product Lariam 250 Mg Roche Pharmaceuticals Role PS Manufacturer Roche Pharmaceuticals
Age: Route ORAL
Gender:Female Dose ONE-1- PER DAY ORAL
I/FU:I Duration
Date:06/08/04ISR Number: 4374191-5Report Type:Direct Outcome Disability PT Balance Disorder Vertigo
Age:40 YR Route
Gender:Male Dose 2 TAB
I/FU:I Duration
Age:33 YR Route
Gender:Female Dose 2 TAB
I/FU:I Duration
Age:46 YR Route
Gender:Male Dose 2 TAB
I/FU:I Duration
Age:45 YR Route
Gender:Male Dose
I/FU:I Duration
Disability
Balance Disorder Vertigo
Larium
PS
2 TAB
03-Apr-2012
09:37 AM
Page: 550
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/04ISR Number: 4374203-9Report Type:Direct Outcome Disability PT Vertigo Balance Disorder Company Report #CTU 220322 Report Source Product Larium Role PS Manufacturer Age:45 YR Route Gender:Male Dose 2 TAB I/FU:I Duration
Date:06/08/04ISR Number: 4374205-2Report Type:Direct Outcome Disability PT Vertigo Balance Disorder
Age:41 YR Route
Gender:Male Dose 2 TABS
I/FU:I Duration
Date:06/09/04ISR Number: 4375988-8Report Type:Direct Outcome Other Serious PT Rash
Company Report #CTU 220405 Report Source Product Larium-MefloquinStandard Pills Role PS Manufacturer
Gender:Female Dose 1 PILL DAILY ORAL
I/FU:I Duration
Date:06/09/04ISR Number: 4376006-8Report Type:Direct Outcome Death PT Aggression Physical Assault Incoherent Psychotic Disorder Completed Suicide
Age:36 YR Route
Gender:Male
I/FU:I
Dose Duration WEEKLY 2/03-> 12/03
Date:06/15/04ISR Number: 4377670-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-369567 Outcome Other Serious PT Heat Stroke Disorientation Tremor Dehydration Cerebral Ventricle Dilatation Normal Pressure Hydrocephalus Report Source Product Lariam Omeprazole Risperdal Role PS C C Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:06/21/04ISR Number: 4381191-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome PT
Age:
Gender:Male
I/FU:F
Disability
Hepatic Failure Cranial Nerve Disorder Balance Disorder Nausea Amnesia Incontinence Aggression Disturbance In Attention 09:37 AM Page: 551
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Photosensitivity Reaction Paranoia Visual Field Defect Depression Photophobia Panic Attack Suicidal Ideation Visual Impairment Vestibular Disorder Hallucination Insomnia Diarrhoea Anger Tremor Vomiting Toxicity To Various Agents
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose 23 TABLETS DISPENSED.
Duration
Date:06/29/04ISR Number: 4386462-7Report Type:Expedited (15-DaCompany Report #CH-ROCHE-371304 Outcome Hospitalization Initial or Prolonged Disability PT Fatigue Urinary Incontinence Asthenia Eosinophilia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
Date:06/29/04ISR Number: 4386466-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-371475 Outcome Other Serious PT Dementia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:07/07/04ISR Number: 4391114-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-372586 Outcome Life-Threatening Disability PT Suicide Attempt Homicide Brain Injury Aggression Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:07/12/04ISR Number: 4394587-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-372726 Outcome Hospitalization Initial or Prolonged PT Sarcoidosis Pulmonary Oedema Left Ventricular Failure Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Myocarditis
03-Apr-2012
09:37 AM
Page: 552
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/04ISR Number: 4395807-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-371475 Outcome Other Serious PT Suicidal Ideation Cognitive Disorder Cerebral Disorder Delusion Dementia Report Source Health Professional Product Lariam Role PS Manufacturer Roche Age:58 YR Route ORAL Gender:Male Dose I/FU:F Duration
Date:08/02/04ISR Number: 4413078-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Outcome Disability PT Suicidal Ideation Heart Rate Irregular Disorientation Balance Disorder Phobia Generalised Anxiety Disorder Abdominal Distension Constipation Anxiety Panic Attack Vestibular Disorder Fatigue Abdominal Discomfort House Dust Allergy Hyperventilation Depression Rash Dyspnoea Headache Irritable Bowel Syndrome Acrophobia Claustrophobia Migraine Heart Rate Increased Nausea Diarrhoea Hypersensitivity Tinnitus Self Esteem Decreased Photophobia Melanocytic Naevus Body Tinea Bronchospasm Emotional Distress Paraesthesia Phobia Of Flying Abdominal Pain Disturbance In Attention
Age:34 YR
Gender:Male
I/FU:F
Weight Decreased Dizziness Insomnia Motion Sickness Sensory Integrative Dysfunction Flatulence Lipoma 03-Apr-2012 09:37 AM Page: 553
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Injury Report Source Product Lariam Role PS Manufacturer Roche Route ORAL Dose Duration THE PATIENT HAD TAKEN 4-5 TABLETS OF MEFLOQUINE IN TOTAL. 5 WK
Date:08/03/04ISR Number: 4414927-8Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Convulsion Bradycardia Atrioventricular Block Complete
Company Report #CTU 224121 Report Source Product Mefloquine 250 Mg Geneva Pharm Tech / Sandoz Role PS Manufacturer Geneva Pharm Tech / Sandoz
Age:44 YR Route
Gender:Male Dose
I/FU:I Duration
ORAL
1 PILL WEEK ORAL
Date:08/05/04ISR Number: 4416339-XReport Type:Expedited (15-DaCompany Report #CH-ROCHE-371304 Outcome Hospitalization Initial or Prolonged Disability PT Urinary Incontinence Fatigue Eosinophilia Asthenia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
Date:08/10/04ISR Number: 4422188-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-376379 Outcome Hospitalization Initial or Prolonged PT Cerebellar Syndrome Coordination Abnormal Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:08/10/04ISR Number: 4422192-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-319597 Outcome Death PT Completed Suicide Anger Social Avoidant Behaviour Communication Disorder Tremor Mood Altered Disorientation Nervousness Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male
I/FU:F
Dose Duration TAKEN WEEKLY 99 DAY
Feeling Abnormal Psychotic Disorder Aggression Abnormal Behaviour
03-Apr-2012
09:37 AM
Page: 554
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/10/04ISR Number: 4424148-0Report Type:Direct Outcome Other Serious PT Amnesia Company Report #CTU 224675 Report Source Product Lariam 250 Mg Mefloquine (Hci) Roche Labs Role PS SS Manufacturer Roche Labs Age:33 YR Route Gender:Male Dose 1 A WK I/FU:I Duration
Date:08/16/04ISR Number: 4426723-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-308521 Outcome Hospitalization Initial or Prolonged PT Pyrexia Vomiting Malaise Sleep Disorder Muscle Twitching Headache Abdominal Pain Balance Disorder Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:08/16/04ISR Number: 4426725-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-369567 Outcome Disability PT Cerebral Ventricle Dilatation Fatigue Disorientation Affect Lability Heat Stroke Tremor Hydrocephalus Dehydration Report Source Health Professional Product Lariam Omeprazole L-Thyroxine Risperdal Role PS C C C Manufacturer Roche
Gender:Female Dose
INCREASED TO 1 MG DAILY FROM 07-15 MAY 2004.
Date:08/20/04ISR Number: 4429680-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377653 Outcome Hospitalization Initial or Prolonged PT Brain Oedema Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:08/20/04ISR Number: 4430060-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-377087 Outcome Other Serious PT Anger Homicide Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:08/20/04ISR Number: 4430095-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-377090 Outcome Other Serious PT Homicide Anger Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 555
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/04ISR Number: 4430108-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-377096 Outcome Other Serious PT Anger Homicide Report Source Product Lariam Role PS Manufacturer Roche Age:33 YR Route ORAL Gender: Dose I/FU:I Duration
Date:08/23/04ISR Number: 4430901-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-377100 Outcome Other Serious PT Injury Anger Physical Assault Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:08/23/04ISR Number: 4430909-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377775 Outcome Hospitalization Initial or Prolonged PT Macular Degeneration Report Source Product Lariam Befizal Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:08/27/04ISR Number: 4435139-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Outcome Disability PT Sleep Disorder Due To General Medical Condition, Hypersomnia Type Suicidal Ideation Disorientation Headache Weight Decreased Fear Injury Nausea Balance Disorder Vestibular Disorder Cold Sweat Body Tinea Emotional Distress Anxiety Abdominal Pain Hypersensitivity Self Esteem Decreased Disturbance In Attention Photophobia Gastrointestinal Pain Adjustment Disorder With Anxiety
Age:34 YR
Gender:Male
I/FU:F
Motion Sickness Diarrhoea Paraesthesia Dyspnoea Bronchospasm Dizziness Heart Rate Irregular Acrophobia 03-Apr-2012 09:37 AM Page: 556
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Claustrophobia Adjustment Disorder Self Esteem Inflated Impetigo Adjustment Disorder With Depressed Mood Insomnia Panic Attack Tinnitus Phobia Rash Irritable Bowel Syndrome Generalised Anxiety Disorder Sensory Integrative Dysfunction Fatigue Sleep Disorder Melanocytic Naevus Lipoma Mood Disorder Due To A General Medical Condition Heart Rate Increased Depression Phobia Of Flying Migraine Lactose Intolerance Cognitive Disorder
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose Duration THE PATIENT HAD TAKEN 4-5 TABLETS OF MEFLOQUINE IN TOTAL. 5 WK
Date:08/27/04ISR Number: 4435146-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-369567 Outcome Disability PT Fatigue Dehydration Tremor Hydrocephalus Affect Lability Disorientation Cerebral Ventricle Dilatation Report Source Health Professional Product Lariam Omeprazole L-Thyroxine Risperdal Role PS C C C Manufacturer Roche
Gender:Female Dose
INCREASED TO 1 MG DAILY FROM 07-15 MAY 2004.
Date:09/02/04ISR Number: 4441050-9Report Type:Direct Outcome Life-Threatening Disability PT Nausea Fear Thinking Abnormal Blood Pressure Decreased Suicidal Ideation
Age:
Gender:Female
I/FU:I
Dizziness Sleep Terror Heart Rate Increased Stress Fatigue Nightmare Decreased Appetite Depression 03-Apr-2012 09:37 AM Page: 557
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Panic Reaction Chest Pain Hypoaesthesia Carpal Tunnel Syndrome Cold Sweat Anxiety Dyspnoea Feeling Abnormal Confusional State Vertigo
Report Source
Product Lariam Antibiotic
Role PS C
Manufacturer
Route
Dose 250 MG ONCE WEEKLY 2 DOSES
Duration
Date:09/03/04ISR Number: 4443505-XReport Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Feeling Abnormal Tremor Nightmare Dizziness Disorientation
Gender:Female
I/FU:I
Dose Duration ONE WEEK ORAL
Date:09/07/04ISR Number: 4441862-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-378987 Outcome Death PT Disorientation Malaise Vomiting Cardiac Failure Diarrhoea Headache Asthenia Dyspnoea Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male
I/FU:I
Dose Duration TAKEN INTERMITTENTL Y
Date:09/08/04ISR Number: 4447144-6Report Type:Direct Outcome Disability PT Hallucination Social Avoidant Behaviour Fall
Gender:Male
I/FU:I
Dose Duration PO 250 MG QWK
Date:09/08/04ISR Number: 4447208-7Report Type:Direct Outcome Other Serious PT Suicide Attempt Depression
Age: Route ORAL
I/FU:I Duration
Date:09/09/04ISR Number: 4444958-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-379100 Outcome Other Serious PT Insomnia Eating Disorder Schizophrenia, Paranoid 09:37 AM
Age:
Gender:Male
I/FU:I
03-Apr-2012
Page: 558
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Type Report Source Product Lariam Role PS Manufacturer Roche Route ORAL Dose Duration
Date:09/09/04ISR Number: 4444960-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377653 Outcome Hospitalization Initial or Prolonged PT Anxiety Brain Oedema Headache Vomiting Vertigo Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:09/09/04ISR Number: 4448491-4Report Type:Direct Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage PT Depression Feeling Abnormal Insomnia Headache Suicidal Ideation Anxiety Anger
Gender:Male
I/FU:I
Dose Duration 1 A DAY ORAL
Date:09/13/04ISR Number: 4449499-5Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Insomnia Anxiety Hypertension Nightmare Panic Attack Suicidal Ideation Tinnitus
Company Report #CTU 226923 Report Source Product Lariam Doxycycline Role PS C Manufacturer
Gender:Male
I/FU:I
Dose Duration TWICE A WEEK ORAL
Date:09/14/04ISR Number: 4449511-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377992 Outcome Hospitalization Initial or Prolonged PT Blood Lactate Dehydrogenase Increased Aspartate Aminotransferase Increased Blood Creatine Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Phosphokinase Increased Alanine Aminotransferase Increased Confusional State Nausea
03-Apr-2012
09:37 AM
Page: 559
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/04ISR Number: 4449981-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377992 Outcome Hospitalization Initial or Prolonged PT Delirium Confusional State Nausea Alanine Aminotransferase Increased Blood Lactate Dehydrogenase Increased Blood Creatine Phosphokinase Increased Aspartate Aminotransferase Increased Report Source Health Professional Product Lariam Role PS Manufacturer Roche Age:42 YR Route UNKNOWN Gender:Female Dose I/FU:F Duration 4 DAY
Date:09/15/04ISR Number: 4450070-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-377992 Outcome Hospitalization Initial or Prolonged PT Confusional State Blood Lactate Dehydrogenase Increased Delirium Pyrexia Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Gastroenteritis Blood Creatine Phosphokinase Increased Nausea Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:09/16/04ISR Number: 4451065-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377992 Outcome Hospitalization Initial or Prolonged PT Blood Lactate Dehydrogenase Increased Alanine Aminotransferase Increased Confusional State Aspartate Aminotransferase Increased Gastroenteritis Blood Creatine Phosphokinase Increased Delirium Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:09/16/04ISR Number: 4451425-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-377992 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Nausea Delirium
Age:42 YR
Gender:Female
I/FU:F
Page: 560
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspartate Aminotransferase Increased Confusional State Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Alanine Aminotransferase Increased
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose
Duration 4 DAY
Date:09/16/04ISR Number: 4451447-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-380221 Outcome Other Serious PT Psychiatric Symptom Brain Stem Syndrome Suicidal Ideation Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:09/17/04ISR Number: 4452279-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Outcome Disability PT Bronchospasm Dizziness Heart Rate Irregular Rash Disturbance In Attention Headache Acrophobia Lactose Intolerance Burning Sensation Anxiety Heart Rate Increased Motion Sickness Hypersensitivity Phobia Of Flying Claustrophobia Migraine Back Pain Nasal Congestion Injury Sleep Disorder Due To General Medical Condition, Hypersomnia Type Insomnia Panic Attack Amnesia Body Tinea Emotional Distress
Age:34 YR
Gender:Male
I/FU:F
Paraesthesia Irritable Bowel Syndrome Weight Decreased Haemorrhoids Vitreous Floaters Mood Disorder Due To A General Medical Condition Disorientation 03-Apr-2012 09:37 AM Page: 561
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vestibular Disorder Throat Irritation Hypoaesthesia Constipation Cold Sweat Impetigo Lipoma Hyperventilation Adjustment Disorder With Depressed Mood Nausea Dyspnoea Self Esteem Decreased Photophobia Flatulence Adjustment Disorder With Anxiety Suicidal Ideation Tinnitus Balance Disorder Phobia Generalised Anxiety Disorder Sensory Integrative Dysfunction Fatigue Musculoskeletal Stiffness Abdominal Distension Abdominal Pain Lower Gait Disturbance Abdominal Discomfort Abdominal Symptom Sinus Bradycardia Abdominal Pain Diarrhoea Depression Sleep Disorder Neck Pain Condition Aggravated Abdominal Pain Upper Melanocytic Naevus Panic Disorder
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Vaccine
OTHER
Dose Duration THE PATIENT HAD TAKEN 4-5 TABLETS OF MEFLOQUINE IN TOTAL. 5 WK 1 DAY
Date:09/17/04ISR Number: 4452299-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-376379 Outcome Hospitalization Initial or Prolonged PT Cerebellar Syndrome Coordination Abnormal Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:09/17/04ISR Number: 4452312-3Report Type:Expedited (15-DaCompany Report #IE-ROCHE-379920 Outcome Other Serious PT Convulsion Dyskinesia Grand Mal Convulsion Muscle Twitching 09:37 AM Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
03-Apr-2012
Page: 562
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/04ISR Number: 4453827-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-377423 Outcome Hospitalization Initial or Prolonged PT Cardiac Failure Electrocardiogram Abnormal Cerebrovascular Accident Report Source Product Lariam Toprol Xl Role PS C Manufacturer Roche Age:63 YR Route ORAL Gender:Female Dose I/FU:F Duration
Date:09/20/04ISR Number: 4453925-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-377423 Outcome Hospitalization Initial or Prolonged PT Electrocardiogram Abnormal Cerebrovascular Accident Cardiac Failure Report Source Health Professional Product Lariam Toprol Xl Role PS C Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:09/20/04ISR Number: 4454571-XReport Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Fatigue Headache Insomnia Anxiety Feeling Of Body Temperature Change Disturbance In Attention Paraesthesia Paranoia Balance Disorder Heart Rate Irregular Hyperhidrosis Chills Depression Panic Reaction Alanine Aminotransferase Increased
Company Report #CTU 227503 Report Source Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Roche
Age:36 YR Route
Gender:Male Dose 1 TABLET PER WEEK FOR 7 WEEKS
I/FU:I Duration
Date:09/21/04ISR Number: 4454933-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Mitral Valve Prolapse Arthralgia Diarrhoea Dry Eye Constipation Upper-Airway Cough Syndrome
Age:42 YR
Gender:Male
I/FU:F
Rhinitis Visual Impairment Adjustment Disorder With Depressed Mood Schizoaffective Disorder Confusional State Angina Pectoris Sleep Apnoea Syndrome 03-Apr-2012 09:37 AM Page: 563
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rash Bronchitis Total Cholesterol/Hdl Ratio Decreased Blood Creatine Phosphokinase Increased Dry Skin Blood Glucose Increased Scratch Headache Weight Increased Cardiac Murmur Abnormal Dreams Skin Disorder Fatigue Hypertension Bronchospasm Nocturia Vitiligo Angiotensin Converting Enzyme Increased Gastrooesophageal Reflux Disease Asthma Affective Disorder Depression Sinus Tachycardia Blood Triglycerides Increased Low Density Lipoprotein Increased Dehydration Dry Mouth Chest Discomfort Balance Disorder Amnesia Diastolic Dysfunction Somnolence Blood Cholesterol Increased Exfoliative Rash Snoring Acrochordon Major Depression Psychotic Disorder Ventricular Hypertrophy Viral Infection Oral Disorder Insomnia Bipolar Disorder Haemorrhoids Coordination Abnormal Memory Impairment
Anxiety Dyspnoea Vestibular Disorder Gastrointestinal Disorder Total Lung Capacity Decreased Restrictive Pulmonary Disease 03-Apr-2012 09:37 AM Page: 564
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clumsiness Contusion Report Source Product Lariam Zoloft Role PS C Manufacturer Roche Route ORAL UNKNOWN Dose Duration
Date:09/22/04ISR Number: 4459307-4Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Paranoia Toxicity To Various Agents Vertigo Tremor Vision Blurred Headache Medication Error
Gender:Male Dose 250 MG Q7D ORAL
I/FU:I Duration
Date:09/29/04ISR Number: 4462210-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-380927 Outcome Other Serious PT Headache Neurotoxicity Diplopia Report Source Product Mefloquine Hydrochloride Beclomethasone Typhim Vi Role PS C C Manufacturer Roche
Age:59 YR Route ORAL RESPIRATORY (INHALATION) INTRAMUSCULAR
Gender:Male Dose SINGLE DOSE TAKEN. 1
I/FU:I Duration
DAY
Date:09/30/04ISR Number: 4463201-2Report Type:Expedited (15-DaCompany Report #IE-ROCHE-379920 Outcome Other Serious PT Muscle Twitching Grand Mal Convulsion Visual Impairment Dyskinesia Fall Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:10/01/04ISR Number: 4464169-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-381273 Outcome Hospitalization Initial or Prolonged PT Gastrointestinal Disorder Diarrhoea Confusional State Psychotic Disorder Disorientation Report Source Product Lariam Aspirine Role PS C Manufacturer Roche
Gender:Female Dose
Delirium
03-Apr-2012
09:37 AM
Page: 565
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/04ISR Number: 4465047-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-381273 Outcome Hospitalization Initial or Prolonged PT Gastrointestinal Disorder Fatigue Diarrhoea Psychotic Disorder Delirium Disorientation Confusional State Report Source Product Lariam Aspirine Role PS C Manufacturer Roche Age:61 YR Route ORAL ORAL Gender:Female Dose I/FU:I Duration 2 DAY
Date:10/08/04ISR Number: 4469780-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-381674 Outcome Congenital Anomaly PT Foetal Malformation Abortion Induced Maternal Exposure During Pregnancy Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:10/08/04ISR Number: 4469794-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-382257 Outcome Other Serious PT Complex Regional Pain Syndrome Report Source Product Lariam Lariam Role PS SS Manufacturer Roche Roche
Gender:Female Dose
I/FU:I Duration
Date:10/12/04ISR Number: 4471713-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Bronchospasm Gastrooesophageal Reflux Disease Adjustment Disorder With Depressed Mood Depression Bronchitis Total Cholesterol/Hdl Ratio Decreased Snoring Nocturia Clumsiness Tremor Confusional State Dyspnoea Headache Rash Blood Cholesterol Increased
Age:42 YR
Gender:Male
I/FU:F
Blood Triglycerides Increased Chest Discomfort Oral Disorder Insomnia Abnormal Dreams Coordination Abnormal Amnesia 03-Apr-2012 09:37 AM Page: 566
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diastolic Dysfunction Arthralgia Sinus Tachycardia Low Density Lipoprotein Increased Blood Creatine Phosphokinase Increased Vitiligo Bipolar Disorder Contusion Aggression Anxiety Skin Disorder Gastrointestinal Disorder Angina Pectoris Sleep Apnoea Syndrome Dry Mouth Constipation Angiotensin Converting Enzyme Increased Major Depression Affective Disorder Psychotic Disorder Hypertension Viral Infection Dry Eye Acrochordon Upper-Airway Cough Syndrome Scratch Vestibular Disorder Mitral Valve Prolapse Restrictive Pulmonary Disease Somnolence Weight Increased Cardiac Murmur Dehydration Exfoliative Rash Dry Skin Blood Glucose Increased Balance Disorder Schizoaffective Disorder Fatigue Ventricular Hypertrophy Total Lung Capacity Decreased Diarrhoea Rhinitis Visual Impairment Asthma Haemorrhoids Memory Impairment
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:10/12/04ISR Number: 4471726-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377775 Outcome Other Serious 03-Apr-2012 09:37 AM PT Macular Degeneration Report Source Health Professional Product Lariam Befizal Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:F Duration 4 MON Page: 567
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/04ISR Number: 4471734-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-382418 Outcome Other Serious PT Abdominal Pain Upper Nausea Full Blood Count Abnormal Oropharyngeal Pain Lymphocyte Count Increased Fatigue Report Source Product Lariam Role PS Manufacturer Roche Age:30 YR Route UNKNOWN Gender:Female Dose I/FU:I Duration
Date:10/12/04ISR Number: 4472797-6Report Type:Direct Outcome Other Serious PT Palpitations Tremor
Company Report #CTU 229406 Report Source Product Lariam 750mg Mefloquine Role PS Manufacturer
I/FU:I Duration
Date:10/15/04ISR Number: 4475448-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-382481 Outcome Other Serious PT Balance Disorder Anxiety Malaria Hallucination, Auditory Psychotic Disorder Homicide Hallucination Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:10/19/04ISR Number: 4478306-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-383127 Outcome Other Serious PT Toxicity To Various Agents Aphasia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:10/19/04ISR Number: 4480777-XReport Type:Direct Outcome Other Serious PT Medication Error
Company Report #CTU 229949 Report Source Product Mefloquine (Lariam) - 250 Mgs -Sandoz Role PS Manufacturer Sandoz
Age:39 YR Route
Gender:Female Dose 1 DAILY W/ SUPPER - X 23
I/FU:I Duration
Age:
Gender:Female
I/FU:I
Outcome Disability
PT Asthenia Dyspnoea Flatulence Eructation Chest Pain Morbid Thoughts 09:37 AM Page: 568
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Palpitations Nausea Dyspepsia Dizziness Tremor Condition Aggravated Panic Attack Eye Disorder Hiatus Hernia Feeling Abnormal
Report Source
Product Larium Roche Protonix
Role 250 Mg La PS C
Manufacturer La Roche
Route ORAL
Dose 1 TABLET ONCE A WEEK ORAL
Duration
Date:10/27/04ISR Number: 4487799-3Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Anxiety Depression Convulsion Mental Disorder
Age:31 YR Route
Gender:Male Dose
I/FU:I Duration
Date:10/28/04ISR Number: 4488116-5Report Type:Expedited (15-DaCompany Report #IE-ROCHE-379920 Outcome Other Serious PT Muscle Twitching Visual Impairment Grand Mal Convulsion Report Source Health Professional Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:10/28/04ISR Number: 4491873-5Report Type:Direct Outcome Disability PT Insomnia Impaired Work Ability Headache Dizziness Depression Vision Blurred Suicidal Ideation
Company Report #CTU 230702 Report Source Product Larium One Tablet Per Week Roche Role PS Manufacturer Roche
Gender:Male Dose 1 TABLET WEEK ORAL
I/FU:I Duration
Date:10/29/04ISR Number: 4489101-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-384026 Outcome Other Serious PT Homicide Medication Error Report Source Product Lariam Role PS Manufacturer Roche
Age: Route INTRAMUSCULAR
Gender:Male Dose
I/FU:I Duration
Date:11/02/04ISR Number: 4490702-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-372726 Outcome Hospitalization Initial or Prolonged PT Sarcoidosis Pulmonary Oedema Pericardial Disease Myocarditis Myocardial Infarction
Age:32 YR
Gender:Male
I/FU:F
03-Apr-2012
09:37 AM
Page: 569
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Left Ventricular Failure Report Source Product Lariam Role PS Manufacturer Roche Route ORAL Dose Duration 41 DAY
Date:11/04/04ISR Number: 4494141-0Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Mood Swings Fatigue Feeling Abnormal Tension Crying Impaired Work Ability Depression Hypersomnia
Company Report #CTU 231293 Report Source Product Lariam Probably 250 Mg Tablet Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose 250 MG WEEKLY ORAL
I/FU:I Duration
Date:11/04/04ISR Number: 4494371-8Report Type:Direct Outcome Disability Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Aphasia Catatonia Toxicity To Various Agents Panic Attack Amnesia Thinking Abnormal Anxiety Psychotic Disorder Antisocial Behaviour Pyrexia
Gender:Male Dose 250 MG PO EVERY WEEK
I/FU:I Duration
Date:11/11/04ISR Number: 4499163-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-381674 Outcome Congenital Anomaly PT Maternal Exposure During Pregnancy Abortion Induced Foetal Malformation Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:11/12/04ISR Number: 4500146-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Disability PT Insomnia Mood Swings
Age:
Gender:Male
I/FU:I
Balance Disorder Toxicity To Various Agents Aggression Abnormal Behaviour Agitation Disturbance In Attention Memory Impairment 03-Apr-2012 09:37 AM Page: 570
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Coordination Abnormal Visual Impairment Hallucination, Visual Depression Anxiety Vertigo
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose
Duration
Date:11/15/04ISR Number: 4501752-2Report Type:Direct Outcome Life-Threatening Disability Required Intervention to Prevent Permanent Impairment/Damage PT Coordination Abnormal Weight Decreased Paranoia Self Esteem Decreased Hypoaesthesia Tinnitus Nausea Panic Attack Thinking Abnormal Decreased Interest Erectile Dysfunction Fear Headache Tremor Pain Disturbance In Attention Loss Of Libido Suicidal Ideation Muscle Twitching Decreased Appetite Hyperhidrosis Amnesia Feeling Abnormal Sensory Disturbance Major Depression Temperature Regulation Disorder Nightmare Functional Gastrointestinal Disorder Chills Autism Emotional Disorder
Company Report #CTU 232000 Report Source Product Lariam - Mefloquine 1 Tablet 250mg Roche Role PS Manufacturer Roche
Gender:Male Dose 250MG WEEKLY ONCE ORAL
I/FU:I Duration
Date:11/16/04ISR Number: 4502163-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-361839 Outcome Other Serious PT Maternal Exposure During Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Pregnancy Ectopic Pregnancy Abortion Spontaneous
03-Apr-2012
09:37 AM
Page: 571
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/04ISR Number: 4512858-6Report Type:Direct Outcome Other Serious PT Tremor Palpitations Feeling Abnormal Feeling Jittery Anxiety Company Report #CTU 232457 Report Source Product Larium 250 Mg Tabs Role PS Manufacturer Age:37 YR Route Gender:Male Dose 1 Q WEEK I/FU:I Duration
Date:11/22/04ISR Number: 4506772-XReport Type:Expedited (15-DaCompany Report #GB-ROCHE-385961 Outcome Hospitalization Initial or Prolonged PT General Physical Health Deterioration Joint Dislocation Balance Disorder Upper Limb Fracture Fall Decreased Appetite Insomnia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:11/23/04ISR Number: 4507897-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-377423 Outcome Hospitalization Initial or Prolonged PT Cerebrovascular Accident Electrocardiogram Abnormal Cardiac Failure Report Source Product Lariam Toprol Xl Role PS C Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:11/23/04ISR Number: 4507908-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-386256 Outcome Hospitalization Initial or Prolonged PT Photosensitivity Reaction Malaise Feeling Abnormal Suicidal Ideation Depression Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:11/29/04ISR Number: 4512071-2Report Type:Expedited (15-DaCompany Report #DE-ROCHE-382481 Outcome Other Serious PT Homicide Malaria Psychotic Disorder Anxiety Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male
I/FU:F
Dose Duration TAKEN WEEKLY. 316 DAY
Hallucination, Auditory Hallucination Balance Disorder
03-Apr-2012
09:37 AM
Page: 572
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4512170-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-386651 Outcome Disability PT Blindness Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Male Dose I/FU:I Duration
Date:11/29/04ISR Number: 4512180-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-386791 Outcome Hospitalization Initial or Prolonged PT Retinopathy Report Source Product Lariam Lariam Lariam Lariam Role PS SS SS SS Manufacturer Roche Roche Roche Roche
Gender:Female Dose UNKNOWN DURATION. 1
I/FU:I Duration 1 MON 1 MON MON
Date:12/08/04ISR Number: 4521121-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-386256 Outcome Hospitalization Initial or Prolonged PT Toxicity To Various Agents Suicidal Ideation Depression Feeling Abnormal Anxiety Photosensitivity Reaction Malaise Fear Negative Thoughts Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:F Duration
Date:12/13/04ISR Number: 4525226-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Tremor Vomiting Vestibular Disorder Tinnitus Muscle Twitching Photophobia Visual Field Defect Nausea Aggression Disturbance In Attention Anxiety Insomnia Jaundice Hallucination Depression Amnesia
Age:44 YR
Gender:Male
I/FU:F
Photosensitivity Reaction Toxicity To Various Agents Irritability Endolymphatic Hydrops Hepatic Failure Cranial Nerve Disorder Visual Impairment 03-Apr-2012 09:37 AM Page: 573
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Suicidal Ideation Asthenia Obsessive Thoughts Depressed Level Of Consciousness Paranoia Incontinence General Symptom Cough Mood Swings Balance Disorder Panic Attack Anger Post-Traumatic Stress Disorder Migraine
Report Source
Product Lariam Sudafed
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:12/15/04ISR Number: 4530035-XReport Type:Direct Outcome Life-Threatening Disability PT Insomnia Panic Attack Anxiety Hallucination Suicidal Ideation Night Sweats Depression Delusion
Company Report #CTU 234381 Report Source Product Mefloquine Sandoz Role 250mg PS Sandoz ORAL Manufacturer
Age:30 YR Route
Gender:Male Dose 250MG WEEK PER ORAL
I/FU:I Duration
Date:12/22/04ISR Number: 4535059-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-388966 Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Tardive Dyskinesia Report Source Product Lariam Zyprexa Role PS SS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:12/23/04ISR Number: 4536778-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-384854 Outcome Other Serious PT Insomnia Paraesthesia Skin Disorder Hyperhidrosis Fatigue Disorientation Liver Function Test Abnormal
Age:37 YR
Gender:Male
I/FU:F
Disturbance In Attention Agitation Vertigo Diarrhoea Paranoia Chills Back Pain Anxiety 03-Apr-2012 09:37 AM Page: 574
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Panic Attack Depression Heart Rate Increased Heart Rate Irregular Mood Swings Balance Disorder
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose 3-4 PILLS WERE TAKEN.
Duration 43 DAY
Date:01/03/05ISR Number: 4544470-7Report Type:Direct Outcome Life-Threatening Disability PT Headache Hallucination Balance Disorder Disturbance In Attention Sleep Disorder Impaired Work Ability Dizziness Confusional State Memory Impairment Homicidal Ideation Thinking Abnormal Mania Motion Sickness Suicidal Ideation Heart Rate Irregular Depression Nightmare Panic Attack Night Sweats Self Esteem Decreased
Gender:Female Dose 1 PILL ORAL WEEK
I/FU:I Duration
Date:01/05/05ISR Number: 4544789-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Diarrhoea Hepatic Failure Nausea Disturbance In Attention Photosensitivity Reaction Jaundice Cranial Nerve Disorder Visual Field Defect Insomnia General Symptom Obsessive Thoughts Depressed Level Of Consciousness Post-Traumatic Stress Disorder
Age:44 YR
Gender:Male
I/FU:F
Migraine Paranoia Depression Amnesia Vestibular Disorder Anxiety Tinnitus Irritability 03-Apr-2012 09:37 AM Page: 575
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Twitching Photophobia Tremor Vomiting Anger Asthenia Endolymphatic Hydrops Panic Attack Aggression Mood Swings Hallucination Balance Disorder Incontinence Toxicity To Various Agents Visual Impairment Suicidal Ideation Cough
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:01/06/05ISR Number: 4546225-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-390293 Outcome Other Serious PT Pneumonitis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:01/07/05ISR Number: 4547388-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-386651 Outcome Disability PT Blindness Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:01/07/05ISR Number: 4547393-2Report Type:Expedited (15-DaCompany Report #KR-ROCHE-389876 Outcome Hospitalization Initial or Prolonged PT Hepatitis Acute Report Source Product Lariam Lariam Role PS SS Manufacturer Roche Roche
Gender:Female Dose DOSAGE REGIMEN: 1T/WEEK DOSAGE REGIMEN: 1T/WEEK
I/FU:I Duration
Date:01/10/05ISR Number: 4549486-2Report Type:Direct Outcome Disability PT Multiple Allergies Hallucination Nightmare
I/FU:I Duration
Headache Diarrhoea
03-Apr-2012
09:37 AM
Page: 576
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/05ISR Number: 4549536-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-390682 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Panic Attack Anxiety Hyperhidrosis Atrial Fibrillation Heart Rate Increased Fluid Retention Palpitations Report Source Product Lariam Role PS Manufacturer Roche Age:59 YR Route UNKNOWN Gender:Female Dose I/FU:F Duration
Date:01/12/05ISR Number: 4550163-2Report Type:Expedited (15-DaCompany Report #KR-ROCHE-389876 Outcome Hospitalization Initial or Prolonged PT Product Quality Issue Hepatitis Acute Report Source Consumer Product Lariam Lariam Role PS SS Manufacturer Roche Roche
Gender:Female Dose DOSAGE REGIMEN: 1T/WEEK DOSAGE REGIMEN: 1T/WEEK
I/FU:F Duration
Date:01/14/05ISR Number: 4552774-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-319597 Outcome Death PT Disorientation Abnormal Behaviour Social Avoidant Behaviour Psychotic Disorder Feeling Abnormal Anger Communication Disorder Tremor Mood Altered Completed Suicide Aggression Nervousness Report Source Product Lariam Primaquine Phosphate Role PS C Manufacturer Roche
Gender:Male
I/FU:F
Dose Duration TAKEN WEEKLY 99 DAY 15 DAY
Date:01/14/05ISR Number: 4552794-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-391105 Outcome Hospitalization Initial or Prolonged Congenital Anomaly PT Oligohydramnios Abortion Induced Premature Rupture Of Membranes Talipes Maternal Exposure During Pregnancy Report Source Product Lariam Lysine Acetylsalicylate Role PS SS Manufacturer Roche
Age:26 YR Route UNKNOWN UNKNOWN
Gender:Female Dose
Date:01/14/05ISR Number: 4552795-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM
Age:
Gender:Male
I/FU:I
Page: 577
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Self Esteem Decreased Depression Anxiety Disorder Panic Attack Mood Swings Memory Impairment Psychotic Disorder Suicidal Ideation Amnesia Mental Disorder Report Source Product Lariam Role PS Manufacturer Roche Route UNKNOWN Dose Duration
Date:01/14/05ISR Number: 4553803-7Report Type:Direct Outcome Other Serious PT Nightmare Pregnancy Maternal Drugs Affecting Foetus Hypervigilance Amnesia Hallucination
Company Report #CTU 236752 Report Source Product Mefloquine (Larium) Role PS Manufacturer
Age:30 YR Route
Gender:Female
I/FU:I
Dose Duration 1 TIME A WEEK 10 WK
I/FU:F Duration 1 MON 1 MON MON
Date:01/24/05ISR Number: 4559263-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Cough Mood Swings Migraine Endolymphatic Hydrops Jaw Disorder Gilbert'S Syndrome Hyperacusis Visual Impairment Tremor Obsessive Thoughts
Age:44 YR
Gender:Male
I/FU:F
Lacrimation Increased Mania Visual Field Defect Balance Disorder Diarrhoea Aggression Anger Jaundice 03-Apr-2012 09:37 AM Page: 578
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Post-Traumatic Stress Disorder Incontinence Vestibular Disorder General Symptom Depressed Level Of Consciousness Confusional State Dysarthria Abnormal Dreams Hallucination Cranial Nerve Disorder Photosensitivity Reaction Toxicity To Various Agents Decreased Appetite Paranoia Nausea Disturbance In Attention Suicidal Ideation Irritability Thirst Cognitive Disorder Gait Disturbance Dysphemia Hepatic Failure Photophobia Panic Attack Insomnia Depression Amnesia Anxiety Tinnitus Tardive Dyskinesia Vomiting Asthenia Muscle Twitching Motor Dysfunction Conduction Disorder
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:01/24/05ISR Number: 4560679-0Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Atrial Fibrillation Nausea Panic Attack Chest Pain Disturbance In Attention Cardiac Disorder Anxiety Arrhythmia
Gender:Female Dose 1 PER WEEK FIVE WEEKS ORAL
I/FU:I Duration
Heart Rate Increased Dizziness
03-Apr-2012
09:37 AM
Page: 579
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/05ISR Number: 4560377-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Outcome Disability PT Motion Sickness Hypersensitivity Irritable Bowel Syndrome Phobia Of Flying Claustrophobia Bronchospasm Mood Disorder Due To A General Medical Condition Balance Disorder Migraine Musculoskeletal Stiffness Adjustment Disorder With Anxiety Suicidal Ideation Sinus Bradycardia Dyspnoea Disturbance In Attention Vestibular Disorder Photophobia Sensory Integrative Dysfunction Throat Irritation Nasal Congestion Vertigo Dizziness Heart Rate Increased Tinnitus Self Esteem Decreased Acrophobia Fatigue Sleep Disorder Neck Pain Hypoaesthesia Amnesia Insomnia Diarrhoea Paraesthesia Disorientation Headache Abdominal Pain Lower Adjustment Disorder With Depressed Mood Abdominal Pain Generalised Anxiety Disorder Lactose Intolerance Abdominal Distension Emotional Distress Anxiety Nausea Age:34 YR Gender:Male I/FU:F
Panic Attack Depression Weight Decreased Back Pain Sleep Disorder Due To General Medical Condition, Hypersomnia Type 03-Apr-2012 09:37 AM Page: 580
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Irregular Rash Phobia
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Vaccine
OTHER
Dose Duration THE PATIENT HAD TAKEN 4-5 TABLETS OF MEFLOQUINE IN TOTAL. 21 DAY 1 DAY
Date:01/27/05ISR Number: 4562580-5Report Type:Expedited (15-DaCompany Report #CH-ROCHE-392759 Outcome Hospitalization Initial or Prolonged PT Hepatocellular Injury Decreased Appetite Gamma-Glutamyltransferase Increased Nausea Abdominal Pain Upper Jaundice Pyrexia Report Source Product Lariam Activelle Alcacyl Selipran Role PS C C C Manufacturer Roche
Gender:Female Dose DOSE DURATION WAS REPORTED AS LONG TERM. DOSE DURATION WAS REPORTED AS LONG TERM.
I/FU:F Duration 1 MON 1 MON MON
Date:01/27/05ISR Number: 4562585-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Outcome Hospitalization Initial or Prolonged PT Disturbance In Attention Grand Mal Convulsion Amnesia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:01/27/05ISR Number: 4570256-3Report Type:Direct Outcome Disability PT Anxiety Depression Abnormal Dreams Stress
Company Report #CTU 238338 Report Source Product Lariam 250 Mg Nsn 6505-00-Foh-3872 Role PS Manufacturer F.Hoffman-La Roche Ltd
Age:45 YR Route
I/FU:I Duration
Date:01/28/05ISR Number: 4564224-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-392922 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Anaemia Thrombocytopenia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Page: 581
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/05ISR Number: 4575489-8Report Type:Direct Outcome Disability PT Depression Feeling Abnormal Anxiety Company Report #CTU 238692 Report Source Product Lariam Role PS Manufacturer Age:42 YR Route ORAL Gender:Male Dose WEEKLY ORAL I/FU:I Duration
Date:02/01/05ISR Number: 4567071-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-393160 Outcome Hospitalization Initial or Prolonged PT Respiratory Arrest Convulsion Report Source Product Lariam Role PS Manufacturer Roche
Age:6 YR Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:02/01/05ISR Number: 4567072-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-393292 Outcome Other Serious PT Hypothyroidism Autoimmune Thyroiditis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:02/04/05ISR Number: 4570324-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Incontinence Amnesia Endolymphatic Hydrops Abnormal Dreams Hyperacusis Tremor Insomnia Photosensitivity Reaction General Symptom Depressed Level Of Consciousness Dysarthria Motor Dysfunction Hallucination Cranial Nerve Disorder Anxiety Obsessive Thoughts Gait Disturbance Visual Field Defect Balance Disorder Panic Attack Vestibular Disorder Migraine Thirst Tardive Dyskinesia
Age:44 YR
Gender:Male
I/FU:F
Conduction Disorder Paranoia Photophobia Nausea Aggression Suicidal Ideation Tinnitus Post-Traumatic Stress 03-Apr-2012 09:37 AM Page: 582
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorder Decreased Appetite Lacrimation Increased Hepatic Failure Diarrhoea Disturbance In Attention Toxicity To Various Agents Mood Swings Dysphemia Visual Impairment Vomiting Anger Asthenia Cough Jaundice Confusional State Mania Gilbert'S Syndrome Depression Irritability Muscle Twitching Jaw Disorder Cognitive Disorder
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:02/04/05ISR Number: 4570348-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-393292 Outcome Other Serious PT Autoimmune Thyroiditis Hypothyroidism Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:02/04/05ISR Number: 4570355-6Report Type:Expedited (15-DaCompany Report #CA-ROCHE-393893 Outcome Other Serious PT Hypotrichosis Hallucination White Blood Cell Count Decreased Vomiting Loss Of Consciousness Fatigue Somnolence Panic Attack Dizziness Report Source Product Lariam Vivotif "Berna" Dukoral Role PS C C Manufacturer Roche
Gender:Male Dose
Date:02/07/05ISR Number: 4571642-8Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12841631 Outcome PT
Age:59 YR
Gender:Female
I/FU:I
Nausea Transaminases Increased Prothrombin Time Prolonged Chromaturia Jaundice Cholestatic Hepatitis A Antibody Positive Page: 583
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abdominal Pain Report Source Product Selipran Tabs Activella Lariam Role PS SS SS Manufacturer Bristol-Myers Squibb Company Route ORAL ORAL ORAL Dose Duration
Date:02/07/05ISR Number: 4571701-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-384854 Outcome Other Serious PT Diarrhoea Mood Swings Fatigue Panic Attack Chills Depression Agitation Liver Function Test Abnormal Heart Rate Increased Anxiety Paranoia Hyperhidrosis Disorientation Disturbance In Attention Back Pain Balance Disorder Vertigo Paraesthesia Cold Sweat Skin Disorder Feeling Abnormal Heart Rate Irregular Insomnia Alanine Aminotransferase Increased Report Source Consumer Product Lariam Role PS Manufacturer Roche
Gender:Male Dose 3-4 PILLS WERE TAKEN.
Date:02/09/05ISR Number: 4578673-2Report Type:Direct Outcome PT Disturbance In Attention Dizziness Memory Impairment Anxiety
Company Report #CTU 239959 Report Source Product Lariam Roxane Role 250mg PS Roxane ORAL Manufacturer
Age:27 YR Route
Gender:Female Dose 1 WEEKLY ORAL
I/FU:I Duration
Date:02/10/05ISR Number: 4577110-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-319597
Age:33 YR
Gender:Male
I/FU:F
Outcome Death
PT Completed Suicide Tremor Brain Oedema Aggression Nervousness Abnormal Behaviour 09:37 AM Page: 584
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Asphyxia Stress Mood Altered Homicide Disorientation Incoherent Communication Disorder Dysphemia Social Avoidant Behaviour Pulmonary Congestion Feeling Abnormal Anger Marital Problem
Report Source
Product Lariam Primaquine Phosphate
Role PS C
Manufacturer Roche
Route ORAL ORAL
Date:02/10/05ISR Number: 4577145-9Report Type:Expedited (15-DaCompany Report #DK-ROCHE-394266 Outcome Other Serious PT Nervousness Mental Impairment Petit Mal Epilepsy Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:02/10/05ISR Number: 4577147-2Report Type:Expedited (15-DaCompany Report #CH-ROCHE-394176 Outcome Hospitalization Initial or Prolonged PT Transaminases Increased Abdominal Pain Jaundice Cholestatic Nausea Chromaturia Prothrombin Time Prolonged Report Source Product Lariam Selipran Activelle Role PS SS SS Manufacturer Roche
Gender:Female Dose FREQUENCY REPORTED AS "AS NECESSARY"
Date:02/10/05ISR Number: 4577157-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-394348 Outcome Disability PT Disturbance In Attention Palpitations Paraesthesia Sleep Disorder Dizziness Restlessness Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration DOSAGE REGIMEN REPORTED AS 1 TABLET WEEKLY 15 DAY
Age:27 YR
Gender:Male
I/FU:I
PT Nightmare Nausea Dizziness
Report Source
Product Lariam Roche
Role PS
Manufacturer Roche
Route
Dose
Duration
03-Apr-2012
09:37 AM
Page: 585
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4584087-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Balance Disorder Diarrhoea Muscle Twitching Endolymphatic Hydrops Tardive Dyskinesia Lacrimation Increased Dysphemia Conduction Disorder Hallucination Cranial Nerve Disorder Tremor Toxicity To Various Agents Obsessive Thoughts Post-Traumatic Stress Disorder Gait Disturbance Abnormal Dreams Neuropathy Peripheral Hepatic Failure Visual Field Defect Insomnia Anger Depression Vestibular Disorder Photosensitivity Reaction Depressed Level Of Consciousness Visual Impairment Amnesia Hyperacusis Paranoia Panic Attack Incontinence Asthenia Cough Tinnitus Jaundice Dysarthria Motor Dysfunction Photophobia Nausea Aggression Anxiety General Symptom Migraine Jaw Disorder Cognitive Disorder Mania Viiith Nerve Lesion Age:44 YR Gender:Male I/FU:F
Vomiting Suicidal Ideation Irritability Disturbance In Attention Mood Swings Decreased Appetite Thirst Confusional State 03-Apr-2012 09:37 AM Page: 586
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gilbert'S Syndrome Report Source Product Lariam Sudafed Role PS C Manufacturer Roche Route ORAL Dose 23 TABLETS DISPENSED. Duration
Date:02/17/05ISR Number: 4586792-XReport Type:Direct Outcome Other Serious PT Insomnia Phobia Panic Attack Suicidal Ideation Personality Change Gastric Disorder Crying Anxiety Paranoia
Age: Route
Gender:Female Dose 1 TABLET DAYS?? 10
I/FU:I Duration
Date:02/23/05ISR Number: 4589655-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-390682 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Anxiety Palpitations Weight Increased Foot Fracture Panic Attack Heart Rate Increased Fluid Retention Balance Disorder Atrial Fibrillation Hyperhidrosis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:03/04/05ISR Number: 4598556-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-381724 Outcome Other Serious PT Abortion Spontaneous Maternal Exposure During Pregnancy Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:03/04/05ISR Number: 4599949-9Report Type:Direct Outcome Hospitalization PT Delirium
Gender:Male
I/FU:I
Dose Duration 250 MG QWEEK
Thinking Abnormal Hallucination
ORAL
03-Apr-2012
09:37 AM
Page: 587
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4603011-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-397065 Outcome Disability PT Toxicity To Various Agents Dizziness Psychotic Disorder Hearing Impaired Visual Impairment Tinnitus Panic Attack Anxiety Depression Confusional State Mood Swings Paranoia Insomnia Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Male Dose FREQUENCY STATED AS WEEKLY. I/FU:I Duration 47 DAY
Date:03/10/05ISR Number: 4603890-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Sinus Tachycardia Blood Cholesterol Increased Snoring Constipation Blood Glucose Increased Upper-Airway Cough Syndrome Visual Impairment Psychotic Disorder Amnesia Dry Mouth Angiotensin Converting Enzyme Increased Bipolar Disorder Scratch Schizoaffective Disorder Depression Fatigue Headache Restrictive Pulmonary Disease Somnolence Viral Infection Bronchospasm Total Cholesterol/Hdl Ratio Decreased Diarrhoea Dehydration Nocturia
Age:42 YR
Gender:Male
I/FU:F
Gastrooesophageal Reflux Disease Confusional State Anxiety Bronchitis Weight Increased Exfoliative Rash Acrochordon 03-Apr-2012 09:37 AM Page: 588
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asthma Major Depression Aggression Skin Disorder Gastrointestinal Disorder Diastolic Dysfunction Total Lung Capacity Decreased Dry Eye Balance Disorder Vestibular Disorder Hypertension Angina Pectoris Arthralgia Low Density Lipoprotein Increased Dry Skin Chest Discomfort Vitiligo Haemorrhoids Contusion Affective Disorder Dyspnoea Sleep Apnoea Syndrome Rash Cardiac Murmur Blood Triglycerides Increased Blood Creatine Phosphokinase Increased Rhinitis Adjustment Disorder With Depressed Mood Memory Impairment Tremor Mitral Valve Prolapse Ventricular Hypertrophy Oral Disorder Insomnia Clumsiness Abnormal Dreams Coordination Abnormal
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:03/10/05ISR Number: 4603962-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-397276 Outcome Hospitalization Initial or Prolonged PT Furuncle Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:03/11/05ISR Number: 4606008-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Hepatic Failure Hallucination Tremor Insomnia Thirst 09:37 AM
Age:44 YR
Gender:Male
I/FU:F
03-Apr-2012
Page: 589
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysphemia Abnormal Dreams Tooth Discolouration Gastroenteritis Incontinence Aggression Suicidal Ideation Irritability Atrial Fibrillation Antisocial Behaviour Amnesia Asthenia Mood Swings Depressed Level Of Consciousness Decreased Appetite Cognitive Disorder Lacrimation Increased Viiith Nerve Lesion Nervous System Disorder Cranial Nerve Disorder Balance Disorder Nausea Cough Tinnitus Jaw Disorder Confusional State Gilbert'S Syndrome Memory Impairment Visual Impairment Depression General Symptom Obsessive Thoughts Post-Traumatic Stress Disorder Endolymphatic Hydrops Dysarthria Photophobia Panic Attack Toxicity To Various Agents Muscle Twitching Tardive Dyskinesia Gait Disturbance Hyperacusis Creutzfeldt-Jakob Disease Paranoia Diarrhoea Vestibular Disorder Anxiety Jaundice Migraine Motor Dysfunction
Conduction Disorder Hepato-Lenticular Degeneration Metal Poisoning Visual Field Defect Vomiting Anger Disturbance In Attention 03-Apr-2012 09:37 AM Page: 590
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Photosensitivity Reaction Mania Alcohol Poisoning Rash Pruritic
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:03/16/05ISR Number: 4610613-XReport Type:Expedited (15-DaCompany Report #004337 Outcome Other Serious PT Asthenia Dizziness Myalgia Pyrexia Gait Disturbance Aphasia Report Source Consumer Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Tablet, 250 Mg Toprol Xl (Metoprolol Succinate) Zoloft (Sertraline Hydrochloride) Role Manufacturer
Age:44 YR Route
Gender:Female Dose
I/FU:I Duration
PS C C
ORAL
SEE IMAGE
30
DAY
Date:03/16/05ISR Number: 4612641-7Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Aggression Self Injurious Behaviour Feeling Of Despair Disturbance In Social Behaviour Thinking Abnormal Anxiety Mental Disorder Emotional Disorder Psychotic Disorder Abnormal Behaviour Suicidal Ideation Multiple Injuries
Company Report #CTU 243413 Report Source Product Mefloquine-LariamRole PS Manufacturer
I/FU:I Duration
Date:03/21/05ISR Number: 4613947-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Fatigue Total Lung Capacity Decreased Abnormal Dreams Asthma Haemorrhoids
Age:42 YR
Gender:Male
I/FU:F
Contusion Psychotic Disorder Amnesia Vestibular Disorder Gastrointestinal Disorder Headache Somnolence Chest Discomfort 03-Apr-2012 09:37 AM Page: 591
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhinitis Insomnia Balance Disorder Adjustment Disorder With Depressed Mood Major Depression Dyspnoea Mitral Valve Prolapse Hypertension Arthralgia Weight Increased Cardiac Murmur Sinus Tachycardia Blood Creatine Phosphokinase Increased Bipolar Disorder Memory Impairment Tremor Depression Restrictive Pulmonary Disease Bronchitis Bronchospasm Dry Eye Blood Glucose Increased Schizoaffective Disorder Angina Pectoris Blood Cholesterol Increased Blood Triglycerides Increased Low Density Lipoprotein Increased Total Cholesterol/Hdl Ratio Decreased Diarrhoea Constipation Acrochordon Coordination Abnormal Affective Disorder Aggression Rash Dehydration Dry Skin Oral Disorder Vitiligo Angiotensin Converting Enzyme Increased Gastrooesophageal Reflux Disease Scratch Anxiety Skin Disorder
Diastolic Dysfunction Exfoliative Rash Nocturia Clumsiness Visual Impairment Confusional State Ventricular Hypertrophy Sleep Apnoea Syndrome 03-Apr-2012 09:37 AM Page: 592
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Viral Infection Dry Mouth Snoring Upper-Airway Cough Syndrome
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:03/21/05ISR Number: 4613968-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Outcome Hospitalization Initial or Prolonged PT Grand Mal Convulsion Disturbance In Attention Amnesia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:03/22/05ISR Number: 4620246-7Report Type:Direct Outcome Disability PT Dizziness Anxiety Depressed Mood Nausea
I/FU:I Duration
Date:03/23/05ISR Number: 4617079-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Dyspnoea Hypertension Restrictive Pulmonary Disease Somnolence Bronchitis Total Cholesterol/Hdl Ratio Decreased Exfoliative Rash Snoring Vitiligo Rhinitis Insomnia Adjustment Disorder With Depressed Mood Major Depression Psychotic Disorder Body Temperature Increased Wheezing Rectal Haemorrhage Depression Angina Pectoris
Age:42 YR
Gender:Male
I/FU:F
Total Lung Capacity Decreased Sleep Apnoea Syndrome Dry Mouth Oral Disorder Aggression Cough Sarcoidosis 03-Apr-2012 09:37 AM Page: 593
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amnesia Vestibular Disorder Fatigue Arthralgia Rash Low Density Lipoprotein Increased Dehydration Upper-Airway Cough Syndrome Asthma Scratch Tremor Productive Cough Photosensitivity Reaction Anxiety Weight Increased Blood Glucose Increased Visual Impairment Peripheral Sensory Neuropathy Exercise Tolerance Decreased Sinusitis Confusional State Mitral Valve Prolapse Blood Cholesterol Increased Diarrhoea Chest Discomfort Constipation Angiotensin Converting Enzyme Increased Nervous System Disorder Skin Disorder Headache Ventricular Hypertrophy Diastolic Dysfunction Bronchospasm Blood Triglycerides Increased Dry Skin Acrochordon Contusion Schizoaffective Disorder Listless Upper Respiratory Tract Infection Oedema Jaw Disorder Gastrointestinal Disorder Cardiac Murmur Blood Creatine
Phosphokinase Increased Dry Eye Nocturia Gastrooesophageal Reflux Disease Haemorrhoids Affective Disorder Eye Pruritus 03-Apr-2012 09:37 AM Page: 594
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lacrimation Increased Viral Infection Sinus Tachycardia Clumsiness Abnormal Dreams Bipolar Disorder Balance Disorder Coordination Abnormal Memory Impairment Sputum Discoloured Myalgia Sjogren'S Syndrome Embolism Arterial Discomfort Nasal Congestion
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:03/23/05ISR Number: 4617081-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Cranial Nerve Disorder Insomnia Disturbance In Attention Vestibular Disorder Cough Irritability Cognitive Disorder Hyperacusis Dizziness Weight Decreased Psychiatric Symptom Nightmare Antisocial Behaviour Incontinence Aggression Obsessive Thoughts Muscle Twitching Thirst Gait Disturbance Motor Dysfunction Gilbert'S Syndrome Electrocardiogram St-T Change Tooth Discolouration Stress Upper Respiratory Tract Infection Tremor Anger Depressed Level Of Consciousness Dysarthria
Age:44 YR
Gender:Male
I/FU:F
Fatigue Electroencephalogram Abnormal Hepatic Failure Hallucination Visual Field Defect Nausea Jaundice 03-Apr-2012 09:37 AM Page: 595
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tearfulness Acoustic Neuritis Vomiting Suicidal Ideation Anxiety General Symptom Tinnitus Post-Traumatic Stress Disorder Endolymphatic Hydrops Decreased Appetite Abnormal Dreams Reading Disorder Tic Panic Attack Toxicity To Various Agents Mania Vertigo Narcissistic Personality Disorder Paranoia Photophobia Diarrhoea Depression Mood Swings Jaw Disorder Tardive Dyskinesia Lacrimation Increased Confusional State Dysphemia Visual Impairment Balance Disorder Amnesia Photosensitivity Reaction Asthenia Migraine Conduction Disorder Bipolar Disorder Gastroenteritis Hyporeflexia Feeling Abnormal
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:03/24/05ISR Number: 4617721-8Report Type:Expedited (15-DaCompany Report #CA-ROCHE-398664 Outcome Other Serious PT Pancreatitis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male
I/FU:I
Dose Duration 3 DOSES TAKEN
Date:03/24/05ISR Number: 4617730-9Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398996
Age:30 YR
Gender:Female
I/FU:I
PT Abortion Spontaneous Maternal Exposure During Pregnancy
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose Duration TOTAL OF 7-8 250 MG TABLETS WERE TAKEN
03-Apr-2012
09:37 AM
Page: 596
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/05ISR Number: 4617734-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-399038 Outcome Other Serious PT Feeling Abnormal Dermatitis Exfoliative Vision Blurred Dry Skin Vomiting Report Source Product Lariam Role PS Manufacturer Roche Age:61 YR Route UNKNOWN Gender:Female Dose I/FU:I Duration
Date:03/30/05ISR Number: 4622495-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-257719 Outcome Disability PT Dizziness Visual Impairment Panic Attack Muscle Twitching Insomnia Anxiety Agoraphobia Confusional State Hepatocellular Injury Hallucination Aggression Nervous System Disorder Suicidal Ideation Paranoia Psychotic Disorder Hypertension Dissociative Disorder Tremor Mood Swings Fatigue Pyrexia Headache Feeling Abnormal Immune System Disorder Amnesia Balance Disorder Depression Myalgia Report Source Product Lariam Tablets Role PS Manufacturer Roche
Gender:Male
I/FU:F
Date:03/31/05ISR Number: 4623912-2Report Type:Expedited (15-DaCompany Report #CA-ROCHE-393893 Outcome Other Serious PT Loss Of Consciousness Dizziness Vomiting Somnolence Panic Attack Report Source Product Lariam Vivotif "Berna" Dukoral Role PS C C Manufacturer Roche
Gender:Male Dose
Hallucination Fatigue White Blood Cell Count Decreased Hypotrichosis
03-Apr-2012
09:37 AM
Page: 597
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/05ISR Number: 4625199-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Mitral Valve Prolapse Diastolic Dysfunction Bronchitis Blood Triglycerides Increased Blood Creatine Phosphokinase Increased Exfoliative Rash Balance Disorder Sinusitis Amnesia Anxiety Sinus Tachycardia Diarrhoea Nocturia Vitiligo Gastrooesophageal Reflux Disease Haemorrhoids Psychotic Disorder Gastrointestinal Disorder Ventricular Hypertrophy Hypertension Restrictive Pulmonary Disease Dry Skin Angiotensin Converting Enzyme Increased Bipolar Disorder Major Depression Contusion Aggression Depression Oral Disorder Fatigue Angina Pectoris Total Lung Capacity Decreased Viral Infection Rash Blood Cholesterol Increased Dehydration Dry Mouth Insomnia Visual Impairment Scratch Memory Impairment Affective Disorder Tremor Age:42 YR Gender:Male I/FU:F
Confusional State Dyspnoea Somnolence Bronchospasm Cardiac Murmur Snoring Chest Discomfort Constipation 03-Apr-2012 09:37 AM Page: 598
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acrochordon Blood Glucose Increased Headache Sleep Apnoea Syndrome Arthralgia Weight Increased Low Density Lipoprotein Increased Total Cholesterol/Hdl Ratio Decreased Clumsiness Asthma Adjustment Disorder With Depressed Mood Vestibular Disorder Skin Disorder Dry Eye Upper-Airway Cough Syndrome Rhinitis Abnormal Dreams Coordination Abnormal Schizoaffective Disorder
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:04/01/05ISR Number: 4625201-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Paranoia Hallucination Depression Anxiety Obsessive Thoughts Jaw Disorder Gait Disturbance Abnormal Dreams Cranial Nerve Disorder Panic Attack Incontinence Cough Irritability Depressed Level Of Consciousness Tardive Dyskinesia Motor Dysfunction Gilbert'S Syndrome Amnesia General Symptom Muscle Twitching Mood Swings Migraine Hepatic Failure
Age:44 YR
Gender:Male
I/FU:F
Tremor Diarrhoea Aggression Vestibular Disorder Photosensitivity Reaction Tinnitus Lacrimation Increased Dysarthria 03-Apr-2012 09:37 AM Page: 599
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Conduction Disorder Hyperacusis Photophobia Disturbance In Attention Visual Impairment Visual Field Defect Balance Disorder Anger Endolymphatic Hydrops Decreased Appetite Mania Insomnia Jaundice Cognitive Disorder Nausea Vomiting Toxicity To Various Agents Suicidal Ideation Asthenia Post-Traumatic Stress Disorder Thirst Confusional State Dysphemia
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:04/04/05ISR Number: 4626282-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-399129 Outcome Other Serious PT Contusion International Normalised Ratio Increased Report Source Product Lariam Cefaclor Warfarin Role PS SS SS Manufacturer Roche
Gender:Female Dose 250 MG RECEIVED WEEKLY.
I/FU:I Duration
DAY
Date:04/08/05ISR Number: 4630752-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-399038 Outcome Disability PT Dermatitis Exfoliative Dry Skin Feeling Abnormal Vision Blurred Vomiting Sensory Disturbance Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:04/11/05ISR Number: 4632263-1Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398996
Age:29 YR
Gender:Female
I/FU:F
PT Abortion Spontaneous Maternal Exposure During Pregnancy Ultrasound Antenatal Screen Abnormal Vaginal Haemorrhage 09:37 AM
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose Duration TOTAL OF 7-8 250 MG TABLETS WERE TAKEN
Trinordiol
ORAL
03-Apr-2012
Page: 600
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/05ISR Number: 4657678-7Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Nausea Tinnitus Convulsion Dizziness Company Report #GXBR2005US00443 Report Source Consumer Product Mefloquine Hcl Tablets (Ngx)(Mefloquine) Tablet Valium (Diazepam) Vicodin (Hydrocodone Bitartrate, Paracetamol) Role Manufacturer Age:51 YR Route Gender:Male Dose I/FU:I Duration
PS C C
ORAL
250 MG, QW, ORAL; 500 MG, QW
Date:04/11/05ISR Number: 4657680-5Report Type:Periodic Outcome Disability PT Dizziness Postural Asthenia Loss Of Consciousness Palpitations Disturbance In Attention Tremor
Company Report #GXBR2005US00448 Report Source Consumer Product Mefloquine Hcl Tablets (Ngx)(Mefloquine) Tablet Cipro (Ciprofloxacin Hydrochloride) Role Manufacturer
Age:44 YR Route
Gender:Male Dose
I/FU:I Duration
PS C
ORAL
250 MG, QW, ORAL
Date:04/18/05ISR Number: 4637881-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Confusional State Depression Headache Bronchospasm Diarrhoea Chest Discomfort Angiotensin Converting Enzyme Increased Bronchitis Weight Increased Cardiac Murmur Sinus Tachycardia Blood Triglycerides Increased Low Density Lipoprotein Increased Nocturia Vitiligo Upper-Airway Cough Syndrome Abnormal Dreams
Age:42 YR
Gender:Male
I/FU:F
Coordination Abnormal Major Depression Aggression Amnesia Gastrointestinal Disorder Hypertension Dry Skin Snoring 03-Apr-2012 09:37 AM Page: 601
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acrochordon Insomnia Anxiety Dyspnoea Vestibular Disorder Mitral Valve Prolapse Skin Disorder Angina Pectoris Restrictive Pulmonary Disease Rhinitis Bipolar Disorder Contusion Schizoaffective Disorder Somnolence Rash Dehydration Dry Eye Blood Glucose Increased Asthma Haemorrhoids Affective Disorder Total Cholesterol/Hdl Ratio Decreased Exfoliative Rash Dry Mouth Scratch Tremor Ventricular Hypertrophy Sleep Apnoea Syndrome Viral Infection Arthralgia Oral Disorder Gastrooesophageal Reflux Disease Clumsiness Balance Disorder Adjustment Disorder With Depressed Mood Psychotic Disorder Fatigue Diastolic Dysfunction Total Lung Capacity Decreased Blood Cholesterol Increased Blood Creatine Phosphokinase Increased Constipation Visual Impairment Memory Impairment
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:04/18/05ISR Number: 4638885-6Report Type:Direct Outcome Other Serious PT Sleep Talking Abnormal Behaviour
Age: Route
Gender:Female Dose
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 602
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/05ISR Number: 4644025-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Diarrhoea Toxicity To Various Agents Irritability Obsessive Thoughts Migraine Endolymphatic Hydrops Thirst Hepatic Failure Gilbert'S Syndrome Hyperacusis Visual Field Defect Balance Disorder Vomiting Asthenia Muscle Twitching Post-Traumatic Stress Disorder Dysphemia Mania Cranial Nerve Disorder Tremor Nausea Suicidal Ideation Motor Dysfunction Photophobia Anger Depressed Level Of Consciousness Tardive Dyskinesia Gait Disturbance Hallucination Insomnia Photosensitivity Reaction Anxiety Tinnitus Decreased Appetite Jaw Disorder Confusional State Dysarthria Abnormal Dreams Incontinence Aggression Amnesia Vestibular Disorder General Symptom Cough Jaundice Mood Swings Cognitive Disorder Report Source Product Lariam Sudafed Role PS C Manufacturer Roche Age:44 YR Route ORAL Gender:Male Dose 23 TABLETS DISPENSED. I/FU:F Duration
Conduction Disorder Paranoia Visual Impairment Panic Attack Disturbance In Attention Depression Lacrimation Increased 03-Apr-2012 09:37 AM Page: 603
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/05ISR Number: 4645005-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Vomiting Blood Pressure Increased Chest Pain Depression Rash Photophobia Phonophobia Insomnia Nightmare Vertigo Tinnitus Inner Ear Disorder Vision Blurred Disturbance In Attention Hypoaesthesia Blood Urea Increased Gait Disturbance Amnesia Dizziness Eye Pain Pain Of Skin Abnormal Dreams Anxiety Disorder Memory Impairment Headache Nystagmus Irritable Bowel Syndrome Neutrophil Count Increased Lymphocyte Count Decreased Epididymitis Nausea Fatigue Psychotic Disorder Testicular Pain Diarrhoea Disorientation Vestibular Disorder Colitis Monocyte Count Increased Night Sweats Agitation Mood Swings Abdominal Pain Nervousness Pain Enteritis Report Source Product Lariam Imodium Compazine Role PS C C Manufacturer Roche Age:35 YR Route ORAL Gender:Male Dose ON 18 APR 2001, THERAPY REPORTED AS TWICE DAILY. BY TAPER. ON 18 APR 2001, THERAPY REPORTED AS: AS NEEDED. I/FU:F Duration
Antibiotics Nos Ambien Prednisone Valium
C C C C
Phenergan Biaxin Advil Bactrim Antivert
C C C C C
Date:04/28/05ISR Number: 4647479-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-319597 Outcome Death PT Completed Suicide Incoherent Feeling Abnormal Aggression 09:37 AM
Age:33 YR
Gender:Male
I/FU:F
03-Apr-2012
Page: 604
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Behaviour Homicide Psychotic Disorder Social Avoidant Behaviour Disorientation Pulmonary Congestion Asphyxia Communication Disorder Mood Altered Dysphemia Anger Tremor Nervousness Brain Oedema
Report Source
Product Lariam Primaquine Phosphate
Role PS C
Manufacturer Roche
Route ORAL ORAL
Date:04/28/05ISR Number: 4647505-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-385961 Outcome Hospitalization Initial or Prolonged Disability PT Insomnia Neuropathy Peripheral Limb Deformity General Physical Health Deterioration Joint Dislocation Upper Limb Fracture Fall Balance Disorder Decreased Appetite Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:04/28/05ISR Number: 4647549-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-402425 Outcome Other Serious PT Hepatocellular Injury Liver Function Test Abnormal Report Source Product Lariam Alcohol Role PS SS Manufacturer Roche
Age: Route ORAL UNKNOWN
Gender:Male Dose
Date:04/28/05ISR Number: 4647735-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-402089 Outcome Other Serious PT Epilepsy Anxiety Nightmare Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Age:
Gender:Male
I/FU:I
Outcome Life-Threatening Disability Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM
PT Nervous System Disorder Cognitive Disorder Toxicity To Various Agents Vestibular Disorder
Report Source
Product Lariam Standard Hoffman Laroche Namenda Paxil Depakote Benzodiazapines
Role PS C C C C
Manufacturer Hoffman Laroche
Route ORAL
Dose 1 PILL WEEKLY ORAL
Duration
Page: 605
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sleeping Pills C
Date:05/02/05ISR Number: 4649996-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Mitral Valve Prolapse Viral Infection Blood Creatine Phosphokinase Increased Exfoliative Rash Oral Disorder Gastrooesophageal Reflux Disease Insomnia Schizoaffective Disorder Confusional State Headache Hypertension Rash Dry Mouth Clumsiness Coordination Abnormal Memory Impairment Restrictive Pulmonary Disease Bronchitis Cardiac Murmur Sinus Tachycardia Dry Eye Blood Glucose Increased Adjustment Disorder With Depressed Mood Depression Diastolic Dysfunction Somnolence Blood Triglycerides Increased Low Density Lipoprotein Increased Dehydration Rhinitis Haemorrhoids Balance Disorder Aggression Angina Pectoris Total Lung Capacity Decreased Diarrhoea Dry Skin Visual Impairment Abnormal Dreams
Age:42 YR
Gender:Male
I/FU:F
Scratch Amnesia Vestibular Disorder Gastrointestinal Disorder Fatigue Sleep Apnoea Syndrome Arthralgia Weight Increased 03-Apr-2012 09:37 AM Page: 606
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Cholesterol Increased Vitiligo Acrochordon Angiotensin Converting Enzyme Increased Upper-Airway Cough Syndrome Asthma Skin Disorder Ventricular Hypertrophy Bronchospasm Nocturia Bipolar Disorder Major Depression Psychotic Disorder Anxiety Dyspnoea Total Cholesterol/Hdl Ratio Decreased Snoring Chest Discomfort Constipation Contusion Affective Disorder Tremor
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:05/10/05ISR Number: 4657892-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Hepatic Failure Visual Impairment Panic Attack Insomnia Nausea Depression Photosensitivity Reaction Anxiety Cough Depressed Level Of Consciousness Cognitive Disorder Dysarthria Dysphemia Tearfulness Hallucination Photophobia Vomiting Muscle Twitching Jaw Disorder Lacrimation Increased
Age:44 YR
Gender:Male
I/FU:F
Tinnitus Irritability Endolymphatic Hydrops Gilbert'S Syndrome Nervous System Disorder Weight Decreased Deafness Toxicity To Various 03-Apr-2012 09:37 AM Page: 607
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Agents General Symptom Post-Traumatic Stress Disorder Thirst Confusional State Gait Disturbance Gastroenteritis Electroencephalogram Abnormal Migraine Decreased Appetite Conduction Disorder Dizziness Sensory Disturbance Paranoia Tremor Incontinence Disturbance In Attention Amnesia Tardive Dyskinesia Abnormal Dreams Water Pollution Stress Chest Pain Balance Disorder Aggression Anger Vestibular Disorder Asthenia Mania Viiith Nerve Lesion Nystagmus Hepato-Lenticular Degeneration Creutzfeldt-Jakob Disease Sinus Tachycardia Cranial Nerve Disorder Visual Field Defect Diarrhoea Suicidal Ideation Obsessive Thoughts Jaundice Mood Swings Motor Dysfunction Hyperacusis Respiratory Disorder Blood Bilirubin Increased Tooth Discolouration Accidental Exposure Binocular Eye Movement Disorder Disorientation Metal Poisoning
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:05/13/05ISR Number: 4661718-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability 03-Apr-2012 09:37 AM PT Anxiety Depression
Age:42 YR
Gender:Male
I/FU:F
Page: 608
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Arthralgia Bronchitis Total Cholesterol/Hdl Ratio Decreased Dry Eye Insomnia Asthma Ventricular Hypertrophy Diastolic Dysfunction Restrictive Pulmonary Disease Sleep Apnoea Syndrome Diarrhoea Dry Skin Constipation Angiotensin Converting Enzyme Increased Balance Disorder Memory Impairment Psychotic Disorder Mitral Valve Prolapse Somnolence Viral Infection Gastrooesophageal Reflux Disease Upper-Airway Cough Syndrome Abnormal Dreams Bipolar Disorder Aggression Dyspnoea Snoring Acrochordon Blood Glucose Increased Scratch Amnesia Vestibular Disorder Skin Disorder Angina Pectoris Weight Increased Exfoliative Rash Dry Mouth Rhinitis Haemorrhoids Rash Sinus Tachycardia Visual Impairment Affective Disorder Confusional State Total Lung Capacity Decreased Cardiac Murmur
Blood Triglycerides Increased Blood Creatine Phosphokinase Increased Coordination Abnormal Adjustment Disorder With Depressed Mood Tremor 03-Apr-2012 09:37 AM Page: 609
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastrointestinal Disorder Fatigue Hypertension Bronchospasm Blood Cholesterol Increased Low Density Lipoprotein Increased Dehydration Nocturia Chest Discomfort Oral Disorder Vitiligo Clumsiness Major Depression Contusion Schizoaffective Disorder
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:05/13/05ISR Number: 4662475-2Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Idiopathic Thrombocytopenic Purpura
Company Report #CTU 248485 Report Source Product Larium 250 Mg Role PS Manufacturer
Gender:Male Dose 250 MG WEEKLY
I/FU:I Duration
ORAL
Date:05/16/05ISR Number: 4662466-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Agitation Vertigo Disorientation Dizziness Nervousness Paraesthesia Migraine Without Aura Diarrhoea Mood Swings Chest Pain Nystagmus Testicular Pain Sinus Disorder Low Density Lipoprotein Increased Night Sweats Anxiety Disorder Memory Impairment Amnesia Asthenia
Age:35 YR
Gender:Male
I/FU:F
Cluster Headache Weight Increased Vomiting Insomnia Psychotic Disorder Inner Ear Disorder Abdominal Pain Rash 03-Apr-2012 09:37 AM Page: 610
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Of Skin Blood Pressure Increased Balance Disorder Upper Respiratory Tract Infection Nightmare Irritable Bowel Syndrome Disturbance In Attention Eye Pain Phonophobia Blood Cholesterol Increased Pharyngitis Streptococcal Fatigue Headache Photophobia Abnormal Dreams Blood Urea Increased Nausea Vestibular Disorder Vision Blurred Depression Colitis Hypoaesthesia Viral Labyrinthitis Blood Triglycerides Increased Toxicity To Various Agents Tinnitus Epididymitis
Report Source
Product Lariam Imodium Compazine
Role PS C C
Manufacturer Roche
Route ORAL
Dose ON 18 APR 2001, THERAPY REPORTED AS TWICE DAILY. BY TAPER. ON 18 APR 2001, THERAPY REPORTED AS: AS NEEDED.
Duration
C C C C
C C C C C
Date:05/17/05ISR Number: 4663595-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-403695 Outcome Other Serious PT Drug Ineffective Malaria Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:05/18/05ISR Number: 4664622-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-384854 Outcome Other Serious PT Feeling Abnormal Cold Sweat Liver Function Test Abnormal Chills Disorientation Agitation Fatigue
Age:37 YR
Gender:Male
I/FU:F
Skin Disorder Vertigo Heart Rate Increased Hyperhidrosis Anxiety Depression Back Pain Heart Rate Irregular 03-Apr-2012 09:37 AM Page: 611
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Diarrhoea Insomnia Mood Swings Paraesthesia Panic Attack Disturbance In Attention Balance Disorder
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose 3-4 PILLS WERE TAKEN.
Duration 43 DAY
Date:05/19/05ISR Number: 4666042-6Report Type:Expedited (15-DaCompany Report #CH-ROCHE-334363 Outcome Disability PT Dyspnoea Headache Memory Impairment Fatigue Asthenia Tachycardia Apathy Dizziness Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:05/19/05ISR Number: 4666059-1Report Type:Expedited (15-DaCompany Report #NO-ROCHE-404116 Outcome Other Serious PT Fatigue Dyspnoea Atrioventricular Block Complete Dizziness Atrioventricular Block Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:05/19/05ISR Number: 4667441-9Report Type:Direct Outcome Life-Threatening Disability Other Serious PT Mental Disorder Injury Ill-Defined Disorder
Company Report #CTU 249136 Report Source Product Mefloquine Unknown Unknown Mefloquine Stronger Than First Dose Unknown Role PS Manufacturer
Gender:Male Dose 2OR3XDAILY ORAL
I/FU:I Duration
SS
ORAL
STRONGER SAME ORAL
Date:05/27/05ISR Number: 4676616-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-405127
Age:
Gender:Female
I/FU:I
PT Speech Disorder Loss Of Consciousness Blood Pressure Increased Paraesthesia
Report Source
Product Lariam Lariam Verapamil
Role PS SS SS
Manufacturer Roche Roche Roche
Route ORAL ORAL UNKNOWN
Dose Duration STARTED AFTER VERAPAMIL. STARTED BEFORE MEFLOQUINE (LARIAM). Page: 612
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Verapamil Aspirin Simvastatin SS C C Roche UNKNOWN
Date:06/02/05ISR Number: 4682080-1Report Type:Periodic Outcome Other Serious PT Weight Decreased Anxiety Paranoia Fear
I/FU:I Duration
Date:06/02/05ISR Number: 4682082-5Report Type:Periodic Outcome Other Serious PT Grand Mal Convulsion
I/FU:I Duration
Date:06/02/05ISR Number: 4682085-0Report Type:Periodic Outcome Death PT Diarrhoea Paranoia Fatigue Depression Aggression Agitation Delusion Headache Completed Suicide Night Sweats Mood Swings Insomnia
Age: Route ORAL
I/FU:I Duration
Date:06/02/05ISR Number: 4682086-2Report Type:Periodic Outcome Other Serious PT Anger Nightmare Abdominal Pain Upper Dizziness Fear Panic Attack Diarrhoea Physical Assault
Age: Route ORAL
I/FU:I Duration
Nausea
03-Apr-2012
09:37 AM
Page: 613
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/05ISR Number: 4682088-6Report Type:Periodic Outcome Death PT Anger Psychotic Disorder Panic Attack Completed Suicide Diarrhoea Physical Abuse Rash Company Report #380311 Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age: Route ORAL Gender:Male Dose ORAL I/FU:I Duration
Date:06/02/05ISR Number: 4682089-8Report Type:Periodic Outcome Disability PT Amnesia Headache
I/FU:I Duration
Date:06/02/05ISR Number: 4682090-4Report Type:Periodic Outcome Other Serious PT Depression Hallucination Anxiety
Age: Route ORAL
I/FU:I Duration
Date:06/02/05ISR Number: 4682091-6Report Type:Periodic Outcome Other Serious PT Depression Imprisonment Paranoia Anxiety Theft
Date:06/02/05ISR Number: 4682156-9Report Type:Periodic Outcome Death PT Agitation Mood Swings Tinnitus Disorientation Self Esteem Decreased Hostility Fear
Age:49 YR
Gender:Male
I/FU:I
Completed Suicide Wound Fatigue Abnormal Dreams Memory Impairment Speech Disorder Communication Disorder Emotional Distress 03-Apr-2012 09:37 AM Page: 614
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sleep Apnoea Syndrome Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Route ORAL Dose ORAL Duration
Date:06/02/05ISR Number: 4682159-4Report Type:Periodic Outcome Death PT Completed Suicide
Age: Route ORAL
I/FU:I Duration
Date:06/02/05ISR Number: 4682161-2Report Type:Periodic Outcome Other Serious PT Hypersensitivity Urticaria Rash Pruritus
I/FU:I Duration
Date:06/02/05ISR Number: 4682163-6Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Panic Attack
Age: Route ORAL
I/FU:I Duration
Date:06/02/05ISR Number: 4682166-1Report Type:Periodic Outcome Death PT Completed Suicide Physical Assault
Age: Route ORAL
I/FU:I Duration
Age: Route ORAL
I/FU:I Duration
Age: Route ORAL
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 615
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/05ISR Number: 4682196-XReport Type:Periodic Outcome Other Serious PT Urticaria Company Report #378593 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Age:15 YR Route ORAL Gender:Female Dose 1 DOSE FORM 1 PER 1 WEEK ORAL I/FU:I Duration
Date:06/02/05ISR Number: 4684026-9Report Type:Periodic Outcome Death PT Mood Swings Deafness Tinnitus Fatigue Completed Suicide Depression Psychotic Disorder Agitation
Age: Route ORAL
I/FU:I Duration
Date:06/02/05ISR Number: 4684027-0Report Type:Periodic Outcome Other Serious PT Suicidal Ideation Disturbance In Attention Amnesia Anxiety
Age: Route ORAL
I/FU:I Duration
Date:06/02/05ISR Number: 4684029-4Report Type:Periodic Outcome Death PT Nightmare Injury Sleep Disorder Personality Change Completed Suicide Weight Decreased Depression
I/FU:I Duration
Date:06/03/05ISR Number: 4681183-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Nausea Diarrhoea Mood Swings
Age:35 YR
Gender:Male
I/FU:F
Vision Blurred Enteritis Infectious Lymphocyte Count Decreased Blood Triglycerides Increased Streptococcal Infection Mucous Membrane Disorder 03-Apr-2012 09:37 AM Page: 616
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Night Sweats Photophobia Blood Pressure Increased Epididymitis Amnesia Headache Psychotic Disorder Nystagmus Testicular Pain Dizziness Eye Pain Colitis Rash Abnormal Dreams Vertigo Chest Pain Depression Agitation Insomnia Anxiety Disorder Memory Impairment Vestibular Disorder Inner Ear Disorder Nervousness Pain Of Skin Blood Cholesterol Increased Low Density Lipoprotein Increased Vomiting Fatigue Abdominal Pain Disturbance In Attention Phonophobia Blood Urea Increased Viral Labyrinthitis Balance Disorder Posture Abnormal Nightmare Disorientation Hypoaesthesia Monocyte Count Increased Upper Respiratory Tract Infection Tinnitus Irritable Bowel Syndrome Paraesthesia Burning Sensation Neutrophil Count Increased Nuclear Magnetic Resonance Imaging Abnormal
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Duration
C C C C
C C C C C
Activities Of Daily Living Impaired
03-Apr-2012
09:37 AM
Page: 617
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/05ISR Number: 4681185-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Vestibular Disorder Hypertension Sinus Tachycardia Low Density Lipoprotein Increased Dry Mouth Constipation Upper-Airway Cough Syndrome Asthma Haemorrhoids Affective Disorder Productive Cough Cough Electrocardiogram T Wave Abnormal Pharyngeal Disorder Weight Decreased Rectal Haemorrhage Anal Fissure Road Traffic Accident Bronchitis Blood Cholesterol Increased Exfoliative Rash Major Depression Musculoskeletal Discomfort Mental Status Changes Hallucination, Auditory Sinusitis Amnesia Anxiety Dyspnoea Restrictive Pulmonary Disease Sleep Apnoea Syndrome Bronchospasm Insomnia Abnormal Dreams Bipolar Disorder Coordination Abnormal Body Temperature Increased Sputum Discoloured Myalgia Collagen-Vascular Disease Fatigue Total Lung Capacity Decreased Age:42 YR Gender:Male I/FU:F
Arthralgia Blood Creatine Phosphokinase Increased Oral Disorder Gastrooesophageal Reflux Disease Scratch Contusion 03-Apr-2012 09:37 AM Page: 618
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Exercise Tolerance Decreased Sleep Disorder Jaw Disorder Rectal Neoplasm Anhedonia Psychomotor Hyperactivity Cognitive Disorder Post-Traumatic Neck Syndrome Skin Disorder Gastrointestinal Disorder Angina Pectoris Total Cholesterol/Hdl Ratio Decreased Diarrhoea Snoring Acrochordon Angiotensin Converting Enzyme Increased Blood Glucose Increased Memory Impairment Aggression Erythema Mitral Valve Prolapse Diastolic Dysfunction Dry Skin Chest Discomfort Vitiligo Visual Impairment Adjustment Disorder With Depressed Mood Oedema Ventricular Hypertrophy Rash Weight Increased Cardiac Murmur Blood Triglycerides Increased Rhinitis Balance Disorder Schizoaffective Disorder Upper Respiratory Tract Infection Colitis Feelings Of Worthlessness Confusional State Depression Headache Somnolence Viral Infection Dehydration Dry Eye
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Nocturia Clumsiness Psychotic Disorder Tremor Wheezing Blood Pressure Diastolic Increased 03-Apr-2012 09:37 AM Page: 619
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/05ISR Number: 4681187-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Visual Field Defect Suicidal Ideation Cough Muscle Twitching Mood Swings Confusional State Hyperacusis Mental Disorder Eye Movement Disorder Dizziness Cranial Nerve Disorder Anger General Symptom Endolymphatic Hydrops Thirst Gilbert'S Syndrome Conduction Disorder Tearfulness Sensory Disturbance Creutzfeldt-Jakob Disease Anxiety Disorder Energy Increased Paranoia Insomnia Depression Vestibular Disorder Photosensitivity Reaction Depressed Level Of Consciousness Migraine Gait Disturbance Dysphemia Nervous System Disorder Antisocial Behaviour Narcissistic Personality Disorder Hepatic Failure Panic Attack Nausea Disturbance In Attention Tardive Dyskinesia Respiratory Disorder Blood Bilirubin Increased Hepato-Lenticular Degeneration Abnormal Behaviour Photophobia Vomiting Aggression Tinnitus Age:44 YR Gender:Male I/FU:F
Mania Water Pollution Binocular Eye Movement Disorder Rapid Eye Movements Sleep Abnormal Electrocardiogram St-T Change 03-Apr-2012 09:37 AM Page: 620
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination Balance Disorder Toxicity To Various Agents Asthenia Obsessive Thoughts Jaundice Post-Traumatic Stress Disorder Amyotrophic Lateral Sclerosis Electroencephalogram Abnormal Hyporeflexia Electrocardiogram Abnormal Tic Incontinence Amnesia Anxiety Irritability Lacrimation Increased Motor Dysfunction Abnormal Dreams Tooth Discolouration Affective Disorder Metal Poisoning Visual Impairment Tremor Diarrhoea Decreased Appetite Jaw Disorder Cognitive Disorder Dysarthria Weight Decreased Gastroenteritis
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:06/08/05ISR Number: 4687515-6Report Type:Direct Outcome Other Serious PT Affect Lability Aggression
Gender:Male
I/FU:I
Dose Duration ONE TABLET WEEK ORAL
Date:06/17/05ISR Number: 4692525-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-407146 Outcome Hospitalization Initial or Prolonged PT Vertigo Fall Glycosylated Haemoglobin Report Source Product Lariam Xalacom Fenofibrate Role PS SS SS Manufacturer Roche
Age:64 YR Route ORAL TOPICAL ORAL
Gender:Female Dose
Increased Vision Blurred Atrioventricular Block Bradycardia
Captopril
SS
Roche
ORAL
03-Apr-2012
09:37 AM
Page: 621
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/05ISR Number: 4693517-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Outcome Disability PT Abdominal Pain Dyspnoea Headache Acrophobia Sensory Integrative Dysfunction Neck Pain Vertigo Insomnia Panic Attack Generalised Anxiety Disorder Sleep Disorder Dizziness Motion Sickness Vestibular Disorder Photophobia Weight Decreased Adjustment Disorder With Anxiety Sinus Bradycardia Migraine Fatigue Lactose Intolerance Abdominal Distension Hypoaesthesia Emotional Distress Diarrhoea Disorientation Self Esteem Decreased Disturbance In Attention Phobia Claustrophobia Back Pain Nasal Congestion Abdominal Pain Lower Bronchospasm Anxiety Heart Rate Increased Nausea Rash Adjustment Disorder With Depressed Mood Heart Rate Irregular Irritable Bowel Syndrome Phobia Of Flying Musculoskeletal Stiffness Amnesia Sleep Disorder Due To General Medical Age:34 YR Gender:Male I/FU:F
Condition, Hypersomnia Type Mood Disorder Due To A General Medical Condition Suicidal Ideation Depression Paraesthesia Hypersensitivity 03-Apr-2012 09:37 AM Page: 622
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tinnitus Balance Disorder Throat Irritation
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Vaccine
OTHER
Date:06/17/05ISR Number: 4693518-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Incontinence Diarrhoea Post-Traumatic Stress Disorder Endolymphatic Hydrops Thirst Dysarthria Hyperacusis Hepatic Failure Paranoia Amnesia Muscle Twitching Lacrimation Increased Gait Disturbance Visual Impairment Tremor Obsessive Thoughts Motor Dysfunction Photophobia Insomnia Vomiting Vestibular Disorder Photosensitivity Reaction Suicidal Ideation Depressed Level Of Consciousness Confusional State Nausea Anxiety Tardive Dyskinesia Abnormal Dreams Conduction Disorder Hallucination Panic Attack Aggression Cough Cognitive Disorder Cranial Nerve Disorder
Age:44 YR
Gender:Male
I/FU:F
Visual Field Defect Balance Disorder Anger Disturbance In Attention Asthenia General Symptom Tinnitus Jaundice 03-Apr-2012 09:37 AM Page: 623
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysphemia Gilbert'S Syndrome Depression Toxicity To Various Agents Irritability Mood Swings Migraine Decreased Appetite Jaw Disorder Mania
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:06/17/05ISR Number: 4693539-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-389470 Outcome Hospitalization Initial or Prolonged PT Personality Disorder Psychomotor Retardation Adjustment Disorder Tinnitus Bipolar I Disorder Psychotic Disorder Hearing Impaired Hallucination, Auditory Depression Suicidal Ideation Major Depression Insomnia Anxiety Headache Decreased Appetite Suicide Attempt Autonomic Nervous System Imbalance Agitation Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:06/20/05ISR Number: 4694445-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Abnormal Behaviour Vertigo Bronchospasm Productive Cough Chest Discomfort Headache Hyperhidrosis Cognitive Disorder Attention Deficit/Hyperactivity Disorder
Age:45 YR
Gender:Male
I/FU:F
Respiratory Rate Increased Convulsion Nocturia Myalgia Eosinophilia Arthralgia Disturbance In Attention 03-Apr-2012 09:37 AM Page: 624
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Visual Major Depression Generalised Anxiety Disorder Fall Decreased Activity Dehydration Musculoskeletal Stiffness Tinnitus Agitation Mood Swings Depression Fatigue Joint Dislocation Psychiatric Symptom Hypoaesthesia Ventricular Extrasystoles Bacterial Infection Dizziness Visual Impairment Asthenia Respiratory Disorder Meniscus Lesion Asthma Oxygen Saturation Decreased Coronary Artery Disease Homicidal Ideation Hiatus Hernia Panic Attack Haemophilus Infection Palpitations Anxiety Balance Disorder Suicidal Ideation Selective Iga Immunodeficiency Cranial Nerve Disorder Dysthymic Disorder Bundle Branch Block Right Eye Movement Disorder Contusion Rhinitis Allergic Insomnia Memory Impairment Panic Disorder Hypertension Psychotic Disorder Self-Injurious Ideation Musculoskeletal Pain Mitral Valve Calcification Humerus Fracture
Gait Disturbance Ulna Fracture Aggression Dyspnoea Sleep Apnoea Syndrome Tremor Mitral Valve Incompetence Exostosis 03-Apr-2012 09:37 AM Page: 625
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Nystagmus Ligament Sprain Pyrexia Rash Papular Weight Increased Deafness Coordination Abnormal Upper Respiratory Tract Infection Blood Pressure Increased Chest Pain Post-Traumatic Stress Disorder Thinking Abnormal Toxicity To Various Agents Antinuclear Antibody Positive Rheumatoid Factor Increased Ill-Defined Disorder Amnesia Snoring Nightmare
Report Source
Product Lariam Primaquine Cipro
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:06/23/05ISR Number: 4698813-4Report Type:Expedited (15-DaCompany Report #05-06-1067 Outcome Hospitalization Initial or Prolonged PT Speech Disorder Blood Pressure Increased Paraesthesia Report Source Foreign Other Product Verapamil Hcl Er -Ipi Lariam Aspirin Simvastatin Role PS SS C C Manufacturer Ipi ORAL
Age: Route
I/FU:I Duration
Date:06/24/05ISR Number: 4699090-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-405127 Outcome Hospitalization Initial or Prolonged PT Paraesthesia Speech Disorder Loss Of Consciousness Blood Pressure Increased Report Source Product Lariam Lariam Verapamil Role PS SS SS Manufacturer Roche Roche Roche
Age: Route ORAL ORAL UNKNOWN
Gender:Female
I/FU:F
Dose Duration STARTED AFTER VERAPAMIL. STARTED BEFORE MEFLOQUINE (LARIAM).
Verapamil Aspirin Simvastatin
SS C C
Roche
UNKNOWN
Date:06/27/05ISR Number: 4700390-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Sleep Apnoea Syndrome Dehydration Rhinitis 09:37 AM
Age:42 YR
Gender:Male
I/FU:F
03-Apr-2012
Page: 626
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clumsiness Upper Respiratory Tract Infection Listless Dyspnoea Exertional Adjustment Disorder Anxiety Dyspnoea Vestibular Disorder Somnolence Nocturia Blood Glucose Increased Memory Impairment Psychotic Disorder Gastrointestinal Disorder Ventricular Hypertrophy Arthralgia Weight Increased Blood Triglycerides Increased Total Cholesterol/Hdl Ratio Decreased Upper-Airway Cough Syndrome Aggression Psychomotor Hyperactivity Confusional State Diastolic Dysfunction Viral Infection Insomnia Visual Impairment Adjustment Disorder With Depressed Mood Contusion Schizoaffective Disorder Condition Aggravated Rectal Haemorrhage Skin Disorder Fatigue Total Lung Capacity Decreased Blood Cholesterol Increased Dry Skin Snoring Acrochordon Abnormal Dreams Affective Disorder Tremor Multiple Allergies Depression Headache Bronchospasm
Diarrhoea Exfoliative Rash Bipolar Disorder Scratch Neck Pain Drug Intolerance Amnesia Mitral Valve Prolapse 03-Apr-2012 09:37 AM Page: 627
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Murmur Sinus Tachycardia Low Density Lipoprotein Increased Dry Mouth Chest Discomfort Angiotensin Converting Enzyme Increased Balance Disorder Nausea Hypertension Angina Pectoris Restrictive Pulmonary Disease Rash Bronchitis Blood Creatine Phosphokinase Increased Dry Eye Constipation Oral Disorder Vitiligo Gastrooesophageal Reflux Disease Asthma Haemorrhoids Coordination Abnormal Major Depression
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:06/28/05ISR Number: 4701483-XReport Type:Expedited (15-DaCompany Report #SE-ROCHE-407993 Outcome Other Serious PT Convulsion Visual Impairment Amnesia Report Source Product Lariam Lexinor Role PS C Manufacturer Roche
Gender:Male Dose
Date:06/28/05ISR Number: 4702207-2Report Type:Direct Outcome Other Serious PT Anxiety Memory Impairment Headache Dizziness
Age:27 YR Route
Gender:Female Dose
I/FU:I Duration
Date:06/29/05ISR Number: 4702966-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-408409 Outcome PT Report Source Product Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
Asthenia Hyponatraemia Feeling Drunk Psychotic Disorder Fatigue
Lariam
PS
Roche
ORAL
THE PATIENT TOOK JUST ONE DOSE OF THREE TABLETS AT ONCE.
03-Apr-2012
09:37 AM
Page: 628
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/05ISR Number: 4706612-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Photophobia Vestibular Disorder Suicidal Ideation Confusional State Motor Dysfunction Abnormal Dreams Gastroenteritis Impulsive Behaviour Hallucination Tinnitus Irritability Thirst Hyperacusis Paranoia Tremor Nausea Vomiting Anger Muscle Twitching Amnesia Photosensitivity Reaction Toxicity To Various Agents Cranial Nerve Disorder Balance Disorder Panic Attack Mood Swings Migraine Dysarthria Hepatic Failure Aggression Anxiety Asthenia Gait Disturbance Tooth Discolouration Ear Infection Visual Impairment Diarrhoea Depression General Symptom Cough Obsessive Thoughts Depressed Level Of Consciousness Jaw Disorder Tardive Dyskinesia Lacrimation Increased Dysphemia Mania Conduction Disorder Age:44 YR Gender:Male I/FU:F
Visual Field Defect Insomnia Incontinence Disturbance In Attention Jaundice Post-Traumatic Stress Disorder Endolymphatic Hydrops 03-Apr-2012 09:37 AM Page: 629
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Appetite Cognitive Disorder Gilbert'S Syndrome Electrocardiogram St-T Change Attention Deficit/Hyperactivity Disorder Daydreaming
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:07/08/05ISR Number: 4711571-XReport Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Grand Mal Convulsion
Age: Route
Gender:Male
I/FU:I
Dose Duration 250 MG Q WEEK
Date:07/12/05ISR Number: 4712969-6Report Type:Direct Outcome Other Serious PT Petechiae Haematochezia Platelet Count Decreased
Company Report #CTU 253019 Report Source Product Mefloquine Tab Bactrim Role 250 Mg PS C ORAL Manufacturer
Age:7 MON Route
Gender: Dose 1/8 TAB WEEK ORAL
I/FU:I Duration
Date:07/13/05ISR Number: 4713176-3Report Type:Direct Outcome Other Serious PT Anxiety Depression
Company Report #CTU 253105 Report Source Product Mefloquine Tri-Sprintec Luvox Role PS C C Manufacturer
Age: Route
Gender:Female Dose 250 MG Q WEEKLY
I/FU:I Duration
Date:07/13/05ISR Number: 4713437-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-402425 Outcome Other Serious PT Liver Function Test Abnormal Hepatocellular Injury Alcohol Use Report Source Product Lariam Alcohol Role PS SS Manufacturer Roche
Age: Route ORAL UNKNOWN
Gender:Male Dose
I/FU:F Duration 3 YR
Date:07/14/05ISR Number: 4714346-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Outcome Hospitalization Initial or Prolonged Disability PT Initial Insomnia Disturbance In Attention Amoebiasis Coordination Abnormal Hypersomnia
Age:
Gender:Male
I/FU:F
03-Apr-2012
09:37 AM
Page: 630
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erectile Dysfunction Social Avoidant Behaviour Judgement Impaired Bradycardia Self Esteem Decreased Generalised Anxiety Disorder Mood Swings Suicidal Ideation Fatigue Crying Somatisation Disorder Varicocele Hypotension Mitral Valve Prolapse Libido Decreased Amnesia Inadequate Diet Psychomotor Retardation Scrotal Varicose Veins Memory Impairment Mental Disorder Palpitations Restlessness Aphasia Dysarthria Blood Pressure Increased Viral Infection Major Depression Psychotic Disorder Terminal Insomnia Adjustment Disorder Panic Attack Self Injurious Behaviour Anhedonia Feeling Jittery Flat Affect
Report Source
Product Lariam Diazepam Lorazepam Seroquel Gabapentin Effexor Xr
Role PS C C C C C
Manufacturer Roche
Route UNKNOWN
Dose
Duration
Date:07/14/05ISR Number: 4714347-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Hepatic Failure Cranial Nerve Disorder Visual Impairment Tremor Photosensitivity Reaction Asthenia Endolymphatic Hydrops Tardive Dyskinesia Motor Dysfunction Hyperacusis
Age:44 YR
Gender:Male
I/FU:F
Hallucination Insomnia Vomiting Anxiety Cough Confusional State Panic Attack Depression 03-Apr-2012 09:37 AM Page: 631
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Post-Traumatic Stress Disorder Dysphemia Gilbert'S Syndrome Balance Disorder Aggression Amnesia Vestibular Disorder Jaw Disorder Gait Disturbance Paranoia Nausea Anger Muscle Twitching Mood Swings Migraine Lacrimation Increased Irritability Depressed Level Of Consciousness Thirst Photophobia Disturbance In Attention Toxicity To Various Agents Suicidal Ideation General Symptom Obsessive Thoughts Cognitive Disorder Dysarthria Conduction Disorder Visual Field Defect Incontinence Diarrhoea Tinnitus Jaundice Decreased Appetite Mania Abnormal Dreams Bipolar Disorder
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:07/15/05ISR Number: 4715449-7Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Suicidal Ideation Screaming Depression Aggression Abnormal Behaviour
Age: Route ORAL
I/FU:I Duration
Date:07/18/05ISR Number: 4718297-7Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability 03-Apr-2012 09:37 AM
Age:28 YR
Gender:Male
I/FU:I
Page: 632
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Serious Required Intervention to Prevent Permanent Impairment/Damage
PT Depression Sensory Loss Anxiety Brain Injury Muscle Twitching Monoplegia Tremor
Report Source
Product Larium
La Roche
Role PS
Manufacturer La Roche
Route ORAL
Dose 1 WEEKLY
Duration ORAL
Date:07/18/05ISR Number: 4718303-XReport Type:Direct Outcome Disability PT Tinnitus Influenza Like Illness Fatigue Diarrhoea Abdominal Pain Upper Emotional Disorder Reading Disorder Pain Anxiety Weight Decreased Abdominal Distension Pyrexia Flatulence Disturbance In Attention Amnesia Myoclonus Dyspepsia Malaise Visual Impairment Dizziness Feeling Abnormal Educational Problem Stress Depression Cognitive Disorder
Company Report #CTU 253466 Report Source Product Mefloquine Generic Gingko Biloba Lexapro Role Unknown PS C C ORAL Manufacturer
Age:37 YR Route
Gender:Female Dose 1 PER WEEK 9 WEEKS ORAL
I/FU:I Duration
Date:07/21/05ISR Number: 4723398-3Report Type:Direct Outcome Disability Other Serious PT Drug Dependence Eye Pain Mood Swings Headache
Company Report #CTU 253857 Report Source Product Lariam Weekly Sr Roche Verapamil Role PS C Manufacturer Roche
Gender:Male Dose 1 WEEKLY ORAL
I/FU:I Duration
Date:07/22/05ISR Number: 4722019-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Insomnia Fatigue Tinnitus Psychotic Disorder 09:37 AM
Age:35 YR
Gender:Male
I/FU:F
03-Apr-2012
Page: 633
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Testicular Pain Irritable Bowel Syndrome Eye Pain Mood Swings Anxiety Disorder Abdominal Pain Photophobia Nightmare Nystagmus Inner Ear Disorder Pain Of Skin Vomiting Rash Nervousness Phonophobia Night Sweats Agitation Nausea Vertigo Headache Hypoaesthesia Blood Pressure Increased Memory Impairment Vestibular Disorder Chest Pain Colitis Disorientation Dizziness Diarrhoea Amnesia Vision Blurred Depression Disturbance In Attention
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Duration
C C C C
C C C C C
Date:07/28/05ISR Number: 4727555-1Report Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Anxiety Lethargy Hallucination Depression Paranoia Nightmare
Company Report #CTU 254655 Report Source Product Lariam Unsure Roche Birth Control Pills Role PS C Manufacturer Roche
Gender:Female Dose DAILY ORAL
I/FU:I Duration
Date:08/02/05ISR Number: 4731828-6Report Type:Direct Outcome Other Serious PT Nausea Motion Sickness
I/FU:I Duration
Dizziness Mood Altered Circadian Rhythm Sleep Disorder Abnormal Dreams Anger Insomnia Depression 03-Apr-2012 09:37 AM Page: 634
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/05ISR Number: 4734187-8Report Type:Direct Outcome Congenital Anomaly Other Serious PT Congenital Anomaly Pregnancy Anencephaly Hallucination Maternal Drugs Affecting Foetus Company Report #CTU 255326 Report Source Product Mefloquine 250mg Qweek Mefloquine 1250mg Stat Dose Role PS SS Manufacturer Age:27 YR Route Gender:Female Dose 250MG Q WEEK X 100 WKS 1250 MG STAT X 1 DOSE I/FU:I Duration
Date:08/04/05ISR Number: 4734436-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-397065 Outcome Hospitalization Initial or Prolonged Disability PT Psychotic Disorder Panic Disorder Paraesthesia Anxiety Disorder Ear Pain Decreased Appetite Tinnitus Chills Headache Mood Swings Depression Diarrhoea Skin Disorder Paranoia Dizziness Hearing Impaired Panic Attack Abdominal Pain Hyperhidrosis Fatigue Toxicity To Various Agents Confusional State Memory Impairment Arthralgia Insomnia Visual Impairment Chest Pain Agitation Myalgia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose FREQUENCY STATED AS WEEKLY.
Date:08/17/05ISR Number: 4746842-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Insomnia Disorientation
Age:35 YR
Gender:Male
I/FU:F
Vestibular Disorder Nystagmus Dizziness Pain Of Skin Agitation Fatigue Amnesia Eye Pain 03-Apr-2012 09:37 AM Page: 635
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rash Headache Chest Pain Irritable Bowel Syndrome Nightmare Tinnitus Disturbance In Attention Hypoaesthesia Memory Impairment Vertigo Psychotic Disorder Inner Ear Disorder Abdominal Pain Enteritis Infectious Night Sweats Nausea Diarrhoea Vision Blurred Nervousness Vomiting Mood Swings Testicular Pain Depression Colitis Phonophobia Blood Pressure Increased Anxiety Disorder Photophobia
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Duration
C C C C
C C C C C
Date:08/22/05ISR Number: 4749682-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-414147 Outcome Disability PT Nausea Disturbance In Attention Vision Blurred Dizziness Paraesthesia Disorientation Report Source Product Lariam Nitrofurantoin Role PS C Manufacturer Roche
Gender:Female Dose
Date:08/23/05ISR Number: 4750604-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-408409 Outcome Hospitalization Initial or Prolonged PT Hyponatraemia Asthenia Psychotic Disorder Fatigue Blood Creatine Phosphokinase Increased Feeling Drunk Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male
I/FU:F
Dose Duration THE PATIENT TOOK JUST ONE DOSE OF THREE TABLETS AT ONCE.
Date:08/26/05ISR Number: 4754048-8Report Type:Expedited (15-DaCompany Report #2005-BP-13941RO Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Nausea Electrocardiogram Qt
Age:20 YR
Gender:Male
I/FU:I
Page: 636
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Paraesthesia Headache Dizziness Depressed Level Of Consciousness Hypotension
Report Source Literature Health Professional
Product Mefloquine (Mefloquine)
Role PS
Manufacturer
Route ORAL
Dose 240 MG ONCE WEEKLY (250 MG, 1 IN 1 WK), PO
Duration
Date:08/29/05ISR Number: 4754920-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Nausea Memory Impairment Nystagmus Irritable Bowel Syndrome Rash Vomiting Headache Abdominal Pain Night Sweats Disorientation Vestibular Disorder Disturbance In Attention Eye Pain Colitis Blood Pressure Increased Mood Swings Insomnia Nightmare Agitation Anxiety Disorder Depression Amnesia Tinnitus Inner Ear Disorder Testicular Pain Hypoaesthesia Nervousness Phonophobia Diarrhoea Fatigue Chest Pain Vision Blurred Photophobia Pain Of Skin Vertigo Psychotic Disorder Dizziness Report Source Product Lariam Imodium Compazine Role PS C C Manufacturer Roche
Gender:Male Dose ON 18 APR 2001, THERAPY REPORTED AS TWICE DAILY. BY TAPER. ON 18 APR 2001, THERAPY REPORTED AS: AS NEEDED.
I/FU:F Duration
C C C C
C C C C C
Date:08/29/05ISR Number: 4754954-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Outcome Hospitalization Initial or Prolonged PT Amnesia Stress Grand Mal Convulsion Fatigue
Age:42 YR
Gender:Male
I/FU:F
03-Apr-2012
09:37 AM
Page: 637
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Disturbance In Attention Palpitations
Report Source
Product Lariam Lexinor Malarone
Role PS C C
Manufacturer Roche
Route ORAL ORAL ORAL
Dose
Duration
Date:08/30/05ISR Number: 4756595-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-415094 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Fall Foaming At Mouth Coma Postictal State Loss Of Consciousness Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration THE PATIENT DID NOT TAKE ANY OTHER DRUGS. 1 DAY
Date:08/31/05ISR Number: 4759812-7Report Type:Direct Outcome Disability Other Serious PT Legal Problem Abnormal Behaviour Stress Treatment Noncompliance Mania Nervousness Economic Problem Insomnia Heart Rate Increased Bipolar Disorder Loss Of Employment Educational Problem Depression
Company Report #CTU 257313 Report Source Product Lariam 250 Mg Hoffman Laroche Role PS Manufacturer Hoffman Laroche
Gender:Female Dose 250 MG 1/WEEK BUCCAL
Date:09/02/05ISR Number: 4763450-XReport Type:Expedited (15-DaCompany Report #2005-BP-14576RO Outcome Other Serious PT Insulinoma Hypoglycaemia Insulin C-Peptide Increased Neuroglycopenia Blood Insulin Increased Report Source Literature Health Professional Product Mefloquine (Mefloquine) Role PS Manufacturer
Age:31 YR Route
Gender:Male Dose ONCE/WEEK
I/FU:I Duration
Age:
Gender:Female
I/FU:I
Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM
PT Anxiety Feeling Abnormal Abnormal Behaviour Homicidal Ideation Creutzfeldt-Jakob Disease Hallucination, Visual Self Injurious Behaviour
Report Source
Product Mefloquine 250 Mg Sandoz
Role PS
Manufacturer Sandoz
Route ORAL
Dose 1 TABLET -250 MG ONCE A WEEK PO
Duration
Page: 638
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/05ISR Number: 4763724-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-415971 Outcome Death PT Amyotrophy Respiratory Failure Amyotrophic Lateral Sclerosis Upper Motor Neurone Lesion Report Source Product Lariam Engerix B Role PS SS Manufacturer Roche Age:61 YR Route ORAL INTRAMUSCULAR Gender:Male Dose THE PATIENT RECEIVED THREE INJECTIONS IN 1995 (MARCH, I/FU:I Duration
189
DAY
Date:09/09/05ISR Number: 4764962-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-415763 Outcome Life-Threatening PT Panic Reaction Disturbance In Attention Psychotic Disorder Depression Report Source Product Lariam Dpt Hepatitis Vaccination Role PS C C Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:09/14/05ISR Number: 4768435-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Gastrointestinal Disorder Arthralgia Blood Triglycerides Increased Diarrhoea Dry Mouth Nocturia Gastrooesophageal Reflux Disease Visual Impairment Abnormal Dreams Major Depression Scratch Anxiety Hypertension Diastolic Dysfunction Angina Pectoris Somnolence Viral Infection Cardiac Murmur Haemorrhoids Memory Impairment Vestibular Disorder Depression Headache Sleep Apnoea Syndrome Bronchospasm Ventricular Hypertrophy
Age:42 YR
Gender:Male
I/FU:F
Exfoliative Rash Dry Skin Contusion Schizoaffective Disorder Tremor Mitral Valve Prolapse Fatigue Restrictive Pulmonary 03-Apr-2012 09:37 AM Page: 639
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disease Snoring Constipation Oral Disorder Bipolar Disorder Skin Disorder Sinus Tachycardia Low Density Lipoprotein Increased Vitiligo Rhinitis Balance Disorder Coordination Abnormal Affective Disorder Amnesia Confusional State Blood Cholesterol Increased Dehydration Angiotensin Converting Enzyme Increased Insomnia Clumsiness Adjustment Disorder With Depressed Mood Psychotic Disorder Aggression Dyspnoea Total Lung Capacity Decreased Rash Bronchitis Weight Increased Total Cholesterol/Hdl Ratio Decreased Blood Creatine Phosphokinase Increased Dry Eye Chest Discomfort Acrochordon Blood Glucose Increased Upper-Airway Cough Syndrome Asthma
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose
Duration
Date:09/14/05ISR Number: 4770717-8Report Type:Direct Outcome Death PT Nightmare Completed Suicide Depression
Age:26 YR Route
Gender:Male Dose ONCE A WEEK
I/FU:I Duration
Date:09/15/05ISR Number: 4770906-2Report Type:Expedited (15-DaCompany Report #SE-ROCHE-407993 Outcome Other Serious PT Visual Impairment Convulsion Disturbance In Attention 09:37 AM
Age:42 YR
Gender:Male
I/FU:F
03-Apr-2012
Page: 640
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amnesia Report Source Product Lariam Lexinor Role PS C Manufacturer Roche Route ORAL Dose Duration 9 DAY
Date:09/22/05ISR Number: 4778888-4Report Type:Expedited (15-DaCompany Report #343474 Outcome Disability PT Vestibular Disorder Bipolar Disorder Major Depression Schizoaffective Disorder Arthralgia Blood Triglycerides Increased Diarrhoea Acrochordon Peripheral Sensory Neuropathy Exercise Tolerance Decreased Hypersensitivity Upper Respiratory Tract Infection Somnolence Contusion Viral Infection Bronchospasm Blood Creatine Phosphokinase Increased Exfoliative Rash Productive Cough Cough Blood Pressure Systolic Increased Allergy To Animal Neck Pain Drug Tolerance Decreased Dyspnoea Exertional Dyspnoea Fatigue Diastolic Dysfunction Affective Disorder Blood Cholesterol Increased Snoring Vitiligo Rhinitis Sleep Apnoea Syndrome Spirometry Abnormal
Age:42 YR
Gender:Male
I/FU:F
Adjustment Disorder Scratch Bronchitis Weight Increased Dry Mouth Insomnia Pyrexia Listless 03-Apr-2012 09:37 AM Page: 641
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram T Wave Abnormal Amnesia Depression Ventricular Hypertrophy Abnormal Dreams Sinus Tachycardia Dry Skin Nocturia Sputum Discoloured Total Cholesterol/Hdl Ratio Increased Restlessness Confusional State Skin Disorder Gastrointestinal Disorder Headache Clumsiness Asthma Coordination Abnormal Depressive Symptom Low Density Lipoprotein Increased Dry Eye Blood Glucose Increased Upper-Airway Cough Syndrome Haemorrhoids Aggression Wheezing Allergy Test Positive Mitral Valve Prolapse Hypertension Angina Pectoris Visual Impairment Balance Disorder Psychotic Disorder Rash Dehydration Chest Discomfort Myalgia Chest X-Ray Abnormal Mycotic Allergy Anxiety Lung Disorder Memory Impairment Cardiac Murmur Constipation Angiotensin Converting Enzyme Increased Gastrooesophageal Reflux Disease Tremor
Product Lariam (Mefloquine Hydrochloride) 250 Mg Zoloft (Sertraline Hydrochloride)
Role PS C
Manufacturer
Route ORAL
Duration
Nervous System Disorder
03-Apr-2012
09:37 AM
Page: 642
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/05ISR Number: 4778694-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-384854 Outcome Other Serious PT Paraesthesia Panic Attack Balance Disorder Paranoia Insomnia Disorientation Feeling Abnormal Fatigue Liver Function Test Abnormal Heart Rate Increased Hyperhidrosis Depression Disturbance In Attention Cold Sweat Vertigo Alcohol Use Mood Swings Alanine Aminotransferase Increased Heart Rate Irregular Diarrhoea Chills Anxiety Skin Disorder Back Pain Agitation Report Source Product Lariam Role PS Manufacturer Roche Age:37 YR Route ORAL Gender:Male Dose 3-4 PILLS WERE TAKEN. I/FU:F Duration 43 DAY
Date:09/26/05ISR Number: 4778714-3Report Type:Expedited (15-DaCompany Report #SE-ROCHE-407993 Outcome Other Serious PT Convulsion Cerebral Disorder Visual Impairment Disturbance In Attention Amnesia Fatigue Report Source Product Lariam Lexinor Role PS C Manufacturer Roche
Gender:Male Dose
Date:09/30/05ISR Number: 4784739-4Report Type:Expedited (15-DaCompany Report #IT-ROCHE-418516 Outcome Life-Threatening PT Anxiety Panic Attack Dyspnoea Crying Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:09/30/05ISR Number: 4784747-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-418484 Outcome Other Serious PT Lung Disorder Hypoxia 09:37 AM Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
03-Apr-2012
Page: 643
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/05ISR Number: 4795220-0Report Type:Direct Outcome Life-Threatening Congenital Anomaly Required Intervention to Prevent Permanent Impairment/Damage PT Nightmare Paranoia Anxiety Suicide Attempt Company Report #CTU 259799 Report Source Product Lariam Role PS Manufacturer Age:23 YR Route Gender:Female Dose 1 PILL /WK I/FU:I Duration
Date:10/07/05ISR Number: 4791872-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Outcome Hospitalization Initial or Prolonged Disability PT Generalised Anxiety Disorder Panic Attack Suicidal Ideation Mood Swings Memory Impairment Mental Disorder Amnesia Self-Medication Self Esteem Decreased Major Depression Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:F Duration
Date:10/11/05ISR Number: 4794427-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-419662 Outcome Death PT Cardiac Arrest Convulsion Haemolytic Uraemic Syndrome Vomiting Report Source Product Lariam Immunizations Role PS C Manufacturer Roche
Age:4 MON Route ORAL SUBCUTANEOUS
Gender:Male
I/FU:I
Dose Duration FREQUENCY: WEEKLY. FIRST AND SECOND SERIES OF CHILDHOOD IMMUNIZATIONS NOS.
Date:10/11/05ISR Number: 4794488-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Vertigo Visual Impairment Panic Disorder Major Depression Generalised Anxiety Disorder Meniscus Lesion Tremor
Age:45 YR
Gender:Male
I/FU:F
Cognitive Disorder Dysthymic Disorder Exostosis Nocturia Agitation Balance Disorder Ill-Defined Disorder Fall 03-Apr-2012 09:37 AM Page: 644
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Attention Deficit/Hyperactivity Disorder Insomnia Memory Impairment Fatigue Dyspnoea Cranial Nerve Disorder Toxicity To Various Agents Bundle Branch Block Right Respiratory Rate Increased Contusion Antinuclear Antibody Positive Eosinophilia Aggression Mitral Valve Incompetence Eye Movement Disorder Ligament Sprain Pyrexia Suicidal Ideation Asthenia Chest Pain Hypertension Psychiatric Symptom Musculoskeletal Pain Decreased Activity Humerus Fracture Weight Decreased Rhinitis Allergic Ventricular Extrasystoles Abnormal Behaviour Mood Swings Depression Hallucination, Visual Headache Sleep Apnoea Syndrome Self-Injurious Ideation Dehydration Myalgia Disturbance In Attention Selective Iga Immunodeficiency Bronchospasm Chest Discomfort Joint Dislocation Post-Traumatic Stress Disorder Hyperhidrosis Homicidal Ideation Oxygen Saturation
Decreased Convulsion Rheumatoid Factor Increased Anxiety Productive Cough Psychotic Disorder Asthma 03-Apr-2012 09:37 AM Page: 645
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Mitral Valve Calcification Hypoaesthesia Nystagmus Rash Papular
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:10/11/05ISR Number: 4794512-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Visual Impairment Dyspnoea Generalised Anxiety Disorder Decreased Activity Respiratory Rate Increased Rhinitis Allergic Mood Swings Bronchospasm Chest Discomfort Chest Pain Self-Injurious Ideation Cognitive Disorder Humerus Fracture Hypoaesthesia Vertigo Hypertension Fall Thinking Abnormal Bundle Branch Block Right Oxygen Saturation Decreased Rash Papular Ventricular Extrasystoles Asthenia Cranial Nerve Disorder Tremor Homicidal Ideation Toxicity To Various Agents Nocturia Eosinophilia Anxiety Suicidal Ideation Selective Iga Immunodeficiency Major Depression Mitral Valve Calcification Antinuclear Antibody
Age:45 YR
Gender:Male
I/FU:F
Positive Pyrexia Insomnia Memory Impairment Balance Disorder Fatigue Ill-Defined Disorder Sleep Apnoea Syndrome 03-Apr-2012 09:37 AM Page: 646
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Post-Traumatic Stress Disorder Musculoskeletal Pain Dysthymic Disorder Dehydration Weight Decreased Nystagmus Eye Movement Disorder Rheumatoid Factor Increased Abnormal Behaviour Aggression Agitation Disturbance In Attention Productive Cough Headache Panic Disorder Joint Dislocation Psychiatric Symptom Hyperhidrosis Mitral Valve Incompetence Exostosis Attention Deficit/Hyperactivity Disorder Convulsion Contusion Myalgia Depression Hallucination, Visual Meniscus Lesion Asthma Ligament Sprain
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:10/13/05ISR Number: 4797132-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Hepatic Failure Cranial Nerve Disorder Tremor Insomnia Disturbance In Attention Tinnitus Migraine Dysarthria Dysphemia Syncope Self-Injurious Ideation Visual Impairment Photophobia
Age:44 YR
Gender:Male
I/FU:F
Visual Field Defect Aggression Amnesia Photosensitivity Reaction Post-Traumatic Stress Disorder Cognitive Disorder Gilbert'S Syndrome 03-Apr-2012 09:37 AM Page: 647
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Dreams Dizziness Sleep Disorder Psychomotor Hyperactivity Panic Attack Nausea Vestibular Disorder Toxicity To Various Agents Muscle Twitching Mood Swings Thirst Neck Pain Homicidal Ideation Abnormal Behaviour Attention Deficit/Hyperactivity Disorder Vomiting Depression Suicidal Ideation Asthenia Cough Confusional State Mania Fatigue Dehydration Obsessive Thoughts Depressed Level Of Consciousness Endolymphatic Hydrops Jaw Disorder Tardive Dyskinesia Gait Disturbance Road Traffic Accident Stress Atrial Fibrillation Anger General Symptom Bipolar Disorder Hypoaesthesia Memory Impairment Alcohol Poisoning Hallucination Balance Disorder Incontinence Anxiety Jaundice Conduction Disorder Hyperacusis Pain In Extremity Paranoia Diarrhoea
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Irritability Decreased Appetite Lacrimation Increased Motor Dysfunction Feeling Abnormal
03-Apr-2012
09:37 AM
Page: 648
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/05ISR Number: 4799799-4Report Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Hallucination Feeling Hot Pruritus Pyrexia Headache Loss Of Consciousness Feeling Abnormal Burning Sensation Company Report #CTU 260561 Report Source Product Mefloquine Lariam Role PS Manufacturer Age:26 YR Route ORAL Gender:Male Dose PO I/FU:I Duration
Date:10/18/05ISR Number: 4801794-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002297 Outcome Hospitalization Initial or Prolonged PT Suicidal Ideation Overdose Report Source Product Imodium Gelonida Talvosilen Lariam Talvosilen Gelonida Ibuprofen Role PS SS SS SS SS SS SS Manufacturer
Age: Route ORAL ORAL ORAL ORAL ORAL ORAL ORAL
Gender:Female Dose
I/FU:I Duration
16 tablets. 20 tablets.
Date:10/18/05ISR Number: 4804112-XReport Type:Direct Outcome Life-Threatening Required Intervention to Prevent Permanent Impairment/Damage PT Paranoia Hallucination Anxiety Suicidal Ideation
Company Report #CTU 260897 Report Source Product Mefloquine 250mg Geneva White Sidel: Gp 118 Role PS C Manufacturer Geneva
Age:55 YR Route
Gender:Female Dose 1 EVERY WEEK
I/FU:I Duration
Date:10/21/05ISR Number: 4805756-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-407993 Outcome Other Serious PT Convulsion Amnesia Visual Impairment Report Source Product Lariam Lexinor Role PS C Manufacturer Roche
Gender:Male Dose
Date:10/21/05ISR Number: 4805757-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-420600 Outcome Other Serious PT Chills Joint Swelling Erythema Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Dyspnoea Arrhythmia
03-Apr-2012
09:37 AM
Page: 649
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/05ISR Number: 4805773-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-420097 Outcome Death Congenital Anomaly PT Hypothyroidism Delayed Fontanelle Closure Haemolytic Uraemic Syndrome Skin Discolouration Pallor Plagiocephaly Penis Disorder Developmental Delay Vomiting Maternal Exposure During Pregnancy Report Source Product Lariam Role PS Manufacturer Roche Age:4 MON Route UNKNOWN Gender:Male Dose I/FU:I Duration
Date:10/21/05ISR Number: 4805981-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Disturbance In Attention Amnesia Endolymphatic Hydrops Conduction Disorder Paranoia Hallucination Cranial Nerve Disorder Tremor Aggression Anger Vestibular Disorder Irritability Dysphemia Ototoxicity Panic Attack Toxicity To Various Agents Suicidal Ideation Anxiety Mood Swings Post-Traumatic Stress Disorder Gait Disturbance Bipolar Disorder Tinnitus Obsessive Thoughts Jaundice Muscle Twitching Cognitive Disorder Syncope Hepatic Failure
Age:44 YR
Gender:Male
I/FU:F
Vomiting Depression Depressed Level Of Consciousness Thirst Confusional State Dysarthria Motor Dysfunction 03-Apr-2012 09:37 AM Page: 650
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Dreams Photophobia Visual Field Defect Balance Disorder Insomnia Asthenia Cough Jaw Disorder Tardive Dyskinesia Hyperacusis Incontinence Diarrhoea Photosensitivity Reaction General Symptom Migraine Gilbert'S Syndrome Visual Impairment Nausea Decreased Appetite Lacrimation Increased Mania Homicidal Ideation
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:10/21/05ISR Number: 4806101-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-419686 Outcome Hospitalization Initial or Prolonged PT Leukopenia Neutropenia Thrombocytopenia Hepatic Enzyme Increased Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration DOSING REGIMEN REPORTED AS 3 TABLETS, 2 TABLETS THEN 2 DAY
Date:10/21/05ISR Number: 4806107-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-419662 Outcome Death PT Haemolytic Uraemic Syndrome Convulsion Vomiting Cardiac Arrest Report Source Product Lariam Immunizations Role PS C Manufacturer Roche
Age:4 MON Route ORAL SUBCUTANEOUS
Gender:Male
I/FU:I
Dose Duration FREQUENCY: WEEKLY. FIRST AND SECOND SERIES OF CHILDHOOD IMMUNIZATIONS NOS.
Date:10/25/05ISR Number: 4811091-8Report Type:Expedited (15-DaCompany Report #385293 Outcome Hospitalization PT Aggression
Age:45 YR
Gender:Male
I/FU:F
Toxicity To Various Agents Chest Discomfort Wheezing Rhinitis Allergic Abnormal Behaviour Hallucination, Visual Snoring Page: 651
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bundle Branch Block Right Generalised Anxiety Disorder Amnesia Coordination Abnormal Palpitations Nocturia Chest Pain Asthma Joint Stiffness Mood Swings Weight Increased Agitation Vertigo Balance Disorder Dyspnoea Pulmonary Function Challenge Test Abnormal Troponin Increased Arthralgia Decreased Activity Chondroplasty Occupational Exposure To Air Contaminants Insomnia Disturbance In Attention Suicidal Ideation Headache Fatigue Hyperhidrosis Tremor Morbid Thoughts Deafness Anxiety Poor Quality Drug Administered Cough Blood Potassium Decreased Loose Body In Joint Rash Papular Musculoskeletal Pain Tinnitus Depression Visual Impairment Myalgia Acute Coronary Syndrome Coronary Artery Disease Meniscus Removal Pyrexia Hypervigilance
Report Source Other
Product Lariam (Mefloquine Hydrochloride) Primaquine (Primaquine Phosphate) Cipro (Ciprofloxacin Hydrochloride)
Role PS C C
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:10/28/05ISR Number: 4814893-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Abnormal Behaviour Mood Swings Cranial Nerve Disorder Joint Dislocation Post-Traumatic Stress
Age:45 YR
Gender:Male
I/FU:F
03-Apr-2012
09:37 AM
Page: 652
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorder Asthma Nystagmus Suicidal Ideation Selective Iga Immunodeficiency Headache Panic Disorder Hypertension Generalised Anxiety Disorder Self-Injurious Ideation Fall Mitral Valve Incompetence Dehydration Weight Decreased Convulsion Eye Movement Disorder Disturbance In Attention Vertigo Hallucination, Visual Asthenia Bronchospasm Chest Discomfort Major Depression Decreased Activity Humerus Fracture Hypoaesthesia Ligament Sprain Rheumatoid Factor Increased Memory Impairment Depression Productive Cough Chest Pain Toxicity To Various Agents Exostosis Antinuclear Antibody Positive Pyrexia Balance Disorder Ill-Defined Disorder Sleep Apnoea Syndrome Psychiatric Symptom Cognitive Disorder Bundle Branch Block Right Contusion Agitation Anxiety Psychotic Disorder Meniscus Lesion Thinking Abnormal Homicidal Ideation
Mitral Valve Calcification Respiratory Rate Increased Myalgia Rash Papular Insomnia Fatigue 03-Apr-2012 09:37 AM Page: 653
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Hyperhidrosis Tremor Dysthymic Disorder Oxygen Saturation Decreased Rhinitis Allergic Eosinophilia Ventricular Extrasystoles Aggression Visual Impairment Musculoskeletal Pain Attention Deficit/Hyperactivity Disorder Nocturia
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:11/02/05ISR Number: 4818003-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Outcome Hospitalization Initial or Prolonged PT Grand Mal Convulsion Palpitations Amnesia Visual Impairment Fatigue Disturbance In Attention Headache Report Source Product Lariam Lexinor Malarone Role PS C C Manufacturer Roche
Gender:Male Dose
Date:11/02/05ISR Number: 4818006-7Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Outcome Hospitalization Initial or Prolonged Disability PT Balance Disorder Tinnitus Nystagmus Hearing Impaired Dizziness Vertigo Diarrhoea Nausea Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:11/03/05ISR Number: 4821792-3Report Type:Expedited (15-DaCompany Report #385293 Outcome Hospitalization Initial or Prolonged Disability PT Disturbance In Attention Memory Impairment Toxicity To Various Agents
Age:45 YR
Gender:Male
I/FU:F
Mood Swings Bronchopneumonia Nocturia Arthralgia Musculoskeletal Stiffness Sputum Culture Joint Dislocation Vestibular Disorder 03-Apr-2012 09:37 AM Page: 654
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cognitive Disorder Agitation Depression Vertigo Visual Impairment Hallucination, Visual Asthenia Dizziness Loss Of Libido Convulsion Dissociation Meniscus Lesion Respiratory Fume Inhalation Disorder Selective Iga Immunodeficiency Haemarthrosis Homicidal Ideation Insomnia Stress Hiatus Hernia Dysthymic Disorder Dehydration Palpitations Rash Papular Bronchial Hyperreactivity Exostosis Amnesia Coordination Abnormal Tinnitus Gait Disturbance Mucosal Inflammation Hypervigilance Eye Movement Disorder Sleep Apnoea Syndrome Mitral Valve Calcification Electroencephalogram Abnormal Nightmare Balance Disorder Electrocardiogram St Segment Depression Panic Attack Accident Decreased Appetite Intentional Self-Injury Nystagmus Derealisation Hypertension Rheumatoid Factor Increased Rhinitis Allergic
Myalgia Marital Problem Medication Error Chondropathy Fatigue Self-Medication Electrocardiogram St Segment Abnormal 03-Apr-2012 09:37 AM Page: 655
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Blood Pressure Increased Paranoia Contusion Blood Potassium Decreased Acute Coronary Syndrome Asthma Nodule Bacterial Infection Haemophilus Infection Mitral Valve Incompetence Tremor Eosinophilia Hallucination Suicidal Ideation Product Quality Issue Fall Deafness Chronic Sinusitis Physical Assault Weight Decreased Respiratory Rate Increased Oxygen Saturation Decreased Ventricular Extrasystoles Joint Lock Humerus Fracture Ototoxicity Aggression Anxiety Poor Quality Drug Administered Productive Cough Hypoaesthesia Ligament Sprain Antinuclear Antibody Positive Weight Increased Bundle Branch Block Right Post-Traumatic Stress Disorder Hyperhidrosis Emotional Disorder Impulsive Behaviour Abnormal Dreams
Report Source Other
Product Lariam (Mefloquine Hydrochloride) Primaquine (Primaquine Phosphate) Cipro (Ciprofloxacin Hydrochloride)
Role PS C C
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:11/04/05ISR Number: 4820968-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization PT Disturbance In Attention
Age:45 YR
Gender:Male
I/FU:F
Vertigo Asthenia Chest Pain Major Depression Toxicity To Various Agents Convulsion Nocturia Page: 656
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coordination Abnormal Electrocardiogram St Segment Depression Panic Attack Skin Mass Productive Cough Chest Discomfort Hypertension Psychotic Disorder Homicidal Ideation Oxygen Saturation Decreased Dizziness Haemarthrosis Decreased Appetite Priapism Weight Increased Snoring Agitation Selective Iga Immunodeficiency Meniscus Lesion Mitral Valve Incompetence Ventricular Extrasystoles Electrocardiogram Qrs Complex Prolonged Disease Recurrence Partner Stress Libido Decreased Paranoia Dissociation Derealisation Acute Coronary Syndrome Insomnia Sleep Apnoea Syndrome Joint Dislocation Generalised Anxiety Disorder Post-Traumatic Stress Disorder Decreased Activity Asthma Dehydration Nystagmus Eye Movement Disorder Ligament Sprain Hyperkeratosis Tinnitus Gait Disturbance Sputum Culture Positive Bronchial Hyperreactivity Nightmare Loss Of Consciousness
Arthralgia Musculoskeletal Stiffness Abnormal Behaviour Visual Impairment Hallucination, Visual Balance Disorder Suicidal Ideation Cranial Nerve Disorder 03-Apr-2012 09:37 AM Page: 657
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Mitral Valve Calcification Respiratory Rate Increased Antinuclear Antibody Positive Rhinitis Allergic Rash Papular Eosinophilia Electrocardiogram T Wave Abnormal Bronchopneumonia Mood Altered Deafness Emotional Disorder Blood Pressure Increased Bronchospasm Headache Panic Disorder Self-Injurious Ideation Fall Musculoskeletal Pain Hyperhidrosis Thinking Abnormal Bundle Branch Block Right Exostosis Hypoaesthesia Contusion Pyrexia Bacterial Infection Amnesia Apathy Aggression Anxiety Memory Impairment Fatigue Ill-Defined Disorder Dyspnoea Psychiatric Symptom Cognitive Disorder Dysthymic Disorder Attention Deficit/Hyperactivity Disorder Rheumatoid Factor Increased Myalgia Chronic Sinusitis Upper Respiratory Tract Infection Vestibular Disorder Injury
Palpitations Wheezing Blood Potassium Decreased Tongue Disorder Mood Swings Depression Humerus Fracture Weight Decreased 03-Apr-2012 09:37 AM Page: 658
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hiatus Hernia Mucous Membrane Disorder Haemophilus Infection Hypervigilance Respiratory Fume Inhalation Disorder Feeling Abnormal
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:11/09/05ISR Number: 4823715-XReport Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Outcome Hospitalization Initial or Prolonged PT Tinnitus Diarrhoea Hearing Impaired Nausea Vertigo Dizziness Nystagmus Balance Disorder Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose TAKEN ON 22 FEB, 01 MAR AND 08 MAR 2005.
I/FU:F Duration
15
DAY
Date:11/11/05ISR Number: 4826347-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Outcome Disability PT Hepatic Failure Tremor Diarrhoea Disturbance In Attention Toxicity To Various Agents Post-Traumatic Stress Disorder Decreased Appetite Mania Hallucination Visual Field Defect Nausea Depressed Level Of Consciousness Ototoxicity Conduction Disorder Hyperacusis Balance Disorder Incontinence General Symptom Cough Migraine Tardive Dyskinesia Vestibular Disorder Suicidal Ideation
Age:44 YR
Gender:Male
I/FU:F
Tinnitus Irritability Muscle Twitching Confusional State Cranial Nerve Disorder Insomnia Photosensitivity Reaction Anxiety 03-Apr-2012 09:37 AM Page: 659
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asthenia Obsessive Thoughts Yellow Skin Lacrimation Increased Paranoia Photophobia Aggression Amnesia Jaw Disorder Cognitive Disorder Motor Dysfunction Dysphemia Visual Impairment Panic Attack Anger Depression Thirst Gait Disturbance Gilbert'S Syndrome Abnormal Dreams Syncope Vomiting Mood Swings Endolymphatic Hydrops Dysarthria Bipolar Disorder
Report Source
Role PS C
Manufacturer Roche
Route ORAL
Duration
Date:11/11/05ISR Number: 4826351-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Insomnia Aggression Sleep Apnoea Syndrome Fall Decreased Activity Dysthymic Disorder Humerus Fracture Respiratory Rate Increased Rash Papular Memory Impairment Mood Swings Visual Impairment Selective Iga Immunodeficiency Major Depression Generalised Anxiety Disorder Post-Traumatic Stress Disorder Musculoskeletal Pain
Age:45 YR
Gender:Male
I/FU:F
Antinuclear Antibody Positive Myalgia Abnormal Behaviour Asthenia Hypoaesthesia Rhinitis Allergic Depression 03-Apr-2012 09:37 AM Page: 660
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bronchial Hyperreactivity Chest Pain Asthma Homicidal Ideation Dehydration Ligament Sprain Contusion Ventricular Extrasystoles Balance Disorder Ill-Defined Disorder Chest Discomfort Cranial Nerve Disorder Hypertension Psychotic Disorder Convulsion Nystagmus Anxiety Disturbance In Attention Hallucination, Visual Suicidal Ideation Productive Cough Dyspnoea Psychiatric Symptom Tremor Thinking Abnormal Cognitive Disorder Attention Deficit/Hyperactivity Disorder Nocturia Vertigo Fatigue Headache Panic Disorder Meniscus Lesion Hyperhidrosis Mitral Valve Calcification Weight Decreased Eye Movement Disorder Pyrexia Agitation Joint Dislocation Self-Injurious Ideation Toxicity To Various Agents Bundle Branch Block Right Mitral Valve Incompetence Exostosis Oxygen Saturation Decreased Rheumatoid Factor Increased
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Eosinophilia
03-Apr-2012
09:37 AM
Page: 661
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4827825-2Report Type:Direct Outcome Other Serious PT Feeling Abnormal Disturbance In Attention Impaired Driving Ability Visual Impairment Raynaud'S Phenomenon Generalised Anxiety Disorder Fatigue Suicidal Ideation Panic Attack Tremor Abdominal Pain Upper Nervousness Thinking Abnormal Company Report #CTU 262994 Report Source Product Lariam-MefloquineRoche Role PS Manufacturer Roche Age:20 YR Route ORAL Gender:Female Dose 1 PILL PER WEEK 11 WEEKS PO I/FU:I Duration
Date:11/14/05ISR Number: 4827832-XReport Type:Direct Outcome Disability Required Intervention to Prevent Permanent Impairment/Damage PT Nausea Weight Decreased Depression Anxiety Nightmare Hallucination Skin Discomfort Social Avoidant Behaviour Paranoia
Gender:Female
I/FU:I
Dose Duration ONE PILL ONCE WEEKLY PO
Date:11/14/05ISR Number: 4832250-4Report Type:Expedited (15-DaCompany Report #385293 Outcome Hospitalization Initial or Prolonged Disability PT Abnormal Behaviour Agitation Anxiety Disturbance In Attention Hallucination, Visual Bronchopneumonia Acquired Diaphragmatic Eventration Electrocardiogram Repolarisation Abnormality Tinnitus Mitral Valve Incompetence Electroencephalogram Abnormal
Age:45 YR
Gender:Male
I/FU:F
Nightmare Dysthymic Disorder Priapism Paranoia Nystagmus Rheumatoid Factor Increased Snoring 03-Apr-2012 09:37 AM Page: 662
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bundle Branch Block Right Aggression Mood Swings Depression Electrocardiogram St Segment Abnormal Cardiac Stress Test Abnormal Deafness Inflammation Sputum Culture Positive Marital Problem Attention Deficit/Hyperactivity Disorder Visual Field Defect Impulsive Behaviour Abnormal Dreams Weight Increased Chest Pain Coronary Artery Disease Generalised Anxiety Disorder Pyrexia Rash Joint Crepitation Arthroscopy Gait Disturbance Major Depression Apathy Respiratory Rate Increased Convulsion Dissociation Cognitive Disorder Vital Functions Abnormal Tongue Disorder Musculoskeletal Pain Musculoskeletal Stiffness Insomnia Chondroplasty Fatigue Pain Headache Panic Attack Rapid Eye Movements Sleep Abnormal Hyperhidrosis Accident Libido Decreased Eye Movement Disorder Hypertension Memory Impairment
Chest Discomfort Self-Medication Stress Dizziness Emotional Disorder Joint Dislocation Exostosis Humerus Fracture 03-Apr-2012 09:37 AM Page: 663
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eosinophilia Psychomotor Skills Impaired Loss Of Consciousness Palpitations Wheezing Rhinitis Allergic Acute Coronary Syndrome Thinking Abnormal Speech Disorder Asthma Poor Quality Drug Administered Vertigo Coordination Abnormal Fall Bronchial Hyperreactivity Haemarthrosis Post-Traumatic Stress Disorder Tremor Divorced Physical Assault Weight Decreased Hypervigilance Derealisation Ventricular Extrasystoles Contusion Antinuclear Antibody Positive Cough Nocturia Myalgia Visual Impairment Suicidal Ideation Mental Disorder Dyspnoea Mood Altered Hiatus Hernia Chronic Sinusitis Haemophilus Infection Bacterial Infection Selective Iga Immunodeficiency Vestibular Disorder Amnesia Decreased Appetite Feeling Abnormal Psychiatric Symptom Heart Rate Decreased Hypoaesthesia Meniscus Lesion Blood Potassium Increased
Rash Papular Balance Disorder Toxicity To Various Agents Productive Cough Respiratory Tract Infection Sleep Apnoea Syndrome 03-Apr-2012 09:37 AM Page: 664
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mitral Valve Calcification Mental Retardation Dehydration Self-Injurious Ideation Ligament Sprain Movement Disorder Eye Disorder Drug Ineffective Arthralgia Joint Lock
Report Source Other
Product Lariam (Mefloquine Hydrochloride) 250 Mg Primaquine (Primaquine Phosphate) Cipro (Ciprofloxacin Hydrochloride)
Role PS C C
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:11/15/05ISR Number: 4828508-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Outcome Hospitalization Initial or Prolonged Disability PT Generalised Anxiety Disorder Mental Disorder Major Depression Self Esteem Decreased Panic Attack Amnesia Suicidal Ideation Mood Swings Memory Impairment Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:F Duration
Date:11/17/05ISR Number: 4832517-XReport Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Paranoia Insomnia Panic Attack Heart Rate Increased Depression Feeling Of Despair Suicidal Ideation
Company Report #CTU 263333 Report Source Product Lariam Laroche Role PS Manufacturer Laroche
Gender:Female
I/FU:I
Dose Duration 1 PILL WEEKLY PO
Date:11/21/05ISR Number: 4833061-6Report Type:Expedited (15-DaCompany Report #FR-ROCHE-415971 Outcome Death PT Upper Motor Neurone Lesion Amyotrophy Report Source Product Lariam Engerix B Role PS SS Manufacturer Roche
Gender:Male Dose THE PATIENT RECEIVED THREE INJECTIONS IN 1995 (MARCH,
I/FU:F Duration
189
DAY
Date:11/21/05ISR Number: 4835576-3Report Type:Expedited (15-DaCompany Report #385293 Outcome Hospitalization Initial or Prolonged Disability 03-Apr-2012 09:37 AM PT Abnormal Behaviour Major Depression Weight Increased
Age:45 YR
Gender:Male
I/FU:F
Page: 665
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Snoring Musculoskeletal Stiffness Sputum Culture Positive Exostosis Insomnia Disturbance In Attention Vertigo Affective Disorder Bronchial Hyperreactivity Hyperhidrosis Dehydration Hypoaesthesia Hypertension Electrocardiogram St Segment Depression Marital Problem Occupational Exposure To Dust Occupational Exposure To Toxic Agent Agitation Memory Impairment Visual Impairment Tinnitus Chronic Sinusitis Nightmare Chest Discomfort Blood Pressure Increased Heart Rate Decreased Posterior Capsule Rupture Rheumatoid Factor Increased Bronchopneumonia Accident At Work Mood Swings Depression Mental Disorder Disease Recurrence Haemorrhage Homicidal Ideation Loss Of Consciousness Myalgia Asthma Rash Decreased Activity Poor Quality Drug Administered Haemophilus Infection Suicidal Ideation Dizziness Fall Gait Disturbance Sleep Apnoea Syndrome
Mitral Valve Calcification Electroencephalogram Abnormal Post-Traumatic Stress Disorder Vision Blurred Ventricular Extrasystoles 03-Apr-2012 09:37 AM Page: 666
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tongue Injury Hiatus Hernia Product Quality Issue Electrocardiogram Repolarisation Abnormality Generalised Anxiety Disorder Deafness Joint Dislocation Cognitive Disorder Amnesia Convulsion Contusion Coronary Artery Disease Self-Medication Stress Electrocardiogram St Segment Abnormal Humerus Fracture Hallucination, Visual Balance Disorder Coordination Abnormal Toxicity To Various Agents Headache Selective Iga Immunodeficiency Mitral Valve Incompetence Vestibular Disorder Dysthymic Disorder Pain Fatigue Acute Coronary Syndrome Aggression Panic Attack Upper Respiratory Tract Infection Emotional Disorder Tremor Eosinophilia Weight Decreased Antinuclear Antibody Positive Rhinitis Allergic Bundle Branch Block Right Haemarthrosis
Report Source Other
Role PS C C
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:11/28/05ISR Number: 4837942-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-424819 Outcome PT Report Source Product Role Manufacturer
Age:40 YR Route
Gender:Male Dose
I/FU:I Duration
Other Serious
Psychotic Disorder
Lariam
PS
Roche
ORAL
03-Apr-2012
09:37 AM
Page: 667
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/05ISR Number: 4837946-6Report Type:Expedited (15-DaCompany Report #HU-ROCHE-424837 Outcome Hospitalization Initial or Prolonged PT Anxiety Persecutory Delusion Hallucination, Auditory Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche Age:59 YR Route UNKNOWN Gender:Male Dose TOTAL DOSE REPORTED AS 2 TABLETS ( 1 TABLET = 250 MG OF ACTIVE I/FU:I Duration
Date:11/28/05ISR Number: 4837983-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-411818 Outcome Other Serious PT Blood Creatine Phosphokinase Increased Report Source Product Lariam Ritonavir Epzicom Fosamprenavir Role PS C C C Manufacturer Roche
Gender:Male Dose
Date:11/29/05ISR Number: 4839920-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-425462 Outcome Other Serious PT Aphasia Catatonia Psychotic Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose
I/FU:I Duration
Date:12/02/05ISR Number: 4844064-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Selective Iga Immunodeficiency Chest Discomfort Sleep Apnoea Syndrome Meniscus Lesion Decreased Activity Mitral Valve Calcification Mitral Valve Incompetence Dehydration Contusion Rash Papular Bronchopneumonia Visual Acuity Reduced Haemarthrosis Aggression Anxiety Depression Suicidal Ideation
Age:45 YR
Gender:Male
I/FU:F
Productive Cough Ill-Defined Disorder Headache Joint Dislocation Hyperhidrosis Nystagmus Stress Dizziness 03-Apr-2012 09:37 AM Page: 668
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bacterial Infection Emotional Disorder Amnesia Hypervigilance Snoring Somnolence Agitation Hallucination, Visual Dyspnoea Chest Pain Weight Decreased Ventricular Extrasystoles Deafness Gait Disturbance Electroencephalogram Abnormal Mental Impairment Vision Blurred Loss Of Consciousness Paranoia Hypertension Tremor Exostosis Convulsion Hypoaesthesia Electrocardiogram St Segment Abnormal Vestibular Disorder Impulsive Behaviour Drug Effect Decreased Memory Impairment Mood Swings Visual Impairment Balance Disorder Asthenia Self-Injurious Ideation Musculoskeletal Pain Asthma Bundle Branch Block Right Humerus Fracture Attention Deficit/Hyperactivity Disorder Conduction Disorder Upper Respiratory Tract Infection Rapid Eye Movements Sleep Abnormal Priapism Palpitations Acute Coronary Syndrome Abnormal Behaviour Insomnia
Panic Disorder Psychotic Disorder Major Depression Generalised Anxiety Disorder Fall Respiratory Rate Increased 03-Apr-2012 09:37 AM Page: 669
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rheumatoid Factor Increased Myalgia Injury Marital Problem Derealisation Rash Bronchial Hyperreactivity Cranial Nerve Disorder Psychiatric Symptom Thinking Abnormal Cognitive Disorder Homicidal Ideation Dysthymic Disorder Toxicity To Various Agents Antinuclear Antibody Positive Rhinitis Allergic Eosinophilia Acquired Diaphragmatic Eventration Cardiac Stress Test Abnormal Panic Attack Chronic Sinusitis Dissociative Disorder Disturbance In Attention Vertigo Fatigue Post-Traumatic Stress Disorder Oxygen Saturation Decreased Eye Movement Disorder Ligament Sprain Nocturia Pyrexia Hyperkeratosis Hiatus Hernia Tinnitus Haemophilus Infection Nightmare Musculoskeletal Stiffness
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:12/02/05ISR Number: 4844102-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Vestibular Disorder Dry Eye Dry Mouth
Age:42 YR
Gender:Male
I/FU:F
Gastrooesophageal Reflux Disease Abnormal Dreams Bipolar Disorder Balance Disorder Confusional State Anxiety Diastolic Dysfunction 03-Apr-2012 09:37 AM Page: 670
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Cholesterol Increased Blood Triglycerides Increased Memory Impairment Upper Respiratory Tract Infection Bursitis Gastrointestinal Disorder Angina Pectoris Dehydration Snoring Oral Disorder Acrochordon Visual Impairment Scratch Contusion Joint Dislocation Colitis Mitral Valve Prolapse Restrictive Pulmonary Disease Bronchitis Diarrhoea Blood Creatine Phosphokinase Increased Nocturia Major Depression Amnesia Skin Disorder Ventricular Hypertrophy Dry Skin Clumsiness Tinnitus Dyspnoea Depression Total Lung Capacity Decreased Bronchospasm Cardiac Murmur Sinus Tachycardia Chest Discomfort Constipation Angiotensin Converting Enzyme Increased Blood Glucose Increased Upper-Airway Cough Syndrome Haemorrhoids Adjustment Disorder With Depressed Mood Affective Disorder Psychotic Disorder
Schizoaffective Disorder Tremor Aggression Headache Hypertension Rash Low Density Lipoprotein Increased 03-Apr-2012 09:37 AM Page: 671
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Total Cholesterol/Hdl Ratio Decreased Rhinitis Asthma Coordination Abnormal Adjustment Disorder Anhedonia Intervertebral Disc Degeneration Fatigue Somnolence Sleep Apnoea Syndrome Viral Infection Arthralgia Weight Increased Exfoliative Rash Vitiligo Insomnia
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose Duration A TOTAL OF 6 TABLETS WERE INGESTED.
Date:12/02/05ISR Number: 4844105-XReport Type:Expedited (15-DaCompany Report #GB-ROCHE-425626 Outcome Disability PT Confusional State Asthma Dizziness Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:12/12/05ISR Number: 4851571-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-419686 Outcome Hospitalization Initial or Prolonged PT Thrombocytopenia Leukopenia Neutropenia Hepatic Enzyme Increased Hyperthermia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration DOSING REGIMEN REPORTED AS 3 TABLETS, 2 TABLETS THEN 2 DAY
Imovane
Date:12/12/05ISR Number: 4851573-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Outcome Disability PT Somnolence Sleep Apnoea Syndrome Viral Infection Bronchitis Vitiligo Angiotensin Converting Enzyme Increased Coordination Abnormal
Age:42 YR
Gender:Male
I/FU:F
Memory Impairment Schizoaffective Disorder Vision Blurred Myalgia Anxiety Ventricular Hypertrophy Total Lung Capacity Decreased 03-Apr-2012 09:37 AM Page: 672
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bronchospasm Chest Discomfort Insomnia Major Depression Paraesthesia Confusional State Skin Disorder Upper-Airway Cough Syndrome Asthma Bipolar Disorder Haemorrhoids Psychotic Disorder Mitral Valve Prolapse Angina Pectoris Restrictive Pulmonary Disease Arthralgia Rash Weight Increased Sinus Tachycardia Low Density Lipoprotein Increased Snoring Oral Disorder Abnormal Dreams Adjustment Disorder With Depressed Mood Amnesia Fatigue Total Cholesterol/Hdl Ratio Decreased Diarrhoea Blood Creatine Phosphokinase Increased Constipation Scratch Affective Disorder Aggression Tinnitus Self Esteem Decreased Gastrointestinal Disorder Depression Diastolic Dysfunction Blood Triglycerides Increased Exfoliative Rash Dry Eye Acrochordon Gastrooesophageal Reflux Disease Hypersensitivity Dyspnoea
Headache Dehydration Dry Mouth Nocturia Rhinitis Contusion Cold Sweat Vestibular Disorder 03-Apr-2012 09:37 AM Page: 673
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Cardiac Murmur Blood Cholesterol Increased Dry Skin Blood Glucose Increased Clumsiness Visual Impairment Balance Disorder Tremor Dizziness
Report Source
Role PS C
Manufacturer Roche
Route ORAL UNKNOWN
Dose Duration A TOTAL OF 6 TABLETS WERE INGESTED.
Date:12/12/05ISR Number: 4851582-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-427130 Outcome Other Serious PT Paralysis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:12/12/05ISR Number: 4853723-4Report Type:Expedited (15-DaCompany Report #343474 Outcome Disability PT Angina Pectoris Somnolence Bipolar Disorder Weight Increased Sinus Tachycardia Dry Skin Chest Discomfort Blood Glucose Increased Myalgia Feelings Of Worthlessness Hallucination, Visual Sinusitis Amnesia Dyspnoea Headache Balance Disorder Scratch Contusion Constipation Tremor Peripheral Sensory Neuropathy Sjogren'S Syndrome Confusional State Skin Disorder Hypertension Clumsiness Asthma Psychotic Disorder
Age:42 YR
Gender:Male
I/FU:F
Bronchitis Blood Cholesterol Increased Blood Triglycerides Increased Low Density Lipoprotein Increased Exfoliative Rash 03-Apr-2012 09:37 AM Page: 674
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dry Mouth Snoring Aggression Pharyngeal Disorder Chronic Fatigue Syndrome Obesity Restrictive Pulmonary Disease Colitis Mental Status Changes Intervertebral Disc Degeneration Bursitis Cold Sweat Dizziness Anxiety Gastrointestinal Disorder Ventricular Hypertrophy Lung Disorder Adjustment Disorder Depressive Symptom Schizoaffective Disorder Rash Cardiac Murmur Diarrhoea Upper-Airway Cough Syndrome Listless Sinus Disorder Anal Neoplasm Anhedonia Tendonitis Fatigue Visual Impairment Coordination Abnormal Arthralgia Acrochordon Anal Fissure Psychomotor Hyperactivity Nightmare Photosensitivity Reaction Asthenia Diplopia Disorientation Vestibular Disorder Mitral Valve Prolapse Abnormal Dreams Affective Disorder Total Cholesterol/Hdl Ratio Increased Dry Eye Nocturia Insomnia
Sleep Apnoea Syndrome Haemorrhoids Dyspnoea Exertional Rectal Haemorrhage Feeling Guilty Disturbance In Attention Hallucination, Auditory Paraesthesia 03-Apr-2012 09:37 AM Page: 675
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vision Blurred Self Esteem Decreased Major Depression Bronchospasm Dehydration Blood Creatine Phosphokinase Increased Vitiligo Gastrooesophageal Reflux Disease Neck Pain Bronchial Hyperreactivity Collagen-Vascular Disease Road Traffic Accident Musculoskeletal Stiffness Post-Traumatic Neck Syndrome Cognitive Disorder Depression Diastolic Dysfunction Memory Impairment Viral Infection Angiotensin Converting Enzyme Increased Rhinitis Upper Respiratory Tract Infection Pain In Jaw Weight Decreased Tinnitus Hyperhidrosis
Role PS C
Manufacturer
Route ORAL
Duration
Date:12/12/05ISR Number: 4853725-8Report Type:Expedited (15-DaCompany Report #385293 Outcome Hospitalization Initial or Prolonged Disability PT Amnesia Coordination Abnormal Productive Cough Tinnitus Sputum Culture Positive Mitral Valve Calcification Dysthymic Disorder Weight Decreased Social Avoidant Behaviour Self-Injurious Ideation Paranoia Derealisation Contusion Wheezing Rash
Age:45 YR
Gender:Male
I/FU:F
Arthralgia Agitation Disturbance In Attention Loose Body In Joint Bronchopneumonia Self-Medication Electrocardiogram St Segment Abnormal 03-Apr-2012 09:37 AM Page: 676
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Selective Iga Immunodeficiency Electroencephalogram Abnormal Homicidal Ideation Apathy Psychiatric Symptom Ligament Sprain Coronary Artery Disease Vertigo Injury Hiatus Hernia Gait Disturbance Condition Aggravated Chronic Sinusitis Mental Impairment Emotional Disorder Post-Traumatic Stress Disorder Tremor Eosinophilia Thinking Abnormal Hypertension Physical Assault Decreased Appetite Eye Movement Disorder Meniscus Lesion Weight Increased Rhinitis Allergic Chest Pain Blood Potassium Decreased Acute Coronary Syndrome Speech Disorder Asthma Arthropathy Insomnia Toxicity To Various Agents Mood Altered Dizziness Sleep Apnoea Syndrome Vestibular Disorder Occupational Exposure To Noise Visual Field Defect Cognitive Disorder Accident Convulsion Nystagmus Dissociation Anxiety Disorder Nocturia
Non-Cardiac Chest Pain Generalised Anxiety Disorder Suicidal Ideation Poor Quality Drug Administered Mental Disorder Unevaluable Event 03-Apr-2012 09:37 AM Page: 677
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chest Discomfort Bronchial Hyperreactivity Mitral Valve Incompetence Humerus Fracture Hyperhidrosis Hypoaesthesia Eye Disorder No Therapeutic Response Cough Myalgia Joint Lock Decreased Activity Aggression Visual Impairment Hallucination, Visual Product Quality Issue Stress Acquired Diaphragmatic Eventration Headache Haemophilus Infection Haemarthrosis Occupational Exposure To Toxic Agent Loss Of Consciousness Occupational Exposure To Dust Psychotic Disorder Impaired Work Ability Oxygen Saturation Decreased Rheumatoid Factor Increased Hallucination, Auditory Blood Creatine Phosphokinase Mb Normal Pyrexia Musculoskeletal Pain Abnormal Behaviour Anxiety Mood Swings Depression Balance Disorder Fatigue Electrocardiogram St Segment Depression Exercise Test Abnormal Deafness Bacterial Test Positive Exostosis Divorced Nightmare Loss Of Libido
Priapism Respiratory Rate Increased Panic Disorder Snoring Tongue Disorder Chondropathy Dyspnoea 03-Apr-2012 09:37 AM Page: 678
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Panic Attack Joint Dislocation Marital Problem Occupational Exposure To Air Contaminants Dehydration Major Depression Palpitations Hypervigilance Ventricular Extrasystoles Antinuclear Antibody Positive Pulmonary Function Challenge Test Abnormal Bundle Branch Block Right Rash Papular Feeling Abnormal Musculoskeletal Stiffness Upper Respiratory Tract Infection
Report Source Other
Role PS C C
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:12/13/05ISR Number: 4852051-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-427130 Outcome Other Serious PT Asthenia Paresis Hypokinesia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:F Duration
Date:12/14/05ISR Number: 4853197-3Report Type:Expedited (15-DaCompany Report #JP-ROCHE-426965 Outcome Hospitalization Initial or Prolonged PT Cyanosis Dyspnoea Pneumonia Red Blood Cell Sedimentation Rate Increased C-Reactive Protein Increased Sinus Tachycardia Blood Lactate Dehydrogenase Increased Respiratory Failure Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male
I/FU:I
Dose Duration PATIENT TOOK FOUR DOSES. 21 DAY
Date:12/16/05ISR Number: 4855695-5Report Type:Expedited (15-DaCompany Report #CA-ROCHE-427697 Outcome PT Report Source Product Role Manufacturer
Age:20 YR Route
Gender:Female Dose
I/FU:I Duration
Other Serious
Irritability Personality Disorder Logorrhoea Aggression Insomnia Thinking Abnormal Neurosis Cognitive Disorder 09:37 AM
Mefloquine Hydrochloride Doxycycline
PS C
Roche
ORAL ORAL
WK
03-Apr-2012
Page: 679
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/05ISR Number: 4855703-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-427620 Outcome Other Serious PT Malaise Chest Pain Dizziness Tinnitus Insomnia Fatigue Nausea Paraesthesia Hypoaesthesia Palpitations Upper Respiratory Tract Infection Hypertension Report Source Product Lariam Malarone Typhoid Vaccine Diphtheria And Tetanus Vaccine Hepatitis A Vaccine Hepatitis B Vaccine Role PS C C C C C Manufacturer Roche Age:22 YR Route UNKNOWN ORAL Gender:Male Dose I/FU:I Duration 6 WK
Date:12/19/05ISR Number: 4864051-5Report Type:Direct Outcome Disability PT Insomnia Agitation Thinking Abnormal Memory Impairment Arthralgia Neck Pain Rash Pruritus Confusional State Headache Fatigue Myalgia Skin Disorder Skin Lesion Anxiety
Age:44 YR Route
Gender:Male
I/FU:I
Dose Duration ONCE PER WEEK
Date:12/22/05ISR Number: 4864524-5Report Type:Expedited (15-DaCompany Report #IT-ROCHE-426078 Outcome Other Serious PT Hepatitis Acute Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:12/22/05ISR Number: 4867674-2Report Type:Direct Outcome Life-Threatening Other Serious Required PT Mental Disorder Stress Feeling Abnormal
Company Report #CTU 265598 Report Source Product Lariam 150 Mg. Not Sure Hoffman Laroche, Inc. Role PS Manufacturer Hoffman Laroche, Inc
Gender:Female Dose 1 PILL EVERY
I/FU:I Duration
Self Injurious Behaviour Paranoia
WEEK
PO
03-Apr-2012
09:37 AM
Page: 680
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4865446-6Report Type:Expedited (15-DaCompany Report #AU-ROCHE-428550 Outcome Hospitalization Initial or Prolonged PT Paranoia Agitation Illusion Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche Age:28 YR Route ORAL Gender:Female Dose ONE DAY TREATMENT. I/FU:I Duration 1 DAY
Date:12/23/05ISR Number: 4865465-XReport Type:Expedited (15-DaCompany Report #CH-ROCHE-428290 Outcome Hospitalization Initial or Prolonged PT General Physical Health Deterioration Pulmonary Toxicity Blood Pressure Decreased Diffuse Alveolar Damage Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose RECEIVED A TOTAL DOSE OF 1500MG OF MEFLOQUINE OVER 24 HOURS FOR 48 HOURS
I/FU:I Duration
Paracetamol Halofantrine
C C
Date:12/23/05ISR Number: 4865509-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-420600 Outcome Other Serious PT Inflammation Joint Swelling Arrhythmia Erythema Chills Dyspnoea Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:12/28/05ISR Number: 4867307-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-407146 Outcome Hospitalization Initial or Prolonged PT Vision Blurred Vertigo Atrioventricular Block Complete Fall Atrioventricular Block Report Source Product Lariam Xalacom Fenofibrate Captopril Role PS SS SS SS Manufacturer Roche Roche
Age:64 YR Route ORAL TOPICAL ORAL ORAL
Gender:Female Dose
Date:12/28/05ISR Number: 4867316-6Report Type:Expedited (15-DaCompany Report #AU-ROCHE-429059 Outcome Other Serious PT Maternal Exposure During Pregnancy Abortion Spontaneous Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:12/28/05ISR Number: 4867318-XReport Type:Expedited (15-DaCompany Report #AU-ROCHE-429052 Outcome Other Serious 03-Apr-2012 09:37 AM PT Oropharyngeal Pain Nausea
Age:42 YR
Gender:
I/FU:I
Page: 681
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Hallucination Vomiting Dysphagia Mouth Ulceration Pruritus Gastrooesophageal Reflux Disease
Report Source
Product Lariam Unspecified Drug Havrix
Role PS C C
Manufacturer Roche
Route ORAL
Dose REPORTED AS ADT.
Duration 41 DAY
Date:12/28/05ISR Number: 4870956-1Report Type:Expedited (15-DaCompany Report #343474 Outcome Disability PT Chest X-Ray Abnormal Exercise Tolerance Decreased Impaired Work Ability Palatal Disorder Feelings Of Worthlessness Sinusitis Asthenia Treatment Noncompliance Hyperhidrosis Amnesia Gastrointestinal Disorder Hypertension Diastolic Dysfunction Psychotic Disorder Bronchospasm Cardiac Murmur Sinus Tachycardia Aggression Drug Intolerance Collagen-Vascular Disease Blood Triglycerides Abnormal Low Density Lipoprotein Abnormal Weight Decreased Feeling Guilty Cognitive Disorder Dislocation Of Vertebra Intervertebral Disc Degeneration Spinal X-Ray Abnormal Vision Blurred Injury Restrictive Pulmonary Disease Bipolar Disorder Blood Cholesterol Increased
Age:42 YR
Gender:Male
I/FU:F
Rhinitis Blood Cholesterol Abnormal Total Cholesterol/Hdl Ratio Abnormal Pharyngeal Disorder Oxygen Saturation Decreased 03-Apr-2012 09:37 AM Page: 682
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Loss Poor Drug Effect Decreased Paraesthesia Diplopia Vestibular Disorder Clumsiness Asthma Adjustment Disorder With Depressed Mood Schizoaffective Disorder Diarrhoea Insomnia Hyperacusis Nocturia Jaw Disorder Neoplasm Musculoskeletal Pain Post-Traumatic Neck Syndrome Rhinitis Perennial Self Esteem Decreased Headache Angina Pectoris Hypersomnia Coordination Abnormal Arthralgia Bronchitis Dehydration Dry Skin Dry Mouth Upper-Airway Cough Syndrome Neck Pain Listless Disturbance In Attention Cervical Spine Flattening Tinnitus Confusional State Fatigue Visual Impairment Affective Disorder Memory Impairment Viral Infection Rash Vitiligo Acrochordon Angiotensin Converting Enzyme Increased Blood Glucose Increased Gastrooesophageal Reflux Disease Sleep Apnoea Syndrome Haemorrhoids
Oedema Obesity Myalgia Rectal Haemorrhage Colitis Psychomotor Hyperactivity Mental Status Changes Nightmare 03-Apr-2012 09:37 AM Page: 683
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Musculoskeletal Stiffness Brain Stem Auditory Evoked Response Abnormal Photosensitivity Reaction Cold Sweat Multiple Allergies Ventricular Hypertrophy Scratch Low Density Lipoprotein Increased Chest Discomfort Upper Respiratory Tract Infection Exercise Lack Of Lung Neoplasm Pulmonary Granuloma Nausea Anhedonia Dizziness Anxiety Mitral Valve Prolapse Depression Abnormal Dreams Condition Aggravated Balance Disorder Major Depression Contusion Snoring Constipation Tremor Embolism Arterial Musculoskeletal Discomfort Hallucinations, Mixed Road Traffic Accident Disorientation Skin Disorder Weight Increased Blood Triglycerides Increased Total Cholesterol/Hdl Ratio Decreased Blood Creatine Phosphokinase Increased Exfoliative Rash Dry Eye Gastrointestinal Tract Mucosal Discolouration
Role PS C
Manufacturer
Route ORAL
Dose 250 MG, 1 PER 1 WEEK, ORAL
Duration
Date:01/04/06ISR Number: 4871979-9Report Type:Expedited (15-DaCompany Report #ZM-ROCHE-430119
Age:28 YR
Gender:Male
I/FU:I
PT Nephrotic Syndrome
Report Source
Product Mefloquine Hydrochloride
Role PS
Manufacturer Roche
Route ORAL
Dose
Duration 3 DAY
03-Apr-2012
09:37 AM
Page: 684
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/06ISR Number: 4873359-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-429867 Outcome Other Serious PT Pericardial Effusion Hypersensitivity Arrhythmia Myocarditis Asthenia Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Male Dose I/FU:I Duration
Date:01/10/06ISR Number: 4876923-6Report Type:Expedited (15-DaCompany Report #DE-ROCHE-430544 Outcome Hospitalization Initial or Prolonged PT Blood Lactate Dehydrogenase Increased Jaundice Blood Alkaline Phosphatase Increased Pyrexia Epigastric Discomfort Gallbladder Oedema Hiatus Hernia Cholecystitis Acute Transaminases Increased Ocular Icterus Report Source Product Lariam Valette Role PS C Manufacturer Roche
Age:42 YR Route UNKNOWN ORAL
Gender:Female Dose
I/FU:I Duration
Date:01/11/06ISR Number: 4879688-7Report Type:Expedited (15-DaCompany Report #2005-BP-21825RO Outcome Hospitalization Initial or Prolonged PT Dysphoria Nausea Treatment Noncompliance Dry Mouth Weight Decreased Anxiety Asthenia Tremor Sleep Disorder Depression Agitation Report Source Foreign Literature Health Professional Product Mefloquine (Mefloquine) Alprazolam (Alprazolam) Fluoxetine (Fluoxetine) Role PS Manufacturer
Gender:Female Dose 250 MG/WEEK X 8 WEEKS (250 MG), PO
I/FU:I Duration
C C
Date:01/16/06ISR Number: 4881711-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-386256 Outcome Hospitalization Initial or Prolonged Disability PT Depression Fear Nervousness Suicidal Ideation
Age:23 YR
Gender:Male
I/FU:F
Malaise Paranoia Toxicity To Various Agents Anxiety Skin Odour Abnormal Photosensitivity Reaction Photophobia 03-Apr-2012 09:37 AM Page: 685
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Epistaxis Abnormal Dreams Feeling Abnormal Lethargy
Report Source
Product Lariam Marijuana
Role PS SS
Manufacturer Roche
Route ORAL ORAL
Dose
Duration
Date:01/20/06ISR Number: 4889556-2Report Type:Direct Outcome Other Serious PT Panic Disorder Anxiety
Company Report #CTU 267348 Report Source Product Lariam 250 Mg Barr Laboratories, Inc. Role PS Manufacturer Barr Laboratories, Inc.
Gender:Male Dose ONE 250 MG PILL ONCE A WEEK PO
I/FU:I Duration
Date:01/23/06ISR Number: 4891871-3Report Type:Expedited (15-DaCompany Report #430544 Outcome Hospitalization Initial or Prolonged PT Hiatus Hernia Cholecystitis Acute Report Source Foreign Literature Health Professional Product Lariam (Mefloquine Hydrochloride) Valette (Dienogest/Ethinyl Estradiol) Role PS C Manufacturer
Age:42 YR Route
Gender:Female Dose
I/FU:I Duration
Date:01/24/06ISR Number: 4890014-XReport Type:Expedited (15-DaCompany Report #DK-ROCHE-430861 Outcome Other Serious PT Hypoaesthesia White Blood Cell Count Decreased Blood Thyroid Stimulating Hormone Increased Leukopenia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration ORDINARY GROWN-UP PROPHYLACTIC LARIAM DOSIS.
Date:01/24/06ISR Number: 4891009-2Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Dizziness Heart Rate Irregular Panic Attack Atrial Fibrillation Chest Pain Nausea Anxiety
Gender:Female
I/FU:I
Dose Duration 1 PER WEEK FIVE WEEKS PO
Date:01/26/06ISR Number: 4892620-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Illogical Thinking Grand Mal Convulsion Amnesia
Age:42 YR
Gender:Male
I/FU:F
Page: 686
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance In Attention Headache Visual Impairment Palpitations Brain Injury Fatigue
Report Source
Product Lariam Lexinor Malarone
Role PS C C
Manufacturer Roche
Dose
Duration 9 DAY
Date:01/27/06ISR Number: 4894727-5Report Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Anxiety Paranoia Weight Increased Heart Rate Increased Hypertension
Age:40 YR Route
I/FU:I Duration
Date:01/30/06ISR Number: 4895159-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002297 Outcome Hospitalization Initial or Prolonged PT Suicidal Ideation Overdose Liver Function Test Abnormal Somnolence Report Source Product Imodium Gelonida Talvosilen Lariam Talvosilen Gelonida Ibuprofen Role PS SS SS SS SS SS SS Manufacturer
Age: Route ORAL ORAL ORAL ORAL ORAL ORAL ORAL
Gender:Female Dose
I/FU:I Duration
16 tablets. 20 tablets.
Date:01/30/06ISR Number: 4895544-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-426242 Outcome Hospitalization Initial or Prolonged PT Nightmare Syncope Malaise Urinary Incontinence Visual Impairment Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:01/31/06ISR Number: 4896641-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-418484 Outcome Other Serious PT Lung Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:02/01/06ISR Number: 4897778-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002297
Age:
Gender:Female
I/FU:I
PT Suicidal Ideation Liver Function Test Abnormal Somnolence Overdose
Report Source
Product Imodium Gelonida Talvosilen Lariam Talvosilen Gelonida Ibuprofen
Role PS SS SS SS SS SS SS
Manufacturer
Route ORAL ORAL ORAL ORAL ORAL ORAL ORAL
Dose
Duration
16 tablets. 20 tablets. Page: 687
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/06ISR Number: 4898042-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Outcome Hospitalization Initial or Prolonged Disability PT Mood Swings Amnesia Self-Medication Feeling Guilty Memory Impairment Suicidal Ideation Fatigue Mental Disorder Major Depression Generalised Anxiety Disorder Anxiety Nervousness Self Esteem Decreased Decreased Interest Panic Attack Social Phobia Disturbance In Attention Report Source Product Lariam Role PS Manufacturer Roche Age: Route UNKNOWN Gender:Male Dose I/FU:F Duration
Date:02/02/06ISR Number: 4899221-3Report Type:Expedited (15-DaCompany Report #AU-ROCHE-433139 Outcome Hospitalization Initial or Prolonged PT Vomiting Dizziness Haemolytic Anaemia Headache Nausea Myalgia Cardiac Murmur Alopecia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:02/03/06ISR Number: 4900280-XReport Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Outcome Hospitalization Initial or Prolonged PT Palpitations Visual Impairment Grand Mal Convulsion Amnesia Disturbance In Attention Headache Feeling Abnormal Fatigue Cerebral Disorder Report Source Product Lariam Lexinor Malarone Role PS C C Manufacturer Roche
Gender:Male Dose
Date:02/09/06ISR Number: 4909064-XReport Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM PT Deafness
Company Report #CTU 269215 Report Source Product Mefloquine 250 Mg Generic Role PS Manufacturer
Age: Route ORAL
Gender:Male Dose 250 MG 3 X WITHIN' 5 DAYS PO
I/FU:I Duration
Page: 688
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/06ISR Number: 4910665-3Report Type:Direct Outcome PT Drug Dispensing Error Medication Error Wrong Drug Administered Company Report #USP 57779 Report Source Product Lariam Zaroxolyn Role PS SS Manufacturer Roche Cell Tech Age: Route Gender:Female Dose TABLET TABLET I/FU:I Duration
Date:02/15/06ISR Number: 4912780-7Report Type:Expedited (15-DaCompany Report #SE-ROCHE-433848 Outcome Hospitalization Initial or Prolonged PT Nephropathy Toxic Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:02/15/06ISR Number: 4912790-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Insomnia Nightmare Irritable Bowel Syndrome Disturbance In Attention Pharyngitis Streptococcal Rash Phonophobia Blood Pressure Increased Epididymitis Agitation Dizziness Mood Swings Anxiety Disorder Fatigue Vertigo Nystagmus Inner Ear Disorder Eye Pain Pain Of Skin Night Sweats Nausea Diarrhoea Amnesia Abdominal Pain Testicular Pain Depression Colitis Hypoaesthesia Nervousness Activities Of Daily Living Impaired Vomiting Disorientation
Age:35 YR
Gender:Male
I/FU:F
Psychotic Disorder Memory Impairment Headache Vestibular Disorder Chest Pain Tinnitus Vision Blurred Photophobia 03-Apr-2012 09:37 AM Page: 689
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Upper Respiratory Tract Infection Weight Increased
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Duration
C C C C
C C C C C
Date:02/16/06ISR Number: 4914041-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-359452 Outcome Hospitalization Initial or Prolonged PT Respiratory Failure Pulmonary Fibrosis Lung Disorder Toxicity To Various Agents Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Unknown Medication
INTRAVENOUS
Dose Duration DOSAGE REPORTED AS 1.1 AND 1.2 MG/L. DRUG REPORTED AS CLAMOXIL. 3 DAY
Date:02/17/06ISR Number: 4915831-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-435505 Outcome Other Serious PT Restlessness Anxiety Chest Discomfort Depression Panic Attack Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:02/17/06ISR Number: 4920328-6Report Type:Expedited (15-DaCompany Report #GXKR2006IT00866 Outcome Hospitalization Initial or Prolonged PT Vision Blurred Leukocytosis Thrombotic
Age:56 YR
Gender:Male
I/FU:I
Thrombocytopenic Purpura Anaemia Neutrophil Count Increased Confusional State Ocular Icterus Anisocytosis Myalgia 03-Apr-2012 09:37 AM Page: 690
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Decreased Appetite Low Density Lipoprotein Increased Plasmapheresis Asthenia
Product Mefloquine (Ngx)(Mefloquine) Tablet
Role PS
Manufacturer
Route
Dose 250 MG,QW
Duration
Date:02/20/06ISR Number: 4916768-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-424819 Outcome Other Serious PT Psychotic Disorder Alcohol Use Stress Anxiety Persecutory Delusion Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:02/23/06ISR Number: 4920624-2Report Type:Expedited (15-DaCompany Report #SE-ROCHE-436796 Outcome Congenital Anomaly PT Trisomy 21 Maternal Exposure During Pregnancy Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:02/24/06ISR Number: 4922524-0Report Type:Expedited (15-DaCompany Report #IT-ROCHE-436175 Outcome Death PT Gastrointestinal Haemorrhage Thrombocytopenia Headache Vomiting Cerebral Haemorrhage Coma Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:02/27/06ISR Number: 4924436-5Report Type:Expedited (15-DaCompany Report #ZM-ROCHE-430119 Outcome Hospitalization Initial or Prolonged PT Nephrotic Syndrome Abdominal Distension Glucose Urine Present Respiratory Rate Increased Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
Date:02/28/06ISR Number: 4928936-3Report Type:Direct Outcome Other Serious PT Anxiety Mental Disorder Panic Attack Hyperhidrosis 09:37 AM
Age:22 YR
Gender:Male
I/FU:I
03-Apr-2012
Page: 691
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fear Palpitations Dyspnoea Thinking Abnormal Hallucination Diarrhoea Feeling Abnormal
Report Source
Product Larium/Mefloquine Roche
Role PS
Manufacturer Roche
Route ORAL
Dose ONE PILL ONCE PER WEEK PO
Duration
Date:03/06/06ISR Number: 4933631-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-432400 Outcome Hospitalization Initial or Prolonged PT Sleep Disorder Dyspnoea Exertional Tachycardia Anxiety Hyperventilation Neurosis Anaemia Malaise Histrionic Personality Disorder Asthenia Vertigo Conversion Disorder Report Source Product Lariam Lariam Role PS SS Manufacturer Roche Roche
Gender:Female Dose
Date:03/06/06ISR Number: 4933637-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-436796 Outcome Congenital Anomaly PT Trisomy 21 Abortion Maternal Exposure During Pregnancy Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:03/06/06ISR Number: 4933650-4Report Type:Expedited (15-DaCompany Report #DK-ROCHE-430861 Outcome Other Serious PT Sensory Disturbance Monocyte Count Abnormal Neutrophil Count Abnormal White Blood Cell Count Decreased Hypoaesthesia Blood Thyroid Stimulating Hormone Increased Abortion Alanine Aminotransferase Abnormal Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Lymphocyte Count Abnormal Leukopenia
03-Apr-2012
09:37 AM
Page: 692
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/06ISR Number: 4937024-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Anxiety Panic Disorder Major Depression Psychiatric Symptom Fall Toxicity To Various Agents Convulsion Nocturia Insomnia Disturbance In Attention Selective Iga Immunodeficiency Fatigue Ill-Defined Disorder Chest Discomfort Joint Dislocation Respiratory Rate Increased Rheumatoid Factor Increased Dizziness Abnormal Behaviour Memory Impairment Hyperhidrosis Tremor Bundle Branch Block Right Exostosis Hypoaesthesia Myalgia Mood Swings Visual Impairment Hallucination, Visual Dyspnoea Post-Traumatic Stress Disorder Decreased Activity Antinuclear Antibody Positive Rhinitis Allergic Ventricular Extrasystoles Balance Disorder Asthenia Chest Pain Psychotic Disorder Generalised Anxiety Disorder Mitral Valve Calcification Dehydration Age:45 YR Gender:Male I/FU:F
Weight Decreased Oxygen Saturation Decreased Eye Movement Disorder Eosinophilia Coordination Abnormal Mood Altered Aggression 03-Apr-2012 09:37 AM Page: 693
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Sleep Apnoea Syndrome Meniscus Lesion Thinking Abnormal Dysthymic Disorder Attention Deficit/Hyperactivity Disorder Ligament Sprain Rash Papular Cervical Vertebral Fracture Bronchopneumonia Agitation Depression Bronchial Hyperreactivity Productive Cough Cranial Nerve Disorder Hypertension Self-Injurious Ideation Cognitive Disorder Mitral Valve Incompetence Humerus Fracture Contusion Pyrexia Tinnitus Vertigo Headache Musculoskeletal Pain Asthma Homicidal Ideation Nystagmus Upper Respiratory Tract Infection
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:03/09/06ISR Number: 4988015-6Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Back Pain Panic Attack Hypoaesthesia Neck Pain Asthenia Headache Dysphemia Muscle Spasms Tremor Disturbance In Attention Anxiety
Company Report #GXBR2005US01407 Report Source Consumer Product Mefloquine Hcl Tablets (Ngx)(Mefloquine) Tablet Motrin (Ibuprofen) Role Manufacturer
Age:19 YR Route
Gender:Female Dose
I/FU:I Duration
PS C
ORAL
250 MG, QW, ORAL
Date:03/09/06ISR Number: 4988019-3Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Platelet Count Decreased
Company Report #GXBR2005US00770 Report Source Consumer Product Mefloquine Hcl Tablets (Ngx)(Mefloquine) Tablet Role Manufacturer
Age:37 YR Route
Gender:Male Dose
I/FU:I Duration
PS
OPHTHALMIC
250 MG QW, Page: 694
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Z-Pak (Azithromycin) Prednisone (Prednisone) Albuterol (Salbutamol) Advair Diskus (Fluticasone Propionate, Salmeterol Xinafoate) C C C
Date:03/13/06ISR Number: 4941688-6Report Type:Expedited (15-DaCompany Report #SE-ROCHE-435563 Outcome Hospitalization Initial or Prolonged PT Arthropod Bite Headache Depressed Mood Sleep Disorder Hyperaesthesia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:03/14/06ISR Number: 4943232-6Report Type:Expedited (15-DaCompany Report #DK-ROCHE-430861 Outcome Other Serious PT Blood Thyroid Stimulating Hormone Increased Leukopenia Hypoaesthesia White Blood Cell Count Decreased Hypothyroidism Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Date:03/14/06ISR Number: 4943235-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-424819 Outcome Other Serious PT Psychotic Disorder Delusion Confusional State Persecutory Delusion Anxiety Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:03/14/06ISR Number: 4943292-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Outcome Hospitalization Initial or Prolonged PT Suicidal Ideation Mental Disorder
Age:
Gender:Male
I/FU:F
Disability
Generalised Anxiety Disorder Major Depression Feeling Guilty Panic Attack Amnesia Self Esteem Decreased Mood Swings 09:37 AM Page: 695
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Memory Impairment Report Source Product Lariam Role PS Manufacturer Roche Route UNKNOWN Dose Duration
Date:03/15/06ISR Number: 4944593-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-439267 Outcome Hospitalization Initial or Prolonged Disability PT Anhedonia Pain Cognitive Disorder Injury Mental Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:03/20/06ISR Number: 4948316-4Report Type:Expedited (15-DaCompany Report #IT-ROCHE-439289 Outcome Hospitalization Initial or Prolonged PT Thrombotic Thrombocytopenic Purpura Asthenia Pyrexia Vision Blurred Confusional State Decreased Appetite Myalgia Lethargy Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:03/20/06ISR Number: 4948344-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Agitation Mood Swings Depression Asthenia Headache Post-Traumatic Stress Disorder Meniscus Lesion Attention Deficit/Hyperactivity Disorder Suicidal Ideation Productive Cough Decreased Activity Dysthymic Disorder Bundle Branch Block Right Eye Movement Disorder
Age:45 YR
Gender:Male
I/FU:F
Contusion Anxiety Bronchial Hyperreactivity Thinking Abnormal Brain Stem Syndrome Memory Impairment Ill-Defined Disorder Dyspnoea 03-Apr-2012 09:37 AM Page: 696
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chest Discomfort Hypertension Psychiatric Symptom Musculoskeletal Pain Homicidal Ideation Convulsion Rheumatoid Factor Increased Nocturia Pyrexia Rash Papular Abnormal Behaviour Aggression Selective Iga Immunodeficiency Cranial Nerve Disorder Joint Dislocation Generalised Anxiety Disorder Asthma Cognitive Disorder Mitral Valve Incompetence Humerus Fracture Dehydration Weight Decreased Respiratory Rate Increased Antinuclear Antibody Positive Rhinitis Allergic Hallucination, Visual Balance Disorder Fatigue Panic Disorder Self-Injurious Ideation Oxygen Saturation Decreased Nystagmus Eosinophilia Insomnia Visual Impairment Chest Pain Hyperhidrosis Tremor Craniocerebral Injury Toxicity To Various Agents Hypoaesthesia Disturbance In Attention Vertigo Sleep Apnoea Syndrome Psychotic Disorder Major Depression
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Fall Mitral Valve Calcification Exostosis Ligament Sprain Myalgia Ventricular Extrasystoles 03-Apr-2012 09:37 AM Page: 697
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/06ISR Number: 4958844-3Report Type:Expedited (15-DaCompany Report #385293 Outcome Hospitalization Initial or Prolonged Disability PT Hypoaesthesia Humerus Fracture Mitral Valve Incompetence Mitral Valve Calcification Aggression Meniscus Lesion Major Depression Panic Disorder Chest Pain Visual Impairment Memory Impairment Abnormal Behaviour Cough Angina Pectoris Joint Lock Deafness Anger Upper Respiratory Tract Infection Eructation Abdominal Pain Upper Mucous Stools Exostosis Homicidal Ideation Post-Traumatic Stress Disorder Joint Dislocation Vestibular Function Test Abnormal Headache Balance Disorder Snoring Speech Disorder Joint Crepitation Diarrhoea Rash Macular Pyrexia Myalgia Rhinitis Allergic Ligament Sprain Convulsion Hypertension Sleep Apnoea Syndrome Productive Cough Poor Quality Drug Administered Weight Increased Thinking Abnormal Sedation Age:45 YR Gender:Male I/FU:F
Tongue Eruption Arthralgia Rectal Haemorrhage Eosinophilia Nystagmus Hyperhidrosis Fatigue Selective Iga 03-Apr-2012 09:37 AM Page: 698
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Immunodeficiency Suicidal Ideation Agitation Insomnia Family Stress Nausea Ventricular Extrasystoles Tremor Nocturia Antinuclear Antibody Positive Bundle Branch Block Right Dysthymic Disorder Dyspnoea Asthenia Coordination Abnormal Vertigo Derealisation Exposure To Toxic Agent Wheezing Occupational Problem Environmental Chondroplasty Musculoskeletal Stiffness Breath Odour Injury Attention Deficit/Hyperactivity Disorder Weight Decreased Generalised Anxiety Disorder Chest Discomfort Pulmonary Congestion Bronchial Hyperreactivity Hallucination, Visual Disturbance In Attention Acute Coronary Syndrome Psychiatric Symptom Tinnitus Hypervigilance Impaired Work Ability Constipation Decreased Activity Rash Papular Oxygen Saturation Decreased Respiratory Rate Increased Dehydration Toxicity To Various Agents Impulsive Behaviour Self-Injurious Ideation
Anxiety Disorder Depression Mood Swings Anxiety Dissociative Disorder Palpitations Dizziness Brain Stem Syndrome 03-Apr-2012 09:37 AM Page: 699
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Visual Field Defect Rheumatoid Factor Increased Contusion Eye Movement Disorder Cognitive Disorder Asthma Musculoskeletal Pain Fall Psychotic Disorder Priapism Paranoia Blood Potassium Decreased Emotional Distress Dyspepsia Abdominal Distension
Report Source Other
Product Lariam (Mefloquine Hydrochloride) 250mg Primaquine (Primaquine Phosphate) Cirpo (Ciprofloxacin Hydrochloride)
Role PS C C
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:03/24/06ISR Number: 4958848-0Report Type:Expedited (15-DaCompany Report #385293 Outcome Hospitalization Initial or Prolonged Disability PT Agitation Product Quality Issue Hyperkeratosis Coronary Artery Disease Headache Dizziness Joint Dislocation Choking Weight Decreased Meniscus Lesion Respiratory Fume Inhalation Disorder Acute Coronary Syndrome Disturbance In Attention Visual Impairment Loose Body In Joint Fall Humerus Fracture Divorced Accident Hypertension Weight Increased Rhinitis Allergic Bundle Branch Block Right Arthralgia Anxiety Suicidal Ideation Chondroplasty Electrocardiogram T Wave Abnormal Chest X-Ray Abnormal
Age:45 YR
Gender:Male
I/FU:F
Haemophilus Infection Sleep Apnoea Syndrome Visual Field Defect Eosinophilia Cognitive Disorder Exposure To Noise Priapism Ventricular Extrasystoles 03-Apr-2012 09:37 AM Page: 700
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Palpitations Snoring Abnormal Behaviour Aggression Vertigo Hallucination, Visual Toxicity To Various Agents Poor Quality Drug Administered Stress Hiatus Hernia Electrocardiogram St Segment Depression Upper Respiratory Tract Infection Mitral Valve Calcification Nightmare Ligament Sprain Nocturia Blood Creatine Phosphokinase Increased Psychiatric Symptom Insomnia Mood Swings Depression Cardiac Stress Test Abnormal Panic Attack Tinnitus Bacteraemia Selective Iga Immunodeficiency Marital Problem Exostosis Post-Traumatic Stress Disorder Vestibular Disorder Hyperhidrosis Abnormal Dreams Nystagmus Blood Potassium Decreased Asthma Rash Fatigue Mood Altered Chronic Sinusitis Rapid Eye Movements Sleep Abnormal Mitral Valve Incompetence Electroencephalogram Abnormal
Emotional Disorder Homicidal Ideation Performance Fear Loss Of Consciousness Eye Movement Disorder Memory Impairment Balance Disorder Coordination Abnormal 03-Apr-2012 09:37 AM Page: 701
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemarthrosis Impulsive Behaviour Dysthymic Disorder Dehydration Paranoia Derealisation Contusion Antinuclear Antibody Positive Rheumatoid Factor Increased Chest Pain Musculoskeletal Stiffness Hypervigilance Meniscus Removal Conduction Disorder Pneumonia Deafness Bronchial Hyperreactivity Tremor Blood Pressure Increased Physical Assault Convulsion Hypoaesthesia Myalgia
Report Source Other
Role PS C C
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:04/03/06ISR Number: 4960823-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-427130 Outcome Hospitalization Initial or Prolonged PT Neuralgic Amyotrophy Paresis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female
I/FU:F
Dose Duration FOR FIVE TO SIX WEEKS, BEGINNING THE END OF AUGUST 2005.
Date:04/10/06ISR Number: 4968399-5Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-06P-151-0329756-00 Outcome Disability PT Paresis Hepatic Cyst Paraesthesia Report Source Product Klaricid Film-Coated Tablets Mefloquine Mefloquine Mefloquine Klaricid Film-Coated Tablets Melisec Thyorsian Yecueine Pepermint Role PS SS SS SS SS C C C C Manufacturer
Gender:Female Dose
DAY
Salvia Clavulin
C C
ORAL
500 MG/125 MG
03-Apr-2012
09:37 AM
Page: 702
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/06ISR Number: 4969270-5Report Type:Expedited (15-DaCompany Report #CH-ROCHE-442702 Outcome Disability PT Paresis Hepatic Cyst Drug Interaction Paraesthesia Confusional State Drug Level Decreased Fatigue Report Source Product Lariam Lariam Role PS SS Manufacturer Roche Roche Age:57 YR Route ORAL ORAL Gender:Female Dose TAKEN 6 CAPSULES OF 250 MG IN 3 DAYS (SELF-MEDICAT STRENGHTH REPORTED AS 500 MG/ 125 MG. FILM COATED FILM COATED TABLETS. I/FU:I Duration
DAY
Lariam Augmentin
SS C
Roche
ORAL ORAL
6 6
DAY DAY
Klacid
ORAL
Date:04/13/06ISR Number: 4973397-1Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Panic Attack
Company Report #CTU 274136 Report Source Product Mefloquine (Unknown Manuf.) Role PS Manufacturer
Gender:Male Dose 250 MG WEEKLY P.O.
I/FU:I Duration
Date:04/14/06ISR Number: 4973077-2Report Type:Expedited (15-DaCompany Report #CA-ROCHE-443261 Outcome Other Serious PT Anxiety Delusion Paranoia Depression Report Source Product Mefloquine Hydrochloride Cipralex Clonazepam Risperdal Role PS C C C Manufacturer Roche
Age:32 YR Route UNKNOWN UNKNOWN UNKNOWN UNKNOWN
Gender:Male Dose
Date:04/18/06ISR Number: 4976519-1Report Type:Direct Outcome Life-Threatening Other Serious PT Anxiety Dyspnoea Insomnia Chest Discomfort
Company Report #CTU 274487 Report Source Product Mefloquine 250mg Barr Laboratories, Role PS Manufacturer Barr Laboratories
Gender:Female Dose 250MG ONCE A WEEK BUCCAL
I/FU:I Duration
Age: Route
Gender:Male Dose
I/FU:I Duration
Other Serious
Panic Attack Hallucination Tinnitus Nightmare Anxiety
Mefloquine Hydrochloride Tablet 250 Mg Sandoz, Inc
PS
Sandoz, Inc
ORAL
1/4 TABLET ONCE WEEKLY PO
03-Apr-2012
09:37 AM
Page: 703
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/06ISR Number: 4979539-6Report Type:Expedited (15-DaCompany Report #NG-ROCHE-444178 Outcome Hospitalization Initial or Prolonged PT Confusional State Hypersensitivity Disorientation Incoherent Report Source Product Lariam Role PS Manufacturer Roche Age:27 YR Route UNKNOWN Gender:Female Dose I/FU:I Duration
Date:04/21/06ISR Number: 4979606-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-444160 Outcome Disability PT Retinal Artery Occlusion Report Source Product Lariam Unspecified Medication Norflex Voltarol Simvastatin Role PS C C C C Manufacturer Roche
Age:76 YR Route ORAL ORAL ORAL INTRAMUSCULAR ORAL
Gender:Male Dose
Date:04/24/06ISR Number: 4980521-3Report Type:Expedited (15-DaCompany Report #SE-ROCHE-444010 Outcome Hospitalization Initial or Prolonged PT Pyrexia Oedema Peripheral Nausea Cold Sweat Fatigue Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:04/25/06ISR Number: 4982322-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Abnormal Behaviour Visual Impairment Suicidal Ideation Selective Iga Immunodeficiency Cranial Nerve Disorder Joint Dislocation Hyperhidrosis Thinking Abnormal Eosinophilia Ventricular Extrasystoles Hypervigilance Ill-Defined Disorder Psychiatric Symptom Cognitive Disorder Dysthymic Disorder Oxygen Saturation
Age:45 YR
Gender:Male
I/FU:F
Decreased Antinuclear Antibody Positive Mood Swings Depression Hallucination, Visual Chest Pain Decreased Activity 03-Apr-2012 09:37 AM Page: 704
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Rate Increased Ligament Sprain Nocturia Anxiety Fatigue Major Depression Generalised Anxiety Disorder Toxicity To Various Agents Bundle Branch Block Right Exostosis Dehydration Convulsion Eye Movement Disorder Insomnia Memory Impairment Vertigo Productive Cough Mitral Valve Calcification Nystagmus Disturbance In Attention Dyspnoea Hypertension Meniscus Lesion Fall Tremor Homicidal Ideation Craniocerebral Injury Mitral Valve Incompetence Attention Deficit/Hyperactivity Disorder Contusion Myalgia Agitation Balance Disorder Chest Discomfort Headache Panic Disorder Sleep Apnoea Syndrome Psychotic Disorder Post-Traumatic Stress Disorder Musculoskeletal Pain Asthma Humerus Fracture Weight Decreased Aggression Asthenia Bronchial Hyperreactivity
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Self-Injurious Ideation Hypoaesthesia Rheumatoid Factor Increased Rhinitis Allergic Pyrexia Rash Papular 03-Apr-2012 09:37 AM Page: 705
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/06ISR Number: 4990843-8Report Type:Expedited (15-DaCompany Report #GXKR2006IN02239 Outcome Disability Other Serious PT Areflexia Abasia Dysgraphia Polyneuropathy Rash Erythematous Hypokinesia Hypotonia Neuropathy Peripheral Report Source Foreign Literature Health Professional Other Product Mefloquine (Ngx) (Mefloquine) Chloroquine Role PS C Manufacturer Age:50 YR Route ORAL Gender:Male Dose SEE IMAGE I/FU:I Duration 1 DAY
Date:04/28/06ISR Number: 4991115-8Report Type:Expedited (15-DaCompany Report #GXKR2006IN01102 Outcome Other Serious PT Asthenia Polyneuropathy Dermatitis Infected Skin Ulcer Report Source Foreign Literature Health Professional Other Product Mefloquine (Ngx) (Mefloquine) Role PS Manufacturer
Age:40 YR Route
I/FU:I Duration
Date:05/01/06ISR Number: 4989706-3Report Type:Expedited (15-DaCompany Report #007178 Outcome Other Serious PT Confusional State Heart Rate Increased Decreased Appetite Suicidal Ideation Disturbance In Attention Anxiety Report Source Consumer Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Tablet, 250mg Prenatal Vitamins (Ascorbic Acid, Vitamin D Nos, Minerals Nos, Vitamins B Nos, Role Manufacturer
Age:39 YR Route
Gender:Female Dose
I/FU:I Duration
PS
ORAL
1 TABLET, WEEKLY, ORAL
Date:05/08/06ISR Number: 4995548-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-329897 Outcome Hospitalization Initial or Prolonged PT Suicide Attempt Depression Paraesthesia Respiratory Disorder Panic Attack Dysthymic Disorder Heart Rate Increased Intentional Self-Injury
Age:30 YR
Gender:Female
I/FU:I
Fatigue Fear Claustrophobia Chest Pain Nightmare Headache Mood Swings Mental Impairment 03-Apr-2012 09:37 AM Page: 706
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastrointestinal Disorder Overdose Anxiety Insomnia
Report Source
Product Lariam Prozac Trazodone
Role PS C C
Manufacturer Roche
Dose TAKEN TWO DOSES IN TOTAL.
Duration 8 DAY
Date:05/11/06ISR Number: 4999408-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-446876 Outcome Hospitalization Initial or Prolonged PT Renal Failure Acute Dialysis Report Source Product Lariam Lasilix Solupred Renitec Neoral Mopral Role PS C C C C C Manufacturer Roche
Age:65 YR Route ORAL ORAL ORAL ORAL ORAL ORAL
Gender:Female Dose 1 DOSE WEEKLY. 3 DOSES DAILY. ONE DOSE DAILY.
Date:05/11/06ISR Number: 4999413-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-446907 Outcome Hospitalization Initial or Prolonged PT Chest Pain Syncope Blood Pressure Decreased Myalgia Musculoskeletal Stiffness Loss Of Consciousness Report Source Product Lariam Cilest Role PS C Manufacturer Roche
Gender:Female Dose
Date:05/16/06ISR Number: 5004582-0Report Type:Direct Outcome Other Serious PT Abnormal Dreams Anxiety Mood Altered Paranoia Nausea
Company Report #CTU 276678 Report Source Product Mefloquine Hydrochloride 250 Mg Roche Laboratories Role PS Manufacturer Roche Laboratories
Gender:Female Dose 1 TABLET ONCE A WEEK PO
I/FU:I Duration
Date:05/18/06ISR Number: 5005520-7Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Outcome Hospitalization PT Nystagmus Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose TAKEN ON 22
I/FU:F Duration
Balance Disorder Diarrhoea Tinnitus Hearing Impaired Vertigo Dizziness Nausea
FEB, 01 MAR AND 08 MAR 2005.
15
DAY
03-Apr-2012
09:37 AM
Page: 707
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/06ISR Number: 5009780-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-444178 Outcome Hospitalization Initial or Prolonged Disability PT Anxiety Confusional State Incoherent Hypersensitivity Depression Disorientation Report Source Product Lariam Role PS Manufacturer Roche Age:27 YR Route ORAL Gender:Female Dose I/FU:I Duration 15 DAY
Date:05/24/06ISR Number: 5011972-9Report Type:Expedited (15-DaCompany Report #2006-BP-05361RO Outcome Other Serious PT Infected Skin Ulcer Polyneuropathy Dermatitis Skin Ulcer Report Source Foreign Literature Health Professional Product Mefloquine (Mefloquine) Role PS Manufacturer
Gender:Female Dose 1000 MG COURSE, PO
I/FU:I Duration
Date:05/24/06ISR Number: 5011974-2Report Type:Expedited (15-DaCompany Report #2006-BP-05360RO Outcome Other Serious PT Polyneuropathy Hypotonia Hypoaesthesia Rash Erythematous Dysstasia Abasia Burning Sensation Muscular Weakness Asthenia Activities Of Daily Living Impaired Paraesthesia Arthropathy Areflexia Report Source Foreign Literature Health Professional Product Mefloquine (Mefloquine) Role PS Manufacturer
Gender:Male Dose 1000 MG DAY 1, 500 MG DAY 2, PO
I/FU:I Duration
Date:05/26/06ISR Number: 5013961-7Report Type:Direct Outcome Other Serious PT Anxiety Nightmare Feeling Abnormal Fear Mental Disorder Depression Suicidal Ideation Mental Impairment
Company Report #CTU 277654 Report Source Product Lariam -MefloquineRole PS Manufacturer
Age: Route ORAL
Gender:Male Dose ONCE A WEEK PO
I/FU:I Duration
Thinking Abnormal Malaise
03-Apr-2012
09:37 AM
Page: 708
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/06ISR Number: 5013837-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-448428 Outcome Hospitalization Initial or Prolonged Congenital Anomaly PT Umbilical Malformation Maternal Exposure During Pregnancy Abortion Induced Report Source Product Lariam Role PS Manufacturer Roche Age:31 YR Route ORAL Gender:Female Dose I/FU:I Duration
Date:05/31/06ISR Number: 5014899-1Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Outcome Hospitalization Initial or Prolonged Disability PT Nystagmus Tinnitus Balance Disorder Diarrhoea Deafness Unilateral Nausea Hearing Impaired Dizziness Vertigo Vestibular Neuronitis Report Source Product Lariam Role PS Manufacturer Roche
I/FU:F Duration
15
DAY
Date:05/31/06ISR Number: 5014941-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-441981 Outcome Other Serious PT Irritable Bowel Syndrome Personality Change Depression Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:06/01/06ISR Number: 5015586-6Report Type:Expedited (15-DaCompany Report #SE-ROCHE-449547 Outcome Hospitalization Initial or Prolonged PT Umbilical Malformation Abortion Maternal Exposure During Pregnancy Pregnancy Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:06/01/06ISR Number: 5036335-1Report Type:Periodic Outcome Death PT Headache Decreased Appetite Chills Abdominal Pain Upper
Age:36 YR
Gender:Male
I/FU:I
Pyrexia Diarrhoea Anuria Respiratory Rate Increased Psychiatric Symptom Eye Disorder Vomiting 03-Apr-2012 09:37 AM Page: 709
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Local Swelling Nausea Oropharyngeal Pain Ear Congestion Balance Disorder Ear Disorder Dizziness Malaria Cough Swelling Face
Role PS
Manufacturer
Route ORAL
Dose ORAL
Duration
Date:06/01/06ISR Number: 5036336-3Report Type:Periodic Outcome Disability PT Loss Of Consciousness Insomnia Vision Blurred Amnesia Depression Mental Impairment Disturbance In Attention Suicidal Ideation Balance Disorder
Age: Route ORAL
I/FU:I Duration
Date:06/01/06ISR Number: 5036337-5Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Panic Attack Anxiety
Age: Route ORAL
Date:06/01/06ISR Number: 5036338-7Report Type:Periodic Outcome Other Serious PT Panic Attack Depression Paranoia
Company Report #412629 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Birth Control Pills Nos (Oral Contraceptive Nos) Albuterol (Albuterol) Lexapro (Escitalopram) Role PS Manufacturer
I/FU:I Duration
C C C
Date:06/01/06ISR Number: 5036339-9Report Type:Periodic Outcome Other Serious PT Suicidal Ideation Memory Impairment Enuresis Emotional Disorder 09:37 AM
Age:22 YR
Gender:Female
I/FU:I
03-Apr-2012
Page: 710
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Joint Injury Disorientation Alcohol Intolerance Anxiety Depression Neurological Examination Abnormal Panic Attack Coordination Abnormal Abnormal Dreams Paranoia
Role PS
Manufacturer
Route ORAL
Duration
Date:06/01/06ISR Number: 5036340-5Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Convulsion
I/FU:I Duration
Date:06/01/06ISR Number: 5036341-7Report Type:Periodic Outcome Life-Threatening Required Intervention to Prevent Permanent Impairment/Damage PT Suicidal Ideation Depression
Company Report #427138 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Antidepressant Nos (Antidepressant Nos) Role PS C Manufacturer
I/FU:I Duration
Company Report #428956 Report Source Consumer Health Professional Product Lariam (Mefloquine Hydrochloride) Birth Control Pills Nos (Oral Contraceptive Nos) Role PS C Manufacturer
I/FU:I Duration
Date:06/01/06ISR Number: 5036343-0Report Type:Periodic Outcome Hospitalization Initial or Prolonged Disability PT Lichen Planus Headache Suicidal Ideation
Age:40 YR
Gender:Male
I/FU:F
Hyperhidrosis Anhedonia Tinnitus Groin Pain Haematuria Vestibular Disorder Oral Disorder Heart Rate Increased 03-Apr-2012 09:37 AM Page: 711
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paraesthesia Nightmare Blood Pressure Increased Hyperventilation Depression Major Depression Dysuria Rash Papular Vision Blurred Insomnia Mood Altered Nystagmus Urethritis Dyspnoea Toxicity To Various Agents Chest Discomfort Depressed Mood Agoraphobia Pain In Extremity Agitation Panic Disorder Epicondylitis Disturbance In Attention Vertigo Balance Disorder Panic Attack Anxiety Erythema Dizziness Fatigue Decreased Activity Decreased Interest Vitreous Floaters Activities Of Daily Living Impaired
Role PS
Manufacturer
Route ORAL
Dose 250 MG ORAL
Duration
Date:06/01/06ISR Number: 5036344-2Report Type:Periodic Outcome Death PT Completed Suicide Fatigue Hostility Sleep Apnoea Syndrome Abnormal Dreams Memory Impairment Disorientation Communication Disorder Emotional Distress Dysarthria Gun Shot Wound
Company Report #369650 Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Inderal (Propranolol) Cimetidine (Cimetidine) Xanax (Alprazolam) Role PS C C C Manufacturer
I/FU:I Duration
Mood Swings Agitation Self Esteem Decreased Tinnitus Fear
03-Apr-2012
09:37 AM
Page: 712
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/06ISR Number: 5036345-4Report Type:Periodic Outcome Death PT Paranoia Night Sweats Fatigue Gun Shot Wound Post-Traumatic Stress Disorder Social Avoidant Behaviour Delusion Diarrhoea Sleep Disorder Emotional Disorder Poor Quality Sleep Completed Suicide Insomnia Agitation Depression Mood Swings Headache Aggression Company Report #380190 Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age:31 YR Route ORAL Gender:Male Dose 1 DOSE FORM 1 PER WEEK ORAL I/FU:I Duration
Date:06/01/06ISR Number: 5036346-6Report Type:Periodic Outcome Disability PT Amnesia Headache
I/FU:I Duration
Date:06/01/06ISR Number: 5036347-8Report Type:Periodic Outcome Death PT Psychotic Disorder Back Pain Depression Agitation Rash Pyrexia Paraesthesia Hypoaesthesia Headache Tinnitus Fatigue Cough Myalgia Diarrhoea Mood Swings
Company Report #395651 Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Glucosamine (Glucosamine) Chondroitin (Chondroitin Sulfate) Celebrex (Celecoxib) Role PS C C C Manufacturer
I/FU:I Duration
Anger Completed Suicide Deafness Arthralgia Asthenia Spousal Abuse Panic Attack 03-Apr-2012 09:37 AM Page: 713
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/06ISR Number: 5036348-XReport Type:Periodic Outcome Disability PT Sleep Disorder Mood Swings Insomnia Company Report #398411 Report Source Health Professional Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age:10 YR Route ORAL Gender:Female Dose 1 PER WEEK ORAL I/FU:I Duration
Date:06/06/06ISR Number: 5019015-8Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0426071A Outcome Hospitalization Initial or Prolonged PT Drug Ineffective Hallucination Major Depression Report Source Product Malarone Lariam Role PS SS Manufacturer Glaxosmithkline
Gender:Female Dose 2250MG per day
Date:06/06/06ISR Number: 5019336-9Report Type:Expedited (15-DaCompany Report #SE-ROCHE-448488 Outcome Other Serious PT Angioedema Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:06/09/06ISR Number: 5022485-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-450157 Outcome Hospitalization Initial or Prolonged PT Pericarditis Ventricular Extrasystoles Myocardial Infarction Sinus Tachycardia Myocarditis Extrasystoles Report Source Product Lariam Mediator 150 Havrix Rabipur Role PS SS C C Manufacturer Roche
Age:43 YR Route ORAL ORAL INTRAMUSCULAR INTRAMUSCULAR
Gender:Male Dose REPORTED AS 250 MG AT TOTAL. 1 DOSE. 1 DOSE.
I/FU:I Duration 1 726 1 1 DAY DAY DAY DAY
Date:06/15/06ISR Number: 5026560-8Report Type:Expedited (15-DaCompany Report #CH-ROCHE-308974 Outcome Hospitalization Initial or Prolonged PT Pulmonary Toxicity Toxicity To Various Agents Diffuse Alveolar Damage Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:06/16/06ISR Number: 5027852-9Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Outcome Hospitalization Initial or Prolonged PT Dizziness Vertigo Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose TAKEN ON 22 FEB, 01 MAR
I/FU:F Duration
Disability
Balance Disorder Nausea Tinnitus Diarrhoea Nystagmus Hearing Impaired
AND 08 MAR 2005.
15
DAY
03-Apr-2012
09:37 AM
Page: 714
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/06ISR Number: 5027885-2Report Type:Expedited (15-DaCompany Report #SE-ROCHE-449547 Outcome Hospitalization Initial or Prolonged PT Maternal Exposure During Pregnancy Abortion Umbilical Malformation Report Source Product Lariam Role PS Manufacturer Roche Age:31 YR Route ORAL Gender:Female Dose I/FU:I Duration
Date:06/20/06ISR Number: 5030269-4Report Type:Expedited (15-DaCompany Report #CH-ROCHE-428290 Outcome Hospitalization Initial or Prolonged PT Hypoxia Haemoglobin Decreased Diarrhoea Lung Infiltration Pulmonary Toxicity Blood Pressure Decreased General Physical Health Deterioration Diffuse Alveolar Damage Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose RECEIVED A TOTAL DOSE OF 1500MG OF MEFLOQUINE OVER 24 HOURS FOR 48 HOURS
I/FU:I Duration
Paracetamol Halofantrine
C C
Date:06/20/06ISR Number: 5032579-3Report Type:Direct Outcome PT Simple Partial Seizures Muscle Spasms Sleep Disorder Paraesthesia Sensory Loss Depression Abnormal Sensation In Eye Dizziness Auricular Swelling Hypoaesthesia Disorientation Paranoia Anxiety Asthenia Fatigue Menstrual Disorder Oropharyngeal Pain Nervous System Disorder Mood Swings Confusional State Intracranial Pressure Increased Feeling Cold Anhidrosis Blindness
Company Report #CTU 279190 Report Source Product Mefloquine (Lariam) Role PS Manufacturer Sandoz
Gender:Female
I/FU:I
Dose Duration 250 MG ONE TIME DOSE PO
Date:06/20/06ISR Number: 5032742-1Report Type:Direct Outcome Life-Threatening Hospitalization 03-Apr-2012 09:37 AM
Age:25 YR
Gender:Male
I/FU:I
Page: 715
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage
PT Dysarthria Hallucination Confusional State Toxicity To Various Agents Disturbance In Attention Fatigue Insomnia Dizziness Suicidal Ideation
Report Source
Role PS
Manufacturer Roche
Route
Dose Duration 250 MG WEEKLY
Date:06/22/06ISR Number: 5033028-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Abnormal Behaviour Disturbance In Attention Productive Cough Ill-Defined Disorder Tremor Oxygen Saturation Decreased Hypoaesthesia Mucous Stools Rectal Haemorrhage Balance Disorder Bronchial Hyperreactivity Headache Sleep Apnoea Syndrome Musculoskeletal Pain Hyperhidrosis Dysthymic Disorder Rheumatoid Factor Increased Rash Papular Eosinophilia Paranoia Hypervigilance Breath Odour Nausea Aggression Psychiatric Symptom Decreased Activity Convulsion Dissociative Disorder Hypoacusis Dyspepsia Insomnia Depression
Age:45 YR
Gender:Male
I/FU:F
Selective Iga Immunodeficiency Fatigue Asthenia Chest Discomfort Chest Pain Psychotic Disorder Self-Injurious Ideation 03-Apr-2012 09:37 AM Page: 716
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Meniscus Lesion Thinking Abnormal Homicidal Ideation Mitral Valve Incompetence Dehydration Attention Deficit/Hyperactivity Disorder Contusion Antinuclear Antibody Positive Derealisation Product Contamination Palpitations Somnolence Dizziness Tinnitus Emotional Disorder Eructation Anxiety Memory Impairment Hallucination, Visual Hypertension Fall Asthma Weight Decreased Nystagmus Eye Movement Disorder Ligament Sprain Coordination Abnormal Vestibular Disorder Weight Increased Snoring Coronary Artery Disease Non-Cardiac Chest Pain Angina Pectoris Visual Impairment Dyspnoea Cranial Nerve Disorder Joint Dislocation Cognitive Disorder Craniocerebral Injury Humerus Fracture Pyrexia Product Quality Issue Abdominal Pain Upper Photophobia Agitation Mood Swings Generalised Anxiety Disorder Post-Traumatic Stress Disorder
Bundle Branch Block Right Exostosis Rhinitis Allergic Nocturia Heart Rate Decreased Rash Vertigo Suicidal Ideation 03-Apr-2012 09:37 AM Page: 717
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Panic Disorder Major Depression Toxicity To Various Agents Mitral Valve Calcification Myalgia Ventricular Extrasystoles Eye Disorder Merycism Upper Respiratory Tract Infection Abdominal Distension Gastrointestinal Motility Disorder
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:06/30/06ISR Number: 5040526-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-452577 Outcome Other Serious PT Depression Suicidal Ideation Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:07/10/06ISR Number: 5046420-6Report Type:Expedited (15-DaCompany Report #ZM-ROCHE-453365 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Blood Creatinine Increased Nephrotic Syndrome Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
Date:07/10/06ISR Number: 5048049-2Report Type:Direct Outcome Other Serious PT Generalised Anxiety Disorder Malaise Emotional Disorder Palpitations Feeling Abnormal Heart Rate Increased
Company Report #CTU 280300 Report Source Product Larium Don'T Know Hoffman-Laroche Role PS Manufacturer Hoffman-Laroche
Age:58 YR Route
Gender:Female Dose 1 PILL WEEKLY
I/FU:I Duration
Date:07/17/06ISR Number: 5052750-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-450157 Outcome Hospitalization Initial or Prolonged PT Myocardial Infarction Supraventricular Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose REPORTED AS 250 MG AS
I/FU:F Duration
Extrasystoles Sinus Tachycardia Pericarditis Ventricular Extrasystoles
TOTAL. Mediator 150 Havrix Rabipur SS C C ORAL INTRAMUSCULAR INTRAMUSCULAR FORM: INJECTABLE SOLUTION.
1 726 1 1
DAY DAY DAY DAY
03-Apr-2012
09:37 AM
Page: 718
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/06ISR Number: 5053702-0Report Type:Expedited (15-DaCompany Report #SE-ROCHE-454148 Outcome Other Serious PT Dyspnoea Angioedema Anxiety Report Source Product Lariam Role PS Manufacturer Roche Age:24 YR Route ORAL Gender:Female Dose I/FU:I Duration 8 DAY
Date:07/18/06ISR Number: 5054159-6Report Type:Expedited (15-DaCompany Report #CA-ROCHE-454857 Outcome Disability PT Nodular Vasculitis Report Source Product Lariam Synthroid Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:07/24/06ISR Number: 5059676-0Report Type:Expedited (15-DaCompany Report #SE-ROCHE-454148 Outcome Other Serious PT Anxiety Angioedema Dyspnoea Sensation Of Foreign Body Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:07/31/06ISR Number: 5065746-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-451414 Outcome Disability PT Asthenia Nausea Oropharyngeal Pain Mood Swings Anxiety Abdominal Discomfort Depression Confusional State Thinking Abnormal Abdominal Pain Diarrhoea Musculoskeletal Pain Tremor Feeling Abnormal Amnesia Disease Recurrence Fatigue Myalgia Bedridden Report Source Product Lariam Lariam Lariam Artesunate Chloroquine Doxycycline Role PS SS SS C C C Manufacturer Roche Roche Roche
Age:25 YR Route ORAL ORAL ORAL ORAL ORAL
Gender:Male Dose
I/FU:I Duration
DAY
Date:08/11/06ISR Number: 5078369-7Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0426071A
Age:28 YR
Gender:Female
I/FU:F
Outcome Hospitalization Initial or Prolonged Disability
PT Drug Ineffective Hallucination Insomnia Major Depression
Report Source
Product Malarone Lariam Rohypnol Ciflox
Role PS SS SS C
Manufacturer Glaxosmithkline Other Other Other
Route ORAL ORAL ORAL UNKNOWN
Dose Duration 2TAB Three times per day 3 DAY 1250MG per day 1 DAY 5MG Per day 3 WK 8 DAY Page: 719
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/06ISR Number: 5079426-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-452577 Outcome Disability PT Psychiatric Symptom Anxiety Suicidal Ideation Depression Panic Attack Report Source Product Lariam Teoptic Role PS C Manufacturer Roche Age:62 YR Route ORAL OPHTHALMIC Gender:Male Dose I/FU:F Duration 29 DAY
Date:08/17/06ISR Number: 5082526-3Report Type:Expedited (15-DaCompany Report #SE-ROCHE-454148 Outcome Other Serious PT Dyspnoea Angioedema Sensation Of Foreign Body Anxiety Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:08/22/06ISR Number: 5087940-8Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Rash Duodenitis Decreased Appetite Leukocytoclastic Vasculitis Infection Nonspecific Reaction Asthenia Gastritis
Company Report #CTU 283391 Report Source Product Mefloquine Chloroquine Pravachol Loratidine Plavix Lotrel Toprol Nitroglycerin Patch Aspirin Role PS SS C C C C C C C Manufacturer
Gender:Male Dose PO PO
I/FU:I Duration
Date:08/23/06ISR Number: 5088480-2Report Type:Direct Outcome Other Serious PT Nausea Vertigo Sleep Disorder Abnormal Dreams Suicidal Ideation Insomnia Paranoia Anger Affect Lability Panic Attack Tinnitus Anxiety Depression Headache
Company Report #CTU 283589 Report Source Product Lariam (Mefloquine) Role PS Manufacturer
Age: Route
Gender:Female
I/FU:I
Dose Duration 250 MG 1 TABLET WEEKLY
Dizziness
03-Apr-2012
09:37 AM
Page: 720
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/06ISR Number: 5088864-2Report Type:Expedited (15-DaCompany Report #BE-ROCHE-460045 Outcome Hospitalization Initial or Prolonged PT Pneumonitis Report Source Product Mefloquine Hydrochloride Mefloquine Hydrochloride Bisoprolol Fumarate Ciprofibratum Aspirin Role PS SS C C C Manufacturer Roche Roche Age:60 YR Route UNKNOWN UNKNOWN REPORTED AS CHRONIC MEDICAITON. REPORTED AS CHRONIC MEDICAITON. REPORTED AS: CHRONIC MEDICATION LOW DOSE ASPIRIN. Gender:Female Dose I/FU:I Duration
Date:08/28/06ISR Number: 5093449-8Report Type:Expedited (15-DaCompany Report #2006-BP-09661RO Outcome Hospitalization Initial or Prolonged Other Serious PT Disinhibition Hallucination, Visual Delusion Delusion Of Grandeur Insomnia Persecutory Delusion Delusion Of Reference Mania Psychotic Disorder Report Source Foreign Literature Health Professional Product Mefloquine (Mefloquine) Role PS Manufacturer
Age:22 YR Route
Gender:Male Dose 250 MG PER WEEK (250 MG), PO
I/FU:I Duration
WK
Date:08/31/06ISR Number: 5094068-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-459650 Outcome Other Serious PT Parkinson'S Disease Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:09/05/06ISR Number: 5096297-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-461700 Outcome Hospitalization Initial or Prolonged PT Anaemia Anxiety Confusional State Psychotic Disorder Insomnia Abnormal Behaviour Liver Disorder Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:09/06/06ISR Number: 5097232-9Report Type:Expedited (15-DaCompany Report #SE-ROCHE-461385 Outcome Other Serious 03-Apr-2012 09:37 AM PT Iron Deficiency Leukopenia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose DOSAGE REGIMEN
I/FU:I Duration
Page: 721
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report REPORTED AS 3/4 TABLET.
Date:09/07/06ISR Number: 5098825-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-461020 Outcome Hospitalization Initial or Prolonged PT Thrombosis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:09/08/06ISR Number: 5099741-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-461579 Outcome Hospitalization Initial or Prolonged PT Delusion Hypomania Insomnia Agitation Tearfulness Delusional Disorder, Persecutory Type Report Source Product Mefloquine Hydrochloride Salbutamol Betnovate Role PS C C Manufacturer Roche
Age:18 YR Route ORAL TOPICAL
Gender:Female Dose
Date:09/08/06ISR Number: 5099758-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-461827 Outcome Hospitalization Initial or Prolonged PT Renal Failure Acute Ecchymosis Headache Tendon Disorder Urinary Tract Infection Vaginal Infection Vertigo Rash Report Source Product Lariam Ciprofloxacine Flagyl Paracetamol Polygynax Solubacter Role PS SS SS C C C Manufacturer Roche
Gender:Female Dose
Date:09/08/06ISR Number: 5099759-2Report Type:Expedited (15-DaCompany Report #GB-ROCHE-461998 Outcome Congenital Anomaly PT Renal Dysplasia Pregnancy Maternal Exposure During Pregnancy Report Source Product Lariam Alcohol Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:09/11/06ISR Number: 5104007-0Report Type:Expedited (15-DaCompany Report #GXKR2006BE05415 Outcome Hospitalization PT Respiratory Distress
Age:60 YR
Gender:Female
I/FU:I
Interstitial Lung Disease Leukocytosis Hypoxia Cyanosis Myalgia Headache Rales Blood Lactate Page: 722
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydrogenase Increased Tachycardia Report Source Foreign Literature Health Professional Other Product Mefloquine (Ngx)(Mefloquine) Bisoprolol Fumarate Ciprofibrate Aspirine (Acetylsalicylic Acid) Role PS C C C Manufacturer Route Dose 250 MG, QW Duration
Date:09/12/06ISR Number: 5102387-3Report Type:Expedited (15-DaCompany Report #FR-AVENTIS-200613012FR Outcome Hospitalization Initial or Prolonged PT Renal Failure Acute Ecchymosis Rash Papular Pruritus Vertigo Chills Tendon Disorder Abdominal Pain Lower Urinary Tract Infection Vaginal Infection Headache Report Source Product Flagyl "Aventis" Lariam Ciprofloxacine Morphine Motilium Di-Antalvic Spasfon Polygynax Solubacter Role PS SS SS C C C C C C Manufacturer Aventis Pharmaceuticals Inc.
Gender:Female Dose
I/FU:I Duration
Date:09/15/06ISR Number: 5105797-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-462646 Outcome Other Serious PT Maternal Exposure During Pregnancy Abortion Spontaneous Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:09/19/06ISR Number: 5108165-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-443462 Outcome Hospitalization Initial or Prolonged PT Diarrhoea Vomiting Fatigue Disturbance In Attention Vertigo Visual Impairment Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male
I/FU:I
Dose Duration 4 TABLETS IN TOTAL.
Age:28 YR
Gender:Male
I/FU:I
Outcome Life-Threatening Hospitalization Initial or Prolonged
PT Blood Creatinine Increased Nephrotic Syndrome Oedema Peripheral Blood Albumin Decreased Blood Sodium Decreased Abdominal Distension Page: 723
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Potassium Decreased Body Temperature Decreased Respiratory Rate Increased
Report Source
Role PS
Manufacturer Roche
Route ORAL
Dose
Duration 1 DAY
Date:09/20/06ISR Number: 5109459-8Report Type:Expedited (15-DaCompany Report #BE-ROXANE LABORATORIES, INC-2006-BP-10708RO Outcome Hospitalization Initial or Prolonged PT Pyrexia Leukocytosis Headache Hypoxia Pneumonitis Dyspnoea C-Reactive Protein Increased Cough Chills Tachycardia Blood Lactate Dehydrogenase Increased Cyanosis Myalgia Report Source Product Mefloquine Bisoprolol Fumarate Ciprofibratum Aspirin Role PS C C C Manufacturer Roxane Laboratories, Inc.
Gender:Female Dose 250 mg x 1 dose
I/FU:I Duration
Date:09/20/06ISR Number: 5109460-4Report Type:Expedited (15-DaCompany Report #FR-ROXANE LABORATORIES, INC-2006-BP-10993RO Outcome Death PT Contusion Malaria Mental Disorder Wound Drug Ineffective Completed Suicide Haemothorax Report Source Product Mefloquine Proguanil-Chloroquin e Role PS SS Manufacturer Roxane Laboratories, Inc.
Age:27 YR Route
Gender:Male Dose
I/FU:I Duration 48 3 HR MON
Date:09/20/06ISR Number: 5112513-8Report Type:Direct Outcome Other Serious PT Incontinence Grand Mal Convulsion Tongue Biting
Age: Route
Gender:Male Dose
I/FU:I Duration
Age:28 YR
Gender:Female
I/FU:I
PT Psychotic Disorder
Report Source
Product Mefloquine Roche
Role PS
Manufacturer Roche
Route ORAL
Dose ONE TABLET ONCE A WEEK PO
Duration
03-Apr-2012
09:37 AM
Page: 724
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/06ISR Number: 5117526-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-447408 Outcome Other Serious PT Vomiting Coordination Abnormal Asthenia Tachycardia Dizziness Nausea Hypertension Hot Flush Report Source Product Lariam Anaesthetic Medication Role PS C Manufacturer Roche Age:44 YR Route ORAL Gender:Female Dose REPORTED AS ANAESTHESIA, LOCAL. I/FU:F Duration
Date:10/09/06ISR Number: 5122975-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-465214 Outcome Other Serious PT Myalgia Monoplegia Pain Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:10/10/06ISR Number: 5123787-1Report Type:Expedited (15-DaCompany Report #FR-AVENTIS-200613012FR Outcome Hospitalization Initial or Prolonged PT Vertigo Rash Papular Headache Leukocytosis Ecchymosis Chills Urinary Tract Infection Renal Failure Acute Tendon Disorder Gamma-Glutamyltransferase Increased Muscle Spasms Pruritus Report Source Product Flagyl "Aventis" Lariam Ciprofloxacine Morphine Motilium Diantalvic Spasfon Polygynax Solubacter Role PS SS SS C C C C C C Manufacturer Aventis Pharmaceuticals Inc.
Gender:Female Dose
I/FU:F Duration
Date:10/16/06ISR Number: 5127772-5Report Type:Expedited (15-DaCompany Report #ZM-ROCHE-430119 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Nephrotic Syndrome Blood Creatinine Increased Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
Age:28 YR
Gender:Male
I/FU:I
PT Blood Creatinine Increased Nephrotic Syndrome Respiratory Rate Increased
Report Source
Role PS
Manufacturer Roche
Route ORAL
Dose
Duration 1 DAY
03-Apr-2012
09:37 AM
Page: 725
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/06ISR Number: 5128708-3Report Type:Expedited (15-DaCompany Report #FR-AVENTIS-200613012FR Outcome Hospitalization Initial or Prolonged PT Constipation Chills Gamma-Glutamyltransferase Increased Muscle Spasms Rash Papular Vertigo Headache Pain Renal Failure Acute Pruritus Abdominal Pain Tendon Disorder Ecchymosis Leukocytosis Report Source Product Flagyl Lariam Ciprofloxacine Morphine Motilium Diantalvic Spasfon Polygynax Solubacter Role PS SS SS C C C C C C Manufacturer Aventis Pharmaceuticals Inc. Age:39 YR Route ORAL ORAL ORAL Gender:Female Dose I/FU:F Duration
Date:10/18/06ISR Number: 5129717-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-466784 Outcome Other Serious PT Tongue Ulceration Pharyngeal Ulceration Oropharyngeal Pain Inflammation Oral Administration Complication Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:10/23/06ISR Number: 5132543-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-461827 Outcome Hospitalization Initial or Prolonged PT Prurigo Urinary Tract Infection Rash Papular Constipation Rash Erythematous Renal Failure Acute Vertigo Abdominal Pain Headache Ecchymosis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Ciprofloxacine Flagyl Paracetamol Polygynax Solubacter
SS SS C C C
ORAL ORAL
Dose Duration FIRST TABLET ON 17 JUL 2006, SECOND TABLET ON 24 JUL 2006. 8 DAY 15 DAY 15 DAY
Date:10/24/06ISR Number: 5133707-1Report Type:Expedited (15-DaCompany Report #IT-ROCHE-467032 Outcome Hospitalization PT Hepatic Failure Report Source Product Mefloquine Role Manufacturer
Age:46 YR Route
Gender:Female Dose
I/FU:I Duration
Hepatomegaly Hepatic Steatosis
Hydrochloride
PS
Roche
UNKNOWN
TREATMENT INTERRUPTED AFTER THE 5TH WEEK
03-Apr-2012
09:37 AM
Page: 726
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/06ISR Number: 5138679-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-459650 Outcome Other Serious PT Parkinsonism Report Source Product Lariam Role PS Manufacturer Roche Age:39 YR Route ORAL Gender:Male Dose I/FU:F Duration
Date:10/30/06ISR Number: 5138717-6Report Type:Expedited (15-DaCompany Report #NL-ROCHE-467834 Outcome Hospitalization Initial or Prolonged PT Hypertensive Crisis Report Source Product Lariam Metoprolol Tartrate Simvastatin Coversyl Plus Role PS C C C Manufacturer Roche
Gender: Dose
STRENGTH REPORTED AS 4/1,25 MG.
Date:10/30/06ISR Number: 5138723-1Report Type:Expedited (15-DaCompany Report #RU-ROCHE-467843 Outcome Other Serious PT Gamma-Glutamyltransferase Increased Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration ONCE ONE TABLET OF 250 MG. 1 DAY
Date:11/06/06ISR Number: 5144153-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457439 Outcome Hospitalization Initial or Prolonged PT Convulsion Haematocrit Decreased Respiratory Disorder Vomiting Salivary Hypersecretion Haemoglobin Decreased Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:11/14/06ISR Number: 5158996-9Report Type:Expedited (15-DaCompany Report #D0045516A Outcome Life-Threatening Hospitalization Initial or Prolonged PT Drug Ineffective Depressed Level Of Consciousness Cerebral Malaria Psychiatric Symptom Myoclonic Epilepsy Report Source Foreign Literature Health Professional Other Product Malarone Sodium Artesunate (Sodium Artesunate) Role PS SS Manufacturer
Gender:Female Dose ORAL PER DAY ORAL
I/FU:I Duration
Age:43 YR
Gender:Female
I/FU:F
PT Tachycardia Asthenia Dizziness Hypertension Hot Flush Vomiting 09:37 AM Page: 727
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coordination Abnormal Nausea Report Source Product Lariam Femoston Jodetten Anaesthetic Medication Role PS C C C REPORTED AS ANAESTHESIA, LOCAL. Manufacturer Roche Route ORAL Dose TAKEN FOR YEARS. Duration
Date:11/22/06ISR Number: 5157901-9Report Type:Direct Outcome Other Serious PT Anxiety Panic Attack Insomnia Depression
Company Report #CTU 289911 Report Source Product Lariam 250 Mg (Weekly) Roche Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose 250 MG ONCE WEEKLY ORALLY
I/FU:I Duration
Date:11/24/06ISR Number: 5156951-6Report Type:Expedited (15-DaCompany Report #NL-ROCHE-467834 Outcome Hospitalization Initial or Prolonged PT Hypertensive Crisis Malignant Hypertension Report Source Product Lariam Cosopt Role PS C Manufacturer Roche
Age:59 YR Route ORAL OTHER
Gender:Male Dose ROUTE REPORTED AS OCULAR AND FORM REPORTED AS EYEDROPS. STRENGTH REPORTED AS 4/1,25 MG.
Simvastatin Coversyl Plus Selokeen
C C C
ORAL ORAL ORAL
Date:11/27/06ISR Number: 5165169-2Report Type:Expedited (15-DaCompany Report #GXKR2006SG07387 Outcome Other Serious PT Contusion Rectal Haemorrhage Platelet Count Increased Report Source Foreign Literature Health Professional Other Product Mefloquine (Ngx) (Mefloquine) Unknown Role PS Manufacturer
Age:46 YR Route
Gender:Female Dose QW
I/FU:I Duration
Date:11/28/06ISR Number: 5159052-6Report Type:Expedited (15-DaCompany Report #SG-ROXANE LABORATORIES, INC-2006-BP-13605RO
Age:46 YR
Gender:Female
I/FU:I
PT Platelet Count Increased Contusion Rectal Haemorrhage
Report Source
Product Mefloquine
Role PS
Manufacturer Roxane Laboratories, Inc.
Route
Dose once weekly x 3 weeks
Duration 3 WK
03-Apr-2012
09:37 AM
Page: 728
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/06ISR Number: 5162883-XReport Type:Expedited (15-DaCompany Report #113217 Outcome Hospitalization Initial or Prolonged PT Hepatomegaly Toxicity To Various Agents Metabolic Disorder Nausea Nervousness Diarrhoea Abdominal Distension Depression Vomiting Alcohol Use Weight Decreased Dehydration Hepatic Steatosis Decreased Appetite Gastroenteritis Gravitational Oedema Hepatic Failure Report Source Product Lariam Tablets Role PS Manufacturer Roche Age:46 YR Route ORAL Gender:Female Dose I/FU:I Duration
Date:12/04/06ISR Number: 5163420-6Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457439 Outcome Hospitalization Initial or Prolonged PT Haematocrit Decreased Platelet Count Increased Fatigue Convulsion Respiratory Disorder Haemoglobin Decreased Vomiting Dyspnoea Salivary Hypersecretion Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:12/08/06ISR Number: 5168390-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-472987 Outcome Other Serious PT Torticollis Laryngeal Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:12/11/06ISR Number: 5175373-5Report Type:Direct Outcome Other Serious Required Intervention to PT Restlessness Tinnitus Fatigue
Age:36 YR Route
Gender:Male
I/FU:I
Dose Duration THREE PILLS OF 250 MG ONE A WEEK 3 WK
Mood Swings
03-Apr-2012
09:37 AM
Page: 729
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/06ISR Number: 5174215-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-474014 Outcome Hospitalization Initial or Prolonged PT Vasculitis Human Ehrlichiosis Creatinine Renal Clearance Increased Nephritis Report Source Product Lariam Role PS Manufacturer Roche Age: Route UNKNOWN Gender:Female Dose I/FU:I Duration
Date:12/18/06ISR Number: 5177195-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-474927 Outcome Congenital Anomaly PT Aplasia Maternal Exposure During Pregnancy Abortion Induced Foetal Malformation Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:12/19/06ISR Number: 5179370-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-98097 Outcome Death PT Depression Femur Fracture Completed Suicide Skull Fracture Abnormal Behaviour Fall Multiple Injuries Facial Bones Fracture Aortic Rupture Report Source Product Lariam Tablets Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:12/19/06ISR Number: 5179424-3Report Type:Expedited (15-DaCompany Report #CA-ROCHE-940804124001 Outcome Death Life-Threatening PT Hallucination Completed Suicide Report Source Product Lariam Alcohol Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:12/19/06ISR Number: 5191295-8Report Type:Direct Outcome Other Serious PT Hallucination Insomnia Rapid Eye Movements Sleep Abnormal Hyperhidrosis
Age:42 YR
Gender:Female
I/FU:I
Crying Nausea Nightmare Emotional Disorder Hypoaesthesia Myocardial Infarction Decreased Appetite Paranoia 03-Apr-2012 09:37 AM Page: 730
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paraesthesia Dizziness Report Source Product Mefloquine 250 Mg Sandoz Role PS Manufacturer Sandoz Route ORAL Dose 1 TABLET WEEKLY PO Duration
Date:12/21/06ISR Number: 5188158-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-447408 Outcome Other Serious PT Hypertension Hot Flush Coordination Abnormal Nausea Vomiting Tachycardia Asthenia Dizziness Report Source Product Lariam Femoston Role PS C Manufacturer Roche
Gender:Female Dose DRUG NAME REPORTED AS FEMOSTON 2/10. TAKEN FOR YEARS. DRUG NAME REPORTED AS JODETTEN DEPOT. DOSAGE REGIMEN REPORTED AS ANAESTHESIA, LOCAL.
I/FU:F Duration
Jodetten
ORAL
Anaesthetic Medication
Date:01/02/07ISR Number: 5195733-6Report Type:Expedited (15-DaCompany Report #FR-ROCHE-472987 Outcome Other Serious PT Laryngeal Disorder Dystonia Torticollis Speech Disorder Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:01/03/07ISR Number: 5199854-3Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Asthenia Depression Hypothyroidism Lethargy Fatigue Mental Disorder
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:01/09/07ISR Number: 5202168-6Report Type:Expedited (15-DaCompany Report #IT-ROCHE-476898
Age:44 YR
Gender:Female
I/FU:I
PT Angioedema Urticaria
Report Source
Product Lariam Amoxicilline
Role PS SS
Manufacturer Roche
Route ORAL ORAL
Dose
03-Apr-2012
09:37 AM
Page: 731
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/07ISR Number: 5203930-6Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Anxiety Paranoia Delusion Convulsion Loss Of Proprioception Heart Rate Increased Panic Attack Psychotic Disorder Company Report #CTU 292996 Report Source Product Larium Role PS Manufacturer Age:16 YR Route ORAL Gender:Female I/FU:I
Dose Duration 1 TABLET ONCE DAILY ORALLY 8 DAY
Date:01/11/07ISR Number: 5208350-6Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Balance Disorder Anxiety Fatigue Brain Injury Hallucination Panic Attack Insomnia Impaired Work Ability Aphasia Suicidal Ideation Psychiatric Symptom Feeling Of Body Temperature Change Cold Sweat Psychotic Disorder Vestibular Neuronitis Dizziness Chills Headache Disturbance In Attention Depression Neurotoxicity Convulsion
Company Report #CTU 293144 Report Source Product Lariam 250mg Roche Travel Role PS C Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration 250 MG WEEKLY PO 3 WK
Date:01/17/07ISR Number: 5210481-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-477655 Outcome Hospitalization Initial or Prolonged PT Vestibular Disorder Convulsion Psychotic Disorder Nightmare Hallucination Suicidal Ideation Thinking Abnormal Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female
I/FU:I
Dose Duration THE PATIENT REPORTED TAKING THREE LARIAM "PILLS" IN
Aggression Insomnia
03-Apr-2012
09:37 AM
Page: 732
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/07ISR Number: 5211569-1Report Type:Direct Outcome Disability PT Night Blindness Maculopathy Visual Acuity Reduced Colour Blindness Scotoma Company Report #CTU 293643 Report Source Product Mefloquine 250 Mg Roche Erythromycin Role PS C Manufacturer Roche Age: Route ORAL Gender:Female Dose 250 MG PO QWK PO I/FU:I Duration
Date:01/19/07ISR Number: 5213113-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-478024 Outcome Hospitalization Initial or Prolonged PT Rectal Haemorrhage Diarrhoea Anisocytosis Poikilocytosis Microcytic Anaemia Blood Potassium Decreased Diarrhoea Infectious Report Source Product Lariam Lariam Tenstaten Role PS SS C Manufacturer Roche Roche
Gender:Male Dose
I/FU:I Duration
Date:01/25/07ISR Number: 5219034-2Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Outcome Hospitalization Initial or Prolonged Disability PT Diarrhoea Tinnitus Hearing Impaired Vertigo Balance Disorder Nausea Dizziness Nystagmus Report Source Product Lariam Role PS Manufacturer Roche
I/FU:F Duration
15
DAY
Date:01/26/07ISR Number: 5221301-3Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-477672 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Dry Eye Corneal Scar Stevens-Johnson Syndrome Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:01/29/07ISR Number: 5224770-8Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Wound Secretion Rash
Gender:Female
I/FU:I
Dose Duration 1 TABLET ONCE DAILY ORALLY 9 DAY
Other Serious
Menstruation Irregular
03-Apr-2012
09:37 AM
Page: 733
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/07ISR Number: 5223920-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Outcome Disability PT Nausea Depression Paraesthesia Disorientation Dyspnoea Irritable Bowel Syndrome Lactose Intolerance Lipoma Haemorrhoids Vitreous Floaters Bronchial Hyperreactivity Anxiety Panic Attack Rash Hypersensitivity Generalised Anxiety Disorder Musculoskeletal Stiffness Amnesia Eye Movement Disorder Treatment Noncompliance Food Allergy Melanocytic Naevus Dizziness Motion Sickness Tinnitus Self Esteem Decreased Disturbance In Attention Headache Neck Pain Abdominal Pain Lower Vertigo Sleep Disorder Due To General Medical Condition, Hypersomnia Type Heart Rate Increased Abdominal Pain Diarrhoea Photophobia Acrophobia Throat Irritation Rhinitis Allergic Mental Disorder Adjustment Disorder With Anxiety Mood Disorder Due To A General Medical Condition Insomnia Balance Disorder Age:34 YR Gender:Male I/FU:F
Abdominal Distension Condition Aggravated Gilbert'S Syndrome Infection Parasitic Emotional Distress Suicidal Ideation Heart Rate Irregular Burning Sensation 03-Apr-2012 09:37 AM Page: 734
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Injury Palpitations Sinus Bradycardia Vestibular Disorder Weight Decreased Phobia Of Flying Phobia Migraine Blood Bilirubin Increased Impetigo Abdominal Pain Upper Adjustment Disorder With Depressed Mood Claustrophobia Sensory Integrative Dysfunction Fatigue Sleep Disorder Back Pain Nasal Congestion Hypoaesthesia Gait Disturbance Visual Impairment
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Vaccine
OTHER
Date:01/30/07ISR Number: 5225876-XReport Type:Direct Outcome Other Serious PT Palpitations Panic Attack Fear Dyspnoea
Company Report #CTU 294564 Report Source Product Mefloquine Hcl 250 Mg Role PS Manufacturer
Gender:Female Dose 1 PO WEEKLY
I/FU:I Duration
Date:01/30/07ISR Number: 5225886-2Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Depression Vomiting Nausea Anxiety Feeling Abnormal Hypophagia Heart Rate Increased Malaise Insomnia Palpitations Chills
Company Report #CTU 294589 Report Source Product Lariam-Mefloquine Hcl- Sandoz Or Roche Role PS Manufacturer Sandoz Or Roche
Gender:Male Dose 250MG ONCE A WEEK PO (2 DOSES ONLY)
I/FU:I Duration
Date:02/16/07ISR Number: 5239696-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Outcome Hospitalization Initial or Prolonged PT Vertigo Sleep Disorder Disturbance In Attention Cardiovascular Disorder Mental Disorder
Age:36 YR
Gender:Female
I/FU:F
03-Apr-2012
09:37 AM
Page: 735
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Headache Coordination Abnormal Fatigue Anxiety Oedema Peripheral Formication Asthenia Abnormal Dreams Paraesthesia Tinnitus Depression Tachycardia Feeling Abnormal Muscle Twitching Night Sweats
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose Duration DOSAGE REGIMEN REPORTED AS FOUR TABS IN TOTAL.
Date:02/16/07ISR Number: 5239744-0Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-477672 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Dry Eye Corneal Scar Stevens-Johnson Syndrome Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:02/20/07ISR Number: 5243672-4Report Type:Direct Outcome Other Serious PT Middle Insomnia Sensitivity Of Teeth Condition Aggravated Fatigue
Company Report #CTU 296345 Report Source Product Mefloquine Std ? Role PS Manufacturer
Gender:Male Dose STD 1/ WEEK PO
I/FU:I Duration
Date:02/21/07ISR Number: 5242741-2Report Type:Expedited (15-DaCompany Report #GB-ROCHE-482808 Outcome Hospitalization Initial or Prolonged PT Renal Failure Acute Report Source Product Lariam Lariam Lariam Lariam Role PS SS SS SS Manufacturer Roche Roche Roche Roche
Age: Route UNKNOWN UNKNOWN UNKNOWN UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:02/28/07ISR Number: 5252267-8Report Type:Direct Outcome Other Serious PT Panic Attack
Company Report #CTU 296837 Report Source Product Larium Mefloquine Role Manufacturer
Age:23 YR Route
Gender:Female Dose
I/FU:I Duration
Dizziness Paranoia Abnormal Dreams Hallucination Anxiety Heart Rate Increased Insomnia Motion Sickness 03-Apr-2012 09:37 AM
Roche
PS
Roche
ORAL
ONE PILL -250MG- PER WEEK PO
10
MON
Page: 736
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/07ISR Number: 5254139-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-483909 Outcome Hospitalization Initial or Prolonged PT Hallucination Delirium Aggression Report Source Product Lariam Role PS Manufacturer Roche Age:21 YR Route ORAL Gender:Male Dose I/FU:I Duration 1 DAY
Date:03/02/07ISR Number: 5256250-8Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder
Company Report #CTU 297137 Report Source Product Lariam Role PS Manufacturer Barr Laboratories, Inc.
Age: Route ORAL
Gender:Male Dose 1 PILL 1/WEEK PO
I/FU:I Duration
Date:03/06/07ISR Number: 5256605-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Outcome Hospitalization Initial or Prolonged Disability PT Psychotic Disorder Antisocial Behaviour Muscle Rigidity Speech Disorder Agitation Memory Impairment Depression Gait Disturbance Blood Potassium Decreased Paranoia Convulsion Hostility Headache Hallucination Incontinence Confusional State Delusion Disorientation Fatigue Loss Of Libido Drug Ineffective Aggression Mania Pyrexia Report Source Product Lariam Valium Prozac Role PS SS C Manufacturer Roche Roche
Age:40 YR Route ORAL INTRAVENOUS ORAL
Date:03/06/07ISR Number: 5258866-1Report Type:Direct Outcome Other Serious PT Paranoia Anxiety
Age:24 YR Route
Gender:Female Dose
I/FU:I Duration
Depression Nightmare
03-Apr-2012
09:37 AM
Page: 737
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/07ISR Number: 5258961-7Report Type:Expedited (15-DaCompany Report #SE-ROCHE-485061 Outcome Life-Threatening PT Increased Upper Airway Secretion Respiratory Arrest Erythema Anaphylactic Reaction Bronchospasm Report Source Product Lariam Role PS Manufacturer Roche Age:3 MON Route ORAL Gender:Male Dose I/FU:I Duration 1 DAY
Date:03/09/07ISR Number: 5260861-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Outcome Hospitalization Initial or Prolonged PT Vertigo Disturbance In Attention Abnormal Dreams Headache Tachycardia Feeling Abnormal Agitation Coordination Abnormal Fatigue Oedema Peripheral Cardiovascular Disorder Anxiety Depression Formication Asthenia Sleep Disorder Muscle Twitching Malaise Mental Disorder Paraesthesia Night Sweats Tinnitus Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration DOSAGE REGIMEN REPORTED AS FOUR TABS IN TOTAL. 22 DAY
Date:03/16/07ISR Number: 5267373-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-485061 Outcome Life-Threatening PT Bronchospasm Erythema Respiratory Arrest Anaphylactic Reaction Increased Upper Airway Secretion Respiratory Disorder Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:03/19/07ISR Number: 5269055-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Outcome Hospitalization Initial or Prolonged PT Febrile Infection Disturbance In Attention Fatigue Malaise Formication
Age:36 YR
Gender:Female
I/FU:F
03-Apr-2012
09:37 AM
Page: 738
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vertigo Oedema Peripheral Dyspepsia Headache Depression Tachycardia Asthenia Muscle Twitching Agitation Paraesthesia Feeling Abnormal Abnormal Dreams Night Sweats Cardiovascular Disorder Anxiety Tinnitus Sleep Disorder Coordination Abnormal Mental Disorder
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose Duration DOSAGE REGIMEN REPORTED AS FOUR TABS IN TOTAL. WEEKLY 22 DAY
Date:03/27/07ISR Number: 5277512-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-485061 Outcome Life-Threatening PT Bronchospasm Respiratory Depression Increased Bronchial Secretion Increased Upper Airway Secretion Respiratory Arrest Respiratory Disorder Erythema Anaphylactic Reaction Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male
I/FU:F
Dose Duration TWO DOSES, THE FIRST DOSE WAS SPITTED OUT. 1 DAY
Date:03/27/07ISR Number: 5277551-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-488026 Outcome Other Serious PT Cardiac Arrest Electrocardiogram Qt Prolonged Report Source Product Lariam Sudafed Role PS C Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose
I/FU:I Duration
Date:03/29/07ISR Number: 5280375-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-487625 Outcome Other Serious PT Homicide Confusional State Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:03/30/07ISR Number: 5281849-2Report Type:Expedited (15-DaCompany Report #SE-ROCHE-488539 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Dyspnoea Increased Bronchial Secretion Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose REPORTED DOSAGE REGIMEN:
I/FU:I Duration
Page: 739
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 62.MG1 MG 1. 1 DAY
Date:04/03/07ISR Number: 5284325-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-439267 Outcome Hospitalization Initial or Prolonged Disability PT Mental Disorder Encephalopathy Panic Attack Cognitive Disorder Speech Disorder Anxiety Disorder Depression Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:04/03/07ISR Number: 5284692-3Report Type:Expedited (15-DaCompany Report #CA-ROCHE-489380 Outcome Other Serious PT Toxicity To Various Agents Maculopathy Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:04/05/07ISR Number: 5288333-0Report Type:Expedited (15-DaCompany Report #SE-ROCHE-490181 Outcome Death Hospitalization Initial or Prolonged PT Pulmonary Fibrosis Respiratory Failure Cough Inflammation Alveolitis Infection Fatigue Rash Weight Decreased Pyrexia Depressed Level Of Consciousness Report Source Product Lariam Role PS Manufacturer Roche
Age:4 YR Route ORAL
Gender:Female Dose DOSAGE REGIMEN REPORTED AS 75MGW MG W.
I/FU:I Duration
WK
Lariam
SS
Roche
ORAL
Date:04/05/07ISR Number: 5288700-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-490463 Outcome Death PT Road Traffic Accident Hyperhidrosis Malaise Dry Mouth Asthenia Report Source Product Lariam Laroxyl Laroxyl Role PS SS SS Manufacturer Roche Roche Roche
Gender:Male Dose
I/FU:I Duration
Date:04/05/07ISR Number: 5288710-8Report Type:Expedited (15-DaCompany Report #KR-ROCHE-490940 Outcome Death PT Myocardial Infarction Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
03-Apr-2012
09:37 AM
Page: 740
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/07ISR Number: 5289566-XReport Type:Expedited (15-DaCompany Report #SE-ROCHE-488539 Outcome Hospitalization Initial or Prolonged PT Increased Bronchial Secretion Dyspnoea Report Source Product Lariam Role PS Manufacturer Roche Age:61 DY Route ORAL Gender:Male I/FU:F
Dose Duration REPORTED DOSAGE REGIMEN: 62.MG1 MG 1. 1 DAY
Date:04/11/07ISR Number: 5299140-7Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability PT Psychotic Disorder Impaired Work Ability Bipolar I Disorder Discomfort
Company Report #CTU 300388 Report Source Product Lariam, 250mg, Hoffman-Laroche Role PS Manufacturer Hoffman-Laroche
Age:30 YR Route
Gender:Female Dose 250 MG ONCE WEEKLY
I/FU:I Duration
Date:04/12/07ISR Number: 5294969-3Report Type:Expedited (15-DaCompany Report #KR-ROCHE-490940 Outcome Death PT Myocardial Infarction Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration 4 WK
Date:04/13/07ISR Number: 5296357-2Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Outcome Hospitalization Initial or Prolonged PT Formication Abnormal Dreams Disturbance In Attention Cardiovascular Disorder Fatigue Agitation Depression Sleep Disorder Headache Anxiety Tinnitus Paraesthesia Feeling Abnormal Mental Disorder Oedema Peripheral Tachycardia Muscle Twitching Night Sweats Malaise Febrile Infection Coordination Abnormal Dyspepsia Asthenia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration DOSAGE REGIMEN REPORTED AS FOUR TABS IN TOTAL. WEEKLY 22 DAY
Vertigo
03-Apr-2012
09:37 AM
Page: 741
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/07ISR Number: 5296514-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-488026 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Cardiac Arrest Electrocardiogram Qt Prolonged Report Source Product Lariam Pseudoephedrine Role PS SS Manufacturer Roche Age:41 YR Route ORAL ORAL Gender:Male I/FU:F
Dose Duration DOSE: 250 MG EVERY WEEK
Date:04/13/07ISR Number: 5300366-4Report Type:Direct Outcome Death PT Abnormal Dreams Adverse Drug Reaction Suicidal Ideation Hallucination Completed Suicide Depression
Age:46 YR Route
Gender:Female Dose
I/FU:I Duration
Date:04/16/07ISR Number: 5297609-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-477655 Outcome Hospitalization Initial or Prolonged PT Vestibular Disorder Nightmare Convulsion Psychotic Disorder Aggression Thinking Abnormal Insomnia Suicidal Ideation Hallucination Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female
I/FU:F
Dose Duration THE PATIENT REPORTED TAKING THREE LARIAM "PILLS" IN
Date:04/16/07ISR Number: 5297627-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-490181 Outcome Death Hospitalization Initial or Prolonged PT Infection Interstitial Lung Disease Weight Decreased Pulmonary Fibrosis Inflammation Respiratory Failure Rash Pyrexia Depressed Level Of Consciousness Fatigue Alveolitis Cough Report Source Product Lariam Role PS Manufacturer Roche
Age:226 WK Route ORAL
Gender:Female Dose DOSAGE REGIMEN REPORTED AS 75MGW MG W.
I/FU:F Duration
WK
Lariam
SS
Roche
ORAL
Date:04/30/07ISR Number: 5311573-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-490463 Outcome Death PT Road Traffic Accident Hyperhidrosis Dry Mouth 09:37 AM
Age:46 YR
Gender:Male
I/FU:F
03-Apr-2012
Page: 742
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asthenia Drug Interaction Report Source Product Lariam Laroxyl Role PS I Manufacturer Roche Roche Route ORAL ORAL Dose Duration
Date:04/30/07ISR Number: 5312051-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-439267 Outcome Hospitalization Initial or Prolonged Disability Other Serious PT Mental Disorder Cognitive Disorder Encephalopathy Suicidal Ideation Depression Speech Disorder Psychotic Disorder Panic Attack Anxiety Disorder Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:04/30/07ISR Number: 5312244-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Agitation Nightmare Vertigo Chest Pain Tinnitus Nervousness Photophobia Phonophobia Amnesia Testicular Pain Disturbance In Attention Rash Blood Pressure Increased Dizziness Irritable Bowel Syndrome Nausea Mood Swings Fatigue Psychotic Disorder Diarrhoea Memory Impairment Disorientation Headache Abdominal Pain Eye Pain Pain Of Skin Night Sweats
Age:35 YR
Gender:Male
I/FU:F
Vomiting Anxiety Disorder Nystagmus Inner Ear Disorder Depression Insomnia Vision Blurred Vestibular Disorder 03-Apr-2012 09:37 AM Page: 743
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypoaesthesia Report Source Product Lariam Imodium Compazine Role PS C C Manufacturer Roche Route ORAL Dose ON 18 APR 2001, THERAPY REPORTED AS TWICE DAILY. BY TAPER. ON 18 APR 2001, THERAPY REPORTED AS: AS NEEDED. Duration
C C C C
C C C C C
Date:04/30/07ISR Number: 5316669-3Report Type:Direct Outcome PT Fatigue Photophobia Malaise Dizziness Disorientation Vision Blurred Headache Circadian Rhythm Sleep Disorder Nausea
Company Report #CTU 301881 Report Source Product Mefloquine 250mg Geneva Pharm Role PS Manufacturer Geneva Pharm
Gender:Female Dose ONE TAB WEEKLY PRIO, 10 DAYS AFTER LEA PO
I/FU:I Duration
Date:05/02/07ISR Number: 5317809-2Report Type:Direct Outcome Disability Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Confusional State Hallucination Amnesia Anxiety Panic Attack
Company Report #CTU 302172 Report Source Product Mefloquine (Lariam) Role PS Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration 1 TABLET ONCE PO
Date:05/03/07ISR Number: 5316001-5Report Type:Expedited (15-DaCompany Report #KR-ROCHE-490940
Age:40 YR
Gender:Male
I/FU:F
Outcome Death
PT Arteriosclerosis Coronary Artery Cardiomegaly Myocardial Infarction
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose
Duration 4 WK
03-Apr-2012
09:37 AM
Page: 744
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/07ISR Number: 5318027-4Report Type:Expedited (15-DaCompany Report #KR-ROCHE-490940 Outcome Death PT Myocardial Infarction Arteriosclerosis Coronary Artery Cardiomegaly Report Source Product Lariam Role PS Manufacturer Roche Age:40 YR Route UNKNOWN Gender:Male Dose I/FU:F Duration 4 WK
Date:05/09/07ISR Number: 5320400-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Outcome Hospitalization Initial or Prolonged Other Serious PT Abnormal Dreams Agitation Dyspepsia Headache Asthenia Mental Disorder Depression Formication Feeling Abnormal Sleep Disorder Fatigue Oedema Peripheral Coordination Abnormal Night Sweats Anxiety Tachycardia Tinnitus Muscle Twitching Upper Respiratory Tract Infection Pyrexia Paraesthesia Disturbance In Attention Vertigo Cardiovascular Disorder Malaise Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration DOSAGE REGIMEN REPORTED AS FOUR TABS IN TOTAL. WEEKLY
Date:05/11/07ISR Number: 5322571-3Report Type:Expedited (15-DaCompany Report #KR-ROCHE-490940 Outcome Death PT Myocardial Infarction Cardiomegaly Arteriosclerosis Coronary Artery Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration 4 WK
Date:05/14/07ISR Number: 5323676-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-490463
Age:46 YR
Gender:Male
I/FU:F
Outcome Death
PT Hyperhidrosis Drug Interaction Road Traffic Accident Asthenia Dry Mouth 09:37 AM
Report Source
Product Lariam Laroxyl
Role PS I
Route ORAL ORAL
Dose
Duration
03-Apr-2012
Page: 745
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/16/07ISR Number: 5326183-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-497219 Outcome Other Serious PT Cardiac Disorder Hypothyroidism Grand Mal Convulsion Report Source Product Lariam Typhoid Vaccine Yellow Fever Vaccine Hepatitis A Vaccine Levothyroxine Role PS C C C C Manufacturer Roche Age:24 YR Route ORAL Gender:Male Dose I/FU:I Duration 37 DAY 1 DAY 1 DAY 1 DAY
ORAL
Date:05/18/07ISR Number: 5328482-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-489574 Outcome Disability PT Vertigo Cognitive Disorder Amnesia Anxiety Hearing Impaired Muscle Spasms Hallucination Palpitations Tremor Disturbance In Attention Nausea Nightmare Dyspnoea Report Source Product Lariam Trinordiol Role PS C Manufacturer Roche
Gender:Female Dose DOSAGE REGIMEN REPORTED AS 1 DOSE ONCE A DAY.
I/FU:F Duration
Date:05/21/07ISR Number: 5330072-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Outcome Hospitalization Initial or Prolonged Other Serious PT Fatigue Tachycardia Coordination Abnormal Mental Disorder Night Sweats Paraesthesia Oedema Peripheral Upper Respiratory Tract Infection Agitation Dyspepsia Disturbance In Attention Pyrexia Headache Vertigo Muscle Twitching Anxiety Depression Abnormal Dreams Formication Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Sleep Disorder Malaise Asthenia Tinnitus Feeling Abnormal Cardiovascular Disorder
03-Apr-2012
09:37 AM
Page: 746
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/07ISR Number: 5336930-6Report Type:Expedited (15-DaCompany Report #IT-ROCHE-498140 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Renal Failure Thrombotic Thrombocytopenic Purpura Report Source Product Lariam Role PS Manufacturer Roche Age:31 YR Route ORAL Gender:Female Dose I/FU:I Duration
Date:05/31/07ISR Number: 5343858-4Report Type:Direct Outcome Other Serious PT Diarrhoea Insomnia Condition Aggravated Anxiety Memory Impairment Impaired Work Ability Amnesia Paraesthesia Vision Blurred Influenza Like Illness Mood Altered Disturbance In Attention
Age: Route ORAL
Gender:Male Dose 1 TABLET WEEKLY PO
I/FU:I Duration
Date:05/31/07ISR Number: 5356549-0Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Panic Attack Agitation Dry Mouth Suicidal Ideation Depression Dizziness Fatigue Dyspnoea Abnormal Dreams Headache Nervousness Hallucination Mood Swings Tremor Eye Irritation Nightmare Heart Rate Increased Claustrophobia Memory Impairment Disturbance In Attention Balance Disorder Psychotic Disorder Insomnia
Company Report #329978 Report Source Consumer Health Professional Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Ultran (Phenaglycodol) Lorazepam (Lorazepam) Unspecified Immunizations (Immunisation) Effexor (Venlafaxine Hydrochloride) Role PS C C C C Manufacturer
I/FU:I Duration
Date:05/31/07ISR Number: 5356550-7Report Type:Periodic Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Psychotic Disorder
Company Report #444908 Report Source Consumer Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
Page: 747
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/07ISR Number: 5356551-9Report Type:Periodic Outcome Other Serious PT Neurotoxicity Fatigue Simple Partial Seizures Abdominal Pain Asthenia Company Report #452842 Report Source Consumer Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer Age:30 YR Route ORAL Gender:Female Dose 250 MG 1 PER ONE DOSE ORAL I/FU:I Duration
Date:05/31/07ISR Number: 5356552-0Report Type:Periodic Outcome Disability PT Anxiety Disorder
Company Report #466044 Report Source Literature Health Professional Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
I/FU:I Duration
Company Report #466080 Report Source Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Prozac (Fluoxetine) Role PS C Manufacturer
Age: Route
Gender:Female Dose
I/FU:I Duration
Company Report #466103 Report Source Consumer Other Product Lariam (Mefloquine Hydrochloride) 250 Mg Role PS Manufacturer
Age: Route
Gender: Dose
I/FU:I Duration
Age:29 YR Route
Gender:Male Dose
I/FU:I Duration
Date:05/31/07ISR Number: 5356556-8Report Type:Periodic Outcome Hospitalization PT Drug Ineffective
Company Report #469321 Report Source Literature Product Mefloquine Role Manufacturer
Age:25 YR Route
Gender:Male Dose
I/FU:I Duration
Plasmodium Falciparum Infection
Hydrochloride (Mefloquine Hydrochloride)
PS
ORAL
03-Apr-2012
09:37 AM
Page: 748
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/07ISR Number: 5356557-XReport Type:Periodic Outcome Hospitalization Initial or Prolonged PT Malaise Psychotic Disorder Company Report #484946 Report Source Consumer Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Age: Route Gender:Male Dose I/FU:I Duration
Date:05/31/07ISR Number: 5356558-1Report Type:Periodic Outcome Other Serious PT Paranoia Depression Headache Speech Disorder Disturbance In Attention Hypoaesthesia Memory Impairment
Company Report #487913 Report Source Consumer Other Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) 250 Mg Zithromax (Azithromycin) Role Manufacturer
Age:25 YR Route
Gender:Male Dose
I/FU:I Duration
PS C
ORAL
Date:05/31/07ISR Number: 5356559-3Report Type:Periodic Outcome Hospitalization Initial or Prolonged Disability PT Rash Papular Disturbance In Attention Groin Pain Panic Attack Oral Disorder Agitation Decreased Activity Hyperventilation Nystagmus Major Depression Chest Discomfort Insomnia Depressed Mood Tinnitus Vitreous Floaters Blood Bilirubin Increased Dyspnoea Paraesthesia Blood Pressure Increased Blood Pressure Agoraphobia Dysuria Blood Creatinine Increased Palpitations Anxiety Lichen Planus Dizziness
Age:40 YR
Gender:Male
I/FU:F
Headache Hyperhidrosis Nightmare Fatigue Balance Disorder Decreased Interest Decreased Appetite Anhedonia 03-Apr-2012 09:37 AM Page: 749
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain In Extremity Haematuria Heart Rate Increased Erythema Mood Altered Depression Epicondylitis Toxicity To Various Agents Vision Blurred Vertigo Panic Disorder Urethritis
Role PS
Manufacturer
Route ORAL
Dose 250 MG ORAL
Duration
Date:05/31/07ISR Number: 5356560-XReport Type:Periodic Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder
Company Report #428956 Report Source Consumer Health Professional Other Product Lariam (Mefloquine Hydrochloride) Birth Control Pills Nos (Oral Contraceptives Nos) Role PS C Manufacturer
I/FU:I Duration
Date:06/04/07ISR Number: 5344208-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-499416 Outcome Other Serious PT Maculopathy Visual Acuity Reduced Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
Date:06/05/07ISR Number: 5345982-9Report Type:Expedited (15-DaCompany Report #AU-ROCHE-499414 Outcome Life-Threatening PT Hepatitis Fulminant Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose
I/FU:I Duration
Date:06/05/07ISR Number: 5345983-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Outcome Hospitalization Initial or Prolonged Other Serious PT Upper Respiratory Tract Infection Malaise Agitation Anxiety Paraesthesia Feeling Abnormal Vertigo
Age:36 YR
Gender:Female
I/FU:F
Disturbance In Attention Pyrexia Dyspepsia Asthenia Depression Tachycardia Tinnitus Formication 03-Apr-2012 09:37 AM Page: 750
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coordination Abnormal Night Sweats Cardiovascular Disorder Abnormal Dreams Headache Sleep Disorder Fatigue Muscle Twitching Mental Disorder Oedema Peripheral
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Date:06/06/07ISR Number: 5347841-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-497864 Outcome Other Serious PT Amenorrhoea Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:06/06/07ISR Number: 5347843-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-500150 Outcome Other Serious PT Amenorrhoea Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:06/06/07ISR Number: 5350805-8Report Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Hallucination Paranoia Panic Attack Nightmare Anxiety Weight Decreased Tremor Crying Insomnia
Gender:Female
I/FU:I
Dose Duration 1 PILL EVERY 7 DAYS PO
Date:06/08/07ISR Number: 5351021-6Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Outcome Other Serious PT Paranoia Hallucination, Olfactory Hallucination, Auditory Hallucination Homicide Flashback Report Source Product Lariam Flagyl Unknown Medication Antidepressants Nos Role PS C C C Manufacturer Roche
Gender:Male Dose
Date:06/13/07ISR Number: 5355886-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-497864 Outcome Other Serious PT Amenorrhoea Report Source Product Lariam Lariam Role PS SS Manufacturer Roche Roche
Gender:Female Dose
03-Apr-2012
09:37 AM
Page: 751
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/07ISR Number: 5355888-7Report Type:Expedited (15-DaCompany Report #AU-ROCHE-499414 Outcome Life-Threatening PT Vomiting Hepatitis Fulminant Hepatic Failure Diarrhoea Report Source Product Lariam Rabies Vaccine Typhoid Vaccine Levlen Ed Tetanus Vaccine Role PS C C C C Manufacturer Roche Age:24 YR Route ORAL Gender:Female Dose I/FU:F Duration
Date:06/18/07ISR Number: 5362132-3Report Type:Direct Outcome PT Drug Dispensing Error Medication Error
Company Report #USP 59046 Report Source Product Lariam Malarone Role PS SS Manufacturer Glaxosmithkline
Age:58 YR Route
Gender:Female Dose TABLET TABLET
I/FU:I Duration
Date:06/19/07ISR Number: 5362230-4Report Type:Expedited (15-DaCompany Report #IT-ROCHE-501993 Outcome Hospitalization Initial or Prolonged PT Mental Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:06/20/07ISR Number: 5363677-2Report Type:Expedited (15-DaCompany Report #ES-ROCHE-502414 Outcome Other Serious PT Hepatitis Toxic Report Source Product Mefloquine Hydrochloride Hepatitis B Vaccine Role PS C Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:06/22/07ISR Number: 5367205-7Report Type:Expedited (15-DaCompany Report #SE-ROCHE-498551 Outcome Hospitalization Initial or Prolonged PT Diplopia Headache Neuropathy Peripheral Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Malarone Unspecified Drug Lexinor
SS SS SS
ORAL UNKNOWN ORAL
Dose Duration THE PATIENT TOOK A TOTAL OF TWO TABLETS. REPORTED 1 DAY FORM: FILM COATED (FC) TABLETS. 5 WK 1 DAY FORM FILM COATED (FC) TABLETS. 1 DAY
Date:06/22/07ISR Number: 5367210-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Outcome Hospitalization Initial or Prolonged Other Serious 03-Apr-2012 09:37 AM PT Dyspepsia Muscle Twitching Paraesthesia Formication
Age:36 YR
Gender:Female
I/FU:F
Page: 752
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Sleep Disorder Upper Respiratory Tract Infection Headache Fatigue Night Sweats Malaise Agitation Abnormal Dreams Tinnitus Asthenia Feeling Abnormal Coordination Abnormal Pyrexia Tachycardia Disturbance In Attention Anxiety Depression Vertigo Mental Disorder Cardiovascular Disorder
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Date:06/25/07ISR Number: 5369184-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-502756 Outcome Hospitalization Initial or Prolonged PT Amyotrophic Lateral Sclerosis Paraneoplastic Syndrome Report Source Product Lariam Vitamin E Alpha Lipoic Vitamins Nos Co-Enzyme Rilutek Vitamin C Role PS C C C C C C Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration REPORTED AS TAKEN 5 WEEKLY DOSES
Acid
Date:06/25/07ISR Number: 5370250-9Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Medication Error Intercepted Drug Dispensing Error
Company Report #CTU 306401 Report Source Product Mercaptopurine 50mg Tab-Roxane Mefloquine 250mg Tab Roxane Role PS SS Manufacturer Roxane Roxane
Age: Route
Gender: Dose
I/FU:I Duration
Date:06/29/07ISR Number: 5374239-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Outcome PT
Age:34 YR
Gender:Male
I/FU:F
Disability
Adjustment Disorder With Anxiety Photophobia Phobia Generalised Anxiety Disorder Hypoaesthesia Amnesia 09:37 AM Page: 753
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Anxiety Panic Attack Diarrhoea Self Esteem Decreased Headache Acrophobia Heart Rate Increased Insomnia Hypersensitivity Musculoskeletal Stiffness Bronchial Hyperreactivity Mood Disorder Due To A General Medical Condition Dizziness Paraesthesia Suicidal Ideation Abdominal Pain Heart Rate Irregular Tinnitus Disturbance In Attention Balance Disorder Vestibular Disorder Weight Decreased Lactose Intolerance Throat Irritation Nausea Motion Sickness Depression Disorientation Dyspnoea Irritable Bowel Syndrome Phobia Of Flying Migraine Nasal Congestion Sleep Disorder Due To General Medical Condition, Hypersomnia Type Adjustment Disorder With Depressed Mood Sinus Bradycardia Rash Sensory Integrative Dysfunction Fatigue Neck Pain Abdominal Distension Abdominal Pain Lower Vertigo Emotional Distress Claustrophobia Sleep Disorder Back Pain
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Vaccine
OTHER
Date:06/29/07ISR Number: 5374266-8Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Outcome Other Serious 03-Apr-2012 09:37 AM PT Flashback Hallucination
Age:27 YR
Gender:Male
I/FU:F
Page: 754
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Auditory Homicide Hallucination, Olfactory Paranoia
Report Source
Product Lariam Flagyl Unknown Medication Antidepressants Nos
Role PS C C C
Manufacturer Roche
Dose
Duration 3 MON
Date:06/29/07ISR Number: 5374267-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Diarrhoea Memory Impairment Vestibular Disorder Nystagmus Abdominal Pain Phonophobia Insomnia Vertigo Depression Eye Pain Nightmare Tinnitus Psychotic Disorder Agitation Vomiting Headache Inner Ear Disorder Photophobia Anxiety Disorder Dizziness Irritable Bowel Syndrome Rash Pain Of Skin Blood Pressure Increased Mood Swings Disorientation Amnesia Nervousness Night Sweats Nausea Fatigue Chest Pain Testicular Pain Vision Blurred Disturbance In Attention Hypoaesthesia Report Source Product Lariam Imodium Compazine Role PS C C Manufacturer Roche
Gender:Male Dose ON 18 APR 2001, THERAPY REPORTED AS TWICE DAILY. BY TAPER. ON 18 APR 2001, THERAPY REPORTED AS: AS NEEDED.
I/FU:F Duration
C C C C
C C C C C
Age:40 YR
Gender:Female
I/FU:F
Outcome Hospitalization Initial or Prolonged Disability
PT Incontinence Drug Ineffective Hostility Headache Muscle Rigidity Agitation Page: 755
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mania Psychotic Disorder Disorientation Loss Of Libido Confusional State Delusion Hallucination Paranoia Convulsion Pyrexia Gait Disturbance Speech Disorder Fatigue Antisocial Behaviour Aggression Blood Potassium Decreased Depression Memory Impairment
Report Source
Role PS SS C
Dose EVERY WEEK.
Date:07/03/07ISR Number: 5377491-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-498551 Outcome Hospitalization Initial or Prolonged PT Diplopia Neuropathy Peripheral Headache Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Malarone Unspecified Drug Lexinor
SS SS SS
ORAL UNKNOWN ORAL
Dose Duration THE PATIENT TOOK A TOTAL OF TWO TABLETS. REPORTED 1 DAY FORM: FILM COATED (FC) TABLETS. 5 WK 1 DAY FORM FILM COATED (FC) TABLETS. 5 DAY
Date:07/09/07ISR Number: 5381827-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-505274 Outcome Hospitalization Initial or Prolonged PT Torsade De Pointes Electrocardiogram Qt Prolonged Report Source Product Lariam Meningococcal Vaccine Hepatyrix Revaxis Warfarin Ramipril Role PS C C C C C Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Age:51 YR
Gender:Female
I/FU:F
PT Amyotrophic Lateral Sclerosis Paraneoplastic Syndrome
Report Source
Product Lariam Vitamin E Alpha Lipoic Vitamins Nos
Role PS C C C
Manufacturer Roche
Route ORAL
Dose Duration REPORTED AS TAKEN 5 WEEKLY DOSES
Acid
03-Apr-2012
09:37 AM
Page: 756
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Co-Enzyme Rilutek Vitamin C C C C
Date:07/09/07ISR Number: 5385345-3Report Type:Direct Outcome Other Serious PT Nightmare Dizziness Mood Swings Sleep Disorder Irritability Insomnia
Company Report #CTU 307608 Report Source Product Mefloquine 250 Mg Barr Laboratories Role PS Manufacturer Barr Laboratories
Age: Route ORAL
Gender:Female Dose ONCE PER WEEK PO
I/FU:I Duration
Date:07/10/07ISR Number: 5386284-4Report Type:Direct Outcome Other Serious PT Headache Convulsion Asthenia Nervous System Disorder Paraesthesia Muscle Spasms Muscle Twitching Hypoaesthesia
Company Report #CTU 307650 Report Source Product Lariam -MefloquineRole PS Manufacturer
Gender:Female Dose 1 TABLET PO
I/FU:I Duration
Date:07/13/07ISR Number: 5390014-XReport Type:Expedited (15-DaCompany Report #GXKR2007TR05543 Outcome Other Serious PT Parkinsonism Report Source Foreign Literature Health Professional Other Product Mefloquine Role PS Manufacturer
Age:35 YR Route
Gender:Male Dose
I/FU:I Duration
Date:07/16/07ISR Number: 5387788-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-503881 Outcome Disability PT Depression Tremor Ill-Defined Disorder Abnormal Dreams Pyrexia Fatigue Sleep Disorder Report Source Product Lariam Allegra Wellbutrin Unspecified Role PS C C Manufacturer Roche
Age:41 YR Route UNKNOWN ORAL ORAL
Gender:Male
I/FU:F
Dose Duration REPORTED THAT PATIENT TOOK 3 DOSES. REPORTED AS 150-450MG.
Mental Disorder
Medication Ativan Lexapro
C C C
ORAL ORAL ORAL
03-Apr-2012
09:37 AM
Page: 757
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/07ISR Number: 5388059-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-54240 Outcome Hospitalization Initial or Prolonged PT Anxiety Visual Impairment Chest Pain Panic Attack Fatigue Head Discomfort Drug Interaction Nausea Report Source Product Lariam Pizotifen Role PS I Manufacturer Roche Age:52 YR Route ORAL UNKNOWN Gender:Female Dose I/FU:I Duration 27 DAY
Date:07/16/07ISR Number: 5388628-6Report Type:Expedited (15-DaCompany Report #CA-ROXANE LABORATORIES, INC-2007-BP-17394RO Outcome Other Serious PT Maculopathy Retinal Pigmentation Report Source Product Mefloquine Role PS Manufacturer Roxane Laboratories, Inc.
Gender:Male Dose
Date:07/16/07ISR Number: 5388633-XReport Type:Expedited (15-DaCompany Report #TR-ROXANE LABORATORIES, INC-2007-BP-17147RO Outcome Other Serious PT Parkinsonism Report Source Product Mefloquine Role PS Manufacturer Roxane Laboratories, Inc.
Gender:Male Dose
I/FU:I Duration
Date:07/17/07ISR Number: 5389111-4Report Type:Expedited (15-DaCompany Report #NL-ROCHE-505944 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Grand Mal Convulsion Report Source Product Lariam Role PS Manufacturer Roche
Age:4 YR Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:07/17/07ISR Number: 5392183-4Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Myalgia Tendonitis Swelling Pain In Extremity
Gender:Female
I/FU:I
Dose Duration 1 ONCE A WEEK PO
Date:07/23/07ISR Number: 5397614-1Report Type:Direct Outcome Life-Threatening PT Infection
Company Report #CTU 308660 Report Source Product Larium Hoffman La Role Manufacturer
Age:25 YR Route
Gender:Male Dose
I/FU:I Duration
Hospitalization Initial or Prolonged Other Serious Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM
Tongue Disorder Partial Seizures Swollen Tongue Epilepsy
Roche
PS
Hoffman La Roche
ORAL
1 TABLET ONCE A WEEK PO
Page: 758
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/07ISR Number: 5397579-2Report Type:Expedited (15-DaCompany Report #NL-ROCHE-507469 Outcome Other Serious PT Diarrhoea Nightmare Psychotic Disorder Disturbance In Attention Bone Pain Report Source Product Lariam Microgynon Role PS C Manufacturer Roche Age:19 YR Route ORAL ORAL Gender:Female Dose DOSAGE REGIMEN REPORTED AS 1X/1 CYCLICAL. I/FU:I Duration
Hepatitis A Vaccine/Hepatitis B Vaccine
Date:07/27/07ISR Number: 5399351-6Report Type:Expedited (15-DaCompany Report #NL-ROCHE-507408 Outcome Death PT Depression Completed Suicide Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:07/30/07ISR Number: 5400247-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-477655 Outcome Hospitalization Initial or Prolonged Disability Other Serious PT Cognitive Disorder Memory Impairment Insomnia Nightmare Suicidal Ideation Convulsion Flight Of Ideas Aggression Visual Impairment Vestibular Disorder Psychotic Disorder Hallucination Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration THE PATIENT REPORTED TAKING THREE LARIAM "PILLS" IN DRUG NAME REPORTED AS: BCP (TYPE UNKNOWN)
Ibuprofen Birth Control Pill
C C
Tylenol
Date:07/30/07ISR Number: 5402419-9Report Type:Direct Outcome Other Serious PT Mood Altered Memory Impairment Headache Feeling Abnormal Thinking Abnormal Confusional State Dizziness Disturbance In Attention Affect Lability
Age:32 YR
Gender:Male
I/FU:I
Anxiety Amnesia Depression Motor Dysfunction Social Avoidant Behaviour Mood Swings Anger Paranoia 03-Apr-2012 09:37 AM Page: 759
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Violence-Related Symptom Crying
Report Source
Product Mefloquine
(Lariam)
Role PS
Manufacturer
Route
Duration
Date:07/30/07ISR Number: 5402425-4Report Type:Direct Outcome Other Serious PT Disturbance In Attention Hallucination, Olfactory Dizziness Vertigo Depression Mania Mood Altered Fatigue Nausea Hallucination, Auditory Vomiting
Gender:Female
I/FU:I
Dose Duration 1 ONCE A WEEK PO
Date:08/03/07ISR Number: 5405080-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-489574 Outcome Disability Other Serious PT Anxiety Amnesia Vertigo Muscle Spasms Asthenia Cognitive Disorder Disturbance In Attention Palpitations Nightmare Hallucination Tremor Hearing Impaired Nausea Dyspnoea Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Trinordiol
Dose Duration FIRST INTAKE (ONE TABLET) ON 19 FEB 2007, SECOND INTAKE (ONE DOSAGE REGIMEN REPORTED AS 1 DOSE ONCE A DAY.
Date:08/03/07ISR Number: 5405240-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-508756 Outcome Hospitalization Initial or Prolonged PT Cerebellar Ataxia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male
I/FU:I
Dose Duration FIRST THREE TABLETS, THEN SIX HOURS LATER TWO TABLETS, THEN
Date:08/09/07ISR Number: 5409796-3Report Type:Expedited (15-DaCompany Report #NL-ROCHE-509467 Outcome Life-Threatening Hospitalization 03-Apr-2012 09:37 AM
Age:59 YR
Gender:Male
I/FU:I
Page: 760
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Orthostatic Hypotension Coma Blood Pressure Decreased Syncope Hyperhidrosis Tremor Bradycardia Report Source Product Lariam Fortzaar Doxazosine Role PS SS SS Manufacturer Roche Route ORAL ORAL ORAL Dose DOSAGE REGIMEN: 2 DD 4 MG. Duration
Date:08/10/07ISR Number: 5411289-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-510074 Outcome Hospitalization Initial or Prolonged PT Depression Headache Vomiting Social Phobia Tinnitus Paraesthesia Nausea Gastrointestinal Disorder Panic Attack Anxiety Hyperhidrosis Sensation Of Foreign Body Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male
I/FU:I
Dose Duration TOTAL OF THREE TABLETS. SECOND TABLET TAKEN IN
Date:08/21/07ISR Number: 5420894-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-511983 Outcome Disability PT Gynaecomastia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:08/22/07ISR Number: 5424395-5Report Type:Expedited (15-DaCompany Report #6036499 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Coma Blood Pressure Decreased Syncope Loss Of Consciousness Bradycardia Drug Interaction Report Source Health Professional Other Product Lariam (250 Mg), Tablet Fortzaar (Tablet) (Hydrochlorothiazide , Losartan Potassium) Doxazosin Tablets 4 Mg (4 Mg Tablet) (Doxazosin) Role PS Manufacturer
Age:59 YR Route
Gender:Male Dose 250 MG (250 MG 1 IN 1 WK)
SS
1 DOSAGE FORMS, 1 D) ORAL 8 MG (4 MG, 2 IN 1 D), ORAL
197
DAY
SS
97
DAY
Date:08/22/07ISR Number: 5424727-8Report Type:Direct Outcome Disability 03-Apr-2012 09:37 AM PT Dizziness Memory Impairment
Age:
Gender:Female
I/FU:I
Page: 761
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bruxism Abdominal Pain Upper Insomnia Anxiety Hallucination Fatigue Depression Paranoia Chills Disturbance In Attention Vision Blurred Panic Attack Diarrhoea Mood Swings Suicidal Ideation
Report Source
Product Lariam (Mefloquine Hcl 250 Mg)
Role PS
Manufacturer
Route
Dose 250 MG 1 X WEEK
Duration
Date:08/24/07ISR Number: 5425148-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-511718 Outcome Other Serious PT Delinquency Schizophrenia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:08/24/07ISR Number: 5425388-4Report Type:Expedited (15-DaCompany Report #DE-ROXANE LABORATORIES, INC-2007-DE-04938GD Outcome Hospitalization Initial or Prolonged PT Vomiting Toxicity To Various Agents Abdominal Pain Report Source Product Morphine Codeine Citalopram Diclofenac Mefloquine Zopiclone Fluoxetine Lansoprazole Penbutolol Rabeprazole Senna Preparation Simeticone Paracetamol Amitriptyline Role PS SS SS SS SS SS SS SS SS SS SS SS SS SS Manufacturer Roxane Laboratories, Inc. Roxane Laboratories, Inc. Roxane Laboratories, Inc.
Age:56 YR Route
Gender:Female Dose
I/FU:I Duration
Date:08/24/07ISR Number: 5427445-5Report Type:Direct Outcome Other Serious PT Dizziness
Gender:Female
I/FU:I
Dose Duration 250 MG ONCE A
Fear Impaired Work Ability Anxiety Fatigue Vertigo
WEEK PO
03-Apr-2012
09:37 AM
Page: 762
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/07ISR Number: 5429208-3Report Type:Direct Outcome Other Serious PT Chest Pain Initial Insomnia Fear Panic Reaction Palpitations Heart Rate Decreased Company Report #CTU 311464 Report Source Product Mefloquine 250 Mg Role PS Manufacturer Age:22 YR Route ORAL Gender:Male I/FU:I
Dose Duration 250MG ONCE A WEEK PO
Date:08/28/07ISR Number: 5435071-7Report Type:Direct Outcome PT Urticaria Rash Pruritic
Company Report #CTU 311536 Report Source Product Mefloquine 7 Tablets Hoffman-Laroche Role PS Manufacturer Hoffman-Laroche
Gender:Female Dose 1 TABLET ONCE A WEEK PO
I/FU:I Duration
Date:08/29/07ISR Number: 5429063-1Report Type:Periodic Outcome PT Drug Dispensing Error
Company Report #A0655132A Report Source Product Malarone Lariam Role PS SS Manufacturer Glaxosmithkline
Gender:Female
I/FU:I
Dose Duration 1TAB Per day 250MG Unknown
Date:08/30/07ISR Number: 5431010-3Report Type:Expedited (15-DaCompany Report #B0485142A Outcome Hospitalization Initial or Prolonged PT Paraesthesia Headache Malaria Diplopia Diarrhoea Abdominal Discomfort Dehydration Facial Paresis Neuropathy Peripheral Report Source Product Malarone Lexinor Lariam Role PS SS SS Manufacturer Glaxosmithkline Glaxosmithkline
Age:20 YR Route
Gender:Female Dose 2TAB Single dose
Date:08/30/07ISR Number: 5441851-4Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Other Serious Required Intervention to PT Accident
Company Report #CTU 311703 Report Source Product Laiam Roche Role PS Manufacturer Roche
Gender:Male Dose 1 WEEKLY PO
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 763
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/04/07ISR Number: 5442028-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-511983 Outcome Disability PT Gynaecomastia Report Source Product Lariam Esomeprazole Role PS C Manufacturer Roche Age:65 YR Route ORAL Gender:Male Dose I/FU:F Duration
Date:09/06/07ISR Number: 5444869-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-509667 Outcome Other Serious PT Vomiting Abdominal Pain Myalgia C-Reactive Protein Increased Pyrexia Cytolytic Hepatitis Report Source Product Lariam Engerix B Role PS SS Manufacturer Roche
Gender:Female Dose DRUG NAME REPORTED AS ENGERIX B 10. INDICATION REPORTED AS
I/FU:I Duration
Date:09/10/07ISR Number: 5447630-6Report Type:Expedited (15-DaCompany Report #BE-ROCHE-514773 Outcome Other Serious PT Hepatitis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:09/11/07ISR Number: 5449004-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-515132 Outcome Other Serious PT Red Blood Cell Sedimentation Rate Increased Polymyalgia Rheumatica Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:09/11/07ISR Number: 5449013-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Vestibular Disorder Chest Pain Testicular Pain Diarrhoea Anxiety Disorder Fatigue Vision Blurred Hypoaesthesia Insomnia Psychotic Disorder Nystagmus Inner Ear Disorder
Age:35 YR
Gender:Male
I/FU:F
Phonophobia Nausea Memory Impairment Nightmare Amnesia Tinnitus Disturbance In Attention Eye Pain 03-Apr-2012 09:37 AM Page: 764
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rash Nervousness Deafness Night Sweats Agitation Vertigo Headache Depression Photophobia Pain Of Skin Mood Swings Disorientation Dizziness Vomiting Abdominal Pain Irritable Bowel Syndrome Blood Pressure Increased
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Duration
C C C C
C C C C C
Date:09/12/07ISR Number: 5452321-1Report Type:Direct Outcome Other Serious PT Mental Disorder Anxiety Panic Attack Impaired Driving Ability
Company Report #CTU 312582 Report Source Product Mefloquine 250 Mg Geneva Role PS Manufacturer Geneva
Gender:Female Dose 250 MG WEEKLY PO DOSE TAKEN
I/FU:I Duration
Date:09/13/07ISR Number: 5451462-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Vomiting Insomnia Vertigo Abdominal Pain Dizziness Vision Blurred Hypoaesthesia Phonophobia Blood Pressure Increased Amnesia Irritable Bowel Syndrome Depression Agitation Vestibular Disorder Nystagmus Inner Ear Disorder
Age:35 YR
Gender:Male
I/FU:F
Testicular Pain Rash Photophobia Deafness Diarrhoea Chest Pain Memory Impairment Eye Pain 03-Apr-2012 09:37 AM Page: 765
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Mood Swings Nightmare Anxiety Disorder Disturbance In Attention Nervousness Pain Of Skin Fatigue Disorientation Headache Tinnitus Night Sweats Psychotic Disorder
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Duration
C C C C
C C C C C
Date:09/14/07ISR Number: 5452778-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-503881 Outcome Disability PT Ill-Defined Disorder Sleep Disorder Pyrexia Fatigue Tremor Abnormal Dreams Mental Disorder Depression Report Source Product Lariam Allegra Wellbutrin Unspecified Medication Ativan Lexapro Role PS C C C C C Manufacturer Roche
Age:41 YR Route UNKNOWN ORAL ORAL ORAL ORAL ORAL
Gender:Male
I/FU:F
Dose Duration REPORTED THAT PATIENT TOOK 3 DOSES. REPORTED AS 150-450MG.
Date:09/14/07ISR Number: 5452940-2Report Type:Expedited (15-DaCompany Report #NL-ROCHE-509467 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Blood Pressure Decreased Syncope Orthostatic Hypotension Hyperhidrosis Tremor Bradycardia Report Source Product Lariam Fortzaar Doxazosine Role PS SS SS Manufacturer Roche
Gender:Male Dose DOSAGE REGIMEN: 2 DD 4 MG.
I/FU:F Duration
Date:09/17/07ISR Number: 5453931-8Report Type:Expedited (15-DaCompany Report #AU-ROCHE-499414
Age:24 YR
Gender:Female
I/FU:F
PT Hepatitis Fulminant Hepatic Failure Jaundice Diarrhoea Vomiting
Report Source
Product Lariam Rabies Vaccine Typhoid Vaccine Levlen Ed Tetanus Vaccine
Role PS C C C C
Manufacturer Roche
Route ORAL
Dose ONE DOSE WEEKLY. ONE DOSE.
Duration
ORAL
03-Apr-2012
09:37 AM
Page: 766
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/07ISR Number: 5460867-5Report Type:Expedited (15-DaCompany Report #6036499 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Syncope Blood Pressure Decreased Bradycardia Report Source Foreign Health Professional Other Product Doxazosin Fortzaar (Hydrochlorothiazide , Losartan Potassium) Role PS Manufacturer Age:59 YR Route ORAL Gender:Male I/FU:F
Dose Duration 8 MG (4 MG, 2 IN 1 D) ORAL 97 DAY
SS
Lariam
SS
1 DOSAGE FORMS (1 DOSAGE FORMS, 1 IN 1 D) 250 MG (250 MG, 1 IN 1 WK)
197 35
DAY DAY
Date:09/24/07ISR Number: 5465671-XReport Type:Expedited (15-DaCompany Report #JP-ROCHE-518961 Outcome Other Serious PT Optic Neuritis Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose
I/FU:I Duration
Date:09/24/07ISR Number: 5465673-3Report Type:Expedited (15-DaCompany Report #JP-ROCHE-518962 Outcome Other Serious PT Lung Neoplasm Malignant Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose
I/FU:I Duration
Date:09/24/07ISR Number: 5465676-9Report Type:Expedited (15-DaCompany Report #JP-ROCHE-518963 Outcome Other Serious PT Glomerulonephritis Proliferative Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose
I/FU:I Duration
Date:09/28/07ISR Number: 5471134-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Vomiting Mood Swings Memory Impairment Amnesia Testicular Pain Irritable Bowel Syndrome Disturbance In Attention Eye Pain
Age:35 YR
Gender:Male
I/FU:F
Tinnitus Nervousness Photophobia Brain Stem Syndrome Anxiety Disorder Nystagmus Dizziness Hypoaesthesia 03-Apr-2012 09:37 AM Page: 767
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Vision Blurred Nightmare Fatigue Headache Inner Ear Disorder Night Sweats Nausea Abdominal Pain Depression Deafness Agitation Insomnia Vertigo Vestibular Disorder Phonophobia Pain Of Skin Blood Pressure Increased Diarrhoea Chest Pain Psychotic Disorder Rash Paraesthesia
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Duration
C C C C
C C C C C
Date:09/28/07ISR Number: 5471155-5Report Type:Expedited (15-DaCompany Report #ES-ROCHE-519121 Outcome Other Serious PT Tumour Marker Increased Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:10/02/07ISR Number: 5474876-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-521722 Outcome Other Serious PT Frequent Bowel Movements Mood Swings Abnormal Dreams Alice In Wonderland Syndrome Clumsiness Report Source Product Mefloquine Hydrochloride Unspecified Drug Nicotine Role PS C C Manufacturer Roche
Age:26 YR Route ORAL TRANSDERMAL
Gender:Male Dose
DOSING AMOUNT AND FREQUENCY REPORTED AS: 21 MG 24 HOURS
DAY
Date:10/02/07ISR Number: 5476961-9Report Type:Direct Outcome PT Paraesthesia
Company Report #CTU 314199 Report Source Product Mefloquine Hydrochloride 250 Mg Sandoz, Inc. Role PS Manufacturer Sandoz, Inc.
Gender:Male Dose 1 TABLET
I/FU:I Duration
WEEKLY
PO
03-Apr-2012
09:37 AM
Page: 768
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/07ISR Number: 5477024-9Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Initial Insomnia Paralysis Feeling Abnormal Dyspnoea Abnormal Dreams Headache Paraesthesia Fear Immobile Disturbance In Attention Company Report #CTU 314251 Report Source Product Lariam Unknown Roche Pharmaceuticals Role PS Manufacturer Age:30 YR Route ORAL Gender:Male Dose ONCE PER WEEK PO I/FU:I Duration
Date:10/02/07ISR Number: 5477059-6Report Type:Direct Outcome Other Serious PT Fear Nightmare Feeling Abnormal
Company Report #CTU 314240 Report Source Product Mefloquine 250mg Hcl Role PS Manufacturer
Gender:Male Dose 252MG TWICE PO
I/FU:I Duration
Date:10/05/07ISR Number: 5478471-1Report Type:Expedited (15-DaCompany Report #DK-ROCHE-521810 Outcome Death PT Arrhythmia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:10/05/07ISR Number: 5478472-3Report Type:Expedited (15-DaCompany Report #ES-ROCHE-519121 Outcome Other Serious PT Tumour Marker Test Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:10/05/07ISR Number: 5478473-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-521263 Outcome Other Serious PT Brachial Plexus Injury Joint Dislocation Grand Mal Convulsion Report Source Product Lariam Microgynon Role PS C Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:10/05/07ISR Number: 5478475-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-510074 Outcome Hospitalization Initial or Prolonged PT Nausea Tachycardia
Age:32 YR
Gender:Male
I/FU:F
Depression Vomiting Hypertension Disorientation Paraesthesia Hyperhidrosis Gastrointestinal Disorder Panic Attack 03-Apr-2012 09:37 AM Page: 769
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tinnitus Social Phobia Headache
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose Duration TOTAL OF THREE TABLETS. SECOND TABLET TAKEN IN
Date:10/18/07ISR Number: 5490518-5Report Type:Direct Outcome PT Hallucination Anxiety Panic Attack
Company Report #CTU 315637 Report Source Product Lariam 250 Mg, Roche Xanax Role PS C Manufacturer Roche
Gender:Male Dose 250 MG ONE TAB Q WK PO
I/FU:I Duration
Date:10/23/07ISR Number: 5493377-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-525623 Outcome Hospitalization Initial or Prolonged PT Feeling Abnormal Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:10/23/07ISR Number: 5494663-XReport Type:Direct Outcome Life-Threatening PT Suicidal Ideation Fear Depression
Age:21 YR Route
I/FU:I Duration
Date:10/23/07ISR Number: 5496173-2Report Type:Direct Outcome Other Serious PT Sleep Disorder Panic Attack Decompression Sickness Memory Impairment Depression Insomnia Blindness Disturbance In Attention Malaise Unevaluable Event Vertigo Dreamy State Hypoaesthesia
Age:18 YR Route
Gender:Male Dose
I/FU:I Duration
Suicidal Ideation Thinking Abnormal Feeling Abnormal Confusional State Somnolence
03-Apr-2012
09:37 AM
Page: 770
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/07ISR Number: 5494720-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Anxiety Asthenia Chest Pain Generalised Anxiety Disorder Self-Injurious Ideation Mitral Valve Calcification Humerus Fracture Oxygen Saturation Decreased Rheumatoid Factor Increased Pyrexia Rash Papular Aggression Memory Impairment Vertigo Dyspnoea Cranial Nerve Disorder Asthma Homicidal Ideation Dehydration Convulsion Abnormal Behaviour Agitation Joint Dislocation Post-Traumatic Stress Disorder Tremor Cognitive Disorder Toxicity To Various Agents Contusion Antinuclear Antibody Positive Ventricular Extrasystoles Productive Cough Ill-Defined Disorder Psychotic Disorder Attention Deficit/Hyperactivity Disorder Nocturia Mood Swings Fatigue Bronchial Hyperreactivity Headache Sleep Apnoea Syndrome Major Depression Age:45 YR Gender:Male I/FU:F
Meniscus Lesion Violence-Related Symptom Craniocerebral Injury Bundle Branch Block Right Ligament Sprain Myalgia Eosinophilia Visual Impairment 03-Apr-2012 09:37 AM Page: 771
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Visual Chest Discomfort Decreased Activity Thinking Abnormal Dysthymic Disorder Rhinitis Allergic Insomnia Disturbance In Attention Depression Suicidal Ideation Selective Iga Immunodeficiency Hypertension Hyperhidrosis Eye Movement Disorder Balance Disorder Panic Disorder Fall Musculoskeletal Pain Mitral Valve Incompetence Exostosis Weight Decreased Respiratory Rate Increased Hypoaesthesia Nystagmus
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:10/25/07ISR Number: 5497070-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-525623 Outcome Hospitalization Initial or Prolonged PT Feeling Abnormal Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:10/25/07ISR Number: 5498506-XReport Type:Direct Outcome PT Sleep Terror Depression Syncope Insomnia Vertigo Abnormal Dreams Alopecia Confusional State
Company Report #CTU 316349 Report Source Product Mefloquine 250mg Tabs Mepha Switzerland Primaquine 15 Mg Tabs Pharm Chem Role PS Manufacturer Mepha Switzerland
Gender:Female Dose ONE TABLET WEEKLY TWO YEARS PO 2 TABLETS DAILY 1X14 DAYS PO
I/FU:I Duration
SS
Pharm Chem
ORAL
Age:52 YR
Gender:Female
I/FU:I
Outcome Hospitalization Initial or Prolonged Other Serious
PT Panic Attack Asthenia Palpitations Flushing Dizziness Hypoaesthesia
Report Source
Product Artequin -Artesimine 200+Meflouquin 600mg
Role PS
Manufacturer
Route ORAL
Dose ONE ARTESIMINE+ ONE MEFLOUQUIN DAILY PO
Duration
03-Apr-2012
09:37 AM
Page: 772
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/07ISR Number: 5504026-6Report Type:Expedited (15-DaCompany Report #FR-ROCHE-499416 Outcome Other Serious PT Maculopathy Report Source Product Lariam Role PS Manufacturer Roche Age:46 YR Route UNKNOWN Gender:Male Dose I/FU:F Duration 6 MON
Date:11/05/07ISR Number: 5506648-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Aggression Memory Impairment Mood Swings Ill-Defined Disorder Cranial Nerve Disorder Hypertension Cognitive Disorder Mitral Valve Incompetence Ligament Sprain Antinuclear Antibody Positive Rheumatoid Factor Increased Pyrexia Brain Stem Syndrome Anger Abdominal Distension Haematochezia Mood Altered Depression Balance Disorder Generalised Anxiety Disorder Meniscus Lesion Dysthymic Disorder Craniocerebral Injury Weight Decreased Convulsion Anxiety Disorder Loose Body In Joint Diarrhoea Abdominal Pain Upper Dyspnoea Headache Sleep Apnoea Syndrome Musculoskeletal Pain Bundle Branch Block Right Exostosis Nystagmus Contusion Blood Potassium Decreased Rash Merycism
Age:45 YR
Gender:Male
I/FU:F
Dyspepsia Eructation Abnormal Behaviour Visual Impairment Selective Iga Immunodeficiency Fatigue Chest Discomfort 03-Apr-2012 09:37 AM Page: 773
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chest Pain Impulsive Behaviour Acute Coronary Syndrome Upper Respiratory Tract Infection Vertigo Hallucination, Visual Asthenia Panic Disorder Fall Tremor Thinking Abnormal Toxicity To Various Agents Attention Deficit/Hyperactivity Disorder Respiratory Rate Increased Eye Movement Disorder Nocturia Rash Papular Coordination Abnormal Wheezing Snoring Vestibular Disorder Deafness Hypervigilance Emotional Disorder Mucous Membrane Disorder Constipation Mucous Stools Nightmare Insomnia Agitation Anxiety Post-Traumatic Stress Disorder Asthma Humerus Fracture Dehydration Hypoaesthesia Myalgia Eosinophilia Ventricular Extrasystoles Injury Visual Field Defect Priapism No Therapeutic Response Tongue Disorder Dizziness Family Stress Nausea
Disturbance In Attention Bronchial Hyperreactivity Joint Dislocation Psychotic Disorder Self-Injurious Ideation Hyperhidrosis Homicidal Ideation Mitral Valve 03-Apr-2012 09:37 AM Page: 774
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcification Rhinitis Allergic Palpitations Tinnitus Hydrocephalus Suicidal Ideation Productive Cough Major Depression Decreased Activity Oxygen Saturation Decreased Joint Range Of Motion Decreased Breath Odour
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:11/08/07ISR Number: 5512218-5Report Type:Direct Outcome Other Serious PT Panic Attack Decreased Appetite Pyrexia Tremor Feeling Abnormal Nervousness Sleep Disorder Influenza Like Illness Palpitations
Age: Route
Gender:Male
I/FU:I
Dose Duration 1 TABLET ONCE A WEEK FOR 5 ONE PILL PER WEEK 5 WK
Date:11/14/07ISR Number: 5516163-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability PT Anxiety Disorder Psychotic Disorder Insomnia Amnesia Vestibular Disorder Nystagmus Eye Pain Rash Mood Swings Tinnitus Disturbance In Attention Dizziness Irritable Bowel Syndrome Hypoaesthesia Night Sweats Vision Blurred Nervousness Pain Of Skin Blood Pressure Increased
Age:35 YR
Gender:Male
I/FU:F
Brain Stem Syndrome Vomiting Memory Impairment Vertigo Headache Phonophobia Paraesthesia Nausea 03-Apr-2012 09:37 AM Page: 775
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Chest Pain Agitation Diarrhoea Nightmare Fatigue Inner Ear Disorder Abdominal Pain Testicular Pain Depression Photophobia Deafness
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Duration
C C C C
C C C C C
Date:11/15/07ISR Number: 5518385-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-472986 Outcome Other Serious PT Nervousness Agitation Hallucination Anxiety Depersonalisation Report Source Product Lariam Wellbutrin Role PS SS Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration PATIENT TOOK ONLY ONE DOSE FORM: SR TABLET
Date:11/15/07ISR Number: 5518594-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-529910 Outcome Other Serious PT Hypotonia Convulsion Report Source Product Mefloquine Hydrochloride 1 Drug Suspected Fansidar Role PS SS C Manufacturer Roche
Age:32 YR Route UNKNOWN INTRAMUSCULAR
Gender:Female Dose FREQUENCY REPORTED: FIRST DOSE
I/FU:I Duration
DAY
Date:11/19/07ISR Number: 5521627-XReport Type:Direct Outcome Required Intervention to Prevent Permanent PT Chills Diarrhoea Depression
Age:18 YR Route
Gender:Female Dose
I/FU:I Duration
Impairment/Damage
Thinking Abnormal Dyspnoea Panic Attack
03-Apr-2012
09:37 AM
Page: 776
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/07ISR Number: 5525171-5Report Type:Direct Outcome Other Serious PT Mental Disorder Adverse Drug Reaction Dizziness Paranoia Anxiety Company Report #CTU 318215 Report Source Product Larium 250 Mg Roche Role PS Manufacturer Roche Age:29 YR Route ORAL Gender:Male Dose 250 MG ONCE PER WEEK PO I/FU:I Duration
Date:11/20/07ISR Number: 5522092-9Report Type:Expedited (15-DaCompany Report #CA-ROCHE-529910 Outcome Other Serious PT Convulsion Hypotonia Report Source Product Mefloquine Hydrochloride 1 Drug Suspected Fansidar Role PS SS C Manufacturer Roche
Age:32 YR Route UNKNOWN INTRAMUSCULAR
Gender:Female Dose FREQUENCY REPORTED: FIRST DOSE
I/FU:I Duration
DAY
Date:11/23/07ISR Number: 5524616-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Agitation Depression Bronchial Hyperreactivity Hypertension Psychotic Disorder Decreased Activity Dysthymic Disorder Nystagmus Rheumatoid Factor Increased Pyrexia Insomnia Fatigue Dyspnoea Fall Cognitive Disorder Bundle Branch Block Right Dehydration Hypoaesthesia Disturbance In Attention Aggression Ill-Defined Disorder Joint Dislocation Post-Traumatic Stress Disorder Violence-Related Symptom Eye Movement Disorder
Age:45 YR
Gender:Male
I/FU:F
Ligament Sprain Antinuclear Antibody Positive Rash Papular Abnormal Behaviour Selective Iga Immunodeficiency Asthenia 03-Apr-2012 09:37 AM Page: 777
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Major Depression Generalised Anxiety Disorder Self-Injurious Ideation Musculoskeletal Pain Hyperhidrosis Mitral Valve Incompetence Oxygen Saturation Decreased Convulsion Balance Disorder Suicidal Ideation Productive Cough Headache Panic Disorder Tremor Thinking Abnormal Mitral Valve Calcification Exostosis Weight Decreased Myalgia Memory Impairment Visual Impairment Hallucination, Visual Asthma Homicidal Ideation Toxicity To Various Agents Humerus Fracture Attention Deficit/Hyperactivity Disorder Respiratory Rate Increased Contusion Rhinitis Allergic Eosinophilia Mood Swings Chest Pain Cranial Nerve Disorder Nocturia Anxiety Vertigo Chest Discomfort Sleep Apnoea Syndrome Meniscus Lesion Craniocerebral Injury Ventricular Extrasystoles
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Age:39 YR
Gender:Female
I/FU:F
PT Feeling Abnormal Dizziness Paraesthesia Sleep Disorder Headache Mental Disorder Page: 778
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain In Extremity Anxiety Paraesthesia Oral
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose
Duration
Date:11/28/07ISR Number: 5527945-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-529962 Outcome Other Serious PT Abortion Spontaneous Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED 4TH
Date:12/03/07ISR Number: 5531862-2Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-532847 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Adverse Drug Reaction Interstitial Lung Disease Respiratory Failure C-Reactive Protein Increased Overdose Laboratory Test Abnormal Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:12/04/07ISR Number: 5533285-9Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-532847 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Overdose Adverse Drug Reaction Respiratory Failure Interstitial Lung Disease Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:12/10/07ISR Number: 5541933-2Report Type:Expedited (15-DaCompany Report #NL-ROCHE-505944 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Status Epilepticus Report Source Product Lariam Role PS Manufacturer Roche
Age:4 YR Route ORAL
Gender:Female Dose
I/FU:F Duration
Date:12/10/07ISR Number: 5542551-2Report Type:Expedited (15-DaCompany Report #TW-SANOFI-SYNTHELABO-A01200713585 Outcome PT Report Source Product Role Manufacturer
Age: Route
Gender: Dose
I/FU:I Duration
Other Serious
Hypotension
Chloroquine Mefloquine
PS SS
UNKNOWN UNKNOWN
UNK UNK
03-Apr-2012
09:37 AM
Page: 779
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/07ISR Number: 5551451-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-534849 Outcome Life-Threatening PT Insomnia Anxiety Dyspnoea Congestive Cardiomyopathy Report Source Product Lariam Role PS Manufacturer Roche Age:59 YR Route ORAL Gender:Male I/FU:I
Dose Duration DOSAGE REGIMEN REPORTED AS 1 DOSE PER WEEK
Date:12/12/07ISR Number: 5564269-2Report Type:Expedited (15-DaCompany Report #GXKR2007GR10354 Outcome Hospitalization Initial or Prolonged PT Malaise Eosinophilic Pneumonia Blood Lactate Dehydrogenase Increased Pulmonary Toxicity Hypoxia Tachycardia Normochromic Normocytic Anaemia Report Source Foreign Literature Health Professional Product Mefloquine (Ngx)(Mefloquine) Unknown Ketoconazole (Ngx)(Ketoconazole) Unknown Role PS Manufacturer
Gender:Female Dose 250 MG, QW, ORAL TOPICAL
I/FU:I Duration
84
DAY
SS
TOPICAL
Date:12/14/07ISR Number: 5558149-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-535633 Outcome Other Serious PT Dyspnoea Exertional Lung Infiltration Pyrexia Eosinophilic Pneumonia Eosinophilia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:12/19/07ISR Number: 5566578-XReport Type:Expedited (15-DaCompany Report #GB-ROCHE-535633 Outcome Other Serious PT Eosinophilic Pneumonia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:12/19/07ISR Number: 5571067-2Report Type:Expedited (15-DaCompany Report #021668 Outcome Other Serious PT Cognitive Disorder Mental Disorder Pain Report Source Other Product Mefloquine Hydrochloride(Mefloq uine Hydrochloride) Tablet, 250mg Role Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
PS
Date:12/21/07ISR Number: 5571533-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-537148 Outcome Other Serious PT Eye Pain Nausea Paralysis Vertigo Headache 09:37 AM Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
03-Apr-2012
Page: 780
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/07ISR Number: 5574447-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Outcome Hospitalization Initial or Prolonged Disability PT Disturbance In Attention Aggression Psychotic Disorder Major Depression Hyperhidrosis Attention Deficit/Hyperactivity Disorder Ligament Sprain Depression Fatigue Productive Cough Chest Pain Sleep Apnoea Syndrome Joint Dislocation Mitral Valve Incompetence Convulsion Hypoaesthesia Contusion Rheumatoid Factor Increased Nocturia Abnormal Behaviour Mood Swings Visual Impairment Suicidal Ideation Bronchial Hyperreactivity Panic Disorder Post-Traumatic Stress Disorder Meniscus Lesion Cognitive Disorder Homicidal Ideation Dysthymic Disorder Toxicity To Various Agents Humerus Fracture Dehydration Respiratory Rate Increased Antinuclear Antibody Positive Myalgia Hallucination, Visual Balance Disorder Selective Iga Immunodeficiency Chest Discomfort Asthma Rhinitis Allergic Age:45 YR Gender:Male I/FU:F
Pyrexia Violence-Related Symptom Fall Exostosis Ventricular Extrasystoles Dyspnoea Tremor Thinking Abnormal 03-Apr-2012 09:37 AM Page: 781
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxygen Saturation Decreased Rash Papular Insomnia Agitation Anxiety Memory Impairment Vertigo Asthenia Generalised Anxiety Disorder Musculoskeletal Pain Craniocerebral Injury Mitral Valve Calcification Eosinophilia Ill-Defined Disorder Headache Cranial Nerve Disorder Hypertension Self-Injurious Ideation Decreased Activity Bundle Branch Block Right Weight Decreased Nystagmus Eye Movement Disorder
Report Source
Role PS C C
Manufacturer Roche
Route ORAL
Dose
Duration
Date:01/03/08ISR Number: 5581533-1Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Hyperventilation Anxiety Thinking Abnormal Toxicity To Various Agents Poor Quality Sleep Stress Dehydration Panic Attack Initial Insomnia Chest Discomfort Heart Rate Increased Fear Palpitations Dyspnoea Impaired Work Ability Middle Insomnia Alcohol Use
Company Report #CTU 321532 Report Source Product Larium ? Hoffman La Roche Role PS Manufacturer Hoffman La Roche
Gender:Female Dose 1 PER WEEK PO
I/FU:I Duration
Date:01/11/08ISR Number: 5588505-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-415971 Outcome Death PT Amyotrophy Upper Motor Neurone Lesion Report Source Product Lariam Engerix B Role PS SS Manufacturer Roche
Gender:Male Dose FORM: INHALATION SOLUTION, THE PATIENT
I/FU:F Duration
03-Apr-2012
09:37 AM
Page: 782
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report RECEIVED
Date:01/14/08ISR Number: 5592903-XReport Type:Direct Outcome Other Serious PT Feeling Abnormal Fear Psychotic Disorder Anxiety
Gender:Female
I/FU:I
Dose Duration ONCE PER WEEK PO
Date:01/14/08ISR Number: 5593124-7Report Type:Direct Outcome Disability PT Road Traffic Accident Vertigo Positional
Gender:Male Dose 250MG PO QWEEK
I/FU:I Duration
Date:01/15/08ISR Number: 5593239-3Report Type:Direct Outcome Other Serious PT Mood Swings Panic Disorder Anxiety Toxicity To Various Agents Fear
Gender:Male Dose 1/WEEK PO
I/FU:I Duration
Date:01/16/08ISR Number: 5593525-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-535633 Outcome Hospitalization Initial or Prolonged PT Eosinophilic Pneumonia Report Source Product Mefloquine Hydrochloride Ketoconazole Ketoconazole Role PS SS SS Manufacturer Roche
Age:67 YR Route ORAL TOPICAL TOPICAL
Gender:Female Dose SHAMPOO SHAMPOO
Date:01/22/08ISR Number: 5601165-6Report Type:Direct Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Tinnitus Mental Disorder Insomnia Mood Altered Anxiety Migraine Visual Impairment
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:01/29/08ISR Number: 5605775-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-537148 Outcome Other Serious 03-Apr-2012 09:37 AM PT Headache Vertigo
Age:
Gender:Male
I/FU:F
Page: 783
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Eye Pain Paralysis
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose
Duration
Date:01/30/08ISR Number: 5609148-7Report Type:Direct Outcome Disability PT Myalgia Hypoaesthesia Dizziness Impaired Work Ability Arthralgia
Age:33 YR Route
Gender:Female Dose ONCE WEEKLY
I/FU:I Duration
Date:02/05/08ISR Number: 5618668-0Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Tinnitus Insomnia Anxiety Palpitations Sinus Tachycardia
Company Report #CTU 324564 Report Source Product Mefloquine Hcl 250mg Sandoz Role PS Manufacturer Sandoz
Gender:Male Dose 1 TABLET ONCE A WEEK PO
I/FU:I Duration
Date:02/07/08ISR Number: 5618791-0Report Type:Expedited (15-DaCompany Report #AU-ROCHE-543953 Outcome Hospitalization Initial or Prolonged PT Paranoia Depression Mania Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:02/07/08ISR Number: 5618980-5Report Type:Expedited (15-DaCompany Report #GR-BOEHRINGER INGELHEIM GMBH, GERMANY-2008-BP-01668RAge:67 YR Outcome Hospitalization Initial or Prolonged PT Pyrexia Eosinophilic Pneumonia Normochromic Normocytic Anaemia Tachypnoea Red Blood Cell Sedimentation Rate Increased Blood Lactate Dehydrogenase Increased Eosinophilia Tachycardia Report Source Product Mefloquine Ketoconazole Role PS SS Manufacturer Boehringer Ingelheim Gmbh, Germany Route ORAL TOPICAL
Gender:Female Dose
C-Reactive Protein Increased Hypoxia
03-Apr-2012
09:37 AM
Page: 784
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/08ISR Number: 5622046-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability Other Serious PT Tinnitus Testicular Pain Photophobia Night Sweats Mood Swings Fatigue Chest Pain Vision Blurred Disturbance In Attention Diarrhoea Diabetes Mellitus Deafness Disorientation Vestibular Disorder Irritable Bowel Syndrome Eye Pain Hypoaesthesia Vertigo Psychotic Disorder Nystagmus Blood Triglycerides Increased Agitation Nausea Insomnia Nightmare Amnesia Headache Abdominal Pain Dizziness Depression Blood Pressure Increased Memory Impairment Inner Ear Disorder Rash Nervousness Phonophobia Paraesthesia Brain Stem Syndrome Vomiting Anxiety Disorder Pain Of Skin Report Source Product Lariam Imodium Compazine Role PS C C Manufacturer Roche Age:35 YR Route ORAL Gender:Male Dose ON 18 APR 2001, THERAPY REPORTED AS TWICE DAILY. BY TAPER. ON 18 APR 2001, THERAPY REPORTED AS: AS NEEDED. I/FU:F Duration
C C C C
C C C C C
Date:02/19/08ISR Number: 5630886-4Report Type:Expedited (15-DaCompany Report #CH-ROCHE-435016 Outcome Congenital Anomaly Other Serious PT Cerebral Ventricle Dilatation Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose INDICATION DRUG ACTING
I/FU:I Duration
Premature Baby Foetal Growth Restriction Maternal Exposure During Pregnancy
ON OTHER BLOOD PROTOZOA Eltroxin Stilnox C C REPORTED FREQUENCY 2 TOTAL.
15
DAY
DAY Page: 785
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/08ISR Number: 5636737-6Report Type:Direct Outcome Other Serious PT Suicidal Ideation Deafness Unilateral Tinnitus Crying Company Report #CTU 326092 Report Source Product Lariam Roche Role 250 Mg PS C C C Roche ORAL 250 MG ONCE WEEKLY PO (ONE DOSE) Manufacturer Age: Route Gender:Female Dose I/FU:I Duration
Klonopin Wellbutrin Lamictal
Date:02/25/08ISR Number: 5637134-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-548290 Outcome Other Serious PT Liver Function Test Abnormal Suicidal Ideation Overdose Somnolence Report Source Product Lariam Imodium Imodium Talvosilen Gelonida Ibuprofen Ibuprofen Talvosilen Lariam Gelonida Role PS SS SS SS SS SS SS SS SS SS Manufacturer Roche
Age:30 YR Route ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL
Gender:Female Dose
I/FU:I Duration
Roche Roche Roche
Date:02/25/08ISR Number: 5637136-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548278 Outcome Death Other Serious PT Homicide Completed Suicide Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:02/25/08ISR Number: 5637320-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548228 Outcome Death Other Serious PT Death Suicide Attempt Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose
I/FU:I Duration
Date:02/25/08ISR Number: 5637331-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548255 Outcome Other Serious PT Cardiovascular Insufficiency Depression Suicidal Ideation Report Source Product Lariam Doxam Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:03/07/08ISR Number: 5655519-2Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548290 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Somnolence Liver Function Test Abnormal
Age:30 YR
Gender:Female
I/FU:F
Page: 786
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Overdose Report Source Product Lariam Talvosilen Ibuprofen Imodium Role PS SS SS SS Manufacturer Roche Route ORAL ORAL ORAL ORAL Dose DRUG REPORTED AS "PANADEINE CO" DRUG REPORTED AS "LOPERAMIDE HYDROCHLORIDE " DRUG REPORTED AS "PANADEINE CO" Duration
Roche
Gelonida
SS
ORAL
Date:03/07/08ISR Number: 5655523-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548255 Outcome Other Serious PT Suicidal Ideation Depression Cardiovascular Insufficiency Report Source Product Lariam Doxam Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:03/11/08ISR Number: 5659980-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-550654 Outcome Hospitalization Initial or Prolonged PT Amyotrophic Lateral Sclerosis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose DOSE REPORTED: 1 COURSE
I/FU:I Duration
Date:03/12/08ISR Number: 5661506-0Report Type:Expedited (15-DaCompany Report #IT-ROCHE-550893 Outcome Hospitalization Initial or Prolonged PT Abdominal Distension Dyspnoea Oedema Peripheral Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:03/12/08ISR Number: 5661510-2Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548228 Outcome Death Other Serious PT Death Suicide Attempt Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose
I/FU:F Duration
Date:03/13/08ISR Number: 5662678-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548278 Outcome Death Other Serious 03-Apr-2012 09:37 AM PT Homicide Completed Suicide Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:F Duration
Page: 787
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/08ISR Number: 5676118-2Report Type:Expedited (15-DaCompany Report #CA-ROCHE-940804124001 Outcome Death Life-Threatening PT Hallucination Completed Suicide Report Source Product Lariam Alcohol Role PS C Manufacturer Roche Age:23 YR Route ORAL ORAL Gender:Male Dose I/FU:F Duration
Date:03/28/08ISR Number: 5685018-3Report Type:Expedited (15-DaCompany Report #CH-ROCHE-84542 Outcome Death PT Nasopharyngitis Death Report Source Product Lariam Tablets Flunitrazepam Neo-Citran Role PS C C Manufacturer Roche
Age:30 YR Route ORAL UNKNOWN ORAL
Gender:Male Dose
I/FU:I Duration
Date:03/28/08ISR Number: 5685028-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-94161 Outcome Death PT Death Report Source Product Lariam Tablets Indapamide Role PS SS Manufacturer Roche
Age:60 YR Route ORAL UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:03/28/08ISR Number: 5685058-4Report Type:Expedited (15-DaCompany Report #NL-ROCHE-104818 Outcome Death PT Malaise Death Nausea Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:03/31/08ISR Number: 5688792-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-550654 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Amyotrophic Lateral Sclerosis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose DOSE REPORTED: 1 COURSE (COMMON)
I/FU:F Duration
Date:03/31/08ISR Number: 5688827-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-305523 Outcome Death PT Death Mental Disorder Report Source Product Lariam Lodoz Role PS SS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Age:27 YR
Gender:Male
I/FU:I
Outcome Death Other Serious
PT Drug Interaction Foot Fracture Death Epilepsy Depression Accidental Death 09:37 AM Page: 788
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drowning Abnormal Behaviour Psychotic Disorder Hallucination
Report Source
Product Lariam Carbamazepine Valproate
Role PS C I
Manufacturer Roche
Dose
Duration
Date:04/01/08ISR Number: 5690471-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-354441 Outcome Death Other Serious PT Death Arrhythmia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:04/01/08ISR Number: 5693443-XReport Type:Direct Outcome Hospitalization Initial or Prolonged PT Anxiety Chest Pain Flight Of Ideas Delusion Agitation Psychotic Disorder Confusional State Altered State Of Consciousness Feeling Abnormal Claustrophobia
Company Report #CTU 330870 Report Source Product Larium 250 Mg Tablet Role PS Manufacturer
Gender:Male Dose 250 MG ONCE WEEKLY ORAL
I/FU:I Duration
Date:04/03/08ISR Number: 5694409-6Report Type:Direct Outcome Other Serious PT Paraesthesia Dry Mouth Asthenia Blood Cholesterol Increased Balance Disorder Hypotension Product Quality Issue Dizziness
Age:64 YR Route
Gender:Female Dose 1 TABLET 1 PER WEEK
I/FU:I Duration
Date:04/04/08ISR Number: 5694932-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-531067 Outcome Disability PT Stress At Work
Age:
Gender:Male
I/FU:F
Anxiety Tachycardia Sensory Disturbance Compulsions Heart Rate Irregular Depression Psychosomatic Disease Irritability 03-Apr-2012 09:37 AM Page: 789
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Twitching Panic Attack Restlessness Nervous System Disorder Self Esteem Decreased Affect Lability Cardiovascular Disorder Tremor Sleep Disorder Personality Change Tachyarrhythmia
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route ORAL
Dose
Duration
Date:04/07/08ISR Number: 5696150-2Report Type:Expedited (15-DaCompany Report #DE-ROCHE-555182 Outcome Other Serious PT Atrial Septal Defect Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
Date:04/07/08ISR Number: 5699102-1Report Type:Direct Outcome Life-Threatening Other Serious PT Insomnia Anxiety Balance Disorder Hallucination Paranoia Nightmare Dizziness Suicidal Ideation
Company Report #CTU 331512 Report Source Product Mefloquine Hcl 250 Mg Sandoz Role PS Manufacturer Sandoz
Age: Route ORAL
Gender:Female Dose 250 MG 1 A WEEK PO
I/FU:I Duration
Date:04/10/08ISR Number: 5700060-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-550654 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Amyotrophic Lateral Sclerosis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose DOSE REPORTED: 1 COURSE (COMMON)
I/FU:F Duration
Date:04/10/08ISR Number: 5702450-XReport Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Psychiatric Symptom Neurological Symptom
Gender:Male Dose 8 WEEKLY BUCCAL
Date:04/18/08ISR Number: 5709774-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Outcome Hospitalization Initial or Prolonged Other Serious 03-Apr-2012 09:37 AM PT Abnormal Dreams Vertigo Depression
Age:
Gender:Female
I/FU:F
Page: 790
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Fatigue Tinnitus Tachycardia Dyspepsia Formication Oedema Peripheral Unevaluable Event Malaise Paraesthesia Sleep Disorder Disturbance In Attention Anxiety Pyrexia Coordination Abnormal Muscle Twitching Cardiovascular Disorder Upper Respiratory Tract Infection Agitation Asthenia Feeling Abnormal Mental Disorder Night Sweats
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Date:04/22/08ISR Number: 5712570-1Report Type:Expedited (15-DaCompany Report #GB-AVENTIS-200811608EU Outcome Death PT Death Report Source Product Indapamide Lariam /00813001/ SS ORAL Role PS Manufacturer Aventis Pharmaceuticals Inc.
Gender:Female Dose dose: UNK dose: UNK
I/FU:I Duration
Date:04/22/08ISR Number: 5716351-4Report Type:Expedited (15-DaCompany Report #2008S1005710 Outcome Death PT Death Report Source Foreign Health Professional Other Product Indapamide (Indapamide) Lariam /00813001/ (Mefloquine) Role PS SS ORAL Manufacturer
Age:60 YR Route
Gender:Female Dose
I/FU:I Duration
ORAL
Date:04/25/08ISR Number: 5717904-XReport Type:Expedited (15-DaCompany Report #GB-ABBOTT-98P-167-0078100-00 Outcome Death PT Depression Social Avoidant Behaviour
Age:27 YR
Gender:Male
I/FU:I
Foot Fracture Psychotic Disorder Fatigue Abnormal Behaviour Epilepsy Drowning Drug Level Below Therapeutic 03-Apr-2012 09:37 AM Page: 791
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Report Source Product Valproate Sodium Valproate Sodium Valproate Sodium Valproate Sodium Carbamazepine Carbamazepine Carbamazepine Mefloquine Role PS SS SS SS C C C I Manufacturer Route ORAL ORAL ORAL ORAL ORAL ORAL ORAL Dose Dose increased 600 mg daily Dose tapered Dose tapered 250 mg weekly Duration
Date:04/29/08ISR Number: 5721785-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-560669 Outcome Hospitalization Initial or Prolonged PT Hypomania Abnormal Behaviour Report Source Product Lariam Fortzaar Fortzaar Role PS C C Manufacturer Roche
Age: Route ORAL ORAL ORAL
Gender:Male Dose
I/FU:I Duration
Date:04/30/08ISR Number: 5724928-5Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Liver Disorder
Age:41 YR Route
Gender:Male Dose
I/FU:I Duration
Date:05/05/08ISR Number: 5731287-0Report Type:Expedited (15-DaCompany Report #2008S1005710 Outcome Death PT Death Report Source Health Professional Other Product Indapamide (Indapamide) Lariam /00813001/ (Mefloquine) Role PS SS ORAL Manufacturer
Age:60 YR Route
Gender:Female Dose
I/FU:I Duration
ORAL
Date:05/07/08ISR Number: 5730460-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-561917 Outcome Hospitalization Initial or Prolonged PT Rhabdomyolysis Pancreatitis Acute Areflexia Pericarditis Report Source Product Lariam Xanax Role PS C Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Age:
Gender:Male
I/FU:F
Outcome Disability Other Serious
PT Nausea Insomnia Irritable Bowel Syndrome Nervousness Blood Pressure Increased Disorientation 09:37 AM Page: 792
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amnesia Nystagmus Blood Triglycerides Increased Toxicity To Various Agents Agitation Anxiety Disorder Eye Pain Rash Memory Impairment Headache Vestibular Disorder Photophobia Paraesthesia Fatigue Tinnitus Inner Ear Disorder Dizziness Disturbance In Attention Hypoaesthesia Phonophobia Brain Stem Syndrome Diarrhoea Night Sweats Mood Swings Vertigo Chest Pain Psychotic Disorder Testicular Pain Depression Vomiting Nightmare Diabetes Mellitus Abdominal Pain Vision Blurred Pain Of Skin Deafness
Report Source
Product Lariam Bactrim Imodium Compazine
Role PS C C C
Manufacturer Roche
Route ORAL
Dose
Duration
ON 18 APR 2001, THERAPY REPORTED AS TWICE DAILY. BY TAPER. ON 18 APR 2001, THERAPY REPORTED AS: AS NEEDED.
C C C C
C C C C C
Date:05/12/08ISR Number: 5735434-6Report Type:Expedited (15-DaCompany Report #SE-ROCHE-560756 Outcome Other Serious PT International Normalised Ratio Increased Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male
I/FU:I
Waran
SS
ORAL
Dose Duration THERAPY START AND STOP DATE REPORTED AS 2008, DOSAGE REGIMEN: DD DOSAGE REGIMEN REPORTED AS D D
Date:05/14/08ISR Number: 5737157-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Outcome Disability Other Serious 03-Apr-2012 09:37 AM PT Vertigo Blood Triglycerides
Age:
Gender:Male
I/FU:F
Page: 793
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Vision Blurred Rash Nausea Mood Swings Insomnia Amnesia Depression Blood Pressure Increased Paraesthesia Diarrhoea Vestibular Disorder Psychotic Disorder Diabetes Mellitus Nervousness Fatigue Photophobia Pain Of Skin Toxicity To Various Agents Vomiting Nightmare Testicular Pain Dizziness Hypoaesthesia Phonophobia Anxiety Disorder Disorientation Chest Pain Nystagmus Inner Ear Disorder Abdominal Pain Irritable Bowel Syndrome Disturbance In Attention Eye Pain Night Sweats Agitation Headache Tinnitus Deafness Brain Stem Syndrome Memory Impairment
Report Source
Product Lariam Bactrim Imodium Compazine
Role PS C C C
Manufacturer Roche
Route ORAL
Dose
Duration
ON 18 APR 2001, THERAPY REPORTED AS TWICE DAILY. BY TAPER. ON 18 APR 2001, THERAPY REPORTED AS: AS NEEDED.
C C C C
C C C C C
Date:05/14/08ISR Number: 5742047-9Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Vertigo Nausea Hallucination Headache
Company Report #CTU 336553 Report Source Product Lariam -MefloquinRole PS Manufacturer
Age: Route ORAL
Gender:Female
I/FU:I
Dose Duration 1 PILL ONCE A WEEK PO
Date:05/29/08ISR Number: 5752217-1Report Type:Expedited (15-DaCompany Report #NL-ROCHE-566208 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Respiratory Distress Cyanosis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Page: 794
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/08ISR Number: 5755389-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-566032 Outcome Other Serious PT Poisoning Sexual Abuse Report Source Product Lariam Unknown Benzodiazepines Role PS SS Manufacturer Roche Age: Route UNKNOWN UNKNOWN Gender:Male Dose I/FU:I Duration
Date:06/02/08ISR Number: 5758017-0Report Type:Direct Outcome Other Serious PT Weight Decreased Aggression Insomnia
Gender:Male Dose 250 MG WEEKLY PO
I/FU:I Duration
Date:06/03/08ISR Number: 5757295-1Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-566339 Outcome Other Serious PT Hepatic Steatosis Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:06/03/08ISR Number: 5757344-0Report Type:Expedited (15-DaCompany Report #SE-ROCHE-566343 Outcome Hospitalization Initial or Prolonged Other Serious PT Nightmare Hallucination, Visual Psychotic Disorder Incoherent Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:06/04/08ISR Number: 5758918-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-564714 Outcome Other Serious PT Disturbance In Attention Herpes Zoster Dizziness Memory Impairment Altered Visual Depth Perception Balance Disorder Colour Blindness Report Source Product Lariam Lariam Role PS C Manufacturer Roche
Age: Route ORAL
Gender:Male Dose DOSING FREQUENCY REPORTED AS 6 TABLETS IN 2 DAYS.
I/FU:I Duration
Age:46 YR Route
Gender:Female Dose
I/FU:I Duration
Death
Suicide Attempt Completed Suicide Suicidal Ideation
Other
Lariam (Mefloquine Hydrochloride)
PS
03-Apr-2012
09:37 AM
Page: 795
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/08ISR Number: 5765660-1Report Type:Periodic Outcome Other Serious PT Paranoia Company Report #512701 Report Source Consumer Company Representative Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer Age: Route Gender: Dose I/FU:I Duration
Date:06/04/08ISR Number: 5765665-0Report Type:Periodic Outcome Life-Threatening PT Suicidal Ideation Disturbance In Attention Panic Attack Anxiety Abnormal Dreams Aggression Depression
Company Report #534035 Report Source Consumer Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:24 YR Route
Gender:Male Dose
I/FU:I Duration
Date:06/04/08ISR Number: 5765670-4Report Type:Periodic Outcome Other Serious PT Medication Error Overdose Agitation Confusional State Ataxia Dizziness Speech Disorder Deafness
Age:82 YR Route
Gender:Female Dose 250 MG DAILY
Date:06/04/08ISR Number: 5765673-XReport Type:Periodic Outcome Other Serious PT Nausea Paraesthesia Overdose Asthenia Depression Medication Error Disorientation Fatigue
Age:53 YR Route
Gender:Male Dose 250 MG DAILY
I/FU:I Duration
Age:
Gender:
I/FU:I
PT Mental Disorder
Role PS
Manufacturer
Route
Dose
Duration
03-Apr-2012
09:37 AM
Page: 796
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/08ISR Number: 5767227-8Report Type:Direct Outcome Other Serious PT Abnormal Dreams Nightmare Company Report #CTU 339638 Report Source Product Mefloquine Malaris E Role PS Manufacturer Age:25 YR Route Gender:Female Dose I/FU:I Duration
Date:06/12/08ISR Number: 5766736-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-569094 Outcome Death Other Serious PT Completed Suicide Delusion Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:06/13/08ISR Number: 5773271-7Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Confusional State Hallucination Adverse Drug Reaction Psychotic Disorder Mania Depression Thinking Abnormal Suicidal Ideation
Company Report #CTU 339922 Report Source Product Lariam Hydrochloride Hoffman-Laroche -RocheRole PS Manufacturer Hoffman-Laroche -Roche-
Age:21 YR Route
Gender:Male Dose
I/FU:I Duration
ORAL
WEEKLY PO
Date:06/17/08ISR Number: 5775289-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-569005 Outcome Hospitalization Initial or Prolonged PT Rhabdomyolysis Report Source Product Lariam Xanax Role PS C Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:06/17/08ISR Number: 5776506-XReport Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Suicidal Ideation Mental Disorder Panic Attack
Age:46 YR Route
Gender:Female Dose ONE TABLET WEEKLY
I/FU:I Duration
Date:06/18/08ISR Number: 5778564-5Report Type:Direct Outcome Life-Threatening Other Serious Required PT Anxiety Insomnia Paranoia
Age:21 YR
Gender:Male
I/FU:I
Attention Deficit/Hyperactivity Disorder Anger Fatigue Mood Swings Suicidal Ideation Aggression Page: 797
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Phobia Nervous System Disorder Brain Injury
Report Source
Role PS
Manufacturer Roche
Route ORAL
Dose 1 PILL ONCE PO
Duration
Date:06/23/08ISR Number: 5781458-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-569094 Outcome Death Other Serious PT Delusion Completed Suicide Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:F Duration
Date:06/23/08ISR Number: 5786900-9Report Type:Direct Outcome Other Serious PT Insomnia Suicidal Ideation Abnormal Dreams Anxiety
Company Report #CTU 340905 Report Source Product Mefloquine Taken Once A Wk X 2 Doses Albendazole Cipro Role PS C C Manufacturer
Age: Route ORAL
Gender:Male Dose 250MG WEEKLY PO
I/FU:I Duration
Date:06/30/08ISR Number: 5794845-3Report Type:Expedited (15-DaCompany Report #SE-ROCHE-566343 Outcome Hospitalization Initial or Prolonged Other Serious PT Incoherent Nightmare Psychotic Disorder Hallucination, Visual Report Source Product Lariam Malarone Malarone Role PS C C Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:07/02/08ISR Number: 5798235-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-570689 Outcome Other Serious PT Drug Ineffective Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:07/03/08ISR Number: 5800412-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-570689 Outcome Other Serious PT Drug Ineffective Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Age:
Gender:Male
I/FU:I
PT Cognitive Disorder
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose
Duration
03-Apr-2012
09:37 AM
Page: 798
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/08ISR Number: 5802953-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-573267 Outcome Other Serious PT Pulmonary Oedema Pulmonary Fibrosis Pneumonia Dyspnoea Report Source Product Lariam Lariam Role PS SS Manufacturer Roche Roche Age: Route ORAL ORAL Gender:Male Dose I/FU:I Duration
Date:07/10/08ISR Number: 5806523-2Report Type:Expedited (15-DaCompany Report #US-BOEHRINGER INGELHEIM GMBH, GERMANY-2008-BP-10301RAge:63 YR Outcome Hospitalization Initial or Prolonged PT White Blood Cell Count Increased Antipsychotic Drug Level Increased Mania Report Source Product Mefloquine Eskalith Cr Eskalith Cr Lunesta Quetiapine Quetiapine Role PS SS SS SS C C Manufacturer Boehringer Ingelheim Gmbh, Germany Route
Gender:Male Dose
Date:07/14/08ISR Number: 5809717-5Report Type:Direct Outcome PT Anxiety Muscle Twitching Malaise Pain Depression Nerve Injury
Company Report #CTU 343343 Report Source Product Larium La Roche Role PS Manufacturer La Roche
Gender:Male Dose 1 TABLET WEEKLY PO
I/FU:I Duration
Date:07/15/08ISR Number: 5810454-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-531067 Outcome Disability PT Depression Tachycardia Affect Lability Stress At Work Anxiety Restlessness Nervous System Disorder Panic Attack Muscle Twitching Cardiovascular Disorder Tremor Sleep Disorder Compulsions Irritability Heart Rate Irregular Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:F Duration
Psychosomatic Disease Sensory Disturbance Self Esteem Decreased Personality Change Tachyarrhythmia
03-Apr-2012
09:37 AM
Page: 799
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/08ISR Number: 5816593-3Report Type:Expedited (15-DaCompany Report #NL-ROCHE-575244 Outcome Other Serious PT Renal Failure Hepatic Failure Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Female Dose I/FU:I Duration
Date:07/22/08ISR Number: 5821277-1Report Type:Direct Outcome Other Serious PT Activities Of Daily Living Impaired Depression Anxiety Insomnia Disorientation Crying Hallucination
Age:22 YR Route
Gender:Male Dose THREE PILLS
I/FU:I Duration
Date:07/23/08ISR Number: 5822351-6Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Grand Mal Convulsion Upper Limb Fracture
Age:33 YR Route
Gender:Male Dose
I/FU:I Duration
Date:07/25/08ISR Number: 5823376-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-314664 Outcome Disability Other Serious PT Anxiety Job Dissatisfaction Depression Restlessness Nervous System Disorder Tremor Panic Attack Affect Lability Palpitations Sleep Disorder Compulsions Irritability Sensory Disturbance Self Esteem Decreased Peripheral Vascular Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Disorder Muscle Twitching Personality Change Arrhythmia Heart Rate Irregular Tachycardia Psychosomatic Disease 03-Apr-2012 09:37 AM Page: 800
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/08ISR Number: 5824289-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-576460 Outcome Hospitalization Initial or Prolonged PT Cytolytic Hepatitis Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Male Dose DOSE: MG/KG MG/KG HOURS 15 THEN 20 EIGHT LATER I/FU:I Duration
Date:07/31/08ISR Number: 5832404-4Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Restlessness Memory Impairment Confusional State Visual Impairment Tinnitus Anxiety Palpitations Dyspepsia Rash Asthma Dyspnoea Mood Altered Oedema Bone Disorder Hypertension Tachycardia Muscular Weakness Back Disorder Depression Myalgia Muscle Spasms Arthralgia Suicidal Ideation Urticaria Hypersensitivity Fatigue
Company Report #CTU 345127 Report Source Product Lariam/Mefloquine N/A N/A Role PS Manufacturer
Gender:Male Dose 60 ONE PER DAY BUCCAL
I/FU:I Duration
Date:08/07/08ISR Number: 5841157-5Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Anger Impaired Work Ability Aggression Suicidal Ideation Bipolar Disorder Activities Of Daily Living Impaired Mental Disorder
Company Report #CTU 345741 Report Source Product Mefloquine Week Dose Role Once A PS ORAL Manufacturer
Age:29 YR Route
Gender:Male Dose ONCE A WEEK PO
I/FU:I Duration
Hallucination Confusional State Feeling Abnormal
03-Apr-2012
09:37 AM
Page: 801
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/08ISR Number: 5842265-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-578606 Outcome Other Serious PT Atrial Fibrillation Ventricular Tachycardia Sinus Arrhythmia Report Source Product Lariam Role PS Manufacturer Roche Age: Route UNKNOWN Gender:Male Dose I/FU:I Duration 3 WK
Date:08/19/08ISR Number: 5849623-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-580275 Outcome Life-Threatening PT Crying Dyspnoea Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose REPORTED AS MEFLOQUINE GIVEN 'CRUSHED IN WATER'
I/FU:I Duration
DAY
Date:08/22/08ISR Number: 5853999-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-581040 Outcome Other Serious PT Hypersensitivity Amnesia General Physical Health Deterioration Tachycardia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:08/22/08ISR Number: 5854000-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-529962 Outcome Other Serious PT Abortion Spontaneous Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female
I/FU:F
Dose Duration ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED 4TH 8 WK
Date:08/29/08ISR Number: 5864202-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-582167 Outcome Death Hospitalization Initial or Prolonged PT Sepsis Chronic Granulomatous Disease Multi-Organ Failure Bronchopulmonary Aspergillosis Pyrexia Report Source Product Mefloquine Hydrochloride Immunoglobulin Injectable Role PS Manufacturer Roche
Age:11 MON Route UNKNOWN
Gender:Male Dose DRUG NAME REPORTED AS MEFLOQUINE DRUG NAME REPORTED AS IMMUNOGLOBULI
I/FU:I Duration
SS
INTRAMUSCULAR
03-Apr-2012
09:37 AM
Page: 802
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/08ISR Number: 5864210-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-582044 Outcome Hospitalization Initial or Prolonged PT Pyrexia Visual Field Defect Restlessness Diarrhoea Insomnia Decreased Appetite Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche Age:26 YR Route UNKNOWN Gender:Male Dose I/FU:I Duration
Date:08/29/08ISR Number: 5867094-8Report Type:Direct Outcome Disability Other Serious PT Panic Attack Ear Pain Loss Of Consciousness Depression Anxiety Psychotic Disorder Hallucination Headache Insomnia Arthralgia Neck Pain Mood Swings Confusional State Myalgia Fatigue Paranoia Dizziness Memory Impairment
Age:19 YR Route
Gender:Male
I/FU:I
Dose Duration 1 PILL 1 PER WEEK
Date:09/02/08ISR Number: 5868957-XReport Type:Direct Outcome Other Serious PT Affect Lability Feeling Of Despair Crying Cold Sweat Emotional Disorder Early Retirement Insomnia Marital Problem Depression Impaired Work Ability Suicidal Ideation Disturbance In Attention Muscle Disorder Divorced
Company Report #CTU 348060 Report Source Product Meflouquine Role PS Manufacturer
Age: Route ORAL
Gender:Male Dose PO
Date:09/03/08ISR Number: 5868533-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-582804 Outcome Other Serious 03-Apr-2012 09:37 AM PT Post-Traumatic Stress Disorder
Age:24 YR
Gender:Male
I/FU:I
Page: 803
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amnesia Physical Assault Sexual Abuse Theft
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose
Duration
Date:09/08/08ISR Number: 5873719-3Report Type:Expedited (15-DaCompany Report #CH-ROCHE-583994 Outcome Other Serious PT Obsessive-Compulsive Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:09/08/08ISR Number: 5874972-2Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Disturbance In Attention Amnesia Aphasia Depression Thinking Abnormal
Company Report #CTU 348811 Report Source Product Mefloquine Hci 250 Mg Tablets Barr Laboratories Inc. Role PS Manufacturer Barr Laboratories Inc.
Age:40 YR Route
Gender:Female Dose
I/FU:I Duration
ORAL
1 TABLET ONCE A WEEK PO
Date:09/08/08ISR Number: 5876479-5Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Abnormal Behaviour Belligerence Paranoia
Gender:Male
I/FU:I
Dose Duration 250MG WEEKLY PO
Date:09/10/08ISR Number: 5880016-9Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Convulsion Vomiting Nightmare Nausea Feeling Abnormal Suicidal Ideation Fear Frequent Bowel Movements Impaired Work Ability Dizziness Gastroenteritis Panic Attack Abnormal Behaviour Retching
Company Report #CTU 349175 Report Source Product Mefloquine Macrobid Dramamine Seasonique Ambien Cr Role PS C C C C Manufacturer
Age: Route ORAL
Gender:Female Dose 1 TABLET WEEKLY PO
I/FU:I Duration
Anxiety Delusion Mental Disorder Pyrexia
03-Apr-2012
09:37 AM
Page: 804
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/08ISR Number: 5883994-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-585370 Outcome Other Serious PT Gamma-Glutamyltransferase Increased Report Source Product Lariam Role PS Manufacturer Roche Age: Route UNKNOWN Gender:Female I/FU:I
Dose Duration DOSE REPORTED AS 250 MG/WEE
Date:09/19/08ISR Number: 5889257-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-581040 Outcome Other Serious PT Amnesia Incorrect Dose Administered Tachycardia Hypersensitivity Unresponsive To Stimuli General Physical Health Deterioration Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:F Duration
Date:09/22/08ISR Number: 5891587-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-586516 Outcome Other Serious PT Hallucination Nausea Euphoric Mood Vomiting Persecutory Delusion Pyrexia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:09/29/08ISR Number: 5901813-7Report Type:Expedited (15-DaCompany Report #CA-ROCHE-319480 Outcome Life-Threatening Other Serious PT Suicide Attempt Physical Assault Homicide Amnesia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:09/30/08ISR Number: 5904319-4Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent PT Activities Of Daily Living Impaired Suicidal Ideation Abnormal Dreams Discomfort Sleep Disorder
Age:22 YR
Gender:Female
I/FU:I
Impairment/Damage
Metamorphopsia Nervousness Panic Attack Malaise Stress Feeling Hot Tension Pyrexia Page: 805
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Anxiety Balance Disorder Malaria Hallucination Tremor Eating Disorder Ill-Defined Disorder Hypochondriasis Psychotic Disorder Insomnia Hypoaesthesia Paraesthesia Mental Disorder Paranoia Depression Morbid Thoughts Asthenia Feeling Abnormal Dyskinesia
Report Source
Product Lariam -Mefloquine250mg Roche/Lariam
Role PS
Manufacturer Roche/Lariam
Route ORAL
Dose 250MG 1/WEEK PO
Duration
Date:10/03/08ISR Number: 5907741-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-581040 Outcome Other Serious PT General Physical Health Deterioration Hypersensitivity Tachycardia Amnesia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:F Duration
Date:10/09/08ISR Number: 5914065-9Report Type:Expedited (15-DaCompany Report #SE-ROCHE-588873 Outcome Hospitalization Initial or Prolonged PT Atrial Fibrillation Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:10/16/08ISR Number: 5920895-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-590200 Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Shock Acute Respiratory Failure Pulmonary Toxicity Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Age:
Gender:Male
I/FU:I
Outcome Hospitalization Initial or Prolonged Other Serious
PT Polyneuropathy Spinal Column Stenosis
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose Duration 'PATIENT TOOK FOUR TABLETS IN TOTAL'. 4 WK
03-Apr-2012
09:37 AM
Page: 806
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/08ISR Number: 5939669-9Report Type:Direct Outcome Other Serious PT Abnormal Dreams Confusional State Panic Attack Paranoia Nightmare Depression Heart Rate Increased Disturbance In Attention Dizziness Flushing Nonspecific Reaction Impaired Driving Ability Company Report #CTU 354413 Report Source Product Mefloquine Hcl 250mg Role PS Manufacturer Age:32 YR Route ORAL Gender:Female I/FU:I
Dose Duration 250MG 1 PILL PER WEEK PO
Date:11/07/08ISR Number: 5945298-3Report Type:Expedited (15-DaCompany Report #NL-ROCHE-594401 Outcome Hospitalization Initial or Prolonged PT Fatigue Psychotic Disorder Tongue Disorder Dizziness Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:11/12/08ISR Number: 5951184-5Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Metabolic Disorder Bronchitis Anxiety Panic Attack Hallucination, Auditory Pneumonitis Overdose Vestibular Disorder Balance Disorder
Company Report #CTU 355843 Report Source Product Lariam-MefloquineHoffman Laroche Role PS Manufacturer Hoffman Laroche
Age: Route ORAL
Gender:Male Dose 250MG WEEKLY PO
I/FU:I Duration
Date:11/13/08ISR Number: 5955004-4Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Myalgia Dyspnoea Diarrhoea Anxiety Vomiting Dyspepsia Pulmonary Embolism
Company Report #CTU 356027 Report Source Product Lariam 250mg R Role PS Manufacturer R
Gender:Male
I/FU:I
Insomnia Chest Pain
03-Apr-2012
09:37 AM
Page: 807
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/08ISR Number: 5961252-XReport Type:Expedited (15-DaCompany Report #08-001813 Outcome Other Serious PT Drug Level Increased Vomiting Cinchonism Tinnitus Headache Pyrexia Nausea Deafness Parasite Blood Test Positive Erythema Flushing Report Source Foreign Literature Health Professional Product Doryx (Doxycycline) Capsule, 100mg Mefloquine (Mefloquine) Quinine Hydrochloride (Quinine Hydrochloride) Role PS SS Manufacturer Age:26 YR Route ORAL ORAL Gender:Male Dose 100 MG, BID, ORAL 500 MG, ORAL I/FU:I Duration
SS
INTRAVENOUS
600 MG, QID, INTRAVENOUS
Date:11/20/08ISR Number: 5960089-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Outcome Hospitalization Initial or Prolonged PT Anxiety Dehydration Gastrointestinal Bacterial Infection Report Source Product Lariam Lariam Role PS SS Manufacturer Roche Roche
Gender:Female Dose FREQUENCY REPORTED: 1X/WEEK.
I/FU:I Duration
Date:11/24/08ISR Number: 5963991-3Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2008-RO-00257RO Outcome Hospitalization Initial or Prolonged Other Serious PT Hospitalisation Drug Prescribing Error Report Source Product Mefloquine Role PS Manufacturer Roxane Laboratories, Inc.
Age: Route
Gender: Dose
Date:11/25/08ISR Number: 5966467-2Report Type:Expedited (15-DaCompany Report #NL-ROCHE-594401 Outcome Hospitalization Initial or Prolonged PT Fatigue Psychotic Disorder Dizziness Tongue Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:F Duration
Date:11/26/08ISR Number: 5972754-4Report Type:Direct Outcome Required Intervention to Prevent Permanent PT Panic Attack Feeling Abnormal Claustrophobia
Age:44 YR Route
Gender:Female Dose
I/FU:I Duration
Impairment/Damage
03-Apr-2012
09:37 AM
Page: 808
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/08ISR Number: 5976051-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-575286 Outcome Hospitalization Initial or Prolonged Disability Other Serious PT Mental Disorder Headache Confusional State Conversion Disorder Weight Decreased Arthralgia Depression Dysphagia Dyspnoea Exertional Agitation Deafness Suicidal Ideation Scab Poor Quality Sleep Constipation Mania Chest Pain Report Source Product Lariam Arthritis Medication Nos Naproxen Hctz Paxil Tramadol Aspirin Heparin Ativan Seroquel Unknown Bp Medicine Enalapril Role PS C C C C C C C C C C C Manufacturer Roche Age: Route ORAL ORAL ORAL ORAL ORAL FREQUENCY: 1 MG Q.H.S ORAL Gender:Male Dose I/FU:I Duration
Date:12/02/08ISR Number: 5976068-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-598858 Outcome Hospitalization Initial or Prolonged Other Serious PT Panic Attack Psychotic Disorder Depression Choking Sensation Paranoia Dehydration Swollen Tongue Fall Report Source Product Lariam Fosamax Role PS C Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:12/08/08ISR Number: 5983945-0Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Outcome Hospitalization Initial or Prolonged PT Gastrointestinal Bacterial Infection Anxiety Report Source Product Lariam Lariam Role PS SS Manufacturer Roche Roche
I/FU:F Duration
Date:12/10/08ISR Number: 5993287-5Report Type:Direct Outcome Other Serious PT Paraesthesia Oral Pain In Extremity Paraesthesia
Company Report #CTU 358888 Report Source Product Mefloquine Hcl 250 Mg Tablesan Sandoz, Inc Role PS Manufacturer Sandoz, Inc
Gender:Female Dose ONE WEEKLY PO
I/FU:I Duration
Mass Headache Neck Pain Burning Sensation
03-Apr-2012
09:37 AM
Page: 809
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/08ISR Number: 5999479-3Report Type:Direct Outcome Life-Threatening PT Convulsion Company Report #CTU 358964 Report Source Product Lariam Dilantin Role PS C Manufacturer Age:48 YR Route ORAL Gender:Female I/FU:I
Dose Duration WEEKLY MOUTH
Date:12/12/08ISR Number: 5995867-XReport Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2008-RO-00369RO Outcome Death Hospitalization Initial or Prolonged PT Interstitial Lung Disease Pulmonary Fibrosis Rash Pyrexia Fatigue Weight Decreased Report Source Product Mefloquine Immunoglobulins Corticosteroids Antibiotics Corticosteroids Role PS C C C C Manufacturer Roxane Laboratories, Inc.
Age:4 YR Route
Gender:Female Dose
I/FU:I Duration
Date:12/18/08ISR Number: 6011449-8Report Type:Expedited (15-DaCompany Report #IE-ROCHE-313825 Outcome Death Other Serious PT Fear Completed Suicide Persecutory Delusion Mood Altered Paranoia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:12/18/08ISR Number: 6011699-0Report Type:Expedited (15-DaCompany Report #CH-ROCHE-890100204001 Outcome Death Other Serious PT Pneumonia Aspiration Shock Cerebral Malaria Pulmonary Oedema Report Source Product Lariam Quinine Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:12/18/08ISR Number: 6011707-7Report Type:Expedited (15-DaCompany Report #CA-ROCHE-900800054001 Outcome Death Life-Threatening Hospitalization Initial or Prolonged Disability PT Disease Progression Report Source Product Lariam Lariam Diclazuril Somatostatin Spiramycin Role PS SS C C C Manufacturer Roche Roche
Age:35 YR Route ORAL ORAL ORAL SUBCUTANEOUS INTRAVENOUS
Gender:Male Dose
I/FU:I Duration
Age:14 YR
Gender:Female
I/FU:I
Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM
PT Tinnitus Vision Blurred Rash Psychotic Disorder Aggression
Report Source
Product Lariam-Mefloquine250 Mg Roche Pharmaceuticals
Role PS
Manufacturer Roche Pharmaceuticals
Route
Dose
Duration
ORAL
250 MG ONCE A WEEK PO Page: 810
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/09ISR Number: 6051859-6Report Type:Expedited (15-DaCompany Report #DE-ROCHE-581040 Outcome Other Serious PT General Physical Health Deterioration Tachycardia Hypersensitivity Amnesia Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Female Dose I/FU:F Duration
Date:01/26/09ISR Number: 6057433-XReport Type:Direct Outcome Other Serious PT Fear Anxiety Nausea Tinnitus Syncope Headache Diarrhoea Dizziness
Company Report #CTU 363921 Report Source Product Mefloquine 250mg Sandoz, Inc. Role PS Manufacturer Sandoz, Inc.
Gender:Female Dose 1 TABLET PER WEEK PO
Date:01/28/09ISR Number: 6055070-4Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Outcome Hospitalization Initial or Prolonged PT Gastrointestinal Bacterial Infection Road Traffic Accident Anxiety Report Source Product Lariam Lariam Lariam Role PS SS SS Manufacturer Roche Roche Roche
I/FU:F Duration
Date:01/30/09ISR Number: 6059290-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-609832 Outcome Hospitalization Initial or Prolonged PT Renal Failure Acute Syncope Rhabdomyolysis Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose DRUG WITHDRAWN
I/FU:I Duration
Date:02/02/09ISR Number: 6061512-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-611253 Outcome Hospitalization Initial or Prolonged PT Alanine Aminotransferase Increased Gamma-Glutamyltransferase Increased Abdominal Pain Upper Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Drug Prescribing Error Nausea Medication Error Bradycardia Vertigo
03-Apr-2012
09:37 AM
Page: 811
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/09ISR Number: 6065717-4Report Type:Expedited (15-DaCompany Report #A03200803370 Outcome Death Hospitalization Initial or Prolonged PT Burkholderia Cepacia Complex Infection Lung Infiltration Blood Culture Positive Granuloma Pneumonitis Pyrexia Aspergillosis Report Source Literature Health Professional Product Chloroquine Unknown - Unit Dose : Unknown Mefloquine - Unknown - Unit Dose : Unknown Role PS SS Manufacturer Age: Route Gender:Male Dose I/FU:I Duration
Date:02/09/09ISR Number: 6073845-2Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Panic Attack Amnesia Suicidal Ideation Drug Ineffective Insomnia Hypomania Thinking Abnormal Anxiety Disturbance In Attention Depressed Level Of Consciousness Impaired Work Ability
Gender:Male
I/FU:I
Dose Duration 1 TABLET PER WEEK PO
Date:02/13/09ISR Number: 6077926-9Report Type:Expedited (15-DaCompany Report #IE-ROCHE-497032 Outcome Other Serious PT Amnesia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male
I/FU:I
Dose Duration DRUG REPORTED AS: LARIAM 250 MG TABLETS
Date:02/17/09ISR Number: 6080007-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-613148 Outcome Hospitalization Initial or Prolonged PT Pre-Eclampsia Maternal Exposure During Pregnancy Caesarean Section Report Source Product Lariam Typhim Vi Stamaril Unidose Havrix Role PS SS SS SS Manufacturer Roche
Age: Route ORAL UNKNOWN UNKNOWN INTRAMUSCULAR
Gender:Female Dose DRUG: STAMRIL
I/FU:I Duration
Age:
Gender:Female
I/FU:I
Outcome Other Serious Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM
PT Fear Paraesthesia Palpitations Hypoaesthesia Tremor Panic Attack Page: 812
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Report Source Product Lariam/Mefloquine Role PS Manufacturer Route ORAL Dose 1 WEEKLY PO Duration 3 WK
Date:03/02/09ISR Number: 6098995-6Report Type:Expedited (15-DaCompany Report #DE-ROCHE-581040 Outcome Other Serious PT Tachycardia General Physical Health Deterioration Amnesia Urticaria Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:F Duration
Date:03/03/09ISR Number: 6102926-XReport Type:Direct Outcome Other Serious PT Insomnia Oesophageal Ulcer
Gender:Female
I/FU:I
Dose Duration 250 MG WEEKLY PO
Date:03/13/09ISR Number: 6115524-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-619054 Outcome Other Serious PT Memory Impairment Speech Disorder Confusional State Cognitive Disorder Unresponsive To Stimuli Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:03/16/09ISR Number: 6119261-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-621179 Outcome Other Serious PT Aggression Disorientation Vestibular Disorder Anger Hallucination Report Source Product Lariam Mefloquine Hydrochloride Role PS SS Manufacturer Roche Roche
Age: Route UNKNOWN UNKNOWN
Gender:Male Dose FORM: PILL FORM: PILL
I/FU:I Duration
Date:03/16/09ISR Number: 6119262-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-621169 Outcome Life-Threatening PT Self Injurious Behaviour Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose FORM: PILL
I/FU:I Duration
Date:03/17/09ISR Number: 6124514-1Report Type:Direct Outcome PT Dizziness Insomnia Nausea 09:37 AM
Age:64 YR
Gender:Female
I/FU:I
03-Apr-2012
Page: 813
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medication Error Disorientation Abnormal Dreams Sinusitis Lethargy Wrong Drug Administered
Report Source
Product Mefloquine Hcl 250mg Sandoz
Role PS
Manufacturer Sandoz
Route ORAL
Dose ONE TABLET DAILY PO
Duration
Date:03/18/09ISR Number: 6123298-0Report Type:Expedited (15-DaCompany Report #SK-ROCHE-619440 Outcome Other Serious PT Disseminated Intravascular Coagulation Thrombocytopenia Report Source Product Mefloquine Hydrochloride Klimicin Role PS SS Manufacturer Roche
Age:37 YR Route INTRAVENOUS INTRAVENOUS
Gender:Male Dose
I/FU:I Duration
Date:03/19/09ISR Number: 6124240-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-620677 Outcome Other Serious PT Anxiety Memory Impairment Brain Injury Fear Convulsion Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:03/19/09ISR Number: 6124241-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-620680 Outcome Other Serious PT Weight Decreased Malaise Tremor Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:03/27/09ISR Number: 6134700-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-622237 Outcome Hospitalization Initial or Prolonged Other Serious PT Blood Pressure Increased Gastritis Vestibular Neuronitis Dehydration Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:03/31/09ISR Number: 6142028-XReport Type:Direct Outcome Other Serious PT Nightmare Insomnia
Company Report #CTU 371475 Report Source Product Lariam 250mg Sandoz Lariam Role PS C Manufacturer Sandoz
Gender:Female
I/FU:I
Dose Duration 11 WEEKLY PO
Anxiety Activities Of Daily Living Impaired Drug Dependence Palpitations Asthenia
03-Apr-2012
09:37 AM
Page: 814
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/09ISR Number: 6145878-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Outcome Hospitalization Initial or Prolonged Other Serious PT Dyspepsia Paraesthesia Feeling Abnormal Sleep Disorder Asthenia Vertigo Mental Disorder Formication Abnormal Dreams Fatigue Oedema Peripheral Anxiety Headache Cardiovascular Disorder Unevaluable Event Depression Pyrexia Muscle Twitching Malaise Upper Respiratory Tract Infection Coordination Abnormal Night Sweats Agitation Tachycardia Tinnitus Disturbance In Attention Report Source Product Lariam Role PS Manufacturer Roche Age: Route UNKNOWN Gender:Female I/FU:F
Date:04/10/09ISR Number: 6155267-9Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Skin Burning Sensation Diarrhoea Tinnitus Pyrexia Tremor Dizziness Anxiety
Company Report #CTU 373056 Report Source Product Lariam/Mefloquine 250 Mg Roche Role PS Manufacturer Roche
Gender:Female Dose 250 MG ONCE A WEEK PO
I/FU:I Duration
Date:04/14/09ISR Number: 6154073-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-622237 Outcome Hospitalization Initial or Prolonged Other Serious PT Blood Pressure Increased Gastritis Vestibular Neuronitis Dehydration Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:F Duration
Date:04/14/09ISR Number: 6157667-XReport Type:Direct Outcome Life-Threatening Other Serious 03-Apr-2012 09:37 AM
Age:55 YR
Gender:Male
I/FU:I
Page: 815
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent Impairment/Damage
PT Tinnitus Judgement Impaired Toxicity To Various Agents Confusional State Disorientation Brain Injury Stress Fatigue Asthenia Anhedonia Burning Sensation Anxiety Hair Colour Changes Sexual Dysfunction Paraesthesia Dizziness Balance Disorder Muscle Twitching Muscle Contractions Involuntary Insomnia Neuralgia Sleep Apnoea Syndrome Nervous System Disorder Myalgia Mental Disorder Emotional Disorder
Report Source
Product Mefloquine (Lariam)
Role PS
Manufacturer Roche Laboratories
Route ORAL
Dose Duration 250 MG WEEKLY PO
Date:04/16/09ISR Number: 6156743-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-625513 Outcome Hospitalization Initial or Prolonged PT Expired Drug Administered Malaria Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose
I/FU:I Duration
Date:04/24/09ISR Number: 6166557-8Report Type:Expedited (15-DaCompany Report #FI-ROCHE-627019 Outcome Hospitalization Initial or Prolonged PT Loss Of Consciousness Convulsion Report Source Product Lariam Primaspan Simvastatin Cozaar Comp Role PS C C C Manufacturer Roche
Age: Route ORAL ORAL ORAL ORAL
Gender:Male Dose
I/FU:I Duration
STRENGTH REPORTED AS 100MG/25MG. DRUG REPORTED:
Age:
Gender:Male
I/FU:I
Page: 816
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent Impairment/Damage
PT Abnormal Dreams Depression Insomnia Hypophagia Weight Decreased Psychomotor Retardation Dyspnoea Panic Attack
Report Source
Product Lariam 250 Mg Roche Risperdal Claritin Periactin Wellbutrin Ambien Klonopin
Role PS C C C C C C
Manufacturer Roche
Route ORAL
Dose Duration 250 MG WEEKLY PO, 3-4 DOSES
Date:05/07/09ISR Number: 6182450-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-620677 Outcome Other Serious PT Brain Injury Anxiety Fear Convulsion Memory Impairment Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:05/12/09ISR Number: 6189598-3Report Type:Direct Outcome Other Serious PT Crying Nightmare Insomnia Hypervigilance Agitation Dyspnoea Paranoia Unevaluable Event Anxiety
Gender:Female
I/FU:I
Dose Duration 250 MG WEEKY PO
Date:05/18/09ISR Number: 6193521-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-631390 Outcome Hospitalization Initial or Prolonged PT Nightmare Insomnia Mania Weight Decreased Report Source Product Lariam Imovane Xanax Laroxyl Rivotril Rohypnol Tercian Stilnox Lysanxia Role PS C C C C C C C C Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:06/02/09ISR Number: 6211453-0Report Type:Expedited (15-DaCompany Report #CH-ROCHE-635186 Outcome Other Serious PT Optic Atrophy Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 817
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/09ISR Number: 6219428-2Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Mania Company Report #563556 Report Source Literature Health Professional Other Product Mefloquine Hydrochloride (Mefloquine Hydrochloride) Lunesta (Eszopiclone) Eskalith Cr (Lithium Nos) Role Manufacturer Age:63 YR Route Gender:Male Dose I/FU:I Duration
PS C C
Date:06/03/09ISR Number: 6219439-7Report Type:Periodic Outcome Death PT Completed Suicide Psychogenic Pain Disorder Abdominal Pain Upper
Age:25 YR Route
Gender:Male Dose
I/FU:I Duration
Date:06/03/09ISR Number: 6219441-5Report Type:Periodic Outcome Hospitalization Initial or Prolonged PT Mania
Company Report #610871 Report Source Health Professional Other Product Lariam (Mefloquine Hydrochloride) Role PS Manufacturer
Age:18 YR Route
Gender:Female Dose
I/FU:I Duration
Company Report #CTU 379716 Report Source Product Mefloquine 250 Mg Unk Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose 250 MG ONCE PO
I/FU:I Duration
Date:06/12/09ISR Number: 6226710-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-636293 Outcome Other Serious PT Methaemoglobinaemia Dyspnoea Cyanosis Hypoxia Report Source Product Mefloquine Hydrochloride Primaquine Role PS SS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Age:20 YR
Gender:Male
I/FU:I
Outcome Hospitalization Initial or Prolonged Disability Other Serious
PT Anxiety Mood Altered Aggression Alcohol Use Panic Attack Sinus Arrhythmia Memory Impairment Page: 818
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nightmare Supraventricular Extrasystoles Depression Tinnitus Psychotic Behaviour Paranoia Agitation Ear Pain
Report Source
Product Mefloquine Hydrochloride Larium Prolixin Paxil Navane
Role PS SS C C C
Manufacturer
Route
Dose 023/047
Duration
Date:06/23/09ISR Number: 6241720-6Report Type:Expedited (15-DaCompany Report #JP-ROCHE-493929 Outcome Hospitalization Initial or Prolonged Other Serious PT Urinary Tract Infection Haemolytic Anaemia Nervous System Disorder Report Source Product Mefloquine Hydrochloride Artesunate Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:06/23/09ISR Number: 6241739-5Report Type:Expedited (15-DaCompany Report #ES-ROCHE-502414 Outcome Other Serious PT Hepatitis Toxic Erythema Skin Exfoliation Report Source Product Mefloquine Hydrochloride Hepatitis B Vaccine Role PS C Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:06/30/09ISR Number: 6250672-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-619054 Outcome Hospitalization Initial or Prolonged Other Serious PT Cognitive Disorder Dizziness Fatigue Aphasia Dissociation Upper Respiratory Tract Infection Delusion Headache Hyperhidrosis Unresponsive To Stimuli Skin Disorder Sleep Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:F Duration
Date:07/22/09ISR Number: 6276324-2Report Type:Expedited (15-DaCompany Report #FI-ROCHE-643178 Outcome Other Serious PT Abdominal Pain Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Throat Irritation Product Quality Issue Fatigue Decreased Appetite
03-Apr-2012
09:37 AM
Page: 819
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/09ISR Number: 6301233-XReport Type:Direct Outcome Other Serious PT Abdominal Pain Upper Nausea Flatulence Company Report #CTU 387916 Report Source Product Mefloquine Role PS Manufacturer Sandoz Age: Route Gender:Male Dose 250 MG 1 X DAY I/FU:I Duration
Date:09/03/09ISR Number: 6339884-9Report Type:Expedited (15-DaCompany Report #FI-ROCHE-643178 Outcome Other Serious PT Abdominal Pain Fatigue Throat Irritation Decreased Appetite Product Quality Issue Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:F Duration
Date:09/04/09ISR Number: 6341111-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-654282 Outcome Hospitalization Initial or Prolonged PT Constipation Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:09/11/09ISR Number: 6356543-7Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Headache Affective Disorder Insomnia Post-Traumatic Stress Disorder Dizziness Arthralgia Tinnitus Photosensitivity Reaction
Company Report #CTU 391604 Report Source Product Mefloquine Lariam Role PS SS Manufacturer
Gender:Male
I/FU:I
Dose Duration 1 WHITE PILL 50 PULSE PO YES YES
Date:09/18/09ISR Number: 6361469-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-653396 Outcome Hospitalization Initial or Prolonged PT Sopor Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Age:22 YR
Gender:Female
I/FU:F
PT Rash Constipation
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose
Duration
03-Apr-2012
09:37 AM
Page: 820
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/09ISR Number: 6387922-XReport Type:Expedited (15-DaCompany Report #DK-ROCHE-658792 Outcome Other Serious PT Amenorrhoea Acne Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Female I/FU:I
Lariam
SS
Roche
ORAL
Dose Duration THE FIRST PERIOD OF TREATMENT WAS TWO YEARS AGO. FREQUENCY: QWK (PER WEEK).
Date:10/13/09ISR Number: 6401872-1Report Type:Direct Outcome Other Serious PT Insomnia Heart Rate Increased Activities Of Daily Living Impaired Mental Disorder Fear Panic Attack Anxiety Hypersomnia
Age: Route ORAL
Gender:Female
I/FU:I
Dose Duration 1 PILL 1 TIME PER WEEK PO
Date:10/15/09ISR Number: 6402365-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-448387 Outcome Other Serious PT Suicidal Ideation Post Concussion Syndrome Report Source Product Lariam Cymbalta Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:10/26/09ISR Number: 6413276-6Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Outcome Hospitalization Initial or Prolonged Other Serious PT Gastrointestinal Bacterial Infection Road Traffic Accident Toxicity To Various Agents Thermal Burn Delirium Psychotic Disorder Panic Attack Contusion Anxiety Dehydration Fear Report Source Product Lariam Lariam Lariam Role PS SS SS Manufacturer Roche Roche Roche
I/FU:F Duration
Date:10/28/09ISR Number: 6417569-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-662936 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Pancreatitis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Page: 821
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/09ISR Number: 6441094-1Report Type:Expedited (15-DaCompany Report #KR-ROCHE-667927 Outcome Death PT Plasmodium Falciparum Infection Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche Age:57 YR Route UNKNOWN Gender:Male Dose I/FU:I Duration
Date:11/27/09ISR Number: 6458750-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-669990 Outcome Other Serious PT Narcolepsy Somnolence Report Source Product Lariam Vaccines Nos Role PS C Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:12/01/09ISR Number: 6464251-7Report Type:Periodic Outcome PT Nausea Anxiety Depression
Company Report #US-ROXANE LABORATORIES, INC.-2009-RO-01199RO Report Source Product Mefloquine Role PS Manufacturer Roxane Laboratories, Inc.
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:12/03/09ISR Number: 6468605-4Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Outcome Hospitalization Initial or Prolonged Other Serious PT Anxiety Gastrointestinal Bacterial Infection Road Traffic Accident Psychotic Disorder Report Source Product Lariam Lariam Lariam Role PS SS SS Manufacturer Roche Roche Roche
I/FU:F Duration
Date:12/04/09ISR Number: 6476837-4Report Type:Direct Outcome Death PT Epistaxis
Company Report #CTU 400853 Report Source Foreign Product Mefloquine Mephaquin 8 Lactab Mepha Lantus Insulin Role PS C Manufacturer Mepha
Gender:Male Dose 250 MG ONCE A WEEK PO
I/FU:I Duration
Date:12/17/09ISR Number: 6503113-3Report Type:Expedited (15-DaCompany Report #CH-ROCHE-673621 Outcome Hospitalization Initial or Prolonged PT Immune Reconstitution Syndrome Confusional State Hallucination Report Source Product Lariam Kaletra Remeron Truvada Role PS SS SS SS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Keppra Benerva Bactrim
C C C
ORAL ORAL ORAL
03-Apr-2012
09:37 AM
Page: 822
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/09ISR Number: 6504148-7Report Type:Expedited (15-DaCompany Report #IN-ROXANE LABORATORIES, INC.-2009-RO-01259RO Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Mania Report Source Product Mefloquine Artesunate Artesunate Artesunate Primaquine Risperidone Risperidone Role PS SS SS SS SS C C Manufacturer Roxane Laboratories, Inc. Age:11 YR Route ORAL PARENTERAL PARENTERAL PARENTERAL Gender:Female Dose I/FU:I Duration
Date:12/18/09ISR Number: 6506374-XReport Type:Expedited (15-DaCompany Report #CH-ABBOTT-09P-151-0613387-00 Outcome Hospitalization Initial or Prolonged Other Serious PT Hallucination Aggression Cognitive Disorder Frontotemporal Dementia Abnormal Behaviour Incoherent Apraxia Persecutory Delusion Nervous System Disorder Grand Mal Convulsion Confusional State Disturbance In Attention Immune Reconstitution Syndrome Progressive Multifocal Leukoencephalopathy Visual Impairment Report Source Product Kaletra Tablets 200mg/50mg Mefloquine Truvada Mefloquine Mirtazapine Levetiracetam Thiamine Hcl Sulfamethoxazole And Trimethoprim Role PS SS SS SS SS C C C Manufacturer
Age:64 YR Route ORAL ORAL ORAL ORAL ORAL ORAL ORAL
Gender:Male Dose 2 doses of 200mg/50mg daily 245mg/200mg daily 250mg weekly
I/FU:I Duration
1 dose 3 times per week
Date:12/21/09ISR Number: 6509110-6Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-09P-151-0613387-00 Outcome Hospitalization Initial or Prolonged Other Serious PT Hallucination Cognitive Disorder Mental Impairment Nervous System Disorder Neurologic Neglect Syndrome Progressive Multifocal Leukoencephalopathy Aggression Persecutory Delusion Immune Reconstitution Syndrome Incoherent Report Source Product Kaletra Tablets 200mg/50mg Mefloquine Truvada Mefloquine Mirtazapine Levetiracetam Thiamine Hcl Sulfamethoxazole And Trimethoprim Role PS SS SS SS SS C C C Manufacturer
Gender:Male Dose 2 doses of 200mg/50mg daily 245mg/200mg daily 250mg weekly
I/FU:F Duration
1 dose 3
Apraxia Disturbance In Attention Confusional State Mental Disorder Abnormal Behaviour Grand Mal Convulsion
times per week
03-Apr-2012
09:37 AM
Page: 823
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/09ISR Number: 6522734-5Report Type:Expedited (15-DaCompany Report #2009SP040553 Outcome Hospitalization Initial or Prolonged Other Serious PT Grand Mal Convulsion Visual Impairment Thinking Abnormal Electroencephalogram Abnormal Incoherent Hallucination Attention Deficit/Hyperactivity Disorder Nervous System Disorder Progressive Multifocal Leukoencephalopathy Abnormal Behaviour Confusional State Persecutory Delusion Psychomotor Hyperactivity Jc Virus Test Positive Hallucination, Visual Aggression Apraxia Immune Reconstitution Syndrome Report Source Foreign Health Professional Product Remeron (Mirtazapine) (Mirtazapine) Truvada (Truvada 01778501/) Kaletra (Kaletra 015066501/) Lariam (Mefloquine) (Mefloquine) Keppra (Con.) Benerva (Con.) Bactrim /00086101/ (Con.) Role PS SS SS SS C C C Manufacturer Age:64 YR Route ORAL ORAL ORAL ORAL Gender:Male Dose 30 MG;QD;PO 1 DF;QD;PO 2 DF; BID; PO 250 MG;QD;PO; 250 MG;QW;PO I/FU:I Duration
Date:12/23/09ISR Number: 6518124-1Report Type:Direct Outcome Other Serious PT Depression Sleep Disorder Suicidal Ideation
Company Report #CTU 402582 Report Source Product Lariam Unknown Role PS Manufacturer
Gender:Male Dose 1/WEEK PO
I/FU:I Duration
Date:12/30/09ISR Number: 6521464-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-676934 Outcome Other Serious PT Pancreatitis Erectile Dysfunction Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose TAKEN FOR 4 WEEKS
I/FU:I Duration
Date:12/31/09ISR Number: 6524131-5Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-09P-151-0613387-00 Outcome Hospitalization Initial or Prolonged Other Serious PT Cognitive Disorder Nervous System Disorder Abnormal Behaviour Incoherent
Age:64 YR
Gender:Male
I/FU:F
Persecutory Delusion Confusional State Mental Impairment Immune Reconstitution Syndrome Grand Mal Convulsion Progressive Multifocal Leukoencephalopathy 03-Apr-2012 09:37 AM Page: 824
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination Aggression Neurologic Neglect Syndrome Apraxia Mental Disorder Disturbance In Attention
Report Source
Product Kaletra Tablets 200mg/50mg Mefloquine Truvada Mefloquine Mirtazapine Levetiracetam Thiamine Hcl Sulfamethoxazole And Trimethoprim
Role PS SS SS SS SS C C C
Manufacturer
Route ORAL ORAL ORAL ORAL ORAL ORAL ORAL
Dose 2 doses of 200mg/50mg daily 245mg/200mg daily 250mg weekly
Duration
1 dose 3 times per week
Date:01/12/10ISR Number: 6537985-3Report Type:Direct Outcome Other Serious PT Paranoia Emotional Disorder Psychomotor Hyperactivity Anxiety Fear Feeling Of Despair Insomnia Thinking Abnormal
Company Report #CTU 404434 Report Source Product Mefloquine Role PS Manufacturer Sandoz
Gender:Female
I/FU:I
Dose Duration 250 MG 1/WEEK PO
Date:01/13/10ISR Number: 6535336-1Report Type:Expedited (15-DaCompany Report #NZ-ROCHE-678722 Outcome Hospitalization Initial or Prolonged PT Mucosal Ulceration Asthenia Agitation Confusional State Nausea Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose FREQUENCY REPORTED AS ONCE.
I/FU:I Duration
Date:01/19/10ISR Number: 6541581-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-679518 Outcome Other Serious PT Psychotic Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:01/25/10ISR Number: 6549089-4Report Type:Expedited (15-DaCompany Report #NG-ROCHE-679647 Outcome Hospitalization Initial or Prolonged PT Intravascular Haemolysis Report Source Product Mefloquine Hydrochloride Artesunate Role PS SS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 825
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/10ISR Number: 6567143-8Report Type:Expedited (15-DaCompany Report #CH-SANOFI-AVENTIS-2010SA005048 Outcome Death PT Sudden Death Report Source Product Lantus Mephaquin Humalog Role PS SS SS Manufacturer Age:24 YR Route SUBCUTANEOUS ORAL SUBCUTANEOUS Gender:Male Dose I/FU:I Duration
Date:02/03/10ISR Number: 6569558-0Report Type:Direct Outcome Disability Other Serious PT Nervous System Disorder Suicidal Ideation Affective Disorder Insomnia Mental Disorder Major Depression Anxiety Disorder Fatigue
Company Report #CTU 407019 Report Source Product Lariam (Mefloquine) Roche + Us Army Role PS Manufacturer Roche
Age: Route ORAL
Gender: Dose ONE PILL ONCE ORAL
I/FU:I Duration
Date:02/17/10ISR Number: 6585163-4Report Type:Expedited (15-DaCompany Report #NL-ROCHE-685113 Outcome Other Serious PT Mental Disorder Anxiety Report Source Product Lariam Lariam Role PS SS Manufacturer Roche Roche
Gender:Male Dose
I/FU:I Duration
Date:02/18/10ISR Number: 6588357-7Report Type:Expedited (15-DaCompany Report #PT-ROCHE-684767 Outcome Hospitalization Initial or Prolonged PT Drug Interaction Atrioventricular Block Report Source Product Mefloquine Hydrochloride Bisoprolol Role PS I Manufacturer Roche
Age:57 YR Route ORAL UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:02/19/10ISR Number: 6590405-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-679518 Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female
I/FU:F
Dose Duration REPORTED AS LARIAM TABL. DOSE REPORTED AS 250 MGW
Date:03/02/10ISR Number: 6610332-4Report Type:Expedited (15-DaCompany Report #GXKR2010DE02231 Outcome PT Report Source Product Role Manufacturer
Age:74 YR Route
Gender:Female Dose
I/FU:I Duration
Pancytopenia
Mirtazapine (Ngx) Lariam /Aut/ Acetylsalicylic Acid (Ngx) Karvea Actrapid Human
PS SS SS C C
ORAL ORAL ORAL
UNK 250 mg, QD 100 mg, QD
70 65
DAY DAY
03-Apr-2012
09:37 AM
Page: 826
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcilac Kt Digitoxin Prednisolon Spironolactone Iscover Torem Pantozol C C C C I I I
ORAL ORAL ORAL
75 mg, QD 10 mg, QD 40 mg, BID
Date:03/02/10ISR Number: 6612109-2Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Psychotic Disorder Insomnia
Company Report #CTU 410025 Report Source Product Lariam -MefloquineHoffman-Laroche Role PS Manufacturer Hoffman-Laroche
Gender:Male Dose WEEKLY PO
I/FU:I Duration
Date:03/03/10ISR Number: 6611774-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-676934 Outcome Other Serious PT Erectile Dysfunction Pancreatitis Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose TAKEN FOR 4 WEEKS
I/FU:F Duration
Date:03/03/10ISR Number: 6611852-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-687965 Outcome Hospitalization Initial or Prolonged PT Pancytopenia Report Source Product Lariam Calcilac Kt Karvea Digitoxin Prednisolon Spironolactone Actrapid Acetylsalicylic Acid Pantozol Mirtazapin Torem Iscover Role PS C C C C C C I I I I I Manufacturer Roche
Age:74 YR Route ORAL ORAL ORAL ORAL ORAL ORAL SUBCUTANEOUS ORAL ORAL ORAL ORAL ORAL
Gender:Female Dose FORM: CHEWABLE TABLET FORM:FILM COATED TABLET
I/FU:I Duration
FORM:INJECTIO N FORM: GASTRO-RESIST ANT TABLET FORM:FILM COATED TABLET
Roche
Date:03/05/10ISR Number: 6616241-9Report Type:Expedited (15-DaCompany Report #GXKR2010PT02277 Outcome Hospitalization Initial or Prolonged PT Fatigue Drug Interaction Atrioventricular Block Bradycardia Presyncope Report Source Product Bisoprolol (Ngx) Mefloquine (Ngx) Role PS I Manufacturer Novartis Sector: Generics
Age:57 YR Route UNKNOWN ORAL
Gender:Female Dose 5 mg/day 250 mg, QW
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 827
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/10ISR Number: 6627028-5Report Type:Expedited (15-DaCompany Report #2010SP012262 Outcome Hospitalization Initial or Prolonged PT Pancytopenia Rhonchi Pyrexia Endocarditis C-Reactive Protein Increased Drug Interaction Report Source Foreign Health Professional Other Product Mirtazapine (Mirtazapine /01293201/) Pantozol (Pantoprazole Sodium) Acetylsalicylic Acid (Acetylsalicylic Acid / 00002701/) Torem (Torasemide) Lariam (Mefloquine) Iscover (Clopidogrel Sulfate) Prednisolon Digitoxin Calcilac Kt Spironolactone Karvea Actrapid Role PS SS Manufacturer Age:74 YR Route ORAL ORAL Gender:Female Dose 15 MG;BID;PO 40 MG;BID;PO I/FU:I Duration
SS SS SS SS C C C C C C
ORAL ORAL ORAL ORAL
100 MG;QD;PO 10 MG;QD;PO 250 MG;QW;PO 75 MG;QD;PO
Date:03/09/10ISR Number: 6621540-0Report Type:Expedited (15-DaCompany Report #DE-WYE-H13829710 Outcome Hospitalization Initial or Prolonged PT Drug Interaction Pancytopenia Report Source Product Iscover Acetylsalicylic Acid Torem Calcilac Actrapid Human Karvea Spironolactone Prednisolone Digitoxin Pantozol Mirtazapine Pantozol Lariam Role PS SS SS C C C C C C I I I I Manufacturer Bristol-Myers Squibb Unknown Boehringer Mannheim Gmbh Jenapharm Gmbh Novo Industri A/S Bristol-Myers Squibb Unknown Unknown Unknown Wyeth Pharmaceuticals Inc. Unknown Wyeth Pharmaceuticals Inc. Hoffman-La Roche, Inc.
Age:74 YR Route ORAL ORAL ORAL ORAL SUBCUTANEOUS ORAL ORAL ORAL ORAL ORAL ORAL ORAL
Gender:Female Dose
I/FU:I Duration
df-4/12/8
70
DAY
65
DAY
Age:48 YR
Gender:Female
I/FU:I
PT Supraventricular Tachycardia Sleep Disorder Impaired Driving Ability Bradycardia Nausea Page: 828
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Palpitations Report Source Product Lariam Role PS Manufacturer Roche Route ORAL Dose Duration ACTION TAKEN: WITHDRAWN.
Date:03/11/10ISR Number: 6631204-5Report Type:Expedited (15-DaCompany Report #DE-MYLANLABS-2010S1003362 Outcome Hospitalization Initial or Prolonged PT Pancytopenia Drug Interaction Report Source Product Mirtazapin Karvea Spironolactone Calcilac Kt Role PS C C C Manufacturer
Gender:Female
I/FU:I
Dose Duration Dosis je Applikation: 15/30 mg 1 Df= 500mg Calcium Carbonate + 400IU Colecalcifero Dosis je Applikation: 4/12/8 IU
Digitoxin Actrapid Prednisolon Torem /01036501/ Acetylsalicylic Acid Pantozol Lariam Iscover
C C C I I I I I
ORAL SUBCUTANEOUS ORAL ORAL ORAL ORAL ORAL ORAL
Date:03/11/10ISR Number: 6631205-7Report Type:Expedited (15-DaCompany Report #DE-MYLANLABS-2010S1003362 Outcome Hospitalization Initial or Prolonged PT Drug Interaction Pancytopenia Report Source Product Mirtazapin Karvea Spironolactone Calcilac Kt Role PS C C C Manufacturer Alphapharm
Gender:Female
I/FU:I
Dose Duration Dosis je Applikation: 15/30 mg 1 Df= 500mg Calcium Carbonate + 400IU Colecalcifero Dosis je Applikation: 4/12/8 IU
Digitoxin Actrapid Prednisolon Torem /01036501/
C C C I
ORAL SUBCUTANEOUS ORAL ORAL
Acetylsalicylic Acid Pantozol Lariam Iscover
I I I I
ORAL ORAL ORAL ORAL
03-Apr-2012
09:37 AM
Page: 829
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/10ISR Number: 6640138-1Report Type:Expedited (15-DaCompany Report #AUR-APL-2010-00611 Outcome Hospitalization Initial or Prolonged PT Pyrexia Pancytopenia Endocarditis Report Source Foreign Health Professional Other Product Mirtazapine Film-Coated Tablet Pantoprazole Acetylsalicylic Acid Torsemide (Torem) Mefloquine (Lariam) Tablet Clopidogrel Sulfate (Iscover) Prednisolone Digitoxin Calcium Carbonate Spironolactone Karvea (Irbesartan) Actrapid (Insulin Human) Role PS SS SS SS SS SS C C C C C C Manufacturer Age:74 YR Route ORAL ORAL ORAL ORAL ORAL ORAL Gender:Female Dose 15/30MG, BID, ORAL 40MG-ORAL 100MG-ORAL 10MG-ORAL 250MG, WEEKLY, ORAL 75MG-ORAL I/FU:I Duration
Date:03/17/10ISR Number: 6638812-6Report Type:Expedited (15-DaCompany Report #PT-MYLANLABS-2010S1003533 Outcome Hospitalization Initial or Prolonged Other Serious PT Atrioventricular Block Second Degree Drug Interaction Report Source Product Bisoprolol Bisoprolol Mefloquine Bisoprolol Role PS I I I Manufacturer
Age:57 YR Route UNKNOWN UNKNOWN ORAL UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:03/19/10ISR Number: 6642420-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-72710 Outcome Disability Other Serious PT Deafness Dizziness Overdose Abasia Respiratory Disorder Ataxia Speech Disorder Bundle Branch Block Medication Error Asthenia Agitation Confusional State Alanine Aminotransferase Increased Report Source Product Lariam Cardizem Propoxyphene Desyrel Ultram Depakote Apresoline Role PS C C C C C C Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration TOTAL DOSE OF 15250 MG 61 DAY
ORAL
Date:03/23/10ISR Number: 6646722-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-676934 Outcome Other Serious PT Overdose Erectile Dysfunction Pancreatitis 09:37 AM Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:F Duration
03-Apr-2012
Page: 830
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/10ISR Number: 6648322-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-691204 Outcome Hospitalization Initial or Prolonged PT Mental Disorder Face Injury Ill-Defined Disorder Limb Injury Abdominal Distension Renal Disorder Proteinuria Report Source Product Lariam Role PS Manufacturer Roche Age: Route UNKNOWN Gender:Female I/FU:I
Dose Duration INDICATION REPORTED AS ANTI MALARIA
Date:03/26/10ISR Number: 6656270-2Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Other Serious PT Aphasia Educational Problem Palpitations Confusional State Arrhythmia Metamorphopsia Insomnia Disorientation Lung Disorder Thinking Abnormal Impaired Work Ability Amnesia Paranoia Suicidal Ideation Dizziness Paraesthesia Hypersomnia Abnormal Dreams Tremor Hallucination Convulsion Malaise Dyspnoea Fatigue Abasia
Company Report #CTU 413026 Report Source Product Mefloquine Larium Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 1 PILL ONCE A WEEK PO
Date:03/26/10ISR Number: 6656273-8Report Type:Direct Outcome Other Serious PT Dyspnoea Hallucination Confusional State Decreased Appetite Personality Change Crying
Company Report #CTU 413007 Report Source Product Mefloquine Hcl 250mg Roxane Role PS Manufacturer Roxane
Gender:Female Dose 1-250 TABLET WEEKLY PO, 1 TABLET PER WEEK
I/FU:I Duration
Abnormal Behaviour Paranoia Heart Rate Irregular Speech Disorder
03-Apr-2012
09:37 AM
Page: 831
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/10ISR Number: 6657893-7Report Type:Expedited (15-DaCompany Report #IT-ROCHE-692416 Outcome Hospitalization Initial or Prolonged PT Anaemia Malaria Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Female Dose I/FU:I Duration
Date:03/31/10ISR Number: 6667768-5Report Type:Expedited (15-DaCompany Report #AUR-APL-2010-00715 Outcome Hospitalization Initial or Prolonged Other Serious PT Atrioventricular Block First Degree Fatigue Presyncope Sinus Bradycardia Drug Interaction Report Source Foreign Literature Health Professional Product Bisoprolol Mefloquine Role PS SS Manufacturer
Gender:Female
I/FU:I
Dose Duration 5 MG, DAILY, UNK 250 MG, WEEKLY, ORAL
Date:04/08/10ISR Number: 6673219-7Report Type:Periodic Outcome PT Hallucination Paranoia Dyspnoea Depression Tinnitus Speech Disorder Anxiety Nightmare Cognitive Disorder Abdominal Pain Upper Fatigue Decreased Appetite Memory Impairment Personality Change
Company Report #US-ROXANE LABORATORIES, INC.-2010-RO-00351RO Report Source Product Mefloquine Multivitamin Nasocort Vyvanse Fexofenadine Role PS C C C C Manufacturer Roxane Laboratories, Inc.
Gender:Female Dose
I/FU:I Duration
Date:04/19/10ISR Number: 6686484-7Report Type:Expedited (15-DaCompany Report #SE-ROCHE-695381 Outcome Life-Threatening PT Angioedema Report Source Product Lariam Dimor Role PS C Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:04/27/10ISR Number: 6701288-4Report Type:Expedited (15-DaCompany Report #2010040047 Outcome Hospitalization Initial or Prolonged PT Pancytopenia Poikilocytosis Report Source Foreign Health Product Torem (Torasemide Role PS Manufacturer
Gender:Female
I/FU:I
Dose Duration 10 MG (10 MG 1 IN 1D),
Haemoglobin Decreased Anisocytosis Endocarditis Pulmonary Congestion
Professional Mirtazapine (Mirtazapine) Pantozol (Pantoprazole) SS SS ORAL
ORAL 5 MG (5MG, 1 IN 1 D), ORAL 40 MG (40 MG, 1 IN 1 D), ORAL Page: 832
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetysalicylic Acid (Acetysalicylic Acid) Lariam (Mefloquine) Iscover (Clopidogrel) Prednisolon (Prednisolone) Digitoxin (Digitoxin) Karvea (Irbesartan) Calcilac Kt (Calcium Carbonate) Spironolactone (Spironolactone) Actrapid (Insulin)
SS SS
ORAL ORAL
100 MG (100 MG, 1 IN 1 D), ORAL 35.7143 MG (250 MG, 1 IN 1 WK), ORAL 75 MG (75 MG, 1 IN 1 D), ORAL
SS
ORAL
C C C C C C
Date:05/03/10ISR Number: 6707157-8Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2010-RO-00351RO Outcome Hospitalization Initial or Prolonged PT Fatigue Contusion Hallucination Paranoia Tinnitus Abdominal Pain Upper Depression Personality Change Dyspnoea Cognitive Disorder Decreased Appetite Speech Disorder Nightmare Anxiety Memory Impairment Sleep Disorder Report Source Product Mefloquine Allegra Nasocort Multivitamin Vyvanse Fexofenadine Role PS C C C C C Manufacturer Roxane Laboratories, Inc.
Age: Route ORAL
Gender:Female Dose
I/FU:F Duration
Date:05/11/10ISR Number: 6720485-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-569005 Outcome Hospitalization Initial or Prolonged PT Rhabdomyolysis Report Source Product Lariam Xanax Role PS C Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:F Duration
Date:05/12/10ISR Number: 6722843-1Report Type:Direct Outcome PT Palpitations Panic Attack Paranoia 09:37 AM
Age:25 YR
Gender:Female
I/FU:I
03-Apr-2012
Page: 833
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nightmare Suicidal Ideation Dizziness Confusional State Coordination Abnormal Cold Sweat Depression Disturbance In Attention
Report Source
Product Mefloquine 250 Mg Mepha / Switzerland
Role PS
Manufacturer Mepha / Switzerland
Route ORAL
Dose 250 MG 1 X WEEK PO
Duration
Date:05/13/10ISR Number: 6723578-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-687965 Outcome Hospitalization Initial or Prolonged PT Pancytopenia Report Source Product Lariam Calcilac Kt Karvea Digitoxin Prednisolon Spironolactone Actrapid Acetylsalicylic Acid Pantozol Mirtazapin Torem Iscover Role PS C C C C C C I I I I I Manufacturer Roche
Age:74 YR Route ORAL ORAL ORAL ORAL ORAL ORAL SUBCUTANEOUS ORAL ORAL ORAL ORAL ORAL
Gender:Female Dose FORM: CHEWABLE TABLET FORM:FILM COATED TABLET
I/FU:F Duration
FORM:INJECTIO N FORM: GASTRO-RESIST ANT TABLET FORM:FILM COATED TABLET
Roche
Date:05/14/10ISR Number: 6726252-0Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2010-RO-00351RO Outcome Hospitalization Initial or Prolonged PT Anxiety Insomnia Sleep Disorder Hallucination Fatigue Speech Disorder Abnormal Dreams Sinusitis Contusion Paranoia Cognitive Disorder Tachycardia Nightmare Dyspnoea Report Source Product Mefloquine Allegra Nasocort Multivitamin Vyvanse Fexofenadine Role PS C C C C C Manufacturer Roxane Laboratories, Inc.
Age: Route ORAL
Gender:Female Dose
I/FU:F Duration
Abdominal Pain Upper Tinnitus Memory Impairment Disturbance In Attention Decreased Appetite Personality Change Depression 03-Apr-2012 09:37 AM Page: 834
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/10ISR Number: 6750020-7Report Type:Expedited (15-DaCompany Report #GXKR2010DE02231 Outcome Hospitalization Initial or Prolonged PT Leukopenia Pyrexia Report Source Product Prednisolone (Ngx) Mirtazapine (Ngx) Lariam /Aut/ Calcilac Kt Digitoxin Spironolactone Acetylsalicylic Acid Actrapid Human Karvea Torem Pantozol Iscover Role PS SS SS C C C C C C I I I Manufacturer Novartis Sector: Generics Age:74 YR Route ORAL ORAL ORAL Gender:Female Dose 5 mg, QD UNK 250 mg, QD I/FU:F Duration 70 69 DAY DAY
ORAL ORAL ORAL ORAL
100 mg, QD 10 mg, QD 40 mg, BID 75 mg, QD
Date:06/03/10ISR Number: 6769667-7Report Type:Expedited (15-DaCompany Report #2010SP012262 Outcome Hospitalization Initial or Prolonged PT Myelodysplastic Syndrome Drug Interaction Endocarditis Leukopenia Pyrexia Rhonchi Erythema Infectiosum Report Source Foreign Health Professional Other Product Mirtazapine (Mirtazapine /01293201/) Pantozol (Pantoprazole Sodium) Torem (Torasemide) Iscover (Clopidogrel Sulfate) (75 Mg) Lariam (Mefloquine) Prednisolon (Prednisolone) Acetylsalicylic Acid (Other Mfr) (Acetylsalicylic Acid /00002701/) Digitoxin Calcilac Kt Spironolactone Karvea Actrapid Role PS Manufacturer
Gender:Female Dose 15 MG; BID; PO 40 MG; BID; PO 10 MG; QD; PO 75 MG; QD; PO 250 MG; QW; PO 5 MG; QD; PO
I/FU:F Duration
SS SS SS SS SS
ORAL ORAL ORAL ORAL ORAL
SS C C C C C
ORAL
100 MG; QD; PO
Date:06/10/10ISR Number: 6764578-5Report Type:Expedited (15-DaCompany Report #DE-MYLANLABS-2010S1003362
Age:74 YR
Gender:Female
I/FU:F
PT Pyrexia Leukopenia
Report Source
Product Mirtazapin Torem /01036501/ Lariam Prednisolon
Role PS SS SS SS
Manufacturer Alphapharm
Route ORAL ORAL ORAL ORAL
Dose Duration Dosis je Applikation: 15/30 mg
03-Apr-2012
09:37 AM
Page: 835
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pantozol Spironolactone Calcilac Kt SS C C ORAL ORAL ORAL
1 Df= 500mg Calcium Carbonate + 400IU Colecalcifero
Digitoxin Acetylsalicylic Acid Karvea Actrapid Iscover
C C C C I
ORAL ORAL ORAL SUBCUTANEOUS ORAL
Dosis je Applikation: 4/12/8 IU
Date:06/10/10ISR Number: 6764579-7Report Type:Expedited (15-DaCompany Report #DE-MYLANLABS-2010S1003362 Outcome Hospitalization Initial or Prolonged PT Leukopenia Pyrexia Report Source Product Mirtazapin Torem /01036501/ Lariam Prednisolon Pantozol Spironolactone Calcilac Kt Role PS SS SS SS SS C C Manufacturer
Gender:Female
I/FU:F
Dose Duration Dosis je Applikation: 15/30 mg
1 Df= 500mg Calcium Carbonate + 400IU Colecalcifero
Digitoxin Acetylsalicylic Acid Karvea Actrapid Iscover
C C C C I
ORAL ORAL ORAL SUBCUTANEOUS ORAL
Dosis je Applikation: 4/12/8 IU
Date:06/15/10ISR Number: 6769769-5Report Type:Expedited (15-DaCompany Report #IT-ROCHE-708290 Outcome Hospitalization Initial or Prolonged PT Plasmodium Falciparum Infection Anaemia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose ROUTE: OS FREQUENCY: WEEKLY
I/FU:I Duration
Age:42 YR
Gender:Female
I/FU:I
Outcome Life-Threatening Other Serious
PT Menstrual Disorder Multiple Allergies Condition Aggravated Fatigue Depression Memory Impairment Page: 836
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Balance Disorder Mood Swings Feeling Of Body Temperature Change Vertigo Headache Pyrexia Insomnia Muscle Spasms Abnormal Dreams Panic Attack Dizziness Disorientation Disturbance In Attention Arthralgia Coordination Abnormal Cold Sweat Confusional State
Report Source
Product Mefloquine Tab 250 Mg Sandoz Inc
Role PS
Manufacturer Sandoz
Route
Dose TAB 250 MG 1 TABLET WEEKLY
Duration
Date:06/16/10ISR Number: 6771209-7Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2010-RO-00351RO Outcome Hospitalization Initial or Prolonged PT Sleep Disorder Memory Impairment Abdominal Pain Upper Depression Abnormal Dreams Cognitive Disorder Sinusitis Dyspnoea Speech Disorder Hallucination Nightmare Anxiety Decreased Appetite Personality Change Fatigue Paranoia Insomnia Tachycardia Tinnitus Contusion Disturbance In Attention Report Source Product Mefloquine Allegra Nasocort Multivitamin Vyvanse Fexofenadine Role PS C C C C C Manufacturer Roxane Laboratories, Inc.
Age: Route ORAL
Gender:Female Dose
I/FU:F Duration
Date:06/16/10ISR Number: 6781696-6Report Type:Expedited (15-DaCompany Report #AUR-APL-2010-00611 Outcome Hospitalization Initial or Prolonged PT Anaemia Drug Interaction Report Source Foreign Health Product Mirtazapine Film-Coated Tablet Role PS Manufacturer
Gender:Female Dose 15/30 MG,
I/FU:F Duration
Pancytopenia Pyrexia
Professional Other
Pantoprazole Prednisolone Torem Mefloquine (Lariam) Tablet
SS SS SS SS
ORAL ORAL ORAL ORAL
BID, ORAL 40MG - ORAL 5MG - DAILY ORAL 10 MG - ORAL 250MG, WEEKLY, ORAL Page: 837
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Iscover Acetylsalicylic Acid Digitoxin Calcium Carbonate Spironolactone Karvea (Irbesartan) Actrapid (Insulin Human) SS C C C C C C ORAL 75MG - ORAL
Date:07/06/10ISR Number: 6817110-1Report Type:Expedited (15-DaCompany Report #ES-ROCHE-711590 Outcome Other Serious PT Tinnitus Visual Impairment Hangover Nervousness Hair Disorder Insomnia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:07/19/10ISR Number: 6856560-4Report Type:Expedited (15-DaCompany Report #NO-ROCHE-714994 Outcome Hospitalization Initial or Prolonged PT Dissociation Anxiety Delusion Psychotic Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:07/22/10ISR Number: 6866191-8Report Type:Expedited (15-DaCompany Report #ES-ROXANE LABORATORIES, INC.-2010-RO-00865RO Outcome Hospitalization Initial or Prolonged PT Mania Report Source Product Mefloquine Role PS Manufacturer Roxane Laboratories, Inc.
Age:26 YR Route
Gender:Female Dose
I/FU:I Duration
Date:08/06/10ISR Number: 6914038-3Report Type:Direct Outcome Other Serious PT Confusional State Chest Pain Anxiety Paraesthesia Palpitations Hyperhidrosis Dyspnoea Dizziness
Company Report #CTU 426167 Report Source Product Mefloquine Primaquine Role PS SS Manufacturer
Gender:Female Dose 250MG 1/WK ORAL 15MG 2/DAY ORAL
I/FU:I Duration
Date:08/20/10ISR Number: 6937750-9Report Type:Direct Outcome Other Serious PT Depression Abnormal Dreams 09:37 AM
Company Report #CTU 427536 Report Source Product Mefloquine Hcl 250 Mg Barr Laboratories Role PS Manufacturer Barr Laboratories
Age: Route
Gender:Male Dose
I/FU:I Duration
03-Apr-2012
Page: 838
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/10ISR Number: 6958591-2Report Type:Expedited (15-DaCompany Report #IT-ROCHE-723784 Outcome Hospitalization Initial or Prolonged PT Convulsion Amnesia Vomiting Incontinence Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Female Dose I/FU:I Duration
Date:09/09/10ISR Number: 6974608-3Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Paranoia Suicidal Ideation Abnormal Dreams Delusion Insomnia Anxiety Tachycardia
Age:32 YR Route
Gender:Female Dose
I/FU:I Duration
Date:09/14/10ISR Number: 6980311-6Report Type:Expedited (15-DaCompany Report #IT-ROCHE-723784 Outcome Hospitalization Initial or Prolonged PT Incontinence Amnesia Convulsion Vomiting Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:F Duration
Date:09/17/10ISR Number: 6992598-4Report Type:Expedited (15-DaCompany Report #CI-ROCHE-726684 Outcome Hospitalization Initial or Prolonged PT Hepatorenal Failure Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age: Route ORAL
Gender: Dose
I/FU:I Duration
Age: Route ORAL
Gender: Dose
I/FU:I Duration
Date:09/17/10ISR Number: 6992649-7Report Type:Expedited (15-DaCompany Report #CI-ROCHE-727701 Outcome Hospitalization PT Hepatorenal Failure Report Source Product Mefloquine Role Manufacturer
Age: Route
Gender: Dose
I/FU:I Duration
Hydrochloride
PS
Roche
ORAL
03-Apr-2012
09:37 AM
Page: 839
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/10ISR Number: 6992650-3Report Type:Expedited (15-DaCompany Report #CI-ROCHE-727705 Outcome Hospitalization Initial or Prolonged PT Hepatorenal Failure Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche Age: Route ORAL Gender: Dose I/FU:I Duration
Age: Route ORAL
Gender: Dose
I/FU:I Duration
Age: Route ORAL
Gender: Dose
I/FU:I Duration
Age: Route ORAL
Gender: Dose
I/FU:I Duration
Date:10/07/10ISR Number: 7032717-7Report Type:Expedited (15-DaCompany Report #NL-ROCHE-730731 Outcome Other Serious PT Malaria Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age: Route ORAL
Gender: Dose
I/FU:I Duration
Date:10/08/10ISR Number: 7035053-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-730882 Outcome Hospitalization Initial or Prolonged Other Serious PT Postural Orthostatic Tachycardia Syndrome Diarrhoea Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:10/19/10ISR Number: 7051782-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-732598 Outcome Other Serious PT Malaria Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Drug Ineffective
03-Apr-2012
09:37 AM
Page: 840
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/10ISR Number: 7053655-XReport Type:Expedited (15-DaCompany Report #IT-ROCHE-734492 Outcome Hospitalization Initial or Prolonged PT Interstitial Lung Disease Hypereosinophilic Syndrome Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Male Dose ROUTE: OS, FREQUENCY: TOTAL I/FU:I Duration
Date:10/22/10ISR Number: 7056933-3Report Type:Periodic Outcome PT Histamine Intolerance
Company Report #US-ROXANE LABORATORIES, INC.-2010-RO-01393RO Report Source Product Mefloquine Role PS Manufacturer Roxane Laboratories, Inc.
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:10/25/10ISR Number: 7060713-2Report Type:Expedited (15-DaCompany Report #IT-ROCHE-734492 Outcome Hospitalization Initial or Prolonged PT Interstitial Lung Disease Hypereosinophilic Syndrome Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose ROUTE: OS, FREQUENCY: TOTAL
I/FU:I Duration
Date:10/27/10ISR Number: 7064702-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-227783 Outcome Congenital Anomaly Other Serious PT Microcephaly Congenital Oesophageal Anomaly Developmental Delay Hypertension Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:10/27/10ISR Number: 7064703-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-244148 Outcome Congenital Anomaly PT Klinefelter'S Syndrome Talipes Maternal Drugs Affecting Foetus Abortion Induced Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
Date:10/27/10ISR Number: 7064711-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-308888 Outcome Congenital Anomaly PT Encephalocele Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Female Dose
I/FU:I Duration
Date:10/27/10ISR Number: 7064715-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-49139 Outcome Death Other Serious 03-Apr-2012 09:37 AM PT Hypoglycaemia Death Report Source Product Lariam Ranitidine Role PS C Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Page: 841
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cotrimoxazole Ketoconazole Penicillin C C C
Date:10/27/10ISR Number: 7064718-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-57420 Outcome Congenital Anomaly PT Congenital Hip Deformity Jaundice Neonatal Imminent Abortion Report Source Product Lariam Role PS Manufacturer Roche
Gender: Dose
I/FU:I Duration
Date:10/27/10ISR Number: 7064969-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-950400276001 Outcome Congenital Anomaly PT Ankyloglossia Congenital Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender: Dose
I/FU:I Duration
Date:10/27/10ISR Number: 7068288-9Report Type:Direct Outcome Other Serious PT Restlessness Nightmare Hallucination Product Quality Issue Hyperacusis Tremor Abnormal Dreams Heart Rate Irregular
Company Report #CTU 433646 Report Source Product Lariam 250mg Role PS Manufacturer Roche
Gender:Female Dose 1 PILL ONCE PER WEEK PO
I/FU:I Duration
Date:10/28/10ISR Number: 7069237-XReport Type:Expedited (15-DaCompany Report #GB-ROXANE LABORATORIES, INC.-2010-RO-01414RO Outcome Hospitalization Initial or Prolonged Other Serious PT Diarrhoea Leukocytosis Postural Orthostatic Tachycardia Syndrome Blood Urine Present Nitrite Urine Present Protein Urine Present Report Source Product Mefloquine Role PS Manufacturer Roxane Laboratories, Inc.
Age:44 YR Route
Gender:Female Dose
I/FU:I Duration
Date:10/29/10ISR Number: 7074206-XReport Type:Expedited (15-DaCompany Report #NL-ROCHE-735888 Outcome Other Serious PT Maternal Exposure During Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Pregnancy Haemorrhage Abortion Missed
Lariam
SS
Roche
ORAL
03-Apr-2012
09:37 AM
Page: 842
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/10ISR Number: 7090977-0Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Completed Suicide Product Quality Issue Company Report #CTU 434769 Report Source Product Mefloquine (Lariam) Role PS Manufacturer Roche Age:40 YR Route ORAL Gender:Male I/FU:I
Dose Duration ONE A WEEK PO 8 MON
Date:11/09/10ISR Number: 7091146-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-730882 Outcome Hospitalization Initial or Prolonged Other Serious PT Leukocytosis Postural Orthostatic Tachycardia Syndrome Palpitations Diarrhoea Chest Discomfort Dizziness Sinus Tachycardia Lethargy Respiratory Alkalosis Hyperhidrosis Fibrin D Dimer Increased Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:11/11/10ISR Number: 7107348-0Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Sleep Terror Convulsion
Age: Route
Gender:Female Dose
I/FU:I Duration
Date:11/22/10ISR Number: 7116028-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-732598 Outcome Other Serious PT Malaria Drug Ineffective Report Source Product Lariam Role PS Manufacturer Roche
Gender:Female Dose
I/FU:F Duration
Date:12/03/10ISR Number: 7134773-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-744914 Outcome Other Serious PT Initial Insomnia Psychotic Disorder Depressed Mood Muscle Contractions Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Involuntary Ill-Defined Disorder
03-Apr-2012
09:37 AM
Page: 843
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/10ISR Number: 7191336-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-748952 Outcome Other Serious PT Nightmare Gait Disturbance Tremor Dizziness Peripheral Paralysis Balance Disorder Loss Of Consciousness Muscular Weakness Drug Dispensing Error Memory Impairment Coordination Abnormal Insomnia Report Source Product Lariam Role PS Manufacturer Roche Age: Route ORAL Gender:Male Dose I/FU:I Duration
Date:12/27/10ISR Number: 7197996-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-749160 Outcome Hospitalization Initial or Prolonged PT Delusion Of Grandeur Hallucination, Auditory Hallucinations, Mixed Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:12/29/10ISR Number: 7201753-XReport Type:Expedited (15-DaCompany Report #IT-ROCHE-750196 Outcome Hospitalization Initial or Prolonged PT Partial Seizures Status Epilepticus Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose FREQUENCY: WEEKLY.
I/FU:I Duration
Date:12/29/10ISR Number: 7206059-0Report Type:Direct Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Hallucination Intentional Self-Injury Anxiety Depression Thermal Burn Paranoia
Company Report #CTU 439781 Report Source Product Mefloquine (Lariam) Role PS Manufacturer Roche
Age:35 YR Route
Gender:Male
I/FU:I
Dose Duration 1 TABLET ONCE A WEEK 3 WK
Date:01/03/11ISR Number: 7207222-5Report Type:Expedited (15-DaCompany Report #IT-ROCHE-750196 Outcome Hospitalization Initial or Prolonged PT Partial Seizures Status Epilepticus Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose FREQUENCY: WEEKLY.
I/FU:F Duration
Date:01/13/11ISR Number: 7224924-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-752549 Outcome Other Serious PT Confusional State Agitation Ataxia 09:37 AM
Age:39 YR
Gender:Male
I/FU:I
03-Apr-2012
Page: 844
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Amnesia Report Source Product Lariam Role PS Manufacturer Roche Route ORAL Dose Duration
Date:01/14/11ISR Number: 7227043-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-102721 Outcome Congenital Anomaly PT Congenital Hearing Disorder Report Source Product Lariam Tablets Vitamins Role PS C Manufacturer Roche
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:01/14/11ISR Number: 7227050-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-59906 Outcome Other Serious PT Dermatitis Atopic Premature Baby Report Source Product Lariam Tablets Paludrine Duphaston Yellow Fever Vaccine Havrix Hepatitis B Vaccine Nivaquine Typhim Vi Role PS C C C C C C C Manufacturer Roche
Gender: Dose
I/FU:I Duration
Date:01/14/11ISR Number: 7227158-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-753136 Outcome Other Serious PT Cholestasis Of Pregnancy Report Source Product Lariam Paludrine Duphaston Yellow Fever Vaccine Havrix Hepatitis B Vaccine Nivaquine Typhim Vi Role PS C C C C C C C Manufacturer Roche
Age:26 YR Route ORAL ORAL SUBCUTANEOUS SUBCUTANEOUS SUBCUTANEOUS ORAL
Gender:Female Dose FREQUENCY: WEEKLY
I/FU:I Duration
Date:01/14/11ISR Number: 7235027-8Report Type:Direct Outcome Other Serious PT Convulsion
Gender:Male Dose 1 ML ONCE A WEEK PO
Age:54 YR
Gender:Male
I/FU:I
PT Rash Pruritic Photosensitivity Reaction
Report Source
Product Mefloquine Hcl 250 Mg Tablets
Role PS
Manufacturer
Route ORAL
Dose 1 TABLET (250 MG) ONCE/WEEK ORAL (047)
Duration
03-Apr-2012
09:37 AM
Page: 845
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/11ISR Number: 7265091-1Report Type:Expedited (15-DaCompany Report #ZA-SANOFI-AVENTIS-2011SA003745 Outcome Other Serious PT Pneumonia Malaria Malaise Drug Interaction Report Source Product Ketek Mefliam Puricos Role PS SS C Manufacturer Age: Route ORAL UNKNOWN UNKNOWN Gender:Male Dose I/FU:I Duration
Date:02/03/11ISR Number: 7280060-3Report Type:Direct Outcome Other Serious PT Aggression Product Label Issue Influenza Like Illness
Company Report #CTU 443409 Report Source Product Mefloquine Role PS Manufacturer Safeway Pharmacy
Gender:Male
I/FU:I
Dose Duration 250 MG 1 PER WEEK PO
Date:02/09/11ISR Number: 7292937-3Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage PT Insomnia Panic Attack Arthralgia Myalgia Self Esteem Decreased Paranoia Disturbance In Attention Thinking Abnormal
Age: Route ORAL
Gender:Male
I/FU:I
Dose Duration 3 LARGE PILLS 3 TIMES A DAY PO 2 WK
Date:02/10/11ISR Number: 7285069-1Report Type:Expedited (15-DaCompany Report #ZA-SANOFI-AVENTIS-2011SA003745 Outcome Other Serious PT Drug Interaction Malaise Malaria Report Source Product Ketek Puricos Panafcort Theophen Mefliam Role PS C C C I Manufacturer
Age:50 YR Route ORAL UNKNOWN UNKNOWN UNKNOWN UNKNOWN
Gender:Male Dose
I/FU:F Duration
Date:02/10/11ISR Number: 7285336-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-753520 Outcome Hospitalization Initial or Prolonged PT Weight Decreased Depression Mental Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Female Dose
I/FU:I Duration
Date:02/25/11ISR Number: 7327952-4Report Type:Direct Outcome Other Serious PT Dizziness Hyperhidrosis Asthenia Depression Nausea 09:37 AM
Age:61 YR
Gender:Female
I/FU:I
03-Apr-2012
Page: 846
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paraesthesia Chest Pain Flushing Bradycardia Headache
Report Source
Product Mefloquine
Role PS
Manufacturer West Ward
Route ORAL
Dose 250MG ONCE WEEKLY ORAL 12/31, 1/7, 1/14, 1/21
Duration
Lisinopril
Date:02/25/11ISR Number: 7328807-1Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Anxiety Insomnia Hallucination, Auditory Vomiting Nausea Weight Decreased Depression
Company Report #CTU 445536 Report Source Product Lariam Role PS Manufacturer Hoffman La Roche
Gender:Female
I/FU:I
Date:03/03/11ISR Number: 7328619-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-218344 Outcome Other Serious PT Haemangioma Report Source Product Lariam Tablets Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:03/04/11ISR Number: 7332509-5Report Type:Expedited (15-DaCompany Report #IE-ROCHE-763058 Outcome Other Serious PT Nerve Injury Nerve Root Injury Cervical Speech Disorder Balance Disorder Depression Tremor Gait Disturbance Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose FREQUENCY: WEEKLY
I/FU:I Duration
Date:03/10/11ISR Number: 7343777-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-107875 Outcome Congenital Anomaly PT Hypotonia Neonatal Vision Abnormal Neonatal Dysmorphism Mental Retardation Developmental Delay Report Source Product Lariam Role PS Manufacturer Roche
Age: Route
Gender: Dose
I/FU:I Duration
Microcephaly Body Height Above Normal
03-Apr-2012
09:37 AM
Page: 847
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/11ISR Number: 7344412-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-940321069001 Outcome Other Serious PT Bradycardia Neonatal Neonatal Asphyxia Hyporeflexia Hyperbilirubinaemia Neonatal Small For Dates Baby Caesarean Section Maternal Drugs Affecting Foetus Respiratory Disorder Neonatal Cyanosis Neonatal Hypotonia Neonatal Report Source Product Lariam Role PS Manufacturer Roche Age: Route Gender: Dose I/FU:I Duration 3 WK
Date:03/14/11ISR Number: 7349953-2Report Type:Expedited (15-DaCompany Report #CA-ROCHE-764134 Outcome Other Serious PT Gait Disturbance Diarrhoea Vertigo Report Source Product Lariam Advil Role PS C Manufacturer Roche
Gender:Female
I/FU:I
Dose Duration DURATION: 23 DAYS
Date:03/23/11ISR Number: 7369129-2Report Type:Expedited (15-DaCompany Report #GB-ROCHE-753520 Outcome Hospitalization Initial or Prolonged Other Serious PT Depressed Mood Weight Decreased Major Depression Insomnia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose 4 TABLETS DISPENSED
I/FU:F Duration
Date:03/28/11ISR Number: 7377882-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-767499 Outcome Hospitalization Initial or Prolonged PT Anaphylactic Reaction Report Source Product Mefloquine Hydrochloride Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose DRUG: MEFLOQUINE
I/FU:I Duration
Date:03/30/11ISR Number: 7383944-0Report Type:Expedited (15-DaCompany Report #FR-PFIZER INC-2011065249 Outcome Hospitalization Initial or Prolonged PT Pancytopenia Report Source Product Zithromax Lariam Role PS SS Manufacturer Pfizer, Inc.
Gender:Female Dose UNK 250 mg, weekly
Tilcotil Inipomp Actonel
C C C
20 mg, 1x/day 20 mg, 1x/day 75 mg twice monthly
03-Apr-2012
09:37 AM
Page: 848
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/11ISR Number: 7405879-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-769860 Outcome Hospitalization Initial or Prolonged PT Pancytopenia Report Source Product Lariam Zithromax Tilcotil Inipomp Actonel Role PS SS C C C Manufacturer Roche Age: Route ORAL ORAL Gender:Female Dose I/FU:I Duration
Date:04/12/11ISR Number: 7409148-0Report Type:Expedited (15-DaCompany Report #IE-ROCHE-769610 Outcome Other Serious PT Hallucination Paranoia Suicidal Ideation Psychotic Disorder Suicide Attempt Anxiety Depression Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender: Dose
I/FU:I Duration
Date:04/13/11ISR Number: 7412305-0Report Type:Expedited (15-DaCompany Report #FI-ROCHE-770160 Outcome Hospitalization Initial or Prolonged PT Psychotic Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:04/18/11ISR Number: 7420609-0Report Type:Expedited (15-DaCompany Report #IE-ROCHE-241671 Outcome Disability Other Serious PT Dizziness Suicidal Ideation Arthralgia Nightmare Palpitations Depression Vestibular Disorder Myalgia Alcohol Intolerance Insomnia Fatigue Visual Impairment Anxiety Disorder Dry Throat Tinnitus Nausea Hypotension Restlessness Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Vertigo
03-Apr-2012
09:37 AM
Page: 849
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/11ISR Number: 7420818-0Report Type:Expedited (15-DaCompany Report #IE-ROCHE-769921 Outcome Other Serious PT Mood Swings Skin Disorder Suicidal Ideation Abnormal Behaviour Fatigue Insomnia Aggression Depression Weight Decreased Memory Impairment Acne Report Source Product Lariam Role PS Manufacturer Roche Age:43 YR Route UNKNOWN Gender:Male Dose I/FU:I Duration
Date:04/20/11ISR Number: 7425453-6Report Type:Periodic Outcome PT Insomnia Decreased Interest Libido Decreased Depressive Symptom Disturbance In Attention Asthenia Chills Anxiety Tearfulness
Company Report #US-ROXANE LABORATORIES, INC.-2011-RO-00514RO Report Source Product Mefloquine Lexapro Role PS C Manufacturer Roxane Laboratories, Inc.
Age: Route ORAL
Gender:Female Dose 20 mg
I/FU:I Duration
Date:04/25/11ISR Number: 7442461-XReport Type:Direct Outcome Hospitalization Initial or Prolonged PT Confusional State Tinnitus Mood Swings Toxicity To Various Agents Cardiac Disorder Chest Discomfort Abnormal Dreams Anxiety Depression Insomnia Abnormal Behaviour
Gender:Male Dose WEEKLY PO
I/FU:I Duration
Age:20 YR
Gender:Female
I/FU:I
Other Serious
Balance Disorder Neurotoxicity Fatigue Panic Attack Disturbance In Attention Anxiety Vertigo Cognitive Disorder 09:37 AM Page: 850
03-Apr-2012
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Report Source Product Lariam 250 Mg/Tablet Mefloquine Role PS Manufacturer Route ORAL Dose 1 TABLET WEEKLY PO Duration
Date:05/02/11ISR Number: 7451500-1Report Type:Expedited (15-DaCompany Report #FR-ROXANE LABORATORIES, INC.-2006-BP-10993RO Outcome Death Hospitalization Initial or Prolonged PT Malaria Drug Ineffective Completed Suicide Report Source Product Mefloquine Proguanil-Chloroquin e Role PS SS Manufacturer Roxane Laboratories, Inc.
Age:27 YR Route
Gender:Male Dose
I/FU:F Duration 48 3 HR MON
Date:05/04/11ISR Number: 7458831-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-774347 Outcome Other Serious PT Hypoaesthesia Drug Level Increased Abdominal Discomfort Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Female Dose TAKEN FOR MANY YEARS FOR TIME PERIODS OF 6-12 WEEKS
I/FU:I Duration
Date:05/10/11ISR Number: 7477508-8Report Type:Direct Outcome Other Serious PT Pruritus Nausea Impetigo Headache Rash Insomnia Bacterial Infection Stomatitis Mood Swings Diarrhoea Pollakiuria Malaise Feeling Jittery Cough Lethargy Dizziness Depression
Company Report #CTU 453058 Report Source Product Mefloquine 250 Mg Unknown -Given By Peace CorpsRole PS Manufacturer
Gender:Male Dose 250 MG WEEKLY PO
I/FU:I Duration
Date:06/08/11ISR Number: 7531752-XReport Type:Expedited (15-DaCompany Report #IE-ROCHE-709959 Outcome Other Serious PT Chest Pain Headache Fatigue Hallucination Diarrhoea 09:37 AM
Age:
Gender:Male
I/FU:I
03-Apr-2012
Page: 851
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Pain Depression Abdominal Pain Upper Joint Swelling Muscle Spasms Oedema Peripheral Insomnia Mental Disorder Anxiety Myalgia
Report Source
Product Lariam
Role PS
Manufacturer Roche
Route UNKNOWN
Dose Duration DOSE AND FREQUENCY NOT PROVIDED.
Date:06/09/11ISR Number: 7536782-XReport Type:Expedited (15-DaCompany Report #IE-ROCHE-769921 Outcome Other Serious PT Abnormal Behaviour Fatigue Acne Arthralgia Anxiety Insomnia Mood Swings Suicidal Ideation Depression Aggression Memory Impairment Weight Decreased Skin Disorder Report Source Product Lariam Role PS Manufacturer Roche
Age: Route UNKNOWN
Gender:Male Dose
I/FU:F Duration
Date:06/09/11ISR Number: 7537009-5Report Type:Expedited (15-DaCompany Report #PHHY2011BE48648 Outcome Other Serious PT Anxiety Drug Interaction Dyspnoea Palpitations Asthenia Neurotoxicity Dizziness Report Source Product Lamivudine Atazanavir Tenofovir Ritonavir Mefloquine Role PS SS SS I I Manufacturer
Age:48 YR Route
Gender:Female Dose 15 mg/day 300 mg/day 300 mg/day 100 mg/day 1 DF, QW (starting 2 weeks before departure)
I/FU:I Duration
Novartis Sector: Generics
Date:06/21/11ISR Number: 7560277-0Report Type:Expedited (15-DaCompany Report #BE-ROXANE LABORATORIES, INC.-2011-RO-00817RO Outcome Other Serious PT Phobia Of Flying Report Source Product Mefloquine Ritonavir Role PS SS Manufacturer Roxane Laboratories, Inc.
Age:48 YR Route
I/FU:I Duration
Atazanavir Tenofovir Lamivudine
SS SS SS
300 mg 300 mg 150 mg
03-Apr-2012
09:37 AM
Page: 852
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/11ISR Number: 7563471-8Report Type:Direct Outcome Other Serious PT Nightmare Insomnia Psychotic Disorder Fear Depression Company Report #CTU 457120 Report Source Product Larium -Mefloquine Hydrochloride Standard Dose Generic? Role Manufacturer Age:33 YR Route Gender:Female Dose I/FU:I Duration
PS
ORAL
WEEKLY PO
Date:06/22/11ISR Number: 7570018-9Report Type:Direct Outcome Death Disability PT Fear Confusional State Negative Thoughts Anxiety Hallucination Depression Disturbance In Attention Completed Suicide Educational Problem
Company Report #CTU 457416 Report Source Product Lariam Melfloquine Role PS SS Manufacturer
Age: Route
Gender:Male Dose 1 TABLET 1 PER WEEK
I/FU:I Duration
Date:06/23/11ISR Number: 7568415-0Report Type:Expedited (15-DaCompany Report #CA-ROCHE-782365 Outcome Other Serious PT Depression Aggression Psychotic Behaviour Physical Assault Paranoia Suicidal Ideation Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:06/28/11ISR Number: 7579274-4Report Type:Expedited (15-DaCompany Report #BE-ABBOTT-11P-013-0731972-00 Outcome PT Asthenia Palpitations Anxiety Neurotoxicity Drug Interaction Dizziness Dyspnoea Report Source Product Ritonavir Tenofovir Doxycycline Lamivudine Atazanavir Mefloquine Role PS C C C C I Manufacturer
Age:48 YR Route
Gender:Female Dose
I/FU:I Duration
Age:61 YR
Gender:Female
I/FU:I
PT Nightmare Middle Insomnia
Report Source
Product Mefloquine I Don'T Remeber
Role PS
Manufacturer
Route ORAL
Dose 1 TABLET ONCE A WEEK PO
Duration
03-Apr-2012
09:37 AM
Page: 853
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/11ISR Number: 7629066-2Report Type:Direct Outcome PT Nightmare Anxiety Disturbance In Attention Depression Suicidal Ideation Tinnitus Company Report #US-FDA-7629066 Report Source Product Lariam Role PS Manufacturer Age:24 YR Route ORAL Gender:Male Dose 250 mg I/FU:I Duration
Date:07/22/11ISR Number: 7629067-4Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Hallucination Sleep Disorder Tachycardia Acute Stress Disorder Panic Attack Bipolar I Disorder Insomnia
Company Report #US-FDA-7629067 Report Source Product Lariam Role PS Manufacturer
Age:40 YR Route
Gender:Female Dose 1 pill per week
I/FU:I Duration
Date:07/22/11ISR Number: 7629077-7Report Type:Direct Outcome Hospitalization Initial or Prolonged Disability Other Serious PT Discomfort Anxiety Somnolence Sleep Terror Balance Disorder Fatigue Restlessness Depression Coordination Abnormal Nausea Abnormal Behaviour Suicidal Ideation Headache Sleep Disorder Memory Impairment Mood Altered Confusional State Decreased Appetite Diarrhoea Paranoia Mental Status Changes Abdominal Pain Upper Myalgia Cognitive Disorder
Company Report #US-FDA-7629077 Report Source Product Mefloquine/Larium Role PS Manufacturer
Gender:Male Dose unknown
I/FU:I Duration
Date:07/22/11ISR Number: 7629089-3Report Type:Direct Outcome Life-Threatening Other Serious 03-Apr-2012 09:37 AM PT Sleep Disorder Affective Disorder Impaired Work Ability
Company Report #US-FDA-7629089
Age:
Gender:Male
I/FU:I
Page: 854
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurotoxicity Paranoia Major Depression Aggression Suicidal Ideation
Report Source
Product Mefloquine -Lariam-
Role PS
Manufacturer
Route
Dose
Duration
Date:07/22/11ISR Number: 7629092-3Report Type:Direct Outcome PT Memory Impairment Paranoia Mental Disorder Anxiety Restlessness Balance Disorder Tinnitus Dyspnoea Depression Hypoaesthesia Paraesthesia Fatigue Mood Altered Confusional State Alopecia Influenza Like Illness Coordination Abnormal Suicidal Ideation
Company Report #US-FDA-7629092 Report Source Product Mefloquine -LariamRole PS Manufacturer
Age:37 YR Route
Gender:Male Dose
I/FU:I Duration
Date:07/25/11ISR Number: 7632099-3Report Type:Direct Outcome PT Insomnia Mental Disorder Emotional Disorder Disturbance In Attention Anger
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:07/25/11ISR Number: 7632140-8Report Type:Direct Outcome Other Serious PT Anxiety Chest Discomfort Palpitations Dizziness
Company Report #US-FDA-7632140 Report Source Product Mefloquine Role PS Manufacturer
Gender:Female Dose 1
I/FU:I Duration
Date:07/26/11ISR Number: 7638848-2Report Type:Direct Outcome Required Intervention to Prevent Permanent Impairment/Damage 03-Apr-2012 09:37 AM PT Mental Disorder Emotional Disorder Insomnia Vision Blurred Anger
Company Report #CTU 460126 Report Source Product Mefloquin Lariam Role PS Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
Page: 855
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/11ISR Number: 7638325-9Report Type:Direct Outcome Other Serious PT Depression Myocardial Infarction Amnesia Anxiety Insomnia Confusional State Visual Impairment Weight Decreased Company Report #US-FDA-7638325 Report Source Product Mefloquine Role PS Manufacturer Age:50 YR Route ORAL Gender:Male Dose 1 pill I/FU:I Duration
Date:08/02/11ISR Number: 7652942-1Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Disability PT Vestibular Disorder
Company Report #CTU 460602 Report Source Product Lariam 250 Mg (Mefloquine) Role PS Manufacturer
Gender:Male Dose 250 MG WEEKLY ORAL
I/FU:I Duration
Date:08/03/11ISR Number: 7653623-0Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Other Serious PT Amnesia Muscle Spasms Deafness Aphasia Dissociation Paranoia Emotional Poverty Confusional State Vision Blurred Feeling Abnormal Insomnia Psychotic Disorder Hallucinations, Mixed Speech Disorder Personality Change Mood Swings Delirium Balance Disorder Depression
Company Report #US-FDA-7653623 Report Source Product Mefloquin Role PS Manufacturer
Gender:Male Dose 250mg
Date:08/04/11ISR Number: 7656076-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-792894 Outcome Hospitalization PT Anaemia Report Source Product Lariam Role PS Manufacturer Roche
Gender:Male Dose LARIAM TABL
I/FU:I Duration
Initial or Prolonged Bricanyl Pulmicort Behepan Entocort C C C C
250 MG
ENTOCORT PROLONGED-REL EASE CAPSULE, HARD Page: 856
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Kalcipos-D C KALCIPOS-D CHEWABLE TABL
Date:09/08/11ISR Number: 7737052-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-787194 Outcome Hospitalization Initial or Prolonged PT Disease Progression Muscular Weakness Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:09/19/11ISR Number: 7759394-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-792894 Outcome Hospitalization Initial or Prolonged PT Anaemia Report Source Product Lariam Role PS Manufacturer Roche
Age: Route ORAL
Gender:Male
I/FU:F
Dose Duration DOSE: 2 TABLETS (500 MG) IN 14 DAY INTERVALS.
Bricanyl Pulmicort Behepan Entocort
C C C C
Kalcipos-D
ENTOCORT PROLONGED-REL EASE CAPSULE, HARD KALCIPOS-D CHEWABLE TABL
Date:09/23/11ISR Number: 7774722-9Report Type:Expedited (15-DaCompany Report #SE-ROCHE-803592 Outcome Hospitalization Initial or Prolonged PT Diarrhoea Cardiac Fibrillation Photopsia Nightmare Hypoaesthesia Report Source Product Lariam Malarone Role PS SS Manufacturer Roche
Gender:Male Dose
I/FU:I Duration
Date:10/06/11ISR Number: 7799537-7Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Other Serious PT Brain Stem Syndrome Mood Altered Hallucinations, Mixed Personality Change Psychotic Disorder
I/FU:I Duration
Date:10/14/11ISR Number: 7815089-7Report Type:Direct Outcome Life-Threatening PT Personality Change Insomnia Fatigue Depression
Age:25 YR
Gender:Female
I/FU:I
03-Apr-2012
09:37 AM
Page: 857
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Rash Hepatitis
Report Source
Product Mefloquine
Role PS
Manufacturer
Route
Dose 25mg
Duration
Date:10/19/11ISR Number: 7825961-XReport Type:Expedited (15-DaCompany Report #IE-ROCHE-1005156 Outcome Other Serious PT Anger Personality Change Suicidal Ideation Amnesia Anxiety Paranoia Report Source Product Lariam Role PS Manufacturer
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:10/31/11ISR Number: 7875822-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-1007641 Outcome Other Serious PT Atrial Fibrillation Report Source Product Lariam Role PS Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:10/31/11ISR Number: 7875861-4Report Type:Expedited (15-DaCompany Report #CA-ROCHE-782365 Outcome Disability Other Serious PT Aggression Paranoia Depression Psychotic Behaviour Suicidal Ideation Physical Assault Report Source Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Male Dose
I/FU:F Duration
Date:11/04/11ISR Number: 7893372-7Report Type:Expedited (15-DaCompany Report #SE-ROCHE-1007641 Outcome Other Serious PT Atrial Fibrillation Report Source Product Lariam Role PS Manufacturer
Gender:Male Dose
I/FU:F Duration
Date:11/04/11ISR Number: 7893376-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-1008551 Outcome Hospitalization Initial or Prolonged PT Hip Arthroplasty Nervous System Disorder Report Source Product Lariam Norco Role PS SS Manufacturer
Age: Route UNKNOWN UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:11/11/11ISR Number: 7910386-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Outcome Life-Threatening Hospitalization Initial or Prolonged Other Serious 03-Apr-2012 09:37 AM PT Rash Hyperaesthesia Dizziness Anxiety Gastrointestinal
Age:
Gender:Female
I/FU:F
Page: 858
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bacterial Infection Road Traffic Accident Sleep Disorder Psychotic Disorder
Report Source
Product Lariam Lariam Lariam
Role PS SS SS
Manufacturer
Dose
Duration
Date:11/16/11ISR Number: 7917500-XReport Type:Expedited (15-DaCompany Report #MA-ROCHE-1012968 Outcome Other Serious PT Mania Psychotic Behaviour Report Source Product Mefloquine Role PS Manufacturer
Age:31 YR Route
Gender:Male Dose
I/FU:I Duration
Date:11/21/11ISR Number: 7931978-7Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2011-RO-01656RO Outcome Death Life-Threatening Other Serious PT Immune Reconstitution Syndrome Jc Virus Infection Progressive Multifocal Leukoencephalopathy Report Source Product Prednisone Hydroxychloroquine Sulfate Rituximab Leflunomide Prednisone Mefloquine Role PS SS SS SS SS SS Manufacturer Roxane Laboratories, Inc.
Age:73 YR Route
I/FU:I Duration
Roxane Laboratories, Inc. Roxane Laboratories, Inc.
2.5 mg
Date:11/21/11ISR Number: 7932129-5Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2011-RO-01657RO Outcome Death Other Serious PT Jc Virus Infection Lymphopenia Progressive Multifocal Leukoencephalopathy Report Source Product Methotrexate Mirtazapine Etanercept Adalimumab Mefloquine Rituximab Role PS SS SS SS SS SS Manufacturer Roxane Laboratories, Inc.
Age:72 YR Route
Gender:Female Dose
I/FU:I Duration
Roxane Laboratories, Inc.
Date:11/29/11ISR Number: 7945806-7Report Type:Expedited (15-DaCompany Report #BE-ROCHE-1014123 Outcome Other Serious PT Abortion Spontaneous Pregnancy Of Partner Report Source Product Lariam Role PS Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:11/29/11ISR Number: 7946293-5Report Type:Expedited (15-DaCompany Report #NO-ROCHE-714994 Outcome Hospitalization Initial or Prolonged 03-Apr-2012 09:37 AM PT Dissociation Psychotic Disorder Delusion
Age:
Gender:Female
I/FU:F
Page: 859
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Anxiety Report Source Product Lariam Role PS Manufacturer Route ORAL Dose Duration
Date:11/30/11ISR Number: 7949244-2Report Type:Expedited (15-DaCompany Report #BE-ROCHE-1014127 Outcome Other Serious PT Abortion Spontaneous Maternal Exposure During Pregnancy Report Source Product Lariam Role PS Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:12/21/11ISR Number: 7997595-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-1022627 Outcome Other Serious PT Headache Dizziness White Blood Cell Count Increased Pyrexia Loss Of Consciousness Report Source Product Lariam Role PS Manufacturer
Gender:Female Dose
I/FU:I Duration
Date:12/22/11ISR Number: 8003452-3Report Type:Direct Outcome PT Sleep Disorder Anxiety Balance Disorder Migraine Nightmare Depression
Age:36 YR Route
Gender:Male Dose 250 mg
I/FU:I Duration
Date:12/22/11ISR Number: 8003453-5Report Type:Direct Outcome PT Suicidal Ideation Somnambulism Nightmare Confusional State Dizziness Anger Loss Of Consciousness Fall
Company Report #US-FDA-8003453 Report Source Product Mefloquine / Lariam Role PS Manufacturer
Gender:Male Dose 250 mg.
I/FU:I Duration
Date:12/22/11ISR Number: 8003460-2Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Dysarthria Amnesia Photophobia Balance Disorder
Age:44 YR
Gender:Male
I/FU:I
03-Apr-2012
09:37 AM
Page: 860
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Tinnitus Nausea Dizziness Postural
Report Source
Product Lariam
Role PS
Manufacturer
Route ORAL
Dose 250mg
Duration
Date:12/22/11ISR Number: 8003461-4Report Type:Direct Outcome PT Sleep Disorder Balance Disorder Irritability Mood Swings
Age:22 YR Route
Gender:Male Dose
I/FU:I Duration
Date:12/22/11ISR Number: 8011342-5Report Type:Expedited (15-DaCompany Report #2011P1014269 Outcome Hospitalization Initial or Prolonged PT Delusion Of Grandeur Mania Hallucination Restlessness Hypomania Delusion Logorrhoea Hallucination, Auditory Neuropsychiatric Syndrome Flight Of Ideas Report Source Foreign Literature Health Professional Product Mefloquine (No Pref. Name) Role PS Manufacturer
Age:31 YR Route
Gender:Male Dose 250 MG;QW
I/FU:I Duration
Date:12/23/11ISR Number: 8004849-8Report Type:Direct Outcome Other Serious PT Balance Disorder Memory Impairment Tinnitus Anxiety Fatigue Tremor Disturbance In Attention
Age: Route ORAL
Gender:Male Dose 1 pill
I/FU:I Duration
Date:12/23/11ISR Number: 8004850-4Report Type:Direct Outcome Other Serious PT Depression Paranoia Anger Anxiety
Age: Route ORAL
Gender:Male Dose unknown
I/FU:I Duration
Gastrointestinal Disorder Bipolar Disorder Post-Traumatic Stress Disorder
03-Apr-2012
09:37 AM
Page: 861
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/11ISR Number: 8004866-8Report Type:Direct Outcome Other Serious PT Unevaluable Event Company Report #US-FDA-8004866 Report Source Product Lariam Role PS Manufacturer Age:22 YR Route Gender:Male Dose I/FU:I Duration
Date:12/23/11ISR Number: 8004874-7Report Type:Direct Outcome Disability PT Anxiety Post-Traumatic Stress Disorder Depression Panic Attack Migraine Nightmare
Company Report #US-FDA-8004874 Report Source Product Larium Role PS Manufacturer
Age: Route
Gender:Male Dose One tablet
I/FU:I Duration
Date:12/23/11ISR Number: 8004883-8Report Type:Direct Outcome Congenital Anomaly Other Serious PT Urticaria Rash Arthralgia Tinnitus Diarrhoea Sleep Disorder
I/FU:I Duration
Date:12/23/11ISR Number: 8004893-0Report Type:Direct Outcome PT Tinnitus Arthralgia Nightmare Balance Disorder Paranoia Loss Of Consciousness Anxiety
Company Report #US-FDA-8004893 Report Source Product Mefloquin Lariam Role PS Manufacturer
Gender:Male Dose 1 weekly
I/FU:I Duration
Date:12/23/11ISR Number: 8005563-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-1023903 Outcome Other Serious PT Drug Ineffective Malaria Report Source Product Lariam Role PS Manufacturer
Age: Route UNKNOWN
Gender:Male Dose
I/FU:I Duration
Date:12/27/11ISR Number: 8011243-2Report Type:Direct Outcome PT Poor Quality Sleep Disturbance In Attention Insomnia
Company Report #US-FDA-8011243 Report Source Product Mefloquine Hydrochoride -LariamRole PS Manufacturer
Age: Route ORAL
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 862
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/11ISR Number: 8011244-4Report Type:Direct Outcome PT Nightmare Insomnia Anger Mood Swings Bipolar Disorder Malaise Company Report #US-FDA-8011244 Report Source Product Lariam Role PS Manufacturer Age:19 YR Route ORAL Gender:Male Dose I/FU:I Duration 1 YR
Date:12/27/11ISR Number: 8011247-XReport Type:Direct Outcome Other Serious PT Emotional Disorder Depression Abnormal Behaviour Sleep Disorder Mental Disorder Apnoea Anxiety
Age: Route ORAL
Gender:Male Dose 1 x 250mg pill
I/FU:I Duration
Date:12/27/11ISR Number: 8011256-0Report Type:Direct Outcome Other Serious PT Paranoia Hypervigilance Anxiety Nightmare Tinnitus
I/FU:I Duration
Date:12/27/11ISR Number: 8011262-6Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Hallucination Insomnia Mental Disorder Abnormal Dreams Bipolar Disorder Cold Sweat Major Depression
I/FU:I Duration
Date:12/27/11ISR Number: 8011265-1Report Type:Direct Outcome Other Serious PT Anxiety Disorder
Age:41 YR
Gender:Female
I/FU:I
Compulsions Dizziness Obsessive Thoughts Asthenia Tachycardia Irritability Panic Attack Major Depression 03-Apr-2012 09:37 AM Page: 863
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Dreams Nightmare Report Source Product Mefloquine Role PS Manufacturer Route BUCCAL Dose 250MG Duration
Date:12/27/11ISR Number: 8011270-5Report Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Insomnia Aphasia Neuropathy Peripheral Brain Injury Convulsion Vestibular Neuronitis Hyperacusis Amnesia Major Depression Photophobia
Age: Route ORAL
Gender:Male Dose 1pill
I/FU:I Duration
Date:12/27/11ISR Number: 8011277-8Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Mood Altered Depression Personality Change Weight Decreased Psychotic Disorder Decreased Appetite
Age: Route ORAL
Gender:Female Dose unknown
I/FU:I Duration
Date:12/27/11ISR Number: 8011281-XReport Type:Direct Outcome PT Balance Disorder Mental Disorder Dizziness Nervous System Disorder
Gender:Male Dose
I/FU:I Duration
Date:12/27/11ISR Number: 8011290-0Report Type:Direct Outcome Other Serious PT Mood Swings Agoraphobia Depression Dizziness Disturbance In Attention
Age:32 YR
Gender:Male
I/FU:I
Memory Impairment Post-Traumatic Stress Disorder Tinnitus Balance Disorder Arthralgia Irritability Hyperhidrosis 03-Apr-2012 09:37 AM Page: 864
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neck Pain Heart Rate Increased Sleep Disorder Anxiety Nightmare Multiple Allergies Migraine
Report Source
Product Lariam
Role PS
Manufacturer
Route ORAL
Dose One pill
Duration
Date:12/28/11ISR Number: 8011094-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-1023903 Outcome Other Serious PT Drug Dose Omission Malaria Report Source Product Lariam Role PS Manufacturer
Age: Route UNKNOWN
Gender:Male Dose
I/FU:F Duration
Date:12/29/11ISR Number: 8013268-XReport Type:Direct Outcome Other Serious PT Depression Anger Postpartum Stress Disorder
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:12/29/11ISR Number: 8014072-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-1026064 Outcome Other Serious PT Abdominal Discomfort Maternal Drugs Affecting Foetus Report Source Product Lariam Role PS Manufacturer
Gender:Male Dose
I/FU:I Duration
Date:12/30/11ISR Number: 8016015-0Report Type:Direct Outcome Other Serious PT Major Depression Suicidal Ideation Sleep Disorder Fatigue Anxiety Affective Disorder
Age: Route ORAL
Gender:Male Dose megadose
I/FU:I Duration
Date:01/02/12ISR Number: 8017322-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-1022627 Outcome Hospitalization PT Dizziness Report Source Product Lariam Role PS Manufacturer
Gender:Female Dose
I/FU:F Duration
Initial or Prolonged Other Serious
Nausea Pyrexia White Blood Cell Count Increased Somnolence Headache Loss Of Consciousness Page: 865
03-Apr-2012
09:37 AM
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/12ISR Number: 8018678-2Report Type:Direct Outcome Other Serious PT Vertigo Gastric Ulcer Haemorrhage Night Sweats Mood Swings Depression Company Report #US-FDA-8018678 Report Source Product Lariam Role PS Manufacturer Age: Route Gender:Male Dose I/FU:I Duration
Date:01/06/12ISR Number: 8027763-0Report Type:Direct Outcome Other Serious PT Coordination Abnormal Social Problem Balance Disorder Psychotic Disorder Hallucination, Visual Nightmare Abnormal Dreams Product Quality Issue Sleep Disorder Diplopia Poor Quality Drug Administered Product Contamination Brain Injury Emotional Poverty
I/FU:I Duration
Date:01/09/12ISR Number: 8030390-2Report Type:Direct Outcome PT Anxiety Depression Anger
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:01/09/12ISR Number: 8030431-2Report Type:Direct Outcome Life-Threatening Other Serious PT Tinnitus Amnesia Balance Disorder Anger Homicidal Ideation Depression Somnambulism
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:01/09/12ISR Number: 8030434-8Report Type:Direct Outcome Life-Threatening Other Serious PT Somnambulism Tinnitus Homicidal Ideation Balance Disorder
Age:
Gender:Male
I/FU:I
03-Apr-2012
09:37 AM
Page: 866
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Anger Depression Amnesia
Report Source
Product Mefoquine
Role PS
Manufacturer
Route
Dose
Duration
Date:01/10/12ISR Number: 8035586-1Report Type:Direct Outcome Life-Threatening Disability PT Tinnitus Skin Infection Loss Of Employment Anxiety Neuropsychiatric Syndrome Depression Headache Dizziness Visual Impairment Paraesthesia Insomnia Malaise Pruritus
Company Report #CTU 468507 Report Source Product Mefloquine 250 Mg Generic Doxycycline Otc Analgesics Lindane Bismuth Subsalicylate Erythromycin Primaquine Role PS C C C C C C Manufacturer
Gender:Male Dose 250 MG WEEKLY ORAL
I/FU:I Duration
Date:01/17/12ISR Number: 8048956-2Report Type:Expedited (15-DaCompany Report #PHHY2012MA001757 Outcome Hospitalization Initial or Prolonged Other Serious PT Delirium Agitation Hallucination, Auditory Mood Altered Psychomotor Hyperactivity Logorrhoea Report Source Product Mefloquine Role PS Manufacturer Novartis Sector: Generics
Age:31 YR Route
Gender:Male Dose 250 mg, QW
I/FU:I Duration
Date:01/17/12ISR Number: 8048957-4Report Type:Expedited (15-DaCompany Report #PHHY2012MA002356 Outcome Hospitalization Initial or Prolonged Other Serious PT Headache Suicidal Ideation Depressive Symptom Anxiety Personality Disorder Vertigo Psychotic Disorder Insomnia Persecutory Delusion Hallucination, Auditory Depression Poisoning Report Source Product Mefloquine Role PS Manufacturer Novartis Sector: Generics
Age:27 YR Route
I/FU:I Duration
Delirium Social Avoidant Behaviour
03-Apr-2012
09:37 AM
Page: 867
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/12ISR Number: 8050687-XReport Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged PT Visual Impairment Deafness Tinnitus Aggression Muscle Spasms Arthralgia Oedema Peripheral Pain In Extremity Insomnia Suicidal Ideation Paraesthesia Abdominal Pain Diarrhoea Headache Musculoskeletal Pain Paranoia Depression Asthenia Malaise Nausea Anxiety Vision Blurred Dry Eye Mood Swings Pruritus Company Report #US-FDA-8050687 Report Source Product Mefloquine Role PS Manufacturer Age:45 MON Route ORAL Gender:Male Dose 250mg I/FU:I Duration
Date:01/17/12ISR Number: 8050698-4Report Type:Direct Outcome Other Serious PT Hepatic Pain Ear Discomfort Panic Attack Insomnia Chills Tinnitus Amnesia Glare Emotional Disorder Anger Lentigo Tremor Photophobia Ear Pain Fatigue Night Sweats Deafness Migraine With Aura Paraesthesia
I/FU:I Duration
Depression
03-Apr-2012
09:37 AM
Page: 868
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/12ISR Number: 8050756-4Report Type:Direct Outcome Other Serious PT Nervous System Disorder Visual Impairment Gastrointestinal Disorder Company Report #US-FDA-8050756 Report Source Product Larium Role PS Manufacturer Age: Route ORAL Gender:Male Dose 250 I/FU:I Duration
Date:01/17/12ISR Number: 8050758-8Report Type:Direct Outcome PT Depression Fibromyalgia Anger Sensory Disturbance Nightmare Myalgia Irritable Bowel Syndrome Multiple Allergies Insomnia Paranoia Arthralgia
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:01/19/12ISR Number: 8058416-0Report Type:Direct Outcome Life-Threatening Disability Other Serious Required Intervention to Prevent Permanent Impairment/Damage PT Fear Insomnia Vertigo Pain In Extremity Panic Reaction Suicidal Ideation Muscular Weakness Feeling Abnormal Headache Chest Pain Dyspnoea Depression Anxiety Nightmare Euphoric Mood Palpitations
Company Report #CTU 469002 Report Source Product Mefloquine - Larian - La Roche Role PS Manufacturer La Roche
Age: Route ORAL
Gender:Female Dose 1X PER WEEK ORAL
I/FU:I Duration
Date:01/24/12ISR Number: 8066421-3Report Type:Direct Outcome Life-Threatening Other Serious PT Hallucination Anger
Age:20 YR
Gender:Male
I/FU:I
Mood Swings Suicidal Ideation Aggression Irritability Partner Stress Mental Disorder Personality Change Insomnia 03-Apr-2012 09:37 AM Page: 869
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Balance Disorder Report Source Product Mefloquine Role PS Manufacturer Route Dose Duration
Date:01/24/12ISR Number: 8067510-XReport Type:Expedited (15-DaCompany Report #AU-ROCHE-1032915 Outcome Other Serious PT Aplastic Anaemia Report Source Product Lariam Role PS Manufacturer
Age: Route
Gender: Dose
I/FU:I Duration
Date:01/30/12ISR Number: 8082004-3Report Type:Expedited (15-DaCompany Report #PHHY2012MA001757 Outcome Hospitalization Initial or Prolonged Other Serious PT Psychomotor Hyperactivity Hallucination, Auditory Restlessness Agitation Delirium Logorrhoea Flight Of Ideas Mood Altered Report Source Product Mefloquine Role PS Manufacturer Novartis Sector: Generics
Age:31 YR Route
I/FU:F Duration
Date:01/30/12ISR Number: 8082017-1Report Type:Expedited (15-DaCompany Report #PHHY2012MA002356 Outcome Hospitalization Initial or Prolonged Other Serious PT Social Avoidant Behaviour Emotional Disorder Persecutory Delusion Depression Anxiety Poisoning Dizziness Insomnia Hallucination, Auditory Headache Withdrawal Syndrome Psychotic Disorder Depressive Symptom Delirium Suicidal Ideation Report Source Product Mefloquine Role PS Manufacturer Novartis Sector: Generics
Age:27 YR Route
I/FU:F Duration
Date:02/01/12ISR Number: 8183412-2Report Type:Periodic Outcome Other Serious PT Glossodynia
Company Report #286078USA Report Source Health Product Mefloquine Role Manufacturer
Age: Route
Gender:Female Dose
I/FU:I Duration
Swollen Tongue
Professional
Hydrochloride Tablet 250mg (Mefloquine)
PS
03-Apr-2012
09:37 AM
Page: 870
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/12ISR Number: 8128421-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-1034260 Outcome Other Serious PT Skin Disorder Asthenia Migraine Dyspnoea Alopecia Headache Lethargy Dizziness Tearfulness Report Source Product Lariam Role PS Manufacturer Age:50 YR Route ORAL Gender:Female Dose I/FU:I Duration
Date:02/13/12ISR Number: 8133825-XReport Type:Direct Outcome Life-Threatening Hospitalization Initial or Prolonged Other Serious PT Vestibular Disorder Dizziness Aggression Insomnia Cognitive Disorder Brain Injury Suicidal Ideation Affective Disorder Impaired Work Ability Convulsion Psychotic Disorder
Gender:Female Dose 1 pill
I/FU:I Duration
Date:02/15/12ISR Number: 8138119-4Report Type:Direct Outcome Other Serious PT No Adverse Event
Company Report #US-FDA-8138119 Report Source Product Mefloquine Hcl Doxycycline Role PS C Manufacturer
I/FU:I Duration
Date:02/17/12ISR Number: 8143978-5Report Type:Direct Outcome PT Abnormal Dreams Panic Attack Confusional State Insomnia Palpitations Pain Nightmare Memory Impairment
Age:29 YR Route
Date:02/17/12ISR Number: 8144002-0Report Type:Direct Outcome PT Nightmare Memory Impairment Abnormal Dreams Pain 09:37 AM
Age:29 YR
Gender:Male
I/FU:I
03-Apr-2012
Page: 871
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Confusional State Insomnia Panic Attack Palpitations
Report Source
Product Mefloquine
Role PS
Manufacturer
Route
Dose 1 pill
Duration 8 MON
Date:02/17/12ISR Number: 8144507-2Report Type:Expedited (15-DaCompany Report #FI-ROCHE-1037088 Outcome Life-Threatening Hospitalization Initial or Prolonged PT Anxiety Mood Swings Hostility Psychotic Disorder Suicidal Ideation Restlessness Depression Hallucination Agitation Fear Of Disease Confusional State Panic Disorder Report Source Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:02/21/12ISR Number: 8152664-7Report Type:Expedited (15-DaCompany Report #PHHY2012US011789 Outcome Other Serious PT Polyneuropathy Allodynia Insomnia Depression Drug Hypersensitivity Neuropathy Peripheral Pain In Extremity Pyrexia Neck Pain Facial Pain Paraesthesia Hypoaesthesia Burning Sensation Report Source Product Mefloquine Mefloquine Mefloquine Mefloquine Naproxen Sodium Gabapentin Ibuprofen Acetaminophen W/Oxycodone Gabapentin Zolpidem Tartrate Esomeprazole Magnesium Role PS SS SS SS C C C C C C C Manufacturer Novartis Sector: Generics Novartis Sector: Generics Novartis Sector: Generics Novartis Sector: Generics
Age:48 YR Route
Gender:Female Dose 250 mg, ONCE/SINGLE 250 mg, ONCE/SINGLE 250 mg, ONCE/SINGLE 250 mg, ONCE/SINGLE 550 mg, BID 300 mg, UNK 600 mg, TID 2 DF, QHS as needed 600 mg, TID 10 mg, QHS 40 mg, daily
I/FU:I Duration
Date:02/23/12ISR Number: 8160310-1Report Type:Direct Outcome Other Serious PT Quality Of Life Decreased
Gender:Male Dose one pill
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 872
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/12ISR Number: 8162503-6Report Type:Direct Outcome Other Serious PT Depression Headache Insomnia Hallucination Suicidal Behaviour Dizziness Abnormal Dreams Abnormal Behaviour Anxiety Company Report #US-FDA-8162503 Report Source Product Mefloquine Role PS Manufacturer Age: Route Gender:Male Dose I/FU:I Duration
Date:02/28/12ISR Number: 8170623-5Report Type:Expedited (15-DaCompany Report #NO-ROCHE-1042181 Outcome Disability PT Dizziness Deafness Disability Tinnitus Report Source Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Male Dose
I/FU:I Duration
Date:03/06/12ISR Number: 8187252-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-769644 Outcome Hospitalization Initial or Prolonged Disability PT Hypertension Nausea Dizziness Sinoatrial Block Cardiac Pacemaker Insertion Sinus Arrest Report Source Product Lariam Role PS Manufacturer
Gender:Male
I/FU:I
Dose Duration DAILY DOSE 1. TOTAL TABLETS ADMINISTERED: 245
Date:03/15/12ISR Number: 8212057-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-1046709 Outcome Hospitalization Initial or Prolonged PT Anaphylactic Shock Report Source Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose
I/FU:I Duration
Date:03/22/12ISR Number: 8227789-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-1046709 Outcome Hospitalization Initial or Prolonged PT Anaphylactic Shock Report Source Product Lariam Role PS Manufacturer
Age: Route ORAL
Gender:Female Dose
I/FU:F Duration
Date:03/23/12ISR Number: 8231170-5Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Nausea Depressed Level Of Consciousness Fear
Age:25 YR
Gender:Male
I/FU:I
03-Apr-2012
09:37 AM
Page: 873
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Grand Mal Convulsion Visual Impairment Vomiting Fatigue Amnesia Asthenia Abasia Vision Blurred Anxiety Headache
Report Source
Product Mefloquine
Role PS
Manufacturer
Route
Dose
Duration
Date:03/23/12ISR Number: 8231209-7Report Type:Direct Outcome Hospitalization Initial or Prolonged PT Road Traffic Accident Drug Dependence Psychotic Disorder Feeling Abnormal
Gender:Male Dose 1 tablet
Date:03/23/12ISR Number: 8231220-6Report Type:Direct Outcome PT Panic Attack Sleep Disorder Feeling Abnormal
Age:30 YR Route
Gender:Male Dose
I/FU:I Duration
Date:03/27/12ISR Number: 8237197-1Report Type:Direct Outcome PT Amnesia Tinnitus Irritable Bowel Syndrome
I/FU:I Duration
Date:03/27/12ISR Number: 8237261-7Report Type:Direct Outcome Life-Threatening Other Serious PT Sleep Disorder Nightmare Post-Traumatic Stress Disorder Suicidal Ideation Depression
Company Report #US-FDA-8237261 Report Source Product Larium Or Mefloquine Role PS Manufacturer
Age: Route
Gender:Male Dose
I/FU:I Duration
Date:03/27/12ISR Number: 8237273-3Report Type:Direct Outcome Hospitalization Initial or Prolonged Other Serious PT Headache Hyperhidrosis Tremor Memory Impairment
Company Report #US-FDA-8237273 Report Source Product Mefloquin Role PS Manufacturer
Age: Route ORAL
Gender:Male Dose 15-25 mg
I/FU:I Duration
03-Apr-2012
09:37 AM
Page: 874
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/12ISR Number: 8240288-2Report Type:Direct Outcome PT Amnesia Vertigo Tinnitus Suicidal Ideation Tremor Abnormal Dreams Sleep Disorder Company Report #US-FDA-8240288 Report Source Product Lariam/Mefloquine Role PS Manufacturer Age:30 YR Route ORAL Gender:Male Dose 250 mg I/FU:I Duration
Date:03/28/12ISR Number: 8240324-3Report Type:Direct Outcome PT Unevaluable Event
Age: Route ORAL
I/FU:I Duration
Date:03/28/12ISR Number: 8240330-9Report Type:Direct Outcome PT Abnormal Dreams Anxiety
Age: Route ORAL
Gender:Male
I/FU:I
Dose Duration Dont remember
03-Apr-2012
09:37 AM
Page: 875
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report
Summary report for FOI selections:
Selection by inexact search of active ingredient: MEFLOQUINE%
Selection by inexact search of Tradename/Verbatim: LARIAM%
Total number of reports:
3,384
From:
01-NOV-1997
To:
03-APR-2012
03-Apr-2012
09:37 AM
Page: 876

Mefloquine Lariam

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Mefloquine Lariam

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Copyright:

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FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report

Age:29 YR Route ORAL

Gender:Female Dose 250.000MG 1.0 X PER WEEK ORAL

Age:29 YR Route ORAL

Dose Duration 250 MG 1.0 X PER WEEK

Age:57 YR Route ORAL

Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL

Age:23 YR Route ORAL

Dose Duration 250.0000 MG 1.0X PER WEEK ORAL

Required Intervention to Prevent Permanent Impairment/Damage

Dose Duration TABS; 250 MG TAB PO ONCE WEEKLY;(PT D'CD DRUG)

Age:53 YR Route ORAL

Gender:Male Dose 250.000 MG 1.0 X PER WEEK ORAL

Company Report # Report Source Product Lariam Mefloquine Role PS SS Manufacturer

Age:39 YR Route ORAL

Intervention to Prevent Permanent Impairment/Damage

Health Professional Other

250MG 1 X PER WEEK ORAL

Age:34 YR Route ORAL

Gender:Female Dose 250MG 1 X PER WEEK ORAL

Age:40 YR Route ORAL

Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL

Date:11/17/97ISR Number: 3000972-6Report Type:Expedited (15-DaCompany Report #85820

Outcome Hospitalization Initial or Prolonged

PT Migraine Headache Gastroenteritis Bacterial Trance Illusion Paraesthesia Page: 3

Report Source Foreign Health Professional

Product Lariam Ciprobay

Dose 250.0000 MG 1.0 X PER WEEK ORAL

Company Report # Report Source Product Mefloquine Prozac Role PS C Manufacturer

Age:30 YR Route ORAL

Dose Duration 1 TABLET PER WEEK

Company Report # Report Source Product Mefloquine Role PS Manufacturer

Age:27 YR Route ORAL

Gender:Female Dose Q WEEK PO

Age:26 YR Route ORAL

Gender:Male Dose 250.000 MG 1.0 X PER WEEK ORAL

Age:28 YR Route ORAL

Gender:Male Dose 250.0000 MG

Tachycardia Arrhythmia Anxiety

1.0 X PER WEEK ORAL

Age:39 YR Route ORAL

Dose Duration 10.0000 MG/KG DAILY ORAL

Age:36 YR Route ORAL

Gender:Female Dose 1.2500 GRAM 1.0 X PER ODOS ORAL

Age:27 YR Route ORAL

Gender:Female Dose 250.0000 MG 1.0 X PER WEEK ORAL

Age:64 YR Route ORAL

Age:39 YR Route ORAL

Dose Duration 10.0000 MG/KG DAILY ORAL

Age: Route ORAL

Gender: Dose ORAL

Age:53 YR Route ORAL

Dose Duration 250.0000 MG 1.0 X PER DAY ORAL

Age:46 YR Route ORAL

Gender:Female Dose 250.0000MG 1.0 X PER WEEK ORAL

Date:12/02/97ISR Number: 3003874-4Report Type:Expedited (15-DaCompany Report #90601

Outcome Other Serious

Report Source Foreign Other

Product Lariam Tablets (Mefloquine Hydrochloride) 250.000 Mg Yellow Fever Vaccine

250.000 MG 1.0 X PER WEEK ORAL Page: 6

Age:26 YR Route ORAL

Age:26 YR Route ORAL

Gender:Female Dose 250 MG