CIOMS/RUCAM scale

Type of liver injury Hepatocellular Cholestatic/mixed Points

Time of onset of the
first exposure second exposure first exposure second exposure
event
Time from drug intake 5 to 90 days 1 to 15 days 5 to 90 days 1 to 90 days +2
until reaction onset <5 or >90 days >15 days <5 or >90 days >90 days +1
Time from drug
withdrawal 15 days 15 days 30 days 30 days +1
until reaction onset
Alcohol Alcohol or pregnancy +1
Risk factors
Age 55 years Age 55 years +1
>50% improvement 8 days +3
>50% improvement 30 days >50% improvement 180 days +2
<50% improvement 180 days +1
Course of the reaction Lack of information or no Lack of information or no
+0
improvement improvement
Worsening or
-1
<50% improvement 30 days
Concomitant therapy:
o Time to onset incompatible: +0
o Time to onset compatible but with unknown reaction: -1
o Time to onset compatible but known reaction: -2
o Role proved in this case: -3
o None or information not available: +0

Exclusion of non drug-related causes:

o Rule out: +2
o Possible to not investigated: -2 to +1
o Probable: -3

Previous information on hepatotoxicity:

o Reaction unknown: +0
o Reaction published but unlabeled: +1
o Reaction labeled in the product's characteristics: +2

Response to re-administration:
o Positive: +3
o Compatible: +1
o Negative: -2
o Not available or not interpretable: +0
o or plasma concentration of drug known as toxic: +3
o or validated laboratory test with high specificity, sensitivity, and predictive values:
Positive: +3
Negative: -3
Not interpretable or not available: +0

Score analysis 0 or lower: relationship with the drug excluded

1-2: unlikely
3-5: possible
6-8: probable
>8: highly probable