CIOMS/RUCAM Scale

CIOMS/RUCAM scale
Type of liver injury / Hepatocellular / Cholestatic/mixed / Points
Time of onset of the event / first exposure / second exposure / first exposure / second exposure / —
Time from drug intake
until reaction onset / 5 to 90 days / 1 to 15 days / 5 to 90 days / 1 to 90 days / +2
<5 or >90 days / >15 days / <5 or >90 days / >90 days / +1
Time from drug withdrawal
until reaction onset / ≤15 days / ≤15 days / ≤30 days / ≤30 days / +1
Risk factors / Alcohol / Alcohol or pregnancy / +1
Age ≥ 55 years / Age ≥ 55 years / +1
Course of the reaction / >50% improvement 8 days / — / +3
>50% improvement 30 days / >50% improvement 180 days / +2
— / <50% improvement 180 days / +1
Lack of information or no improvement / Lack of information or no improvement / +0
Worsening or
<50% improvement 30 days / — / -1

·  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