Updated Roussel Uclaf Causality Assessment Method for cholestatic/mixed injury of drug-induced liver injury (RUCAM score)
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When to use
Timing of onset
5-90 days rechallenge: 1-90 days) from the beginning of the drug/herbal supplement
< 5 or > 90 days rechallenge: > 90 days) from the beginning of the drug/herbal supplement
≤ 15 days except for slowly metabolized chemicals: <= 30 days) from the cessation of the drug/herbal supplement
Course of alkaline phosphatase after cessation of the drug/herbal supplement (percentage difference between alkaline phosphatase peak and the upper limit of normal)
Decrease ≥ 50% within 180 days
Decrease < 50% within 180 days
No information, persistence, increase, or continued drug/herbal supplement use
Risk factors, age
≥ 55 years
< 55 years
Risk factors, pregnancy
Yes
No
Risk factors, alcohol use (current drinks/day)
> 2 for females, > 3 for males
≤ 2 for females, <= 3 for males
Concomitant drugs/herbal supplements
None or no information
Concomitant drug/herbal supplement with incompatible time to onset
Concomitant drug/herbal supplement with compatible or suggestive time to onset
Concomitant drug/herbal supplement known as hepatotoxin and with compatible or suggestive time to onset
Concomitant drug/herbal supplement with evidence for its role in this case positive rechallenge or validated test)
Alternative causes, classified into group I (hepatitis A virus: anti-hepatitis A virus-immunoglobulin M; hepatitis B virus: hepatitis B surface antigen, anti-hepatitis B core-immunoglobulin M, hepatitis B virus-deoxyribonucleic acid; hepatitis C virus: anti-hepatitis C virus antibodies, hepatitis C virus-ribonucleic acid; hepatitis E virus: anti-hepatitis E virus-immunoglobulin M/immunoglobulin G, hepatitis E virus-ribonucleic acid; hepatobiliary condition: hepatobiliary ultrasound/color Doppler ultrasound of liver vessels/endoscopic ultrasound/computed tomography/magnetic resonance cholangiopancreatography; alcohol use disorder: aspartate aminotransferase/alanine aminotransferase ≥ 2; acute recent hypotension episode, particularly in case of underlying heart disease) and group II (complications of underlying diseases: sepsis, metastatic malignancy, autoimmune hepatitis, chronic hepatitis B or C, primary biliary cholangitis or sclerosing cholangitis, genetic liver diseases; infection suggested by polymerase chain reaction and immunoglobulin M/immunoglobulin G titer change: cytomegalovirus, Epstein-Barr virus, herpes simplex virus, varicella zoster virus)
All causes groups I and II) are reasonably ruled out
7 causes of group I are ruled out
5-6 causes of group I are ruled out
< 5 causes of group I are ruled out
An alternative cause is highly probable
Previous hepatotoxicity of the drug/herbal supplement
Reaction labeled in the product characteristics
Reaction published but unlabeled
Reaction unknown
Response to unintentional re-exposure
Doubling of alkaline phosphatase with the drug/herbal supplement alone, provided alkaline phosphatase is < 2x the upper normal limit before re-exposure
Doubling of alkaline phosphatase with the drug/herbal supplement already given at the time of first reaction
Increase of alkaline phosphatase but less than the upper normal limit in the same conditions as for the first administration
Other situations
Calculation
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