Updated Roussel Uclaf Causality Assessment Method for cholestatic/mixed injury of drug-induced liver injury (RUCAM score)
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 ALP after cessation of the drug/herbal supplement (percentage difference between ALP peak and the ULN)
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 (HAV: anti-HAV-IgM; HBV: HBsAg, anti-hepatitis B core-IgM, HBV-DNA; HCV: anti-HCV antibodies, HCV-RNA; HEV: anti-HEV-IgM/IgG, HEV-RNA; hepatobiliary condition: hepatobiliary ultrasound/color Doppler ultrasound of liver vessels/EUS/CT/MRCP; alcohol use disorder: AST/ALT ≥ 2; acute recent hypotension episode, particularly in case of underlying heart disease) and group II (complications of underlying diseases: sepsis, metastatic malignancy, AIH, chronic hepatitis B or C, primary biliary cholangitis or sclerosing cholangitis, genetic liver diseases; infection suggested by PCR and IgM/IgG titer change: CMV, EBV, HSV, VZV)
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 ALP with the drug/herbal supplement alone, provided ALP is < 2x the upper normal limit before re-exposure
Doubling of ALP with the drug/herbal supplement already given at the time of first reaction
Increase of ALP but less than the upper normal limit in the same conditions as for the first administration
Other situations
Please complete all sections.
Reference
Gaby Danan, Rolf Teschke. RUCAM in Drug and Herb Induced Liver Injury: The Update. Int J Mol Sci. 2015 Dec 24;17(1):14.
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