Table 2.

Pitfalls and Ambiguities in RUCAM Scoring (after 7)

RUCAM Criteria	Comment
1 Age > or < 55 years are arbitrary cutoffs.	Many cases occur under age 55.
2 No specific amount of alcohol use defined.	Uncertain if alcohol is risk factor or a confounder.
3 Role of pregnancy in DILI undefined.	Unclear if pregnancy is risk factor or confounder.
4 Narrow latency period for maximal points.	Fewer points awarded if < 5 days or > 90 days.
5 Does not account for delayed reactions occurring >15 days after stopping a drug.	(eg, amoxicillin‐clavulanate occurring up to 6 weeks after use)
6 Narrowly defined responses to dechallenge.	Decreases from peak ALT values are arbitrary.
7 The 8 nondrug exclusions are incomplete.	Does not include specific mention of hepatitis E, etc.
8 Hepatotoxicity in the product label may score higher than published reports.	RUCAM was not designed for drugs in clinical trials.
9 Rechallenge response not well‐defined.	Doubling of ALT is arbitrary criterion.
10 Liver histology not considered.	Liver biopsy information is not taken into account.
11 Does not allow for diagnosis of tolerance or adaptive response while drug is continued.	No dechallenge criteria to evaluate.

Abbreviation: ALT, alanine aminotransferase.