PubMed Central, : RMMJ Rambam Maimonides Medical Journal Rambam Health Care Campus 2026; 17(1): e0005. ISSN: 2076-9172Published online 2026 January 28. doi: 10.5041/RMMJ.10571

Grade^{^*}	CTCAE	DILIN
Grade 1	ALT >ULN to ≤3× ULN AST >ULN to ≤3× ULN Total serum bilirubin ULN to ≤1.5× ULN ALP ULN to ≤2.5× ULN	Elevation in ALT and/or ALP levels Total serum bilirubin <2.5 mg/dL INR <1.5 Present with or without symptoms (nausea, vomiting, asthenia, fatigue, RUQ pain, jaundice, rash, pruritus, weight loss)
Grade 2	ALT >3–5× ULN AST >3–5× ULN Total serum bilirubin >1.5–3× ULN ALP >2.5–5× ULN	Elevation in ALT and/or ALP levels Total serum bilirubin ≥2.5 mg/dL or INR ≥1.5 Symptoms may become aggravated
Grade 3	ALT >5–20× ULN AST >5–20× ULN Total serum bilirubin >3–10× ULN ALP >5–20× ULN	Elevation in ALT, ALP, and total serum bilirubin ≥2.5 mg/dL and/or INR ≥1.5 Symptoms are further aggravated Indication for hospitalization No evidence of hepatic encephalopathy
Grade 4	ALT >20× ULN AST >20× ULN Total serum bilirubin >10× ULN ALP >20× ULN	Elevation in ALT, ALP, and total serum bilirubin ≥2.5 mg/dL Signs of hepatic failure (INR ≥1.5, ascites, hepatic encephalopathy) and/or DILI-related dysfunction of another organ
Grade 5	Death/mortality due to ILICI	Death/mortality due to ILICI OR Requires liver transplantation for survival

Note: CTCAE and DILIN grades are not directly interchangeable.

* Severity grade is determined by the highest grade for which at least one criterion is met.

ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; DILI, drug-induced liver injury; DILIN, Drug-induced Liver Injury Network; dL, deciliter; INR, international normalized ratio; mg, milligram; RUQ, right upper quadrant; ULN, upper limit of normal.