Classification of DILI based on liver enzyme derangement1
| Phenotype | Case definition | Commonly implicated agents |
| Idiosyncratic |
Hepatocellular: If ALT alone is elevated less than fivefold above ULN or R≥5. Cholestatic: ALP alone is elevated less than twofold above ULN or R≤2. Mixed: R>2 to<5 Chronic DILI: DILI with acute presentation, with evidence of persistent liver injury at >1 year after its onset | Antimicrobials, anticonvulsants, antiarrhythmic, androgens, oestrogens/progesterone, immunomodulatory and antineoplastic |
| Drug reaction with eosinophilia and systemic symptoms | Drug-related hypersensitivity with eosinophilia and systemic inflammation | Anticonvulsants, NRTIs |
| Drug-induced autoimmune hepatitis | Acute DILI with serological and/or histological features of AIH | NSAIDs, statins, minocycline and nitrofurantoin |
| Secondary sclerosing cholangitis | Presenting as acute DILI with histological/radiological features of sclerosing cholangiopathy | Inhalational anaesthetics, atorvastatin, 6-MP |
| Granulomatous hepatitis | Granulomas on histology with exposure to implicated agent(s) | Anticonvulsants, sulphonamides |
| Acute fatty liver | Acute development of microvesicular steatohepatitis | Reverse transcriptase inhibitors |
| Drug-associated fatty liver disease | Consistent with NAFLD and attributable exposure | Methotrexate, corticosteroids, 5-FU |
| Nodular regenerative hyperplasia | Diffuse nodularity organised around central hepatocytes | Antineoplastic/cytotoxic |
| Ductopaenia | Chronic cholestasis and ductular loss | Antimicrobials (β-lactams, tetracyclines and sulphonamides) |
| Liver tumours | Features of hepatocellular adenoma or carcinoma dependent of histological/imaging characteristics | Anabolic androgenic steroids and oral contraceptives |
5-FU, 5-fluorouracil; 6-MP, 6-mercaptopurine; AIH, autoimmune hepatitis; ALP, alkaline phosphatase; ALT, alanine transferase; DILI, drug-induced liver injury; NAFLD, non-alcoholic fatty liver disease; NRTI, nucleoside reverse transcriptase inhibitor; NSAID, non-steroidal antiinflammatory drug; ULN, upper limit of normal.