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Updated: Sep 19, 2026

Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
Azithromycin-induced hepatocellular liver injury in a healthy young male: A case report
Ghaleb Alharbi1, Mabrouk Al-Rasheedi2,3, Hind Khalid Goresh3
1Department of Clinical Pharmacy, College of Pharmacy, Shaqra University, Shaqra, 11961, Saudi Arabia.
Abstract:
Drug-induced liver injury (DILI) is an important and frequently under-recognized cause of acute hepatitis. Antibiotics represent one of the most commonly implicated drug classes. Azithromycin, a widely used macrolide antibiotic, is generally well tolerated; however, rare cases of idiosyncratic hepatotoxicity have been reported in the literature. This report describes a case of azithromycin-induced acute hepatocellular liver injury in a previously healthy 20-year-old male who developed jaundice, elevated aminotransferases, and hyperbilirubinemia within three days of initiating a standard three-day course of oral azithromycin 500 mg once daily (cumulative dose 1500 mg) prescribed for an upper respiratory tract infection. Biochemical analysis demonstrated a hepatocellular pattern of injury, confirmed by an R-value of 10.6 (ALT/ULN ÷ ALP/ULN), which exceeds the threshold of 5 required for this classification according to international guidelines. Viral hepatitis and autoimmune etiologies were excluded, and the patient specifically denied the use of dietary supplements, vitamins, bodybuilding or protein powders, and herbal remedies. Causality was assessed using the Roussel Uclaf Causality Assessment Method (RUCAM); on recalculation using the 2016 updated criteria, the score is 6, consistent with a probable causal relationship. The patient recovered fully with supportive care following prompt drug discontinuation, with normalization of liver function tests within eight weeks. This case highlights the importance of accurate biochemical classification of DILI, rigorous causality assessment, and heightened clinical vigilance when prescribing azithromycin even under standard guideline-recommended dosing regimens in young patients without pre-existing liver disease.
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