Drug-induced liver injury: a real-world pharmacovigilance study using the FDA adverse event reporting system database 2004-2024

Ann Hepatol. 2025 Nov 15:102156. doi: 10.1016/j.aohep.2025.102156. Online ahead of print.

ABSTRACT

INTRODUCTION AND OBJECTIVES: Timely identification and discontinuation of culprit-drug is the cornerstone in managing drug-induced liver injury (DILI), and this study aims to thoroughly investigate the potential hepatotoxic drugs by using the FDA Adverse Event Reporting System (FAERS) database.

MATERIALS AND METHODS: DILI-related reports in the FAERS database between 2004 and 2024 were used to compile a reported culprit-drug list, and the single drug and drug class with the highest reporting frequency were counted accordingly. The disproportionality analysis was used to assess the DILI risk of each reported culprit-drug.

RESULTS: 236,918 DILI-related reports were submitted to the FAERS database between 2004 and 2024, in which 1459 drugs were reported as culprit-drug. Paracetamol is the most frequently reported single drug, while antineoplastic agents are the most frequently reported drug class. 806 of 1459 drugs showed positive signals in disproportionality analysis, among which vorasidenib is the drug with the highest signal strength, followed by floxuridine, pyrazinamide, delandistrogene moxeparvovec, and isoniazid. In the distribution analysis of positive signal drugs, antineoplastic agents have the largest number of positive drugs and occupy a dominant position among high-risk level drugs.

CONCLUSIONS: Our study summarized a reported culprit-drug list of DILI by comprehensively reviewing the liver injury-related reports in the FAERS database, and highlighted the prominent position of antineoplastic agents in reporting frequency, risk signal strength ranking, number of positive signal drugs, and high-risk drug distribution, suggesting that we may need to pay more attention to the liver injury risk of antineoplastic agents in clinical practice.

PMID:41248852 | DOI:10.1016/j.aohep.2025.102156