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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
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Drug-induced liver injury: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database
Dongxuan Li1, Duan Wang2, Guili Huang1
1Department of Pharmacy, The Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China.
Annals of Hepatology
|November 17, 2025
Summary
This study identified frequently reported hepatotoxic drugs using FDA data, highlighting antineoplastic agents as a high-risk drug class for drug-induced liver injury (DILI). Further attention to DILI risk associated with these agents is recommended.
Area of Science:
- Pharmacovigilance
- Hepatology
- Drug Safety
Background:
- Drug-induced liver injury (DILI) management relies on timely culprit-drug identification.
- The FDA Adverse Event Reporting System (FAERS) database is a valuable resource for pharmacovigilance.
Purpose of the Study:
- To investigate potential hepatotoxic drugs using FAERS data.
- To identify single drugs and drug classes most frequently associated with DILI.
Main Methods:
- Analysis of DILI-related reports in FAERS (2004-2024).
- Compilation of a reported culprit-drug list.
- Disproportionality analysis to assess DILI risk for each drug.
Main Results:
- Over 236,000 DILI reports identified 1459 culprit drugs.
- Paracetamol was the most reported single drug; antineoplastic agents were the most reported drug class.
- 806 drugs showed positive DILI signals, with vorasidenib having the highest strength; antineoplastic agents dominated high-risk categories.
Conclusions:
- A comprehensive list of DILI culprit drugs was generated from FAERS data.
- Antineoplastic agents are a significant concern for DILI due to reporting frequency, risk signals, and distribution.
- Increased clinical vigilance for DILI risk associated with antineoplastic agents is warranted.
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