Region-Specific Agomelatine-Associated Hepatic Disorder Signals Using the World Health Organization VigiBase Pharmacovigilance Database

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Key Points

The study aims to analyze hepatic adverse events associated with agomelatine using global pharmacovigilance data.
Analyzed Individual Case Safety Reports (ICSRs) from VigiBase between 2009 and 2024.
Defined agomelatine as the drug of interest, comparing it with other drugs and antidepressant classes.
Identified hepatic disorders via MedDRA Query and performed disproportionality analysis to calculate reporting odds ratios across regions.
Conducted subgroup analyses by sex, reporting year, and clinical presentation of liver injury.
Agomelatine showed a significantly increased reporting odds ratio (aROR 15.83) compared to all other drugs.
Elevated hepatic signals were confirmed across regions with specific aRORs for Europe (13.24), Western Pacific (11.72), and others (20.30).
A higher aROR was observed in females compared to males, with signal strength increasing over time.

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This analysis reveals agomelatine's hepatic adverse events worldwide, implying consistent reporting patterns across regions.

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Lee et al. (2026) studied this question.

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