Pembrolizumab-associated hepatobiliary disorders: a real-world pharmacovigilance study using the FDA Adverse Events Reporting System (FAERS)

Abstract

Purpose

The aim of this study was to evaluate hepatobiliary disorders adverse events associated with pembrolizumab by using the Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods

We collected FAERS data from the first quarter of 2009 to the third quarter of 2024 and used reporting odds ratio (ROR) to detect pembrolizumab-associated hepatobiliary adverse events (AEs). A signal was considered significant when the lower limit of the 95% confidence interval (CI) of the ROR exceeded 1, and≥5 AEs were reported. Serious and nonserious cases were compared by statistical analysis, and signals were further prioritized using a rating scale.

Results

A total of 20,225,379 AEs were reported in the FAERS database, of which 45,774 AEs listed pembrolizumab as the ‘primary suspected’ drug. Pembrolizumab treatment was significantly associated with hepatobiliary disorders. Among these AEs, 101 signals were detected at the preferred term (PT) levels, and 56 of them were identified as significant signals by using disproportionality analyses. The median time-to-onset (TTO) was 63 days. Notably, most hepatobiliary AEs occurred within three months after pembrolizumab therapy.

Conclusion

Based on pharmacovigilance data from FAERS, different hepatobiliary AEs should be closely monitored and managed according to the indications for which pembrolizumab is used.

Keywords

pembrolizumab - FAERS - disproportionality analyses - hepatobiliary disorders - safety

^# Likun Ding and Ning Ma have contributed equally to this work and share first authorship.

Publikationsverlauf

Eingereicht: 01. Juni 2025

Angenommen: 18. Juli 2025

Artikel online veröffentlicht:
18. August 2025

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