Pembrolizumab-associated hepatobiliary disorders: a real-world pharmacovigilance study using the FDA Adverse Events Reporting System (FAERS). (2025)

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).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.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 tre