Vedolizumab adverse event profile: pharmacovigilance study based on FDA Adverse Event Reporting System (FAERS)

Abstract Objective: This study aims to assess the adverse event profile of Vedolizumab using FDA Adverse Event Reporting System (FAERS) data to identify potential safety risks and support clinical use. Methods: FAERS data from Q1 2014 to Q1 2024 were analyzed. Adverse drug events (ADEs) related to Vedolizumab were extracted and evaluated using four signal detection methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). Results: Analysis included 50,852 reports identifying vedolizumab as the primary suspected drug. At the system organ class (SOC) level, it was significantly associated with gastrointestinal disorders, pregnancy-related conditions, infections, and procedural complications. Using all four algorithms, 103 adverse event (AE) signals were detected, with venous access complications, urgency of defecation, and fistulas being most common. Notable AEs absent from the drug label were also identified. Conclusion: This study underscores certain safety risks of Vedolizumab, particularly gastrointestinal reactions and infections, providing valuable evidence for clinical decision-making and future research.