Beyond the label: real-world gastrointestinal adverse events associated with vedolizumab - a decade of FAERS pharmacovigilance.

ABSTRACT:

Background

Vedolizumab is a gut-selective biologic widely used for inflammatory bowel disease (IBD). While randomized controlled trials (RCTs) provide initial safety profiles, real-world pharmacovigilance data are crucial for identifying a broader spectrum of adverse events (AEs), including rare or underrecognized associations. This study aimed to comprehensively characterize the real-world reporting frequency and characteristics of gastrointestinal AEs associated with vedolizumab using spontaneous reporting data.

Methods

We analyzed 59,976 vedolizumab-related individual case safety reports from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, covering the period from Q1 2014 to Q4 2024. After meticulous exclusion of IBD diagnostic terms

SUBMITTER: Zheng J 

PROVIDER: S-EPMC12847282 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature