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

This comprehensive real-world FAERS analysis identifies both known and a substantial number of previously underrecognized gastrointestinal AEs associated with vedolizumab. The high proportion of serious events, particularly observed in male patients and those with lower body weight, underscores the need for enhanced clinical vigilance and targeted monitoring, especially early in the treatment course. These hypothesis-generating findings warrant further validation through dedicated clinical studies.