Gastrointestinal adverse events associated with semaglutide: A pharmacovigilance study based on FDA adverse event reporting system.

ABSTRACT:

Background

Semaglutide was approved for treatment of type 2 diabetes mellitus (T2DM) and chronic weight management in obesity or overweight adults. However, real-world data regarding its long-term gastrointestinal safety and tolerability in large sample population are incomplete. We evaluated semaglutide-associated gastrointestinal safety signals by data mining of the FDA pharmacovigilance database.

Methods

Reporting odds ratio (ROR) was employed to quantify the signals of semaglutide-related gastrointestinal adverse events (AEs) from 2018 to 2022. Serious and non-serious cases were compared by Mann-Whitney U test or Chi-squared (χ²) test, and signals were prioritized using a rating scale.

Results

We identified 5,442 cases of semaglutide-associated g

SUBMITTER: Shu Y 

PROVIDER: S-EPMC9631444 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature