Post-marketing safety monitoring of tirzepatide: a pharmacovigilance study based on the FAERS database.

Abstract

Objective: To explore adverse drug events (ADEs) associated with tirzepatide using real-world data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database to guide its safe management.

Methods: ADE reports from the second quarter of 2022 to the fourth quarter of 2023 were analyzed using the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) methods. Gender-specific differences and reporting biases were also assessed.

Results: Among 25,212 tirzepatide-related ADE reports, 101 significant ADE signals across 15 system organ classifications were identified. Common ADEs included nausea (n = 3030, ROR 5.38) and vomiting (n = 1147, ROR 3.44). Previously unreported ADEs included eructation (n = 500, ROR 46.56), gastroesophageal reflux disease (n = 191, ROR 3.24), injection site hemorrhage (n = 1610, ROR 27.8), and increased blood glucose (n = 641, ROR 6.22). Women reported more injection-site reactions, while men experienced more gastrointestinal issues. Weibull analysis indicated a median ADE onset time of 23 days (IQR: 6-90 days).

Conclusion: This pharmacovigilance study identified both known and novel ADEs of tirzepatide, highlighting gender differences and reporting biases. Close monitoring and further research are needed to ensure its safe use.