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

To explore adverse drug events (ADEs) associated with tirzepatide in a real-world setting using data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) to provide guidance for the safe management of tirzepatide. ADE reports related to tirzepatide from the second quarter of 2022 to the fourth quarter of 2023 were obtained from the FAERS database. Data mining and analysis were performed using the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) methods. Gender-specific differences and potential reporting biases were also evaluated. A total of 25,212 tirzepatide-related ADE reports were obtained, yielding 101 significant ADE signals across 15 system organ classifications (SOCs). Common ADEs, such as nausea (n = 3030, ROR 5.38) and vomiting (n = 1147, ROR 3.44), were consistent with those listed in the drug insert. Additionally, several ADEs not mentioned in the drug insert were identified, including 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). Gender differences in ADEs were notable, with women reporting more injection-site reactions and men experiencing more gastrointestinal issues. Weibull distribution analysis revealed a median onset time of 23 days (IQR: 6-90 days), suggesting a tendency for early occurrence of ADEs. This real-world pharmacovigilance study identified both common and previously unreported ADEs associated with tirzepatide, including gastroesophageal and injection-site reactions. Gender differences and potential reporting biases were observed, underscoring the need for further research and close monitoring by clinicians and pharmacists to ensure the safety use of tirzepatide in diverse patient population.