Signal Data Mining of Adverse Events of Tirzepatide Based on FAERS
Objective To mine signals of adverse events(ADEs)of tirzepatide in order to provide a reference for safe drug use in clinic.Methods Data of ADEs associated with tirzepatide collected from the first quarter of 2022 to the second quarter of 2023 was extracted from FAERS database and analyzed using the reporting odds ratio method and Medicines and Healthcare Products Regulatory Agency(MHRA)meth-od.Results Totally,14 863 reports of adverse events with tirzepatide as the target drug were collected,and 132 valid signals were detected,involving 16 system organ classes(SOCs).The top three reported cases included injury,poisoning and procedural complications in 9049 cases(38.20%),general disorders and administration site conditions in 6214 cases(26.23%)and gastrointestinal systemic diseases in 5839 cases(24.65%).A total of 108 adverse drug reaction(ADR)signals related to 15 SOCs were identified,and the top three ADRs in signal intensity were injection site coldness(ROR=101.47),injection site injury(ROR=76.17)and starvation(ROR=53.75).A total of 47 signals and 5 SOCs were not mentioned in the latest label.Conclusion Injection site reactions and gastronintestinal disorders are worthy of attention in clinical applications of tirzepatide,which can provide a reference for effective pharmaceutical care and quick treatment of adverse reactions.
Tirzepatideadverse drug eventsreporting odd ratio methoddata mining