Mining and analysis of adverse reaction risk signals of tirzepatide based on OpenFDA
Objective Based on the U.S.Food and Drug Administration Open database(OpenFDA),the adverse reactions related to tirzepatide and its safety warning signals were mined and analyzed,which provided a reference for clinical safe medication.Methods The related adverse drug event(ADE)reports from July1,2022 to December 31,2023 were retrieved in the Adverse event Reporting System(FAERS)with the keyword"Tirzepatide".The raw data were mined and analyzed by the reporting odds ratio(ROR)method.Results During this period,a total of 2 129 332 adverse event reports were retrieved,of which 25 659 were related to tirzepatide.The number of tirzepatide-related ADE reports was increasing gradually,and the ADE reports were mainly from the United States,mainly reported by consumers and non-health professional.67.19%of the patients were female,18.57%were male,and 14.24%were of unknown gender.The age distribution was between 18 and 74 years old.A total of 50 positive signals with clinical reference significance were detected,involving 10 systems/organs.Conclusion Gastrointestinal reactions were the most common adverse events.Pancreatitis,diabetic retinopathy,gallbladder/biliary tract diseases and thyroid diseases were the adverse events that should be paid more attention in clinical practice.In addition to the adverse reactions recorded in the instructions,the increase of blood glucose,glycosylated hemoglobin,diabetic ketoacidosis and mental illness also need clinical attention.
TirzepatideOpenFDAReporting odds ratioAdverse drug eventRisk signal mining
万方数据
维普
