Analytical study of adverse drug events of vonoprazan based on FAERS
Objective:To explore the safety of vonoprazan by collecting the adverse events of FDA Adverse Event Reporting System(FAERS)and provide reference for its safe use in clinic.Methods:The FAERS data of vonoprazan from 2016 to 2022Q2 were downloaded and matched with MedDRA adverse event system.The adverse event reports with vonoprazan as the primary suspect drug were extracted,and the adverse event signals were detected utilizing reporting odds ratio(ROR)and proportional reporting ratio(PRR).Results:A total of 987 adverse drug event reports with vonoprazan as the primary suspect drug were obtained.The male/female ratio was 1.33,and the median age was 65.33 years old.Reports from"doctor"accounted for 68.90%,and 94.63%reports were from Japan.The top five system organ classes(SOCs)were gastrointestional disease,general disorders and administration site conditions,various examinations,chest and mediastinal diseases and cardiac disorders causing by vonoprazan.Conclusion:Through analysis of the adverse reactions of vonoprazan in the FAERS database,it may be helpful to provide important information on the safety of vonoprazan.
vonoprazanFDA Adverse Event Reporting Systemadverse drug eventsignal mining