Objective Data analysis of Pralsetinib adverse event was conducted to explore the risk factors for serious ad-verse events.Methods According to the adverse reaction data of 12 quarters from the 3rd quarter of 2020 to the 2nd quarter of 2023 in FDA Adverse Event Reporting System(FAERS)database,reporting odds ratio(ROR)and proportional reporting ra-tio(PRR)methods were used to mine the risk signals of Pralsetinib adverse reaction.Results A total of 1 431 cases of ad-verse events of Pralsetinib were found by ROR and PRR methods,including some potential adverse event signals not men-tioned in the instructions,such as increased markers of myocardial necrosis,pleural effusion,cognitive impairment,etc.,which should be vigilant in clinical administration.Conclusion ROR and PRR methods can effectively excavate the risk signal of Pralsetinib's adverse reactions,and provide reference for clinical safe drug use.
PralsetinibAdverse event reports signalReporting odds ratioProportional reporting ratio