Adverse event signals of pralsetinib and selpercatinib based on the FAERS database

SU Shan; CHEN Fang-wei; YE Cui-fen; CHEN Shao-zhuang; LIU Jia-wei

doi:10.20251/j.cnki.1003-3734.2026.10.014

Abstract：Objective:To identify and analyze post-marketing adverse drug event(ADE)signals associated with pralsetinib and selpercatinib,compare their respective adverse event profiles,and provide a more comprehensive evidence base to support clinical decision-making in drug selection.Methods:ADE reports for pralsetinib and selpercatinib were extracted from the U.S.FDA Adverse Event Reporting System(FAERS)database from April 2020 to December 2024.Disproportionality analysis was conducted using the reporting odds ratio(ROR)method.Results:The analysis revealed significant differences in the adverse event profiles of the two drugs.For instance,in the affected system,although the system organ class(SOC)distribution for the top three adverse events was similar between the two drugs,pratinib was associated with a higher frequency of risk signals in gastrointestinal disorders,respiratory/thoracic/mediastinal disorders,and nervous system disorders.In contrast,cepratinib exhibited a greater incidence of adverse reactions related to hepatobiliary disorders,skin and subcutaneous tissue disorders,and other system-specific effects compared to pratinib.Notably,even within the same SOC,the specific adverse reactions differed between the two drugs.For instance,in regard to cardiovascular toxicity,pralsetinib was linked to elevated myocardial necrosis markers,whereas selpercatinib was more frequently associated with QT interval prolongation.These distinctions highlight the need for drug-specific monitoring in clinical practice.Conclusion:While pralsetinib and selpercatinib share some overlapping adverse effects,their risk profiles exhibit distinct patterns.Individualized drug selection,guided by patient-specific factors and the unique toxicity profiles of each agent,is essential to optimize therapeutic outcomes.