Data Mining and Analysis of Adverse Events of Darolutamide Based on FAERS Database
Objective:To explore the risk signals of adverse reactions associated with darolutamide and provide reference for clinical safe drug use.Methods:The reported odds ratio(ROR)method of the pro-portional imbalance method was used to mine adverse reactions in the FDA Adverse Reaction Reporting System(FAERS)of the United States from the third quarter of 2019 to the fourth quarter of 2022 with darolutamide as the primary suspect drug.The detection threshold was for adverse reactions with a reported number ≥ 3 and a lower limit of the 95％confidence interval of the ROR greater than 1.Results &Conclusion:A total of 1376 adverse reaction reports with darolutamide as the primary suspected drug were screened,and after removing non drug adverse reactions,1013 reports of darolutamide adverse reactions were obtained,involving 589 patients.Forty risk signals were detected,involving 16 systemic organs.The adverse reaction signals mainly focused on systemic diseases and various reactions at the administration sites,gastrointestinal system diseases,skin and subcutaneous tissue diseases,various examinations and vari-ous nervous system diseases.The most common adverse reactions of darolutamide occurred in the first month of medication.Twenty-one signals not mentioned in the medication package inserts were found,in-cluding rhabdomyolysis,delirium,gynecomastia,peripheral neuropathy and edema.
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