Abstract:Objective To mine the signals of adverse drug events (ADE) of the novel androgen receptor inhibitors (enzalutamide, apalutamide and darolutamide) based on the FAERS database, so as to provide reference for clinical safe drug use.Methods The reported data of the three drugs from marketing to the first quarter of 2023 were extracted from the FAERS database, and the reported odds ratio (ROR) method and proportional reporting ratio (PRR) method were used to mine the ADE signals of the three drugs.Results A total of 135 ADE signals were obtained for enzalutamide, involving 14 system organ classes (SOCs). Of the 135 signals, 98 signals were not included in the instruction of enzalutamide. There were 77 ADE signals for apalutamide, involving 16 SOCs, and 46 signals of them were not included in the instruction of apalutamide. Totally 29 ADE signals were obtained for darolutamide, involving 13 SOCs, and 23 signals of them were not included in the instruction of darolutamide. Comparing all ADE signals for different drugs, it was found that enzalutamide-related signals were mainly about the nervous system diseases (dizziness, taste disorder, impaired memory, balance disorder, amnesia, peripheral neuropathy, etc.), gastrointestinal system diseases (dysphagia, constipation, abdominal discomfort, etc.) and musculoskeletal and connective tissue diseases (back pain, muscular weakness, musculoskeletal pain, etc.). Apalutamide-related signals were mainly about the skin and subcutaneous tissue disorders (rash, Stevens-Johnson syndrome, pruritic rash, erythematous rash, etc.), while darolutamide-related signals were mainly distributed in various examinations (elevated serum creatinine, elevated liver enzymes, etc.), and kidney and urinary system diseases (renal function damage, etc.).Conclusion The ADE signals involved in this study verified the safety content in the instructions of the three drugs, and the signals not included in the instructions need to be further evaluated. The ADEs of different drugs were different, so it is better to choose drugs on the base of patient's medical history and medication history.