Abstract: Objective To provide data for rational drug use via the mining and analysis of adverse drug reaction signals of abiraterone. Methods Based on the adverse Event Reporting System (FAERS) of the United States Food and Drug Administration (FDA), the reporting odds ratio (ROR) and information component (IC) method were used to mine and analyze the data on AEs of abiraterone reported between the first quarter of 2011 and the fourth quarter of 2022. Statistical analysis was performed according to the preferred terms (PT) and system organ class (SOC) of the International Dictionary of Medical Terms (MedDRA). Results A total of 34 432 reports of AEs of abiraterone were retrieved, and mostly involved males (32 823 reports, 95.3%). The mean age of onset in patients with known age was 74.7. AEs were chiefly reported in the United States (24 948 cases, 72.5%). Most of the interviewees were consumers (12 237, 35.8%). Reports of AEs kept increasing since 2011 and peaked in 2019 (5 517, 16.0%). A total of 280 abiraterone AE signals were detected in 24 SOCs. Among the top 50 PTs of occurrence, 18 positive signals were not recorded in the drug package, which were concentrated in various examinations (2 cases), diseases of the nervous system (1 case), diseases of the blood and lymphatic system (1 case), diseases of the respiratory, chest and mediastinum (2 cases), infectious and invasive diseases (1 case), benign, malignant and unknown tumors (6 cases), metabolic and nutritional diseases (3 cases), musculoskeletal and connective tissue diseases (2 cases). Conclusion The results of mining of suspicious abiraterone AE signals are generally consistent with those recorded in the manual, but new signals are still found and need to be actively monitored.

Key words: abiraterone, loss of appetite, dehydration, hyponatremia, adverse drug events, FAERS, signal mining