Adverse events related to darolutamide treatment: analysis of "real life" data from EudraVigilance and the Food and Drug Administration database entries

Background: Aim of our study was to analyze adverse events (AEs) associated with darolutamide using real life data from Eudra-Vigilance (EV) and the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) databases. Methods: EV database in European Economic Area (EEA) and the FDA FAERS database were queried to identify darolutamide AEs occurred from 30th July 2019 to May 2022. AEs were recorded in according to category and severity. Real-life data was compared to Aramis registry study. Results: The total number of AEs including data from both databases was 409 reported by FDA-FAERS and 253 reported by EV databases. On registry study, 794 AEs were reported, with serious AEs occurring in 24.8% of patients in the darolutamide group and with 1 death related to trial regimen. The most frequently reported AEs from both database were general disorders (33% and 26%), investigations (19% and 22%), gastrointestinal (15% and 11%), renal and urinary (9%), gastrointestinal (6%) and musculoskeletal disorder (5%). Conclusions: According to our results darolutamide is safe in a real-life scenario and the most frequent side effect is fatigue. Although up to now there are few reports in both real-life databases, these data are encouraging for clinicians using darolutamide in every day clinical practice.