Objective  To provide reference for clinical drug safety, the postmarketing safety signals of degarelix for prostate cancer were explored and evaluated.

Methods  Adverse drug events (ADE) reports of degarelix from January 1, 2004 to November 4, 2021 were extracted from the database of the US Food and Drug Administration Public Data Open Project (openFDA). ADE signals were detected and analyzed by using reporting odds ratio (ROR) and information component (IC). The systems involved in ADEs were classified and evaluated through Medical Dictionary for Drug Regulatory Activities (MedDRA).

Results  During the limited  search period, 4 663 ADE reports with degarelix as the suspected drug were extracted, and serious adverse events accouted for 51.30%. 35 ADE risk signals related to degarelix were mined, involving 9 organs or systems. Based on system organ classification (SOC), the number of positive signals exerted by general disorders and administration site ADE was largest and accounted for 57.14%. Disproportionality analyses showed ADEs induced by general disorders and administration site, investigations, and musculoskeletal and connective tissue disorders exhibited high signal strength.

Conclusion  When took degarelix, more attention should be paid to the serious ADEs, especially the ADEs for the administration site. Meanwhile, the attention should also be paid to the increase of PSA and ALT, musculoskeletal pain and cardiovascular events.

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