Adverse event reporting patterns associated with Degarelix and Relugolix: a pharmacovigilance study based on the FAERS database

Urol Int. 2026 Apr 17:1-13. doi: 10.1159/000551870. Online ahead of print.

ABSTRACT

Background：Degarelix and Relugolix are two GnRH antagonists approved by the FDA for androgen deprivation therapy (ADT) in the treatment of prostate cancer. However, differences in their safety profiles and the characteristics of specific adverse events (AEs) remain insufficiently characterized. Methods：This study analyzes adverse events (AEs) associated with Degarelix and Relugolix reported in the FAERS from Q1 2009 through Q2 2024. Multiple signal detection methods, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM), were employed to assess drug-AE associations. Results：A total of 3,357 adverse event (AE) reports associated with Degarelix and 4,075 reports related to Relugolix were retrieved from the FAERS database. Signal analysis revealed that the most common adverse events associated with Degarelix were injection site reactions, whereas Relugolix was frequently associated with hot flushes. Furthermore, the study identified several rare AEs not included in the drug labeling. Conclusion: This study identified common adverse events associated with Degarelix and Relugolix but also identified several potential safety signals. These findings provide additional pharmacovigilance evidence for post-marketing safety monitoring and highlight potential safety signals that warrant further clinical and epidemiological investigation.

PMID:41996296 | DOI:10.1159/000551870