Differences in adverse drug reactions between GnRH antagonists and agonists in the treatment of prostate cancer: a retrospective analysis using real-world data.

Yingxun Luo, Xuwei Hong, Weiqiang Lin, Hong Huang, Jiawei Wang, Zeyao Xu, Weinan Zeng, Yuanfeng Zhang, Yonghai Zhang

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Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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9 authors.

Yingxun Luo *Department of Urology, Shantou Central Hospital, Shantou, China.

Xuwei Hong *Department of Urology, Shantou Central Hospital, Shantou, China.

Weiqiang LinDepartment of Urology, Shantou Central Hospital, Shantou, China.

Hong HuangDepartment of Urology, Shantou Central Hospital, Shantou, China.

Jiawei WangDepartment of Nephrology, Shantou Central Hospital, Shantou, China.

Zeyao XuDepartment of Urology, Shantou Central Hospital, Shantou, China.

Weinan ZengDepartment of Urology, Shantou Central Hospital, Shantou, China.

Yuanfeng ZhangDepartment of Urology, Shantou Central Hospital, Shantou, China.

Yonghai ZhangDepartment of Urology, Shantou Central Hospital, Shantou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: This study aimed to evaluate the safety profiles of gonadotropin-releasing hormone (GnRH) antagonists and agonists in the treatment of prostate cancer (PC). Methods: A retrospective pharmacovigilance analysis was conducted using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the fourth quarter of 2024. Within-class direct comparison analyses between GnRH antagonists and GnRH agonists were performed using disproportionality methods, including the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Further analyses on age stratification, combination therapy, and onset time of adverse events (AEs) were conducted to explore the safety differences between GnRH antagonists and agonists. Results: A total of 2,486 reports were included in the study, comprising 444 reports for GnRH antagonists and 2,042 reports for GnRH agonists. GnRH antagonists showed higher risk for injection site reactions compared with GnRH agonists, with the strongest signals observed for injection site erythema (ROR = 16.07, 95% confidence interval [CI] = 9.14-28.28; PRR = 14.33; χ Conclusion: This pharmacovigilance study identified distinct AE reporting patterns between GnRH antagonists and GnRH agonists in PC treatment. GnRH antagonists were primarily characterized by higher risk of local injection site reactions, whereas AE profiles varied according to patient age, treatment duration, and concomitant medication exposure.

Indexed as

adverse drug reactionGnRH agonistGnRH antagonistprostate cancerreal-world study

Identifiers

PMID42682597

DOI10.3389/fphar.2026.1895503

PMCPMC13529942

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