Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system

Abstract

ABSTRACT Background Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database. Methods This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals. Results A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital (n = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (n = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (n = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5). Conclusion Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.