Evaluation of adverse event profiles for leuprolide and goserelin: Insights from the FDA adverse event reporting system following STROBE guidelines

Leuprolide and Goserelin, both gonadotropin-releasing hormone (GnRH) agonists, are commonly used for ovarian function suppression and the management of hormone-dependent cancers. However, systematic comparisons of their adverse event (AE) profiles based on real-world pharmacovigilance data remains limited. This study aimed to compare the safety signals associated with Leuprolide and Goserelin using the the U.S. Food and Drug Administration AE Reporting System (FAERS), thereby providing insights into their distinct AE patterns. Food and Drug Administration Adverse Event Reporting System reports from the first quarter of 2004 to the third quarter of 2024 were extracted and standardized. Disproportionality signal detection was performed using the reporting odds ratio, proportional reporting ratio, chi-square (χ2) test, and Bayesian confidence propagation neural network. Significant signals were defined as reporting odds ratio lower 95% CI >1, proportional reporting ratio ≥2 with χ2 ≥4, or Bayesian confidence propagation neural network information component (IC)-2SD >0. Key signals were compared between Leuprolide- and Goserelin-related reports. A total of 12,418,989 AE reports were identified, including 64,324 Leuprolide-related and 4253 Goserelin-related cases. Both drugs showed strong signals for "prostatic specific antigen increased" (Leuprolide: χ2 = 84,009.65, IC-2SD = 5.42; Goserelin: χ2 = 820.31, IC-2SD = 3.38), "blood testosterone increased" (Leuprolide: χ2 = 22,845.52, IC-2SD = 5.56; Goserelin: χ2 = 290.23, IC-2SD = 2.28), and "prostatic specific antigen abnormal" (Leuprolide: χ2 = 51,615.98, IC-2SD = 6.46; Goserelin: χ2 = 422.43, IC-2SD = 2.16). Additional strong signals, such as "prostate cancer metastatic" and "hot flush," were consistently detected in both groups. Notably, the distribution of AEs differed between drugs, suggesting drug-specific safety patterns. Leuprolide demonstrated strong associations with AEs in "Reproductive system and breast disorders," "Neoplastic benign and malignant conditions," and procedure-related categories, whereas Goserelin was more strongly linked to "Endocrine disorders." These findings highlight distinct pharmacovigilance profiles between the 2 drugs and provide clinically relevant evidence to support individualized risk monitoring in hormone-dependent cancer therapies.