Sex and age disparities in goserelin safety: a global pharmacovigilance study.
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Goserelin, a synthetic analogue of gonadotropin-releasing hormone, is widely used in breast cancer and prostate cancer. However, significant sex-based disparities exist in its therapeutic effects and safety profiles. What's more, current evidence remains insufficient to characterize age-related adverse drug event (ADEs) risks. Given these gaps, comprehensive real-world studies are required to systematically analyze ADEs in male and female patients separately. The analytical dataset was derived from the FAERS (2004 Q1-2025 Q1) and VigiBase (1987.01.01-2025.07.01) databases. Disproportionality analysis was performed using the reporting odds ratio and information component. All statistical analyses and visualizations were conducted using Microsoft Excel 2019, R4.4.2, and GraphPad Prism. The FAERS database recorded 8,245 ADEs (2,325 female; 3,190 male), while VigiBase contained 10,524 (3,274 female; 4,941 male). Baseline clinical outcomes revealed higher mortality rates and more serious reports in males. System organ class analysis demonstrated that males showed greater susceptibility to general disorders and administration site conditions. Several strong signals in the preferred term level not currently listed in the drug label were identified, including neutropenia, jaundice, and pleural effusion. Age-stratified analysis indicated ADEs predominantly occurred in males aged 65-74 years and females aged 40-54 years. The most frequently reported events, hot flush and interstitial lung disease, displayed stronger associations in male patients. Using real-world pharmacovigilance data, we identify sex- and age-related safety disparities for goserelin, supporting individualized monitoring and risk management to enhance treatment safety.