Comparative Pharmacovigilance Analysis of Safety Signals Among Advanced Prostate Cancer Therapies Using FAERS (FDA Adverse Event Reporting System)

Abstract

Simple Summary Advanced prostate cancer is treated with several types of medications, including hormone therapies, chemotherapy, targeted therapies, immunotherapy, and radioligand therapy. Although these treatments have been proven effective in clinical trials, less is known about how they perform in routine clinical practice, where larger and more diverse patient populations may experience uncommon side effects. In this study, more than 172,000 reports from the U.S. Food and Drug Administration Adverse Event Reporting System were analyzed to compare the safety profiles of commonly used advanced prostate cancer therapies. The findings suggest that different treatments were associated with distinct patterns of side effects. Chemotherapy was linked to the greatest proportion of serious adverse events, whereas hormonal therapies and other targeted treatments showed more organ-specific toxicity patterns. These findings provide real-world evidence that may help clinicians better anticipate treatment-related toxicities, improve patient counseling, and guide safer treatment selection for men with advanced prostate cancer.