A pharmacovigilance study of FDA Adverse Event Reporting System for drug-induced endometrial hyperplasia

Endometrial hyperplasia (EH) is a common disease within the realm of gynecological endocrinology and is considered a precancerous lesion. The aim of this study is to identify and assess the most prevalent drugs associated with the risks of EH by using real-world data. Adverse drug events (ADEs) related to EH were retrieved from the FAERS database (FAERS, Q1/2004-Q3/2024). A disproportionality analysis was conducted to identify drugs that have a significant connection with EH. In this study, 601 ADEs related to endometrial hyperplasia were identified. Among these, 21 drugs were detected to link to significant risks by using multiple methods including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the information component (IC), the empirical bayesian geometric mean (EBGM). The strongest singals for EH were observed with toremifene, drospirenone - estradiol, bazedoxifene - estrogens conjugated. Also it was revealed that genito - urinary system and sex hormones drugs had the strongest association with EH. Through a comprehensive analysis of drugs strongly associated with EH, this study provides strong evidence for professional healthcare providers and patients to render rational decisions, enhance their vigilance, and design follow - up strategies.