Drug Discov Ther. 2025;19(1):22-28. (DOI: 10.5582/ddt.2024.01071)

A pharmacovigilance study based on the FAERS database focusing on anticoagulant and hormonal drugs that induce vaginal hemorrhage

Li RH, Hu PW, Qian L

Numerous medications have been associated with an increased risk of vaginal hemorrhage in women. In this study, we analyzed data from the FDA Adverse Event Reporting System (FAERS), focusing on reports of drug-induced vaginal bleeding in women. Risk signals were assessed using disproportionality analyses, specifically the reporting odds ratio (ROR) and the proportional reporting ratio (PRR), to identify significant associations between drugs and adverse events. We found that anticoagulants, hormonal drugs, psychotropic drugs, hypoglycemic agents, antineoplastic agents, anti-inflammatory drugs, immunological agents, and some drugs for osteoporosis were significantly associated with the risk of vaginal hemorrhage. Hormonal drugs, anticoagulants, and particularly antifungal agents were attributed to a notably high proportion of vaginal hemorrhage cases, necessitating further investigation into the underlying mechanisms. Therefore, precise clinical management of medications and optimization of treatment regimens are necessary to reduce the risk of vaginal hemorrhage and improve safety.

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