Drug-associated deep vein thrombosis: a disproportionality analysis of the FDA adverse event reporting system (FAERS)...

Drug-associated deep vein thrombosis (DVT) poses a growing clinical concern, yet the thrombotic risk profiles of many medications are not fully established. This study aimed to systematically detect and characterize drug safety signals for DVT using real-world pharmacovigilance data. A disproportionality analysis was conducted using reports from the FDA adverse event reporting system (FAERS) spanning the first quarter of 2004 to the second quarter of 2025. After deduplication and filtering, 43,226 DVT cases linked to a primary suspect drug were analyzed. Four disproportionality metrics-the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS)-were applied to identify safety signals. Drugs were categorized using the anatomical therapeutic chemical (ATC) classification system. Time-to-onset (TTO) profiles were assessed via the Weibull distribution modeling and the Kaplan-Meier analysis. Among the included reports, 60.23% involved female patients, and 97.48% were classified as serious outcomes. Eighty-eight drugs met the predefined signal threshold. The ten highest-ranking agents by case count were drospirenone/ethinyl estradiol (ROR 69.09), ethinyl estradiol/etonogestrel (ROR 43.41), lenalidomide (ROR 4.89), testosterone (ROR 30.13), rofecoxib (ROR 5.41), ethinyl estradiol/norelgestromin (ROR 28.53), bevacizumab (ROR 3.53), thalidomide (ROR 9.26), pomalidomide (ROR 3.18), and celecoxib (ROR 3.90). These agents predominantly belonged to antineoplastic/immunomodulatory or genitourinary/hormonal therapeutic classes. The median TTO was 120 days (IQR 29-441), with 25.87% of events occurring within the first month of treatment. Early failure patterns were most frequent (52.6% of drugs), especially among hormonal contraceptives, immunomodulators, and chemotherapeutic agents. This large-scale pharmacovigilance analysis identifies robust DVT signals across multiple drug classes, notably hormonal therapies, immunomodulators, and targeted anticancer agents. The results highlight the importance of proactive thrombotic risk assessment and monitoring in clinical practice when using these medications.