Real-world assessment of thromboembolic risk associated with tamoxifen

It has been confirmed that tamoxifen (TAM) use is associated with thromboembolic risks; however, it remains uncertain which specific thromboembolic events warrant prioritized surveillance beyond those already listed in the prescribing information. This study was conducted to assess the relationship between TAM use and reported thromboembolic events using the latest FDA Adverse Event Reporting System (FAERS) data. Tamoxifen-related AEs reported in FAERS between January 2004 and December 2024 were extracted, screened for thromboembolic cases, and subjected to disproportionality analysis to identify significant signals. A clinical prioritization scoring system was then applied to rank signal relevance, and multivariate regression analyses were performed to identify factors associated with thromboembolic outcomes. Among 385 TAM-associated thromboembolic events, 28 significant signals were detected. Newly detected signals comprised unilateral paralysis, retinal artery occlusion, and atrial thrombosis. Male sex, older age, and elevated body mass were identified as risk indicators for thromboembolism. These findings may inform enhanced clinical surveillance and TAM risk stratification; however, further validation is warranted.