Age-related adverse effects of Tamoxifen in female breast cancer patients: Insights from the FDA's adverse event reporting system.

BackgroundTamoxifen is an effective treatment for hormone receptor-positive breast cancer (BC). Despite its effectiveness, there have been many reports of adverse reaction. However, the relationship between Tamoxifen-related adverse events (ADEs) and patient age remains unclear.AimTo enhance clinical medication guidance and drug safety by identifying age-specific ADEs associated with Tamoxifen therapy in female breast cancer patients, thereby offering a more robust foundation for evidence-based clinical practice.MethodsADEs reports of Tamoxifen from the FAERS database were extracted from the first quarter of 2004 to the second quarter of 2023. Reporting odds ratio (ROR) data analysis strategy was used for mining signal strength that represents age differences in ADEs related to Tamoxifen.ResultsThe number of efficient ADE signals associated with Tamoxifen for female BC included in the analysis was 338 in premenopausal women, 847 in perimenopause and 1525 in postmenopause respectively. Our study showed age differences in three age groups of ADEs with Tamoxifen in female BC. Perimenopausal and postmenopausal women receiving tamoxifen therapy demonstrated a significantly higher incidence of adverse drug reactions, particularly involving the gastrointestinal tract, renal/urinary systems, hematologic/lymphatic systems, endocrine functions, and immune responses. It was particularly concerned that ADEs associated with ear and labyrinth disorders had only been reported in perimenopause.ConclusionAge differences was detected in ADE signals related to Tamoxifen. There were significant differences in Tamoxifen related ADEs of premenopausal, perimenopausal and postmenopausal women with BC in different systems. To ensure the safety of medicines, we should be aware of the age-related differences in ADEs and take appropriate preventive measures to reduce incidence of serious ADEs.