Abstract
BACKGROUND: Postmarketing pharmacovigilance data have raised concerns regarding the potential cognitive effects associated with finasteride administration. However, existing epidemiological evidence remains inconclusive, with studies reporting both positive and null associations between finasteride exposure and memory dysfunction. This highlights the need for further comprehensive clinical investigations. OBJECTIVE: This investigation employed a comprehensive, multi-source analytical approach to evaluate the potential correlation between finasteride administration and self-reported memory dysfunction, aiming to establish an evidence-based framework for clinical safety evaluation and therapeutic risk-benefit analysis. METHODS: This study incorporated two principal data repositories: the National Health and Nutrition Examination Survey (NHANES, 2001-2018) and the Food and Drug Administration Adverse Event Reporting System (FAERS, 2004-2018). A comprehensive analytical framework was implemented, incorporating descriptive statistics, multivariable logistic regression modeling, and receiver operating characteristic (ROC) curve analysis to examine potential associations between finasteride exposure and cognitive performance metrics. RESULTS: Multivariable logistic regression analysis of the NHANES dataset, adjusted for demographic variables and lifestyle factors, revealed a significant positive correlation between finasteride exposure and memory impairment risk (adjusted OR = 6.15, 95% CI: 1.62-23.4, p = 0.008). Concurrent analysis of the FAERS database identified 6,624 finasteride-related adverse reports, with cognitive dysfunction (n = 526) comprising a notable proportion of documented complications. CONCLUSION: Convergent evidence from both epidemiological studies and pharmacovigilance surveillance suggests a potential association between finasteride administration and cognitive dysfunction, particularly in memory-related domains. These findings underscore the need for comprehensive risk communication strategies regarding potential neurocognitive adverse effects during clinical consultations and for establishing routine cognitive monitoring protocols for patients undergoing prolonged finasteride therapy.