Pharmacovigilance evidence of drug induced urinary incontinence in the FDA adverse event reporting system

Li, Chen and Wu, Cangui and Cai, Shanshan and Wang, liqin (2025) Pharmacovigilance evidence of drug induced urinary incontinence in the FDA adverse event reporting system. Scientific Reports, 15 (1): 38278. ISSN 2045-2322

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Abstract

Existing research is limited, and evidence suggests that urinary incontinence may be induced by certain medications, highlighting the urgent need for systematic studies. This study uses the reporting odds ratio (ROR) to evaluate the reports of drug-induced urinary incontinence in the FAERS database from the first quarter of 2004 to the fourth quarter of 2024.Univariate analysis, LASSO regression, and multivariate regression analysis were conducted to further explore the risk factors for drug-induced urinary incontinence. Bonferroni correction was applied to the results of the multiple comparisons. Additionally, the Weibull distribution test was used to assess the temporal characteristics of drug-induced urinary incontinence. Multivariate regression analysis ultimately identified 19 medications as independent risk factors for drug-induced urinary incontinence, including neuropsychiatric drugs (13/19), gastrointestinal and metabolic drugs (2/19), musculoskeletal system drugs (2/19), cardiovascular drugs (1/19), and urogenital and sex hormone drugs (1/19). Over half (57.12%) of the cases of drug-induced urinary incontinence occurred within 30 days after the initiation of medication. This study provides important insights for clinicians in preventing drug-induced urinary incontinence. However, future mechanistic studies and randomized controlled trials are needed to further elucidate and validate these findings.