Drug-induced urinary incontinence in pediatric patients: A disproportionality analysis of the FDA Adverse Event...

Despite the substantial impact of urinary incontinence (UI) on the physical and mental health of children, research on drug-induced pediatric UI (PUI) remains limited. This study aimed to identify drugs associated with PUI by analyzing data from the FDA Adverse Event Reporting System (FAERS). We analyzed FAERS data from Q1 2004 to Q4 2024 to identify PUI cases in children aged 5 to 17 years. Disproportionality signals were assessed using reporting odds ratios (RORs) and proportional reporting ratios (PRRs). Additionally, we conducted a subgroup analysis of enuresis and compared the risks of drug-induced UI between children and adults. Our analysis identified 1252 reports of PUI from the FAERS database. Montelukast was the most frequently reported drug (91 cases), followed by risperidone (74 cases). Forty drugs were significantly associated with PUI, with drugs acting on the nervous system accounting for 52.5%. The top 3 drugs with the strongest signals were glipizide (ROR = 141.1, 95% CI 37.4-532.4; PRR = 102.9), ropinirole (ROR = 125.7, 95% CI 49.8-317.2; PRR = 94.5), and sodium oxybate (ROR = 19.8, 95% CI 15.1-26.0; PRR = 18.9). Twenty-two drugs, such as montelukast, sodium oxybate, and sertraline, had a higher risk of UI in children than in adults. We also discovered unexpected associations, such as miglustat, tisagenlecleucel, and vamorolone. This study systematically identified a range of drugs, including several unexpected ones, associated with PUI. These findings enhance the understanding of the safety profile of drugs associated with PUI and provide important insights for optimizing clinical practice in pediatrics.