Neuropsychiatric suspected Adverse Drug Reaction Reporting Patterns for Bladder Medications in Children: An Analysis of UK Yellow Card data.

Background Anticholinergic and beta-3-agonist medications are commonly used for overactive bladder in children and young people (CYP). Their neuropsychiatric safety profile in this population remains poorly characterised. Methods Suspected adverse drug reaction (ADR) reports for oxybutynin, tolterodine, solifenacin, and mirabegron (patients aged 0–19 years) were extracted from the UK MHRA Yellow Card scheme. Proportional reporting ratios (PRRs) were calculated for psychiatric and nervous system disorders. Pairwise comparisons of psychiatric suspected ADR proportions were conducted. The following detection thresholds were applied (PRR ≥2, chi-squared ≥4, n ≥3). Results A total of 297 suspected ADR reports were identified. Oxybutynin accounted for the largest number of reports (n=224, 75.2%). Psychiatric disorders were the most frequently reported MedDRA (Medical Dictionary for Regulatory Activities) System Organ Class (SOC) category for both oxybutynin (n=140, 27.3%) and mirabegron (n=10, 26.3%). Oxybutynin demonstrated a higher proportional reporting for suspected psychiatric disorders (PRR 1.56, 95% CI: 1.075-2.255), though this did not meet the formal detection threshold. No drug demonstrated disproportionality for nervous system disorders. Oxybutynin showed a numerically higher proportion of suspected psychiatric ADRs than solifenacin (27.3% vs 12.2%) and tolterodine (27.3% vs 16.0%), though neither reached significance under the pre-specified chi-square test (p=0.053 and p=0.052, respectively). No significant difference was observed with mirabegron (27.3% vs 26.3%; p=1.00). Conclusion Oxybutynin was associated with a greater proportional reporting of suspected psychiatric ADR reporting compared to other bladder medications for CYP, though this did not reach conventional detection thresholds. Mirabegron demonstrated a similar psychiatric reporting proportion to oxybutynin but given the small number of events, continued monitoring is advised. Robust, prospective safety studies in paediatric populations are needed.