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News
Oxybutynin tops the list for psychiatric side effect reports in kids, but no bladder drug triggers a formal safety alarm. A UK-based analysis of nearly 300 adverse drug reaction reports in children found that while oxybutynin had the highest proportion of psychiatric reactions, none of the four drugs studied — oxybutynin, solifenacin, tolterodine, or mirabegron — met the threshold for a disproportionality safety signal.
Researchers took a closer look at neuropsychiatric side effects linked to four commonly used pediatric bladder drugs — oxybutynin, solifenacin, tolterodine, and mirabegron — by analyzing spontaneous adverse drug reaction reports from a UK-based system covering children and young people aged 0–19, with data through December 2025. The goal was to see whether any drug showed a disproportionately high rate of psychiatric or nervous system reactions.
Out of 297 total reports, oxybutynin dominated with 224 cases and showed the highest proportion of psychiatric disorder reports. Still, when researchers ran the numbers using proportional reporting ratios (PRRs), no drug crossed the threshold needed to flag a formal safety signal — not even oxybutynin.
By the Numbers:
Why it matters: While no formal safety signal was triggered, the pattern of psychiatric reaction reporting — especially with oxybutynin — adds weight to calls for larger, long-term studies on how anticholinergic drugs may affect children's cognitive, behavioral, and educational outcomes.
