FDA — authorised 16 July 1975
- Application: NDA017577
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: DITROPAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 oxybutynin IR in United States
FDA authorised oxybutynin IR on 16 July 1975 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 29 November 1979
- Application: NDA018211
- Marketing authorisation holder: ORTHO MCNEIL JANSSEN
- Local brand name: DITROPAN
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 10
Most-reported reactions
- Acute Myocardial Infarction — 1 report (10%)
- Asthenia — 1 report (10%)
- Atrial Fibrillation — 1 report (10%)
- Cardiac Disorder — 1 report (10%)
- Drug Hypersensitivity — 1 report (10%)
- Fall — 1 report (10%)
- Fatigue — 1 report (10%)
- Heart Rate Decreased — 1 report (10%)
- Malaise — 1 report (10%)
- Pyrexia — 1 report (10%)
oxybutynin IR in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is oxybutynin IR approved in United States?
Yes. FDA authorised it on 16 July 1975; FDA authorised it on 29 November 1979; FDA has authorised it.
Who is the marketing authorisation holder for oxybutynin IR in United States?
JANSSEN PHARMS holds the US marketing authorisation.