🇺🇸 Oxybutynin ER in United States

FDA authorised Oxybutynin ER on 26 February 2003 · 124 US adverse-event reports

Marketing authorisation

FDA — authorised 26 February 2003

  • Application: NDA021351
  • Marketing authorisation holder: ALLERGAN
  • Local brand name: OXYTROL
  • Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
  • Status: approved

Read official source →

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.

Most-reported reactions

  1. Drug Ineffective — 20 reports (16.13%)
  2. Fall — 18 reports (14.52%)
  3. Fatigue — 17 reports (13.71%)
  4. Diarrhoea — 14 reports (11.29%)
  5. Dizziness — 12 reports (9.68%)
  6. Pruritus — 10 reports (8.06%)
  7. Headache — 9 reports (7.26%)
  8. Death — 8 reports (6.45%)
  9. Depression — 8 reports (6.45%)
  10. Dry Mouth — 8 reports (6.45%)

Source database →

Frequently asked questions

Is Oxybutynin ER approved in United States?

Yes. FDA authorised it on 26 February 2003.

Who is the marketing authorisation holder for Oxybutynin ER in United States?

ALLERGAN holds the US marketing authorisation.