🇺🇸 Oxytrol in United States

FDA authorised Oxytrol on 26 February 2003 · 7,286 US adverse-event reports

Marketing authorisations

FDA — authorised 26 February 2003

  • Application: NDA021351
  • Marketing authorisation holder: ALLERGAN
  • Status: supplemented

FDA — authorised 25 January 2013

  • Application: NDA202211
  • Marketing authorisation holder: ABBVIE
  • 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.

Most-reported reactions

  1. Drug Ineffective — 2,402 reports (32.97%)
  2. Application Site Erythema — 894 reports (12.27%)
  3. Product Adhesion Issue — 741 reports (10.17%)
  4. Application Site Pruritus — 580 reports (7.96%)
  5. Drug Effect Decreased — 561 reports (7.7%)
  6. Pruritus — 526 reports (7.22%)
  7. Off Label Use — 436 reports (5.98%)
  8. Erythema — 398 reports (5.46%)
  9. Product Quality Issue — 383 reports (5.26%)
  10. Rash — 365 reports (5.01%)

Source database →

Other Neuroscience approved in United States

Frequently asked questions

Is Oxytrol approved in United States?

Yes. FDA authorised it on 26 February 2003; FDA authorised it on 25 January 2013; FDA has authorised it.

Who is the marketing authorisation holder for Oxytrol in United States?

ALLERGAN holds the US marketing authorisation.