🇺🇸 Ozurdex in United States

FDA authorised Ozurdex on 17 June 2009 · 1,925 US adverse-event reports

Marketing authorisations

FDA — authorised 17 June 2009

  • Application: NDA022315
  • Marketing authorisation holder: ABBVIE
  • Status: supplemented

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. Endophthalmitis — 274 reports (14.23%)
  2. Off Label Use — 265 reports (13.77%)
  3. Device Dislocation — 251 reports (13.04%)
  4. Intraocular Pressure Increased — 218 reports (11.32%)
  5. Complication Of Device Insertion — 195 reports (10.13%)
  6. Visual Acuity Reduced — 165 reports (8.57%)
  7. No Adverse Event — 146 reports (7.58%)
  8. Visual Impairment — 145 reports (7.53%)
  9. Death — 137 reports (7.12%)
  10. Drug Ineffective — 129 reports (6.7%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Ozurdex approved in United States?

Yes. FDA authorised it on 17 June 2009; FDA has authorised it.

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

ABBVIE holds the US marketing authorisation.