🇺🇸 Maxidex in United States

FDA authorised Maxidex on 20 June 1962 · 840 US adverse-event reports

Marketing authorisations

FDA — authorised 20 June 1962

  • Application: NDA013422
  • Marketing authorisation holder: HARROW EYE
  • 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. Eye Pain — 113 reports (13.45%)
  2. Visual Acuity Reduced — 97 reports (11.55%)
  3. Intraocular Pressure Increased — 96 reports (11.43%)
  4. Endophthalmitis — 91 reports (10.83%)
  5. Uveitis — 91 reports (10.83%)
  6. Condition Aggravated — 82 reports (9.76%)
  7. Drug Ineffective — 76 reports (9.05%)
  8. Off Label Use — 67 reports (7.98%)
  9. Nausea — 65 reports (7.74%)
  10. Choroiditis — 62 reports (7.38%)

Source database →

Maxidex in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Maxidex approved in United States?

Yes. FDA authorised it on 20 June 1962; FDA has authorised it.

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

HARROW EYE holds the US marketing authorisation.