🇺🇸 Azopt in United States

FDA authorised Azopt on 1 April 1998 · 3,781 US adverse-event reports

Marketing authorisations

FDA — authorised 1 April 1998

  • Application: NDA020816
  • Marketing authorisation holder: SANDOZ
  • Local brand name: AZOPT
  • Indication: SUSPENSION/DROPS — OPHTHALMIC
  • Status: approved

Read official source →

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. Treatment Failure — 1,335 reports (35.31%)
  2. Drug Ineffective — 445 reports (11.77%)
  3. Dyspnoea — 287 reports (7.59%)
  4. Intraocular Pressure Increased — 280 reports (7.41%)
  5. Eye Irritation — 271 reports (7.17%)
  6. Glaucoma — 254 reports (6.72%)
  7. Vision Blurred — 241 reports (6.37%)
  8. Fatigue — 237 reports (6.27%)
  9. Diarrhoea — 216 reports (5.71%)
  10. Eye Pain — 215 reports (5.69%)

Source database →

Azopt in other countries

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

Other Cardiovascular approved in United States

Frequently asked questions

Is Azopt approved in United States?

Yes. FDA authorised it on 1 April 1998; FDA has authorised it.

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

SANDOZ holds the US marketing authorisation.