🇺🇸 Otiprio in United States

28 US adverse-event reports

Marketing authorisation

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. Device Occlusion — 15 reports (53.57%)
  2. Foreign Body — 3 reports (10.71%)
  3. Drug Ineffective — 2 reports (7.14%)
  4. Ear Haemorrhage — 2 reports (7.14%)
  5. Condition Aggravated — 1 report (3.57%)
  6. Deafness — 1 report (3.57%)
  7. Device Issue — 1 report (3.57%)
  8. Ear Disorder — 1 report (3.57%)
  9. Ear Pruritus — 1 report (3.57%)
  10. Headache — 1 report (3.57%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Otiprio approved in United States?

Yes. FDA has authorised it.

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

Boston Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.