🇺🇸 Optison in United States

85 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. Dizziness — 12 reports (14.12%)
  2. Drug Ineffective — 11 reports (12.94%)
  3. Back Pain — 10 reports (11.76%)
  4. No Adverse Event — 10 reports (11.76%)
  5. Nausea — 9 reports (10.59%)
  6. Dyspnoea — 8 reports (9.41%)
  7. Chest Pain — 7 reports (8.24%)
  8. Feeling Hot — 6 reports (7.06%)
  9. Off Label Use — 6 reports (7.06%)
  10. Product Quality Issue — 6 reports (7.06%)

Source database →

Optison 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 Optison approved in United States?

Yes. FDA has authorised it.

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

Mayo Clinic is the originator. The local marketing authorisation holder may differ — check the official source linked above.