🇺🇸 Zofran 8 mg in United States

47 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. Dyspnoea — 7 reports (14.89%)
  2. Infusion Related Reaction — 6 reports (12.77%)
  3. Nausea — 6 reports (12.77%)
  4. Diarrhoea — 5 reports (10.64%)
  5. Erythema — 5 reports (10.64%)
  6. Flushing — 5 reports (10.64%)
  7. Asthenia — 4 reports (8.51%)
  8. Chest Discomfort — 3 reports (6.38%)
  9. Deep Vein Thrombosis — 3 reports (6.38%)
  10. Febrile Neutropenia — 3 reports (6.38%)

Source database →

Zofran 8 mg in other countries

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

Frequently asked questions

Is Zofran 8 mg approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Zofran 8 mg in United States?

Medical University of Gdansk is the originator. The local marketing authorisation holder may differ — check the official source linked above.