🇺🇸 ondansetron (Zofran) in United States

102 US adverse-event reports

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.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 102

Most-reported reactions

1. Nausea — 19 reports (18.63%)
2. Dyspnoea — 16 reports (15.69%)
3. Diarrhoea — 12 reports (11.76%)
4. Vomiting — 11 reports (10.78%)
5. Abdominal Pain — 8 reports (7.84%)
6. Fatigue — 8 reports (7.84%)
7. Flushing — 8 reports (7.84%)
8. Pyrexia — 8 reports (7.84%)
9. Chest Discomfort — 6 reports (5.88%)
10. Cough — 6 reports (5.88%)

Source database →

Frequently asked questions

Is ondansetron (Zofran) approved in United States?

ondansetron (Zofran) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for ondansetron (Zofran) in United States?

National Institute on Alcohol Abuse and Alcoholism (NIAAA) is the originator. The local marketing authorisation holder may differ — check the official source linked above.