🇺🇸 5-Fluorouracile in United States

44 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: 21 April 2025 – 21 April 2026
• Total reports: 44

Most-reported reactions

1. Paraesthesia — 7 reports (15.91%)
2. Neutropenia — 5 reports (11.36%)
3. Rash — 5 reports (11.36%)
4. Thrombocytopenia — 5 reports (11.36%)
5. Erythema — 4 reports (9.09%)
6. Infusion Related Reaction — 4 reports (9.09%)
7. Pruritus — 4 reports (9.09%)
8. Vomiting — 4 reports (9.09%)
9. Asthenia — 3 reports (6.82%)
10. Hypertension — 3 reports (6.82%)

Source database →

Frequently asked questions

Is 5-Fluorouracile approved in United States?

5-Fluorouracile does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for 5-Fluorouracile in United States?

Groupe Oncologie Radiotherapie Tete et Cou is the originator. The local marketing authorisation holder may differ — check the official source linked above.