🇺🇸 5-Flurouracil in United States
30 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: 30
Most-reported reactions
- Febrile Neutropenia — 5 reports (16.67%)
- Vomiting — 5 reports (16.67%)
- Acute Kidney Injury — 3 reports (10%)
- Neuropathy Peripheral — 3 reports (10%)
- Neutropenia — 3 reports (10%)
- Pneumonia — 3 reports (10%)
- Blood Pressure Inadequately Controlled — 2 reports (6.67%)
- Colitis — 2 reports (6.67%)
- Decreased Appetite — 2 reports (6.67%)
- Diarrhoea — 2 reports (6.67%)
Other Oncology approved in United States
Frequently asked questions
Is 5-Flurouracil approved in United States?
5-Flurouracil does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for 5-Flurouracil in United States?
Janssen Research & Development, LLC is the originator. The local marketing authorisation holder may differ — check the official source linked above.