FDA
- Status: approved
🇺🇸 Flulaval in United States
143 US adverse-event reports
Marketing authorisation
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: 27 March 2025 – 27 March 2026
- Total reports: 143
Most-reported reactions
- Pain — 21 reports (14.69%)
- Dyspnoea — 16 reports (11.19%)
- Chronic Kidney Disease — 15 reports (10.49%)
- Cough — 15 reports (10.49%)
- Drug Ineffective — 15 reports (10.49%)
- Dizziness — 14 reports (9.79%)
- Acute Kidney Injury — 12 reports (8.39%)
- Fatigue — 12 reports (8.39%)
- Renal Failure — 12 reports (8.39%)
- Death — 11 reports (7.69%)
Other Other approved in United States
Frequently asked questions
Is Flulaval approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Flulaval in United States?
University of Massachusetts, Worcester is the originator. The local marketing authorisation holder may differ — check the official source linked above.