Drug Landscape ›
Fluzone Quadrivalent ›
Regulatory · United States
Marketing authorisation
FDA
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: 20 April 2025 – 20 April 2026
Total reports: 296
Most-reported reactions
Fatigue — 45 reports (15.2%) Nausea — 36 reports (12.16%) Off Label Use — 31 reports (10.47%) Product Dose Omission — 31 reports (10.47%) Diarrhoea — 29 reports (9.8%) Product Dose Omission Issue — 29 reports (9.8%) Headache — 28 reports (9.46%) Pain — 24 reports (8.11%) Fall — 22 reports (7.43%) Arthralgia — 21 reports (7.09%)
Source database →
Fluzone Quadrivalent 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 Fluzone Quadrivalent approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Fluzone Quadrivalent in United States?
Fatimah Dawood is the originator. The local marketing authorisation holder may differ — check the official source linked above.