🇺🇸 FLOVENT HFA in United States

FDA authorised FLOVENT HFA on 14 May 2004 · 4,103 US adverse-event reports

Marketing authorisations

FDA — authorised 14 May 2004

  • Application: NDA021433
  • Marketing authorisation holder: GLAXO GRP LTD
  • Local brand name: FLOVENT HFA
  • Indication: AEROSOL, METERED — INHALATION
  • Status: approved

Read official source →

FDA

  • Status: approved

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.

Most-reported reactions

  1. Wrong Technique In Product Usage Process — 584 reports (14.23%)
  2. Product Dose Omission Issue — 499 reports (12.16%)
  3. Wrong Technique In Device Usage Process — 477 reports (11.63%)
  4. Dyspnoea — 469 reports (11.43%)
  5. Drug Ineffective — 401 reports (9.77%)
  6. Product Complaint — 400 reports (9.75%)
  7. Fatigue — 357 reports (8.7%)
  8. Off Label Use — 328 reports (7.99%)
  9. Asthma — 296 reports (7.21%)
  10. Nausea — 292 reports (7.12%)

Source database →

FLOVENT HFA 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 FLOVENT HFA approved in United States?

Yes. FDA authorised it on 14 May 2004; FDA has authorised it.

Who is the marketing authorisation holder for FLOVENT HFA in United States?

GLAXO GRP LTD holds the US marketing authorisation.