🇺🇸 Serevent in United States

FDA authorised Serevent on 19 September 1997 · 5,308 US adverse-event reports

Marketing authorisations

FDA — authorised 19 September 1997

  • Application: NDA020692
  • Marketing authorisation holder: GLAXOSMITHKLINE
  • Status: supplemented

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. Drug Ineffective — 1,122 reports (21.14%)
  2. Dyspnoea — 1,050 reports (19.78%)
  3. Asthma — 702 reports (13.23%)
  4. Cough — 457 reports (8.61%)
  5. Dizziness — 348 reports (6.56%)
  6. Headache — 342 reports (6.44%)
  7. Nausea — 341 reports (6.42%)
  8. Pharmaceutical Product Complaint — 317 reports (5.97%)
  9. Pneumonia — 317 reports (5.97%)
  10. Fatigue — 312 reports (5.88%)

Source database →

Other Respiratory approved in United States

Frequently asked questions

Is Serevent approved in United States?

Yes. FDA authorised it on 19 September 1997; FDA has authorised it.

Who is the marketing authorisation holder for Serevent in United States?

GLAXOSMITHKLINE holds the US marketing authorisation.