🇺🇸 Symbicort in United States

FDA authorised Symbicort on 21 July 2006 · 76,667 US adverse-event reports

Marketing authorisations

FDA — authorised 21 July 2006

  • Application: NDA021929
  • Marketing authorisation holder: ASTRAZENECA
  • 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. Dyspnoea — 17,913 reports (23.36%)
  2. Asthma — 12,043 reports (15.71%)
  3. Cough — 7,846 reports (10.23%)
  4. Drug Ineffective — 6,767 reports (8.83%)
  5. Off Label Use — 5,973 reports (7.79%)
  6. Pneumonia — 5,804 reports (7.57%)
  7. Wheezing — 5,658 reports (7.38%)
  8. Fatigue — 5,377 reports (7.01%)
  9. Malaise — 4,735 reports (6.18%)
  10. Headache — 4,551 reports (5.94%)

Source database →

Symbicort in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Symbicort approved in United States?

Yes. FDA authorised it on 21 July 2006; FDA has authorised it.

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

ASTRAZENECA holds the US marketing authorisation.