🇺🇸 Combivent in United States

FDA authorised Combivent on 7 October 2011 · 20,323 US adverse-event reports

Marketing authorisations

FDA — authorised 7 October 2011

  • Application: NDA021747
  • Marketing authorisation holder: BOEHRINGER INGELHEIM
  • 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 — 4,973 reports (24.47%)
  2. Drug Ineffective — 2,736 reports (13.46%)
  3. Off Label Use — 2,193 reports (10.79%)
  4. Product Quality Issue — 2,035 reports (10.01%)
  5. Cough — 1,791 reports (8.81%)
  6. Pneumonia — 1,750 reports (8.61%)
  7. Chronic Obstructive Pulmonary Disease — 1,377 reports (6.78%)
  8. Asthma — 1,372 reports (6.75%)
  9. Nausea — 1,083 reports (5.33%)
  10. Wheezing — 1,013 reports (4.98%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Combivent approved in United States?

Yes. FDA authorised it on 7 October 2011; FDA has authorised it.

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

BOEHRINGER INGELHEIM holds the US marketing authorisation.