🇺🇸 Incruse in United States

FDA authorised Incruse on 30 April 2014 · 5,479 US adverse-event reports

Marketing authorisations

FDA — authorised 30 April 2014

  • Application: NDA205382
  • Marketing authorisation holder: GLAXO GRP ENGLAND
  • Status: approved

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 — 1,264 reports (23.07%)
  2. Drug Ineffective — 710 reports (12.96%)
  3. Cough — 650 reports (11.86%)
  4. Asthma — 536 reports (9.78%)
  5. Wrong Technique In Device Usage Process — 520 reports (9.49%)
  6. Pneumonia — 486 reports (8.87%)
  7. Chronic Obstructive Pulmonary Disease — 352 reports (6.42%)
  8. Fatigue — 335 reports (6.11%)
  9. Product Dose Omission Issue — 316 reports (5.77%)
  10. Death — 310 reports (5.66%)

Source database →

Other Respiratory approved in United States

Frequently asked questions

Is Incruse approved in United States?

Yes. FDA authorised it on 30 April 2014; FDA has authorised it.

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

GLAXO GRP ENGLAND holds the US marketing authorisation.