🇺🇸 pulmicort respules in United States

FDA authorised pulmicort respules on 8 August 2000 · 1,277 US adverse-event reports

Marketing authorisations

FDA — authorised 8 August 2000

  • Application: NDA020929
  • 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 — 296 reports (23.18%)
  2. Off Label Use — 197 reports (15.43%)
  3. Asthma — 164 reports (12.84%)
  4. Cough — 147 reports (11.51%)
  5. Drug Ineffective — 102 reports (7.99%)
  6. Wheezing — 102 reports (7.99%)
  7. Chest Discomfort — 76 reports (5.95%)
  8. Pneumonia — 76 reports (5.95%)
  9. Dysphonia — 59 reports (4.62%)
  10. Medication Error — 58 reports (4.54%)

Source database →

pulmicort respules 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 pulmicort respules approved in United States?

Yes. FDA authorised it on 8 August 2000; FDA has authorised it.

Who is the marketing authorisation holder for pulmicort respules in United States?

ASTRAZENECA holds the US marketing authorisation.