🇺🇸 Budesonide nasal wash in United States

FDA authorised Budesonide nasal wash on 24 June 1997 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 24 June 1997

  • Application: NDA020441
  • Marketing authorisation holder: ASTRAZENECA
  • Local brand name: PULMICORT
  • Indication: POWDER, METERED — INHALATION
  • Status: approved

Read official source →

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. Asthenia — 1 report (10%)
  2. Chest Discomfort — 1 report (10%)
  3. Chronic Sinusitis — 1 report (10%)
  4. Cough — 1 report (10%)
  5. Drug Ineffective — 1 report (10%)
  6. Dysphonia — 1 report (10%)
  7. Facial Paralysis — 1 report (10%)
  8. Fall — 1 report (10%)
  9. Fatigue — 1 report (10%)
  10. Malaise — 1 report (10%)

Source database →

Budesonide nasal wash 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 Budesonide nasal wash approved in United States?

Yes. FDA authorised it on 24 June 1997; FDA has authorised it.

Who is the marketing authorisation holder for Budesonide nasal wash in United States?

ASTRAZENECA holds the US marketing authorisation.