🇺🇸 Budesonide Nasal in United States

FDA authorised Budesonide Nasal on 14 February 1994 · 45 US adverse-event reports

Marketing authorisations

FDA — authorised 14 February 1994

  • Application: NDA020233
  • Marketing authorisation holder: ASTRAZENECA
  • Local brand name: RHINOCORT
  • Indication: AEROSOL, METERED — NASAL
  • Status: approved

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FDA — authorised 1 October 1999

  • Application: NDA020746
  • Marketing authorisation holder: KENVUE BRANDS
  • Local brand name: RHINOCORT
  • Indication: SPRAY, METERED — NASAL
  • Status: approved

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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. Drug Ineffective — 10 reports (22.22%)
  2. Headache — 5 reports (11.11%)
  3. Dizziness — 4 reports (8.89%)
  4. Dyspnoea — 4 reports (8.89%)
  5. Nausea — 4 reports (8.89%)
  6. Pruritus — 4 reports (8.89%)
  7. Weight Increased — 4 reports (8.89%)
  8. Wheezing — 4 reports (8.89%)
  9. Asthma — 3 reports (6.67%)
  10. Cough — 3 reports (6.67%)

Source database →

Budesonide Nasal 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 approved in United States?

Yes. FDA authorised it on 14 February 1994; FDA authorised it on 1 October 1999; FDA has authorised it.

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

ASTRAZENECA holds the US marketing authorisation.