🇺🇸 Budesonide Powder in United States

FDA authorised Budesonide Powder on 9 February 2024 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 9 February 2024

  • Application: NDA213976
  • Marketing authorisation holder: TAKEDA PHARMS USA
  • Local brand name: EOHILIA
  • Indication: SUSPENSION — ORAL
  • 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. Asthma — 1 report (10%)
  2. Cerebral Atrophy — 1 report (10%)
  3. Chest Discomfort — 1 report (10%)
  4. Cyanosis — 1 report (10%)
  5. Death — 1 report (10%)
  6. Disability — 1 report (10%)
  7. Gait Disturbance — 1 report (10%)
  8. Hypotension — 1 report (10%)
  9. Hypothermia — 1 report (10%)
  10. Musculoskeletal Stiffness — 1 report (10%)

Source database →

Budesonide Powder 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 Powder approved in United States?

Yes. FDA authorised it on 9 February 2024; FDA has authorised it.

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

TAKEDA PHARMS USA holds the US marketing authorisation.