🇺🇸 BECLOMETHASONE DIPROPIONATE in United States

FDA authorised BECLOMETHASONE DIPROPIONATE on 12 May 1976 · 3,390 US adverse-event reports

Marketing authorisations

FDA — authorised 12 May 1976

  • Application: NDA017573
  • Marketing authorisation holder: SCHERING
  • Local brand name: VANCERIL
  • Indication: AEROSOL, METERED — INHALATION
  • Status: approved

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FDA — authorised 15 September 2000

  • Application: NDA020911
  • Marketing authorisation holder: TEVA BRANDED PHARM
  • Local brand name: QVAR 40
  • Indication: AEROSOL, METERED — INHALATION
  • Status: approved

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FDA — authorised 16 December 2025

  • Application: ANDA213811
  • Marketing authorisation holder: AMNEAL IRELAND LTD
  • 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 — 588 reports (17.35%)
  2. Asthma — 358 reports (10.56%)
  3. Diarrhoea — 358 reports (10.56%)
  4. Vomiting — 330 reports (9.73%)
  5. Nausea — 326 reports (9.62%)
  6. Pneumonia — 306 reports (9.03%)
  7. Fatigue — 302 reports (8.91%)
  8. Malaise — 297 reports (8.76%)
  9. Headache — 277 reports (8.17%)
  10. Dizziness — 248 reports (7.32%)

Source database →

BECLOMETHASONE DIPROPIONATE 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 BECLOMETHASONE DIPROPIONATE approved in United States?

Yes. FDA authorised it on 12 May 1976; FDA authorised it on 15 September 2000; FDA authorised it on 16 December 2025.

Who is the marketing authorisation holder for BECLOMETHASONE DIPROPIONATE in United States?

SCHERING holds the US marketing authorisation.