🇺🇸 Asmanex twisthaler in United States

FDA authorised Asmanex twisthaler on 30 March 2005 · 3,125 US adverse-event reports

Marketing authorisations

FDA — authorised 30 March 2005

  • Application: NDA021067
  • Marketing authorisation holder: ORGANON LLC
  • Local brand name: ASMANEX TWISTHALER
  • Indication: POWDER — INHALATION
  • 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. Product Quality Issue — 849 reports (27.17%)
  2. Drug Dose Omission — 820 reports (26.24%)
  3. No Adverse Event — 673 reports (21.54%)
  4. Dyspnoea — 218 reports (6.98%)
  5. Drug Ineffective — 134 reports (4.29%)
  6. Cough — 124 reports (3.97%)
  7. Asthma — 117 reports (3.74%)
  8. Incorrect Dose Administered — 67 reports (2.14%)
  9. Device Malfunction — 62 reports (1.98%)
  10. Headache — 61 reports (1.95%)

Source database →

Asmanex twisthaler 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 Asmanex twisthaler approved in United States?

Yes. FDA authorised it on 30 March 2005; FDA has authorised it.

Who is the marketing authorisation holder for Asmanex twisthaler in United States?

ORGANON LLC holds the US marketing authorisation.