🇺🇸 Formoterol-budesonide in United States

55 US adverse-event reports

Marketing authorisation

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 — 9 reports (16.36%)
  2. Nausea — 8 reports (14.55%)
  3. Diarrhoea — 7 reports (12.73%)
  4. Drug Interaction — 6 reports (10.91%)
  5. Asthma — 5 reports (9.09%)
  6. Drug Ineffective — 5 reports (9.09%)
  7. Dizziness — 4 reports (7.27%)
  8. Electrocardiogram Qt Prolonged — 4 reports (7.27%)
  9. Fatigue — 4 reports (7.27%)
  10. Chronic Obstructive Pulmonary Disease — 3 reports (5.45%)

Source database →

Formoterol-budesonide 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 Formoterol-budesonide approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Formoterol-budesonide in United States?

The First Affiliated Hospital of Guangzhou Medical University is the originator. The local marketing authorisation holder may differ — check the official source linked above.