🇺🇸 Aridol in United States

FDA authorised Aridol on 5 October 2010 · 33 US adverse-event reports

Marketing authorisations

FDA — authorised 5 October 2010

  • Application: NDA022368
  • Marketing authorisation holder: PHARMAXIS EUROPE
  • Local brand name: ARIDOL
  • Indication: POWDER — INHALATION
  • 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. Bronchospasm — 6 reports (18.18%)
  2. Forced Expiratory Volume Decreased — 6 reports (18.18%)
  3. Chest Discomfort — 4 reports (12.12%)
  4. Cough — 4 reports (12.12%)
  5. Wheezing — 4 reports (12.12%)
  6. Asthma — 3 reports (9.09%)
  7. Condition Aggravated — 2 reports (6.06%)
  8. Viral Infection — 2 reports (6.06%)
  9. Blood Glucose Increased — 1 report (3.03%)
  10. Headache — 1 report (3.03%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Aridol approved in United States?

Yes. FDA authorised it on 5 October 2010; FDA has authorised it.

Who is the marketing authorisation holder for Aridol in United States?

PHARMAXIS EUROPE holds the US marketing authorisation.