🇺🇸 Salmeterol (DISKUS) in United States

FDA authorised Salmeterol (DISKUS) on 24 August 2000 · 23 US adverse-event reports

Marketing authorisation

FDA — authorised 24 August 2000

  • Application: NDA021077
  • Marketing authorisation holder: GLAXO GRP LTD
  • Status: supplemented

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 Substitution Issue — 5 reports (21.74%)
  2. Asthma — 2 reports (8.7%)
  3. Condition Aggravated — 2 reports (8.7%)
  4. Drug Ineffective — 2 reports (8.7%)
  5. Dyspnoea — 2 reports (8.7%)
  6. Febrile Neutropenia — 2 reports (8.7%)
  7. Influenza Like Illness — 2 reports (8.7%)
  8. Pancreatitis — 2 reports (8.7%)
  9. Respiratory Failure — 2 reports (8.7%)
  10. Staphylococcal Infection — 2 reports (8.7%)

Source database →

Other Respiratory approved in United States

Frequently asked questions

Is Salmeterol (DISKUS) approved in United States?

Yes. FDA authorised it on 24 August 2000.

Who is the marketing authorisation holder for Salmeterol (DISKUS) in United States?

GLAXO GRP LTD holds the US marketing authorisation.