🇺🇸 Remodulin in United States

FDA authorised Remodulin on 21 May 2002 · 47,335 US adverse-event reports

Marketing authorisations

FDA — authorised 21 May 2002

  • Application: NDA021272
  • Marketing authorisation holder: UNITED THERAP
  • Status: supplemented

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 — 8,355 reports (17.65%)
  2. Headache — 5,777 reports (12.2%)
  3. Diarrhoea — 5,673 reports (11.98%)
  4. Infusion Site Pain — 5,335 reports (11.27%)
  5. Nausea — 5,168 reports (10.92%)
  6. Death — 4,767 reports (10.07%)
  7. Fatigue — 3,228 reports (6.82%)
  8. Dizziness — 3,094 reports (6.54%)
  9. Infusion Site Erythema — 3,068 reports (6.48%)
  10. Vomiting — 2,870 reports (6.06%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Remodulin approved in United States?

Yes. FDA authorised it on 21 May 2002; FDA has authorised it.

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

UNITED THERAP holds the US marketing authorisation.