🇺🇸 Revatio in United States

FDA authorised Revatio on 3 June 2005 · 24,987 US adverse-event reports

Marketing authorisations

FDA — authorised 3 June 2005

  • Application: NDA021845
  • Marketing authorisation holder: VIATRIS
  • Local brand name: Revatio
  • Status: supplemented

FDA — authorised 18 November 2009

  • Application: NDA022473
  • Marketing authorisation holder: VIATRIS
  • Local brand name: Revatio
  • Status: supplemented

FDA — authorised 30 August 2012

  • Application: NDA203109
  • Marketing authorisation holder: VIATRIS
  • Local brand name: Revatio
  • 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 — 5,019 reports (20.09%)
  2. Death — 4,465 reports (17.87%)
  3. Headache — 2,651 reports (10.61%)
  4. Diarrhoea — 2,141 reports (8.57%)
  5. Pneumonia — 2,069 reports (8.28%)
  6. Nausea — 1,910 reports (7.64%)
  7. Fatigue — 1,764 reports (7.06%)
  8. Dizziness — 1,746 reports (6.99%)
  9. Malaise — 1,744 reports (6.98%)
  10. Fluid Retention — 1,478 reports (5.92%)

Source database →

Revatio in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Cardiovascular approved in United States

Frequently asked questions

Is Revatio approved in United States?

Yes. FDA authorised it on 3 June 2005; FDA authorised it on 18 November 2009; FDA authorised it on 30 August 2012.

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

VIATRIS holds the US marketing authorisation.