🇺🇸 Entresto in United States

FDA authorised Entresto on 7 July 2015 · 75,870 US adverse-event reports

Marketing authorisations

FDA — authorised 7 July 2015

  • Application: NDA207620
  • Marketing authorisation holder: NOVARTIS PHARMS CORP
  • Status: supplemented

FDA — authorised 12 April 2024

  • Application: NDA218591
  • Marketing authorisation holder: NOVARTIS
  • Status: approved

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. Hypotension — 11,461 reports (15.11%)
  2. Death — 9,102 reports (12%)
  3. Dyspnoea — 8,906 reports (11.74%)
  4. Dizziness — 8,629 reports (11.37%)
  5. Fatigue — 8,608 reports (11.35%)
  6. Cough — 7,824 reports (10.31%)
  7. Wrong Technique In Product Usage Process — 7,289 reports (9.61%)
  8. Weight Decreased — 5,174 reports (6.82%)
  9. Cardiac Failure — 4,456 reports (5.87%)
  10. Malaise — 4,421 reports (5.83%)

Source database →

Entresto in other countries

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

Other Other approved in United States

Frequently asked questions

Is Entresto approved in United States?

Yes. FDA authorised it on 7 July 2015; FDA authorised it on 12 April 2024; FDA has authorised it.

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

NOVARTIS PHARMS CORP holds the US marketing authorisation.