🇺🇸 Valsartan and Sacubitril in United States

58 US adverse-event reports

Marketing authorisation

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. Ventricular Arrhythmia — 18 reports (31.03%)
  2. Ventricular Tachycardia — 14 reports (24.14%)
  3. Drug Interaction — 5 reports (8.62%)
  4. Cardiogenic Shock — 4 reports (6.9%)
  5. Hypotension — 4 reports (6.9%)
  6. Ventricular Fibrillation — 4 reports (6.9%)
  7. Multiple Organ Dysfunction Syndrome — 3 reports (5.17%)
  8. Atrial Tachycardia — 2 reports (3.45%)
  9. Atrioventricular Block Second Degree — 2 reports (3.45%)
  10. Cardiac Arrest — 2 reports (3.45%)

Source database →

Valsartan and Sacubitril in other countries

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

Frequently asked questions

Is Valsartan and Sacubitril approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Valsartan and Sacubitril in United States?

University Hospital Ostrava is the originator. The local marketing authorisation holder may differ — check the official source linked above.