🇺🇸 valsartan and amlodipine in United States

22 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. Acute Kidney Injury — 3 reports (13.64%)
  2. Intentional Overdose — 3 reports (13.64%)
  3. Metabolic Acidosis — 3 reports (13.64%)
  4. Serotonin Syndrome — 3 reports (13.64%)
  5. Major Depression — 2 reports (9.09%)
  6. Physical Deconditioning — 2 reports (9.09%)
  7. Pruritus — 2 reports (9.09%)
  8. Suicide Attempt — 2 reports (9.09%)
  9. Angina Unstable — 1 report (4.55%)
  10. Atrial Thrombosis — 1 report (4.55%)

Source database →

valsartan and amlodipine 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 amlodipine approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for valsartan and amlodipine in United States?

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