🇺🇸 Norvasc in United States

FDA authorised Norvasc on 31 July 1992 · 36,984 US adverse-event reports

Marketing authorisations

FDA — authorised 31 July 1992

  • Application: NDA019787
  • Marketing authorisation holder: VIATRIS
  • Local brand name: Norvasc
  • 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. Nausea — 4,653 reports (12.58%)
  2. Fatigue — 4,425 reports (11.96%)
  3. Dyspnoea — 4,026 reports (10.89%)
  4. Diarrhoea — 3,876 reports (10.48%)
  5. Dizziness — 3,683 reports (9.96%)
  6. Drug Ineffective — 3,556 reports (9.61%)
  7. Pain — 3,299 reports (8.92%)
  8. Asthenia — 3,248 reports (8.78%)
  9. Headache — 3,243 reports (8.77%)
  10. Hypertension — 2,975 reports (8.04%)

Source database →

Norvasc 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 Norvasc approved in United States?

Yes. FDA authorised it on 31 July 1992; FDA has authorised it.

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

VIATRIS holds the US marketing authorisation.