🇺🇸 Zocor in United States

FDA authorised Zocor on 23 December 1991 · 23,930 US adverse-event reports

Marketing authorisations

FDA — authorised 23 December 1991

  • Application: NDA019766
  • Marketing authorisation holder: ORGANON
  • 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 — 2,948 reports (12.32%)
  2. Fatigue — 2,731 reports (11.41%)
  3. Dyspnoea — 2,561 reports (10.7%)
  4. Drug Ineffective — 2,429 reports (10.15%)
  5. Pain — 2,352 reports (9.83%)
  6. Asthenia — 2,268 reports (9.48%)
  7. Dizziness — 2,246 reports (9.39%)
  8. Myocardial Infarction — 2,168 reports (9.06%)
  9. Myalgia — 2,158 reports (9.02%)
  10. Diarrhoea — 2,069 reports (8.65%)

Source database →

Zocor 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 Zocor approved in United States?

Yes. FDA authorised it on 23 December 1991; FDA has authorised it.

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

ORGANON holds the US marketing authorisation.