🇺🇸 Omega-3 Ethyl Esters in United States

FDA authorised Omega-3 Ethyl Esters on 12 June 2007 · 33 US adverse-event reports

Marketing authorisations

FDA — authorised 12 June 2007

  • Application: NDA021853
  • Marketing authorisation holder: RELIANT PHARMS
  • Local brand name: OMACOR
  • Indication: CAPSULE — ORAL
  • Status: approved

Read official source →

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. Fatigue — 5 reports (15.15%)
  2. Asthenia — 4 reports (12.12%)
  3. Acne — 3 reports (9.09%)
  4. Acute Kidney Injury — 3 reports (9.09%)
  5. Chest Pain — 3 reports (9.09%)
  6. Chronic Kidney Disease — 3 reports (9.09%)
  7. Drug Ineffective — 3 reports (9.09%)
  8. Psoriasis — 3 reports (9.09%)
  9. Renal Failure — 3 reports (9.09%)
  10. Weight Decreased — 3 reports (9.09%)

Source database →

Omega-3 Ethyl Esters 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 Omega-3 Ethyl Esters approved in United States?

Yes. FDA authorised it on 12 June 2007; FDA has authorised it.

Who is the marketing authorisation holder for Omega-3 Ethyl Esters in United States?

RELIANT PHARMS holds the US marketing authorisation.