🇺🇸 Eicosapentaenoic acid ethyl ester in United States

103 US adverse-event reports

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. Drug Ineffective — 28 reports (27.18%)
  2. Myocardial Infarction — 20 reports (19.42%)
  3. Cerebrovascular Accident — 18 reports (17.48%)
  4. Cerebral Infarction — 8 reports (7.77%)
  5. Angina Pectoris — 6 reports (5.83%)
  6. Acute Graft Versus Host Disease — 5 reports (4.85%)
  7. Angina Unstable — 5 reports (4.85%)
  8. Product Use In Unapproved Indication — 5 reports (4.85%)
  9. Erythema — 4 reports (3.88%)
  10. Erythema Multiforme — 4 reports (3.88%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is Eicosapentaenoic acid ethyl ester approved in United States?

Eicosapentaenoic acid ethyl ester does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Eicosapentaenoic acid ethyl ester in United States?

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