🇺🇸 Epadel, Eicosapentaenoic acid in United States

28 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. Cerebral Infarction — 4 reports (14.29%)
  2. Fall — 3 reports (10.71%)
  3. Hepatic Function Abnormal — 3 reports (10.71%)
  4. Intentional Product Misuse — 3 reports (10.71%)
  5. Seizure — 3 reports (10.71%)
  6. Thrombocytopenia — 3 reports (10.71%)
  7. Thrombotic Cerebral Infarction — 3 reports (10.71%)
  8. Blood Glucose Increased — 2 reports (7.14%)
  9. Cardiac Failure — 2 reports (7.14%)
  10. Deep Vein Thrombosis — 2 reports (7.14%)

Source database →

Epadel, Eicosapentaenoic acid 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 Epadel, Eicosapentaenoic acid approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Epadel, Eicosapentaenoic acid in United States?

Osaka General Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.