Vascepa Side Effects Center

Last updated on RxList: 7/29/2022
Vascepa Side Effects Center

What Is Vascepa?

Vascepa (icosapent ethyl) is a type of omega-3 fatty acid, a fat found in fish oil. It is used along with a low-fat and low-cholesterol diet, to lower high triglycerides (fats). Vascepa is thought to work by decreasing the amount of triglycerides made by the body.

What Are Side Effects of Vascepa?

Common side effects of Vascepa include:

Dosage for Vascepa

The recommended dosage is 2 capsules (4 grams) twice daily with food.

What Drugs, Substances, or Supplements Interact with Vascepa?

Vascepa may interact with other drugs affecting coagulation (e.g., anti-platelet agents). Tell your doctor all medications and supplements you take.

Vascepa During Pregnancy and Breastfeeding

If you are pregnant, only take Vascepa if the potential benefit outweighs the potential risk to the fetus. Vascepa passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Vascepa (icosapent ethyl) Side Effects Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

How to Lower Your Cholesterol & Save Your Heart See Slideshow
Vascepa Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fast or irregular heartbeats, dizziness, shortness of breath, chest discomfort, fainting, or if you feel light-headed; or
  • serious bleeding.

Common side effects may include:

  • muscle or joint pain;
  • constipation;
  • swelling of the hands, legs, or feet.
  • gout; or
  • chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vascepa (Icosapent Ethyl Capsules)

QUESTION

What is cholesterol? See Answer
Vascepa Professional Information

SIDE EFFECTS

The following important adverse reactions are described below and elsewhere in the labeling:

  • Atrial Fibrillation or Atrial Flutter [see WARNINGS AND PRECAUTIONS]
  • Potential for Allergic Reactions in Patients with Fish Allergy [see WARNINGS AND PRECAUTIONS]
  • Bleeding [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Cardiovascular Outcomes Trial

In a double-blind, randomized, placebo-controlled cardiovascular outcomes trial, 8,179 statin-stabilized patients were randomized to receive VASCEPA or placebo and followed for a median of 4.9 years [see Clinical Studies]. The median age at baseline was 64 years, 29% were women, 90% White, 5% Asian, 2% were Black, and 4% identified as Hispanic ethnicity.

Common adverse reactions (incidence ≥3% on VASCEPA and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation.

Hypertriglyceridemia Trials

In two randomized, double-blind, placebo-controlled trials in patients with triglyceride levels between 200 and 2000 mg/dL treated for 12 weeks, adverse reactions reported with VASCEPA at an incidence ≥1% more frequent than placebo based on pooled data included arthralgia and oropharyngeal pain.

Postmarketing Experience

Additional adverse reactions have been identified during post-approval use of VASCEPA. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Diarrhea
  • Blood triglycerides increased
  • Abdominal discomfort
  • Pain in the extremities

Read the entire FDA prescribing information for Vascepa (Icosapent Ethyl Capsules)

© Vascepa Patient Information is supplied by Cerner Multum, Inc. and Vascepa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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