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Vascepa

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Vascepa

Vascepa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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). This medication is thought to work by decreasing the amount of triglycerides made by the body. The most common side effect is joint pain.

The recommended dosage is 2 capsules (4 grams) twice daily with food. Vascepa may interact with other drugs affecting coagulation (e.g., anti-platelet agents). Tell your doctor all medications and supplements you take. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Vascepa in Detail - Patient Information: Side Effects

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

Common side effects may include:

  • joint pain; or
  • sore throat.

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) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Vascepa FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Adverse reactions reported in at least 2% and at a greater rate than placebo for patients treated with VASCEPA based on pooled data across two clinical studies are listed in Table 1.

Table 1: Adverse Reactions Occurring at Incidence > 2% and Greater than Placebo in Double-Blind, Placebo-Controlled Trials*

Adverse Reaction Placebo
(N=309)
VASCEPA
(N=622)
n % n %
Arthralgia 3 1 14 2.3
*Studies included patients with triglycerides values of 200 to 2000 mg/dL.

An additional adverse reaction from clinical studies was oropharyngeal pain.

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

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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