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Icosapent Side Effects

Medically reviewed by Drugs.com. Last updated on April 30, 2020.

For the Consumer

Applies to icosapent: oral capsule liquid filled

Side effects requiring immediate medical attention

Along with its needed effects, icosapent may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking icosapent:

Less common

Side effects not requiring immediate medical attention

Some side effects of icosapent may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Constipation
  • difficulty with moving
  • muscle pain or stiffness
  • pain in the joints
  • pain in the mouth or throat

Incidence not known

  • Diarrhea
  • pain in the arms or legs
  • stomach discomfort

For Healthcare Professionals

Applies to icosapent: oral capsule

General

The more commonly reported adverse reactions in the cardiovascular outcome trial included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. The more commonly reported adverse reactions in the hypertriglyceridemia trials included arthralgia and oropharyngeal pain.

Cardiovascular

During clinical trials in patients with established cardiovascular disease (CVD) or diabetes plus and additional risk factor for CVD, adjudicated atrial fibrillation or atrial flutter requiring hospitalization for 24 hours or more occurred in 3% of patients (n=127) receiving this drug compared with 2% (n=84) placebo-treated patients. The incidence of atrial fibrillation was greater in patients with a history of atrial fibrillation or atrial flutter.

Common (1% to 10%): Atrial fibrillation/flutter, peripheral edema

Hematologic

During clinical trials in patients with established cardiovascular disease (CVD) or diabetes plus and additional risk factor for CVD, a bleeding event occurred in 12% (n=482) of patients receiving this drug compared to 10% (n=404) of placebo-treated patients. A serious bleeding event occurred in 3% (n=111) of patients receiving this drug compared to 2% (n=85) of placebo-treated patients.

Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in those studies did not exceed normal limits and did not produce clinically significant bleeding episodes.[Ref]

Very Common (10% or greater): Bleeding event

Common (1% to 10%): Serious bleeding event

Frequency not reported: Prolonged bleeding time[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, oropharyngeal pain

Postmarketing reports: Diarrhea, abdominal discomfort[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, musculoskeletal pain

Postmarketing reports: Extremity pain[Ref]

Metabolic

Common (1% to 10%): Gout

Postmarketing reports: Increased blood triglycerides

References

1. "Product Information. Vascepa (icosapent)." Amarin Pharmaceuticals Inc, Warren, NJ.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.