Vascepa Side Effects
Generic Name: icosapent
Medically reviewed by Drugs.com. Last updated on April 30, 2020.
Note: This document contains side effect information about icosapent. Some of the dosage forms listed on this page may not apply to the brand name Vascepa.
For the Consumer
Applies to icosapent: oral capsule liquid filled
Side effects requiring immediate medical attention
Along with its needed effects, icosapent (the active ingredient contained in Vascepa) 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:
- fast or irregular heartbeat
- swelling of the hands, ankles, feet, or lower legs
- unusual bleeding
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:
- difficulty with moving
- muscle pain or stiffness
- pain in the joints
- pain in the mouth or throat
Incidence not known
- pain in the arms or legs
- stomach discomfort
For Healthcare Professionals
Applies to icosapent: oral capsule
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.
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
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]
Common (1% to 10%): Constipation, oropharyngeal pain
Postmarketing reports: Diarrhea, abdominal discomfort[Ref]
Common (1% to 10%): Arthralgia, musculoskeletal pain
Postmarketing reports: Extremity pain[Ref]
Common (1% to 10%): Gout
Postmarketing reports: Increased blood triglycerides
1. "Product Information. Vascepa (icosapent)." Amarin Pharmaceuticals Inc, Warren, NJ.
Frequently asked questions
- Is this the same as fish oil?
- Can it help with weight loss?
- How long does it take to work?
- Does it cause hair loss?
- Does it thin your blood?
- Lovaza vs. Vascepa - what's the difference between them?
More about Vascepa (icosapent)
- During Pregnancy
- Dosage Information
- Patient Tips
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- 94 Reviews
- Generic Availability
- Drug class: miscellaneous antihyperlipidemic agents
- FDA Approval History
Related treatment guides
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.