Icosapent: Side Effects, Uses & Monitoring
VASCEPA® (icosapent ethyl) is indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization
- Data source
- FDA labeling via NIH DailyMed (label 9c1a2828…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
VASCEPA® (icosapent ethyl) is indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Conditions associated with Icosapent in labeling
Chest Pain
Discomfort or pain in the chest that can range from minor muscle strain to a life-threatening heart condition....
Myocardial Infarction
A heart attack, occurring when blood flow to part of the heart muscle is blocked, causing chest pain and heart...
Pancreatitis
Inflammation of the pancreas that causes severe upper abdominal pain radiating to the back, nausea, and vomiti...
Stroke
Sudden interruption of blood flow to the brain, causing rapid loss of brain function. Time-critical medical em...
Frequently Asked Questions
What is Icosapent used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Icosapent?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Icosapent require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Icosapent.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.