Icosapent Ethyl: uses, dosing, side effects & brands
Icosapent Ethyl is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Capsule
- Sold as
- Vascepa
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $13 for a 30-count supply — not your price
How icosapent ethyl is dosed
From the FDA label for Vascepa (application NDA202057). Other icosapent ethyl products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels and manage as appropriate. ( 2.1 ) Patients should engage in appropriate nutritional intake and physical activity before receiving VASCEPA, which should continue during treatment. ( 2.1 ) The daily dose of VASCEPA is 4 grams per day taken as either four 0.5 gram capsules twice daily with food or two 1 gram capsules twice daily with food. ( 2.2 ) Advise patients to swallow capsules whole. Do not break open, crush, dissolve, or chew VASCEPA. ( 2.2 ) 2.1 Prior to Initiation of VASCEPA Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. Patients should engage in appropriate nutritional intake and physical activity before receiving VASCEPA, which should continue during treatment with VASCEPA. 2.2 Dosage and Administration The daily dose of VASCEPA is 4 grams per day taken as either: four 0.5 gram capsules twice daily with food; or as two 1 gram capsules twice daily with food. Advise patients to swallow VASCEPA capsules whole. Do not break open, crush, dissolve, or chew VASCEPA.
Icosapent Ethyl side effects
The following important adverse reactions are described below and elsewhere in the labeling: Atrial Fibrillation or Atrial Flutter [see Warnings and Precautions ( 5.1 )] Potential for Allergic Reactions in Patients with Fish Allergy [see Warnings and Precautions ( 5.2 )] Bleeding [see Warnings and Precautions ( 5.3 )] Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation ( 6.1 ) Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amarin Pharma, Inc. at 1-855-VASCEPA (1-855-827-2372) or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 ( 14.1 )] . The…
Who shouldn’t take icosapent ethyl
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. ( 4 )
Icosapent Ethyl drug interactions
Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents: Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. Monitor patients receiving VASCEPA and concomitant anticoagulants and/or antiplatelet agents for bleeding. ( 7 ) 7.1 Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Monitor patients receiving VASCEPA and concomitant anticoagulants and/or antiplatelet agents for bleeding.
Every icosapent ethyl product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Vascepa.
What icosapent ethyl pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Icosapent Ethyl recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Zydus Pharmaceuticals (USA) Inc · Mar 9, 2026
Icosapent Ethyl capsules
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Zydus Pharmaceuticals (USA) Inc · Dec 30, 2025
Icosapent Ethyl Capsules 1 gram
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Zydus Pharmaceuticals (USA) Inc · May 30, 2025
Can you crush or split icosapent ethyl?
At least one icosapent ethylproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each icosapent ethyl label says about crushing, splitting and chewingHow long icosapent ethyl keeps
No icosapent ethyl label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does icosapent ethyl expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about icosapent ethyl
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,122 reports naming icosapent ethyl, and the FDA flagged 74% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- diarrhoea66 reports
- maternal exposure during pregnancy52 reports
- nausea48 reports
- overlap syndrome46 reports
- myocardial infarction41 reports
- cerebrovascular accident38 reports
- fatigue37 reports
- pneumonia36 reports
Read these as a signal, not a rate. A report does not mean icosapent ethyl caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is icosapent ethyl?
VASCEPA, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Each VASCEPA capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA).
Can you take icosapent ethyl with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run icosapent ethyl against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does icosapent ethyl come in?
Across the brands we track, icosapent ethyl is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic icosapent ethyl?
We do not currently list a generic-labelled icosapent ethyl product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has icosapent ethyl been recalled?
The FDA's Enforcement database lists 3 recall records whose product description mentions icosapent ethyl. The most recent: Icosapent Ethyl Capsules (Mar 9, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Icosapent Ethyl: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/icosapent-ethyl
- MLA
- “Icosapent Ethyl: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/icosapent-ethyl.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for icosapent ethyl on DailyMed (NIH) ↗.