Prescription medication · Omega-3 Fatty Acid (EPA)
icosapent ethyl
Also sold as Vascepa. This medicine helps lower very high triglyceride levels in adults.
- 7,801
- FDA reportsLightly reported
- 1
- InteractionFew interactions
- 58% less
- Generic vs brandBig savings
- 3
- Recall records
What the data shows
icosapent ethyl (Vascepa) is a prescription Omega-3 Fatty Acid (EPA), reported less often than most tracked drugs (7,801 FDA reports), whose generic runs roughly half the brand price or less (58% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
icosapent ethyl (Vascepa) is a prescription Omega-3 Fatty Acid (EPA). This medicine helps lower very high triglyceride levels in adults.
Icosapent ethyl (Vascepa) is a medicine that helps lower very high triglyceride levels in adults. It is used along with a healthy diet.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$1.66/unit
Generic Price
$0.70/unit
Generic Savings
58%
Generic Available
Yes (10 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine helps lower very high triglyceride levels in adults.
Common side effects
Muscle or joint pain, Swelling in your legs or feet, Constipation
Key warnings
This medicine may increase your risk of having an irregular heartbeat (atrial fibrillation or flutter) that requires hospitalization.
The sections below are summarized in plain English from icosapent ethyl's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Icosapent ethyl is a type of omega-3 fatty acid. It contains EPA, which helps to lower triglyceride levels in your blood. The exact way it works is not fully understood.
How to Take It
Take this medicine exactly as your doctor tells you. The usual dose is 4 grams per day. You can take four 0.5 gram capsules twice a day with food. Or, you can take two 1 gram capsules twice a day with food. Swallow the capsules whole; do not crush, chew, or dissolve them.
This is a plain-language summary of icosapent ethyl's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. Talk to your doctor about the risks and benefits of taking this medicine while pregnant or breastfeeding.
This is a plain-language summary of icosapent ethyl's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of icosapent ethyl's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store this medicine at room temperature, away from heat and moisture, and keep out of reach of children.
Side Effects (from patient reports)
Based on 7,801 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for icosapent ethyl, by number of reports
- The product smells strange
The product smells strange
963 reports
- Problem with the product's appearance
Problem with the product's appearance
733 reports
- Diarrhea
Diarrhea
546 reports
- A low-quality product was given
A low-quality product was given
501 reports
- Feeling sick to your stomach
Feeling sick to your stomach
488 reports
- Joint pain
Joint pain
468 reports
- The product tastes strange
The product tastes strange
430 reports
- Feeling tired
Feeling tired
389 reports
- The prescribed dose was too low 301
The prescribed dose was too low
301 reports
- Triglyceride levels in the blood went up 283
Triglyceride levels in the blood went up
283 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for icosapent ethyl each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where icosapent ethyl sits
icosapent ethyl has more FDA adverse-event reports than 34% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is icosapent ethyl; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 7,801 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2011–2025.
Total Reports
7,801
Reports Mentioning Death
497
6.4% of reports — not proof of cause
Hospitalization Reports
1,413
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | PRODUCT ODOUR ABNORMAL | 963 |
| 2 | PRODUCT PHYSICAL ISSUE | 733 |
| 4 | DIARRHOEA | 546 |
| 6 | POOR QUALITY PRODUCT ADMINISTERED | 501 |
| 7 | NAUSEA | 488 |
| 8 | ARTHRALGIA | 468 |
| 9 | PRODUCT TASTE ABNORMAL | 430 |
| 10 | FATIGUE | 389 |
| 11 | PRESCRIBED UNDERDOSE | 301 |
| 12 | BLOOD TRIGLYCERIDES INCREASED | 283 |
| 13 | HEADACHE | 274 |
| 14 | DIZZINESS | 271 |
| 15 | ERUCTATION | 265 |
| 16 | ABDOMINAL DISCOMFORT | 250 |
| 17 | CONDITION AGGRAVATED | 249 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine may increase your risk of having an irregular heartbeat (atrial fibrillation or flutter) that requires hospitalization. Your risk may be higher if you have had this condition before. This medicine may also increase your risk of bleeding, especially if you take blood thinners like aspirin, clopidogrel, or warfarin. Tell your doctor if you are allergic to fish or shellfish, as this medicine is made from fish oil.
Known Drug Interactions
7 DRUG INTERACTIONS Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents: Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. (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.
Mechanism: Both of these medications can slow down how quickly your blood clots, which may make you bleed more easily.
What to do: Tell your doctor if you notice any unusual bruising or bleeding while taking these together.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I do if I experience bleeding while taking this medication?
Can I take this medication if I am allergic to shellfish?
Will this medication cure my high triglycerides?
How long does it take for this medication to work?
Can I stop taking this medication if my triglyceride levels go down?
Are there any foods I should avoid while taking this medication?
Can I drink alcohol while taking this medication?
Does this medication have any effect on my cholesterol levels?
Can I take this medication with other medications?
What tests will I need while taking this medication?
What are the common side effects of icosapent ethyl?
Does icosapent ethyl interact with other medications?
What drug class is icosapent ethyl?
Is there a generic version of icosapent ethyl?
Is icosapent ethyl safe during pregnancy?
Has icosapent ethyl been recalled?
Active Recalls
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Zydus Pharmaceuticals (USA) Inc
Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
Zydus Pharmaceuticals (USA) Inc
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
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What the FDA Data Shows for icosapent ethyl
The FDA label for icosapent ethyl (sold under brand names such as Vascepa) classifies it as a prescription-only medication in the Omega-3 Fatty Acid (EPA) class. This medicine helps lower very high triglyceride levels in adults. Official labeling lists 7 commonly reported side effects, including Muscle or joint pain, Swelling in your legs or feet, Constipation.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 7,801 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.70 versus $1.66 for the brand - a 58% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 3 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: March 15, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages