Prescription medication · Omega-3 Fatty Acid (EPA)

icosapent ethyl

Also sold as Vascepa. This medicine helps lower very high triglyceride levels in adults.

Data updated 2026-05-15

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 →

Compare with Another Drug → Full Side Effects Report →

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.

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

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.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for icosapent ethyl each year to the FDA Adverse Event Reporting System (FAERS).

05001,0001,500 20112013201520172019202120232025 1,032

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.

fewest reports most reports

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

Female 3,300 (47%)
Male 3,684 (52%)

Age Distribution

0–17 68
18–44 464
45–64 1,701
65–74 1,594
75+ 996

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

DEATH 224
CONDITION AGGRAVATED 129
MATERNAL EXPOSURE DURING PREGNANCY 101
TYPE 2 DIABETES MELLITUS 68
FIBROMYALGIA 67
OVERLAP SYNDROME 67
STOMATITIS 67
HYPOAESTHESIA 65
URTICARIA 65
SWELLING 64

Reactions in Hospitalization Reports

FATIGUE 120
PNEUMONIA 95
CONDITION AGGRAVATED 93
HEADACHE 92
HYPERTENSION 92
PYREXIA 92
DYSPNOEA 89
VOMITING 89
HYPOAESTHESIA 84
SWELLING 81

Source: 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

moderate omega-3 fatty acids

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.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

What should I do if I experience bleeding while taking this medication?
Contact your doctor immediately if you experience any unusual or severe bleeding.
Can I take this medication if I am allergic to shellfish?
Tell your doctor if you are allergic to fish or shellfish before taking this medication.
Will this medication cure my high triglycerides?
This medication helps to lower triglyceride levels, but it is not a cure. You must also follow a healthy diet and exercise plan.
How long does it take for this medication to work?
It may take several weeks or months to see the full effect of this medication on your triglyceride levels.
Can I stop taking this medication if my triglyceride levels go down?
Do not stop taking this medication without talking to your doctor first.
Are there any foods I should avoid while taking this medication?
Follow a healthy diet as directed by your doctor. Limit your intake of saturated and trans fats, cholesterol, and sugary foods.
Can I drink alcohol while taking this medication?
Talk to your doctor about whether it is safe for you to drink alcohol while taking this medication.
Does this medication have any effect on my cholesterol levels?
This medication primarily lowers triglyceride levels, but it may also have a small effect on cholesterol levels.
Can I take this medication with other medications?
Tell your doctor about all the medications you take, including prescription and over-the-counter drugs, vitamins, and herbal supplements.
What tests will I need while taking this medication?
Your doctor will likely check your triglyceride levels regularly while you are taking this medication.
What are the common side effects of icosapent ethyl?
The registry lists Muscle or joint pain, Swelling in your legs or feet, Constipation, Gout, Irregular heartbeat among the most-reported FAERS reaction terms for icosapent ethyl. The compiled record contains 7,801 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does icosapent ethyl interact with other medications?
The registry has 1 documented interaction rows for icosapent ethyl. Notable source-record pairings include omega-3 fatty acids. These rows are not a complete medication review.
What drug class is icosapent ethyl?
icosapent ethyl belongs to the Omega-3 Fatty Acid (EPA) drug class. It requires a prescription (Rx). This medicine helps lower very high triglyceride levels in adults.
Is there a generic version of icosapent ethyl?
Yes, generic icosapent ethyl is available from 10 manufacturers. The generic costs $0.70 per unit compared to $1.66 for the brand version, saving approximately 58%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
What pregnancy or breastfeeding source fields are listed for icosapent ethyl?
The FDA label for icosapent ethyl contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has icosapent ethyl been recalled?
There are 3 recalls associated with icosapent ethyl products. Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. Check the recalls section below for full details and affected products.

Active Recalls

Class II March 9, 2026

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

Zydus Pharmaceuticals (USA) Inc

Class II December 30, 2025

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

Class II May 30, 2025

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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Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for icosapent ethyl: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

Similar FAERS report volume

Nearest drugs by total FAERS reports. This record: 7,801.

4 peers

Similar death-report share

Nearest drugs by FAERS death-report share. This record: 6.37%.

4 peers

Medication Guides

Understanding Drug Interactions

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Generic vs Brand Name Drugs

FDA requirements, cost savings, and when the difference matters

Narrow Therapeutic Index Drugs

FDA bioequivalence and label-record context for narrow therapeutic index medicines

Common Drug Interactions

Dangerous medication combinations and how to protect yourself

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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

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. This registry does not provide medication decisions.

Last updated: March 15, 2024

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

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