FDA-filed SPL labeling · retrieved through openFDA

Omega-3-Acid Ethyl Esters

Omega-3-acid ethyl esters is a prescription omega-3 fatty acid used alongside diet to lower severely elevated triglycerides (fats in the blood) in adults.

Brand names LovazaOmega-3-Acid Ethyl Ester

Drug class ⓘ Omega-3 Fatty Acid

Rx Forms 3 Route Oral

Reviewed by Dr. Brian Staiger, PharmD, BCPS Last reviewed Jul 10, 2026

🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 30 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance

Linked label effectiveMar 9, 2026

Clinical labels in scope ⓘ30

AvailabilityRx

Earliest approval/marketing year ⓘ2004

FDA-listed product records ⓘ84

Boxed warningNone found in compared labels

How we combine label and product data →

✓No current FDA shortage listed · checked Sep 23, 2026 🚨Recall on record

⭐ Omega-3-Acid Ethyl Esters at a glance The quick version — the full detail is in the Patient Information Guide below.

💊

HelloPharmacist Editorial Team Bottom Line

Omega-3-acid ethyl esters capsules, including Lovaza, are a prescription-strength treatment for adults with severely elevated triglyceride levels, used alongside — not instead of — a healthy diet. Common side effects are mild digestive complaints like burping and upset stomach, but people taking blood thinners or those with a history of irregular heartbeat should discuss extra precautions with their doctor. Follow your prescriber's guidance and get your triglyceride and LDL levels checked as directed.

How we write & review this content — our editorial policy →

📖 Omega-3-Acid Ethyl Esters: Patient Information Guide

A plain-language walkthrough of Omega-3-Acid Ethyl Esters — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Omega-3-acid ethyl esters is a prescription medication approved to reduce triglyceride levels in adults with severely elevated triglycerides — used alongside, not instead of, a triglyceride-lowering diet.

Lovaza (omega-3-acid ethyl esters capsules) is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglycerides of 500 mg/dL or higher).
Omega-3-acid ethyl esters capsules (generic) are indicated for the same use: reducing severely elevated triglyceride levels in adults, alongside dietary management.
This medication has not been shown to reduce the risk of pancreatitis or cardiovascular death and is not approved to treat atrial fibrillation or flutter.

⚙️How it works▾

Omega-3-acid ethyl esters contains EPA and DHA — two omega-3 fatty acids derived from fish oil. The exact way it lowers triglycerides isn't fully understood, but EPA and DHA appear to reduce triglyceride production in the liver, partly because they are poor building blocks for the enzymes that make triglycerides, and partly because they block a process called esterification that the liver uses to assemble fats. The medication may also increase the activity of lipoprotein lipase — an enzyme that breaks down triglycerides in the blood — and boost fat-burning pathways in the liver.

💊How it's taken▾

Omega-3-acid ethyl esters capsules are taken by mouth with meals. The total daily dose may be taken all at once or divided into two doses taken twice a day. Capsules must be swallowed whole — never break, crush, dissolve, or chew them.

Take with food to help with absorption and reduce stomach upset.
Continue following your lipid-lowering diet throughout treatment.
Follow your prescriber's instructions exactly — do not adjust the dose on your own.

🤒Side effects — in detail▾

The most commonly reported side effects in clinical trials were:

Burping (eructation) — the most frequently reported complaint
Upset stomach (dyspepsia)
Taste changes or unpleasant taste (taste perversion)

Contact your doctor promptly if you notice signs of an allergic reaction (hives, swelling, difficulty breathing), irregular heartbeat, unusual bruising or bleeding, or any symptoms suggesting liver problems such as yellowing of the skin or eyes.

⚠️Warnings & precautions▾

Atrial fibrillation risk: There is a possible association between this medication and more frequent recurrences of symptomatic atrial fibrillation (AF) or flutter in people who already have paroxysmal or persistent AF — especially in the first 2 to 3 months of therapy. This drug is not approved to treat AF or flutter.
LDL cholesterol increase: In some patients, omega-3-acid ethyl esters can raise LDL cholesterol ("bad" cholesterol). Your doctor should monitor LDL levels periodically.
Liver monitoring: In patients with liver problems, liver enzyme levels (ALT and AST) should be checked regularly during treatment.
Fish/shellfish allergy: This medication comes from fish oil. If you have a known fish or shellfish allergy, use with caution and discuss the risk with your doctor.
Bleeding risk: Omega-3 fatty acids may prolong bleeding time. This has not caused major bleeding events in studies, but extra monitoring is needed if you take blood thinners or antiplatelet medications.

🔀What it interacts with▾

There are two main interaction categories to be aware of with omega-3-acid ethyl esters capsules:

Blood thinners and antiplatelet drugs (e.g., warfarin, aspirin, clopidogrel): omega-3-acid ethyl esters may prolong bleeding time, so your doctor should monitor you more closely if you take these together.
Triglyceride-raising medications (e.g., beta-blockers, thiazide diuretics, estrogens): these drugs can worsen high triglyceride levels. Your doctor may need to stop or switch them before starting omega-3-acid ethyl esters therapy.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾

Allergy to omega-3 fatty acid products: Do not take this medication if you've had a serious allergic reaction (such as anaphylaxis) to omega-3-acid ethyl esters or any of its ingredients.
Fish or shellfish allergy: Tell your doctor — this medication is derived from fish oil and should be used with caution.
Liver disease: Liver enzymes will need to be monitored during treatment; tell your doctor about any history of liver problems.
Atrial fibrillation or flutter: Let your doctor know if you have a history of paroxysmal or persistent AF — this medication may increase the frequency of episodes.
Pregnancy: Human safety data are limited. Animal studies at very high doses showed some effects on fetal development. Discuss risks and benefits with your doctor.
Breastfeeding: EPA and DHA are found in breast milk. The effects on a nursing infant are unknown; discuss with your doctor.
Children: Safety and effectiveness have not been established in pediatric patients.
Older adults (over 65): A limited number of older adults were studied; safety and efficacy appeared similar to younger patients.
Kidney or liver impairment: This medication has not been formally studied in patients with kidney or liver disease; use with appropriate caution and monitoring.

🔬Pharmacokinetics — how your body processes it▾

EPA and DHA from omega-3-acid ethyl esters capsules are absorbed through the gut after oral dosing. Taking higher doses produces larger increases in EPA levels in the blood (a dose-dependent effect), though DHA levels rise less predictably. Age does not appear to affect how well the body absorbs EPA and DHA, but females tend to absorb more EPA into their blood cells than males — the significance of this is not yet known. Studies show that taking this medication alongside common statins (simvastatin, atorvastatin, rosuvastatin) does not meaningfully change how those drugs behave in the body, and omega-3-acid ethyl esters are not expected to significantly interact with the liver's main drug-processing enzyme system (cytochrome P450).

📦How to store it▾

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Do not freeze. Keep out of reach of children.

📄 Written from Omega-3-Acid Ethyl Esters’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Omega-3-Acid Ethyl Esters — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is this medication for — isn't fish oil something you can just buy at the store? ▾

Great question. Omega-3-acid ethyl esters capsules — including the brand Lovaza — are a prescription-strength, highly concentrated form of omega-3 fatty acids. They're specifically approved to lower severely high triglyceride levels (500 mg/dL or above) in adults when diet alone isn't enough. Over-the-counter fish oil supplements are a very different product and are not FDA-approved to treat high triglycerides at this level. Think of this as a pharmaceutical-grade treatment, not a supplement.

Do I still need to follow a diet even though I'm taking this medication? ▾

Yes, absolutely. This medication is meant to work alongside a triglyceride-lowering diet — not replace it. You should start the diet before beginning treatment and continue it the whole time you're taking the capsules. Diet, exercise, and managing conditions like diabetes or thyroid disease that can raise triglycerides are all still important parts of the plan.

What side effects should I expect, and when should I call my doctor? ▾

The most common side effects are burping, upset stomach, and a fishy or altered taste — these tend to be mild and often improve with time. More serious things to call your doctor about include signs of an allergic reaction (like hives, swelling, or trouble breathing), an irregular or racing heartbeat — especially if you've had atrial fibrillation before — or any unusual bruising or bleeding, particularly if you also take a blood thinner.

I take a blood thinner. Is it safe to take this along with it? ▾

You can take them together, but your doctor should monitor you more closely. Omega-3 fatty acids can slightly prolong the time it takes your blood to clot. In studies this didn't cause serious bleeding, but when combined with a blood thinner or antiplatelet medication, regular check-ins with your prescriber are important. Make sure your doctor and pharmacist know everything you're taking.

Is it okay to take this medication if I'm pregnant or breastfeeding? ▾

There's not enough human data to fully confirm it's safe during pregnancy. Animal studies at very high doses showed some effects, but not at doses close to what people take. If you are pregnant, planning to become pregnant, or breastfeeding, have a conversation with your doctor before starting or continuing this medication — they'll weigh the benefits against any potential risks for you and your baby.

How do I take the capsules — is there anything special I need to know? ▾

Take the capsules by mouth with a meal. The key rule: swallow them whole. Don't break, crush, dissolve, or chew them. You can take your full daily dose all at once or split it into two doses — one in the morning and one in the evening with meals — whichever your doctor recommends. Keep following your diet throughout, and expect your doctor to check your triglyceride and LDL cholesterol levels periodically while you're on this medication.

Is Omega-3-Acid Ethyl Esters available over the counter? ▾

Omega-3-Acid Ethyl Esters is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

When was Omega-3-Acid Ethyl Esters first available? ▾

Omega-3-Acid Ethyl Esters has been available in the United States since at least 2004, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Omega-3-Acid Ethyl Esters? ▾

Omega-3-Acid Ethyl Esters is supplied by 35 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Apotex Corp..

💬 Answers drafted from Omega-3-Acid Ethyl Esters’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerOmega-3-Acid Ethyl Esters vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Omega-3-Acid Ethyl Esters NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

📊 Detailed data & references for Omega-3-Acid Ethyl Esters Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here.

💊 How Omega-3-Acid Ethyl Esters comes

Omega-3-Acid Ethyl Esters is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth

Brands Lovaza Omega-3-Acid Ethyl Ester

How this form is used

What it may be used for

Lovaza capsules are used alongside diet to reduce severely elevated triglyceride levels in adults.
Omega-3-acid ethyl esters capsules are used alongside diet to reduce severely elevated triglyceride levels in adults.

Important instructions

Lovaza capsules are taken by mouth with meals — either all at once or split into two doses daily.
Lovaza capsules must be swallowed whole; do not break, crush, dissolve, or chew them.
Omega-3-acid ethyl esters capsules are taken by mouth with meals — either all at once or split into two doses daily.
Omega-3-acid ethyl esters capsules must be swallowed whole; do not break, crush, dissolve, or chew them.

Available strengths 2 strengths

900 mg 1 g

Other oral form

By mouth

Available strengths 1 strength

1 kg/kg

Oral solution

By mouth

Available strengths 2 strengths

1 kg/kg 190 kg/190 kg

📊 Omega-3-Acid Ethyl Esters across the U.S. market

How Omega-3-Acid Ethyl Esters appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

Dose forms ⓘ

Manufacturers

Brand names

FDA-listed product records ⓘ

2004

First marketed ⓘ

Capsule

Other oral form

Oral solution

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

35makers

Bryant Ranch Prepack14%

A-S Medication Solutions13%

Apotex Corp.5%

Remedyrepack Inc.5%

KD Pharma USA, Inc.5%

Amneal Pharmaceuticals LLC4%

Other makers55%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Omega-3-Acid Ethyl Esters is used

A general measure of how commonly Omega-3-Acid Ethyl Esters is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Omega-3-Acid Ethyl Esters is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

450,937

Medicaid prescriptions filled (Q1–Q4 2025)

$13.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Omega-3-Acid Ethyl Esters prescribed? Of the 1,596 medications we measure, Omega-3-Acid Ethyl Esters ranks #275 by Medicaid prescriptions — more than 83% of them.

Where Omega-3-Acid Ethyl Esters ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Total prescriptions — #275 of 1,596

#270 Levofloxacin 474,527 Rx #271 Nortriptyline 455,288 Rx #272 Carbamazepine 452,754 Rx #273 Penicillin V Potassium 451,965 Rx #274 Viloxazine 451,086 Rx #275 Omega-3-Acid Ethyl Est... 450,937 Rx #276 Fentanyl 440,395 Rx #277 Formoterol / Mometason... 440,187 Rx #278 Ziprasidone 438,206 Rx #279 Ciclopirox Topical 437,507 Rx #280 Diltiazem 435,096 Rx

Utilization by Omega-3-Acid Ethyl Esters product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule

450,937 Medicaid prescriptions (Q1–Q4 2025) 100% of Omega-3-Acid Ethyl Esters prescriptions shown $13.2M gross reimbursement (before rebates) ≈ $29 per prescription (gross)

Summed across the 10 of 66 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 577208

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Omega-3-Acid Ethyl Esters, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 10 of 66 listed Omega-3-Acid Ethyl Esters NDCs with Medicaid activity.

🔍 Compare Omega-3-Acid Ethyl Esters products

A representative set of FDA-listed product records for Omega-3-Acid Ethyl Esters — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength	Route	Manufacturer / Labeler	Category ⓘ	Details
💊Capsule
900 mg	Oral	A-S Medication Solutions × 2 listings	ANDA	Find on DailyMed ↗
1 g	Oral	A-S Medication Solutions × 9 listings	ANDA	View NDC →
900 mg	Oral	American Health Packaging	ANDA	View NDC →
1 g	Oral	American Health Packaging	ANDA	View NDC →
1 g	Oral	Amneal Pharmaceuticals LLC × 3 listings	ANDA	View NDC →
900 mg	Oral	ANI Pharmaceuticals, Inc.	ANDA	Find on DailyMed ↗
1 g	Oral	Apotex Corp. × 4 listings	ANDA	View NDC →
1 g	Oral	AvKARE × 2 listings	ANDA	View NDC →
900 mg	Oral	AvPAK × 2 listings	ANDA	View NDC →
900 mg	Oral	Bionpharma Inc.	ANDA	View NDC →
900 mg	Oral	Bryant Ranch Prepack × 3 listings	ANDA	View NDC →
1 g	Oral	Bryant Ranch Prepack × 9 listings	ANDA	View NDC →
1 g	Oral	Camber Pharmaceuticals, Inc. × 2 listings	ANDA	View NDC →
1 g	—	Catalent Pharma Solutions, LLC	DRUG FOR FURTHER PROCESSING	View NDC →
900 mg	Oral	Chartwell RX, LLC × 2 listings	ANDA	View NDC →
1 g	Oral	Direct_Rx × 3 listings	ANDA	Find on DailyMed ↗
1 g	Oral	Epic Pharma, Llc × 2 listings	ANDA	View NDC →
1 g	Oral	Golden State Medical Supply, Inc.	ANDA	View NDC →
1 g	Oral	KD Pharma USA, Inc. × 4 listings	ANDA	View NDC →
1 g	Oral	Lifestar Pharma LLC × 2 listings	ANDA	View NDC →
1 g	Oral	Major Pharmaceuticals × 3 listings	ANDA	View NDC →
1 g	Oral	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	View NDC →
900 mg	Oral	Par Pharmaceutical Inc.	ANDA	View NDC →
900 mg	—	Patheon Softgels Inc	DRUG FOR FURTHER PROCESSING	View NDC →
900 mg	—	Patheon Softgels Inc.	DRUG FOR FURTHER PROCESSING	View NDC →
1 g	Oral	Procaps S A	ANDA	View NDC →
1 g	Oral	Puracap Laboratories Llc Dba Blu Pharmaceuticals × 2 listings	ANDA	View NDC →
900 mg	Oral	QPharma Inc	ANDA	Find on DailyMed ↗
1 g	Oral	Quality Care Products, LLC	ANDA	Find on DailyMed ↗
1 g	Oral	Remedyrepack Inc. × 4 listings	ANDA	View NDC →
900 mg	Oral	Strides Pharma Science Limited × 3 listings	ANDA	View NDC →
1 g	Oral	Waylis Therapeutics LLC	NDA	View NDC →
1 g	Oral	Woodward Pharma Services LLC × 2 listings	ANDA	View NDC →
1 g	Oral	XLCare Pharmaceuticals, Inc. × 2 listings	ANDA	View NDC →
💊Oral solution
190 kg/190 kg	—	Huatai Biopharm Inc	BULK INGREDIENT	View NDC →
1 kg/kg	—	Shandong Xinhua Pharmaceutical Co., Ltd.	BULK INGREDIENT	View NDC →
💊Other oral form
1 kg/kg	—	BASF AS avd Sandefjord × 2 listings	BULK INGREDIENT	View NDC →
1 kg/kg	—	K.D. Pharma Bexbach GmbH	BULK INGREDIENT	View NDC →

Showing 84 of 84 products — FDA National Drug Code Directory. See every product, package size and price: browse all 84 Omega-3-Acid Ethyl Esters NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Omega-3-Acid Ethyl Esters RxCUI 484348 1 dose form · 1 strength

Dose form (SCDF) Oral Capsule RxCUI 809886 In current FDA listings
Clinical drug / strength (SCD) 1000 MG RxCUI 577208

Look up RxCUI 484348 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Lovaza Omega-3-Acid Ethyl Ester

🏭 Manufacturers & labelers

Bryant Ranch Prepack 12 A-S Medication Solutions 11 Apotex Corp. 4 Remedyrepack Inc. 4 KD Pharma USA, Inc. 4 Amneal Pharmaceuticals LLC 3 Strides Pharma Science Limited 3 Major Pharmaceuticals 3 Direct_Rx 3 American Health Packaging 2 XLCare Pharmaceuticals, Inc. 2 Woodward Pharma Services LLC 2 Puracap Laboratories Llc Dba Blu Pharmaceuticals 2 Lifestar Pharma LLC 2 AvKARE 2 Chartwell RX, LLC 2 AvPAK 2 Camber Pharmaceuticals, Inc. 2 BASF AS avd Sandefjord 2 Epic Pharma, Llc 2 Patheon Softgels Inc. 1 ANI Pharmaceuticals, Inc. 1 Waylis Therapeutics LLC 1 Shandong Xinhua Pharmaceutical Co., Ltd. 1

…and 11 more on the FDA NDC directory.

triglycerides: A type of fat (lipid) found in the blood; very high levels can raise the risk of pancreatitis and other health problems.

hypertriglyceridemia: A condition in which triglyceride levels in the blood are abnormally high.

EPA (eicosapentaenoic acid): One of the two main omega-3 fatty acids in this medication, derived from fish oil.

DHA (docosahexaenoic acid): The second key omega-3 fatty acid in this medication, also derived from fish oil.

adjunct to diet: A treatment meant to be used alongside dietary changes, not as a standalone solution.

LDL cholesterol: Low-density lipoprotein, often called "bad" cholesterol — high levels are linked to heart disease.

ALT and AST: Liver enzymes (alanine aminotransferase and aspartate aminotransferase) measured in blood tests to assess liver health.

atrial fibrillation (AF): An irregular, often rapid heartbeat that can cause palpitations, fatigue, and increased stroke risk.

paroxysmal atrial fibrillation: Atrial fibrillation that comes and goes, starting and stopping on its own.

persistent atrial fibrillation: Atrial fibrillation that lasts more than seven days and does not stop on its own without treatment.

atrial flutter: A related heart rhythm disorder similar to atrial fibrillation, where the upper chambers of the heart beat too fast but in a regular pattern.

anticoagulant: A drug that reduces the blood's ability to clot, commonly called a blood thinner (e.g., warfarin).

antiplatelet agent: A medication that prevents blood platelets from clumping together to form clots (e.g., aspirin, clopidogrel).

esterification: A chemical process in which fatty acids are combined to form fats (triglycerides); this medication helps block that process in the liver.

lipoprotein lipase: An enzyme in the blood that breaks down triglycerides; omega-3-acid ethyl esters may increase its activity.

lipogenesis: The process by which the liver makes new fat; this medication may help reduce that process.

serum phospholipids: Fat-containing molecules in the blood that serve as part of cell membranes; used as a measure of how much EPA and DHA the body has absorbed.

cytochrome P450: A family of liver enzymes responsible for processing many drugs; omega-3-acid ethyl esters are not expected to significantly affect these enzymes.

pancreatitis: Inflammation of the pancreas, which can be triggered by very high triglyceride levels.

hepatic impairment: Reduced liver function, which may affect how drugs are processed and require extra monitoring.

anaphylaxis: A severe, life-threatening allergic reaction that requires immediate medical attention.

hypersensitivity: An exaggerated immune reaction to a substance, ranging from mild allergy to severe anaphylaxis.

lipid-lowering diet: A diet designed to reduce fat and cholesterol levels in the blood, typically low in saturated fats and refined carbohydrates.

beta-blockers: A class of blood pressure and heart medications that can also raise triglyceride levels as a side effect.

thiazides: A type of diuretic (water pill) used for high blood pressure that can also increase triglyceride levels.

organogenesis: The stage of fetal development when organs are forming — a critical window for assessing drug safety in pregnancy.

eructation: The medical term for burping or belching.

dyspepsia: Upset stomach or indigestion — discomfort in the upper abdomen often including bloating or nausea.

taste perversion: A change in the sense of taste, often described as a fishy or unpleasant aftertaste.

statin: A class of cholesterol-lowering medications (e.g., simvastatin, atorvastatin, rosuvastatin).

AUC: Area under the curve — a measure of the total amount of a drug your body is exposed to over time, used to assess drug interactions.

dose-dependent: When the effect of a drug increases as the dose increases.

cardiovascular mortality: Death caused by heart or blood vessel disease.

hypothyroidism: An underactive thyroid gland, which can contribute to elevated triglyceride levels.

diabetes mellitus: A condition of chronically high blood sugar that can also raise triglyceride levels.

contraindicated: Should not be used — the risks outweigh any possible benefit in that situation.

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

atrial fibrillation: An irregular, often fast heart rhythm coming from the heart's upper chambers, which can raise the risk of blood clots.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

nursing infant: A baby who is being fed breast milk.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄

FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 9, 2026

🏭

Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Omega-3-Acid Ethyl Esters.

📈

Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.

🚨

Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.

🧾 Clinical label set — FDA-filed SPL labels retained for Omega-3-Acid Ethyl Esters after exact ingredient or ingredient-combination matching and applicable route/form matching

Clinical labels in scope: 30
NDC products indexed: 84
Distinct labelers/manufacturers represented: 35
Linked representative label ⓘ: Waylis Therapeutics LLC
Linked label effective: Mar 9, 2026
Composite sections available: 21
Linked SPL Set ID: 21cfa4ce-0b05-47ed-b268-339eb1b83b75
Linked SPL Document ID: bb196245-0938-40a1-bba1-c96dee9cf645

Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 30 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Waylis Therapeutics LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.

Omega-3-Acid Ethyl Esters

📖 Omega-3-Acid Ethyl Esters: Patient Information Guide

🩺 Pharmacist Counseling Corner

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💊 How Omega-3-Acid Ethyl Esters comes

Capsule

Other oral form

Oral solution

📊 Omega-3-Acid Ethyl Esters across the U.S. market

📈 How widely Omega-3-Acid Ethyl Esters is used

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📈 What people report — real-world data (FDA FAERS)

🏛️ The road to your pharmacy

🚨 Recall history

RxNorm Concept Web — From Ingredient to Every Form and Strength

📦 Supply & shortage status

🏷️ Sold under these brand names

🏭 Manufacturers & labelers

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How we combine label and product data

Omega-3-Acid Ethyl Esters

📖 Omega-3-Acid Ethyl Esters: Patient Information Guide

🩺 Pharmacist Counseling Corner

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💊 How Omega-3-Acid Ethyl Esters comes

📊 Omega-3-Acid Ethyl Esters across the U.S. market

📈 How widely Omega-3-Acid Ethyl Esters is used

🔍 Compare Omega-3-Acid Ethyl Esters products

📈 What people report — real-world data (FDA FAERS)

🏛️ The road to your pharmacy

🚨 Recall history

🗺️ RxNorm Concept Web — From Ingredient to Every Form and Strength

📦 Supply & shortage status

🏷️ Sold under these brand names

🏭 Manufacturers & labelers

🔬 Where this comes from

How we combine label and product data

🔗 Related medications

RxNorm Concept Web — From Ingredient to Every Form and Strength