Omega-3-Acid Ethyl Esters

Omega-3-acid ethyl esters is a prescription medication used to lower very high triglycerides (fats) in the blood. It is made from fish oils that work by lowering liver production of triglycerides.

This medication comes in capsule form and is usually taken once or twice daily, with or without food.

Take omega-3-acid ethyl esters capsules whole. Do not break, crush, dissolve, or chew omega-3-acid ethyl esters capsules before swallowing.

Common side effects include burping, upset stomach, and change in taste sensation.

Omega-3-acid ethyl esters is prescription medication, used along with a low-fat and low-cholesterol diet, to lower very high triglycerides (fats) in your blood.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Omega-3-Acid Ethyl Esters may be found in some form under the following brand names:

• Lovaza

The most common side effects with omega-3-acid ethyl esters are burping, upset stomach, and a change in your sense of taste.

Omega-3-acid ethyl esters may affect certain blood tests. It may change:

• one of the tests to check liver function (ALT)
• one of the tests to measure cholesterol levels (LDL-C)

Talk to your doctor if you have side effects that bother you or that will not go away. You may report side effects to FDA at 1-800-FDA-1088.

These are not all the side effects with omega-3-acid ethyl esters. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicine, vitamins, and herbal supplements. Omega-3-acid ethyl esters and certain other medicines can interact. Especially tell your doctor if you take medicines that affect clotting such as anticoagulants or blood thinners. Examples of these medicines include aspirin, nonsteroidal anti-inflammatory agents (NSAIDS), warfarin, coumarin, and clopidogrel (Plavix).

Do not take omega-3-acid ethyl esters if you are allergic to any of its ingredients. 

Omega-3-acid ethyl esters may cause serious side effects, including:

• increases in the results of blood tests used to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C) cholesterol.
• increases in the frequency of a heart rhythm problem (atrial fibrillation or flutter) may especially happen in the first few months of taking omega-3-acid ethyl esters if you already have that problem.

Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy, low-cholesterol diet. Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. There are no specific foods to avoid while taking omega-3-acid ethyl esters.

Tell your doctor about all of your medical conditions, including if you:

• drink more than 2 glasses of alcohol daily
• have diabetes
• have a thyroid problem called hypothyroidism
• have a liver problem
• have a pancreas problem
• have a certain heart rhythm problem called atrial fibrillation or flutter
• are allergic to fish and/or shellfish. Omega-3-acid ethyl esters may not be right for you.
• are pregnant, or planning to become pregnant. It is not known if omega-3-acid ethyl esters can harm your unborn baby.
• are breastfeeding. It is not known if omega-3-acid ethyl esters passes into your milk and if it can harm your baby.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicine, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Omega-3-acid ethyl esters falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Omega-3-acid ethyl esters has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from omega-3-acid ethyl esters, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Take omega-3-acid ethyl esters exactly as prescribed. Do not change your dose or stop omega-3-acid ethyl esters without talking to your doctor.
• The usual dose of omega-3-acid ethyl esters is 4 capsules:
  • Take all 4 capsules at the same time, or
  • Take 2 capsules two times a day
• Take omega-3-acid ethyl esters at the same time or times each day.
• Take omega-3-acid ethyl esters with or without food. You may find it easier to take omega-3-acid ethyl esters with food.
• Do not take more than 4 capsules a day. Taking more than 4 capsules per day may increase the chance of side effects.
• Take omega-3-acid ethyl esters capsules whole. Do not break, crush, dissolve, or chew omega-3-acid ethyl esters capsules before swallowing. If you cannot swallow omega-3-acid ethyl esters capsules whole, tell your doctor. You may need a different medicine.
• Your doctor should start you on a low-fat and low-cholesterol diet before giving you omega-3-acid ethyl esters. Stay on this low-fat and low-cholesterol diet while taking omega-3-acid ethyl esters.
• Your doctor should do blood tests to check your triglyceride and cholesterol levels during treatment with omega-3-acid ethyl esters.
• If you have liver disease, your doctor should do blood tests to check your liver function during treatment with omega-3-acid ethyl esters.
• If you miss a dose of omega-3-acid ethyl esters, take it as soon as you remember. However, if you miss one day of omega-3-acid ethyl esters, do not double your dose when you next take it.

Take omega-3-acid ethyl esters exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended daily dose of omega-3-acid ethyl esters is 4 grams per day. The daily dose is to be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).

If you take too much omega-3-acid ethyl esters, call your local Poison Control Center or seek emergency medical attention right away.

• Store omega-3-acid ethyl esters at room temperature, 59° to 86° F (15° to 30° C). Do not freeze.
• Do not keep medicine that is out of date or that you no longer need.
• Keep omega-3-acid ethyl esters out of the reach of children. Be sure that if you throw medicines away, it is out of the reach of children.