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Lovaza

Last reviewed on RxList: 10/20/2020
Lovaza Side Effects Center

What Is Lovaza?

Lovaza (omega-3-acid ethyl esters) is a combination of fatty acids used together with diet and exercise to help lower triglyceride levels in the blood. Lovaza is made of omega-3 polyunsaturated fatty acids, which are found in oil from fish, vegetables, and other plant sources. These fatty acids are not made by the body and must be consumed in the diet.

What Are Side Effects of Lovaza?

Common side effects of Lovaza include:

  • back pain,
  • upset stomach,
  • burping,
  • skin rash, and
  • unusual or unpleasant taste in your mouth.

Tell your doctor if you experience rare but very serious side effects of Lovaza including:

  • easy bleeding/bruising,
  • black or tarry stool, or
  • vomit that looks like coffee grounds.

Dosage for Lovaza?

The daily dose of Lovaza is 4 grams per day, taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).

What Drugs, Substances, or Supplements Interact with Lovaza?

Lovaza may interact with birth control pills or hormone replacement, blood thinners, beta-blockers, or diuretics (water pills). Tell your doctor all medications you use.

Lovaza During Pregnancy and Breastfeeding

Lovaza should be used only when prescribed during pregnancy. It is not known if this medication passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Lovaza (omega-3-acid ethyl esters) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What are triglycerides? See Answer
Lovaza Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • chest pain; or
  • uneven heartbeats.

Common side effects may include:

  • loss of appetite;
  • diarrhea, constipation, upset stomach, belching;
  • back pain; or
  • dry mouth, altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lovaza (Omega-3-Acid Ethyl Esters)

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Lovaza Professional Information

SIDE EFFECTS

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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions reported in at least 3% of subjects treated with LOVAZA and at a greater rate than placebo based on pooled data across 23 clinical trials are listed in Table 1.

Table 1: Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Trials of LOVAZA

Adverse ReactionaLOVAZA
(n = 655)
Placebo
(n = 370)
n%n%
Eructation29451
Dyspepsia22362
Taste perversion2741<1
a Trials included subjects with hypertriglyceridemia and severe hypertriglyceridemia.

Additional adverse reactions from clinical trials are listed below:

Digestive System

Constipation, gastrointestinal disorder, and vomiting.

Metabolic And Nutritional Disorders

Increased ALT and increased AST.

Skin

Pruritus and rash.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of LOVAZA. Because these events are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or to always establish a causal relationship to drug exposure.

The following events have been reported: anaphylactic reaction, hemorrhagic diathesis, urticaria.

Read the entire FDA prescribing information for Lovaza (Omega-3-Acid Ethyl Esters)

Related Resources for Lovaza

Read the Lovaza User Reviews »

© Lovaza Patient Information is supplied by Cerner Multum, Inc. and Lovaza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

What are triglycerides? See Answer

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