Lovaza

Lovaza

Lovaza Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lovaza (omega-3-acid ethyl esters) is used together with diet and exercise to help lower triglyceride levels in the blood. It 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. Common side effects include upset stomach, burping, and strange taste in mouth.

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lovaza in Detail - Patient Information: Side Effects

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • chest pain; or
  • uneven heartbeats.

Less serious side effects may include:

  • back pain;
  • unusual or unpleasant taste in your mouth;
  • upset stomach, belching; or
  • mild skin rash.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lovaza Overview - Patient Information: Side Effects

SIDE EFFECTS: Upset stomach, burping, and strange taste in mouth may occur. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, black/tarry stool, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Lovaza (Omega-3-Acid Ethyl Esters)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lovaza FDA Prescribing Information: Side Effects
(Adverse Reactions)

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% and at a greater rate than placebo for subjects treated with LOVAZA 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 Reactiona LOVAZA (N = 655) Placebo (N = 370)
n % n %
Eructation 29 4 5 1
Dyspepsia 22 3 6 2
Taste perversion 27 4 1 < 1
a Trials included subjects with HTG and severe HTG.

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.

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

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Lovaza - User Reviews

Lovaza User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Lovaza sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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