Epanova

Epanova Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Epanova (omega-3-carboxylic acids) is a lipid-regulating agent used as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Common side effects include diarrhea, nausea, abdominal pain, and belching.

The dosage of Epanova is 2 grams (2 capsules) or 4 grams (4 capsules) once daily. Epanova may interact with drugs affecting coagulation (e.g., anti-platelet agents). Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before taking Epanova. The effects of this drug on a fetus are unknown. This drug can pass into breast milk and its effect on a nursing infant is unknown. Consult your doctor before breastfeeding.

Our Epanova (omega-3-carboxylic acids) 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 Prescribing information?

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

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

Adverse reactions reported by at least 3% of EPANOVA-treated individuals and with a higher incidence than placebo (olive oil), based on pooled data from two clinical trials of 6-and 12week duration involving subjects with hypertriglyceridemia, are listed in Table 1.

Table 1: Adverse Reactions Occurring at Incidence ≥ 3% and Greater than Placebo in Placebo-Controlled Trials*

Adverse Reaction Placebo
N=314
EPANOVA 2g
N=315
EPANOVA 4g
N=315
Diarrhea 2% 7% 15%
Nausea 1% 4% 6%
Abdominal pain or discomfort 2% 3% 5%
Eructation < 1% 3% 3%
* Trials included subjects with hypertriglyceridemia of varying severity.

In a pool of two longer-term ( ≥ 52 weeks) placebo-controlled clinical trials involving 748 patients (376 EPANOVA 4 grams per day; 372 placebo) with chronic gastrointestinal disease, additional common adverse reactions reported more often by EPANOVA-treated patients included abdominal distension, constipation, vomiting, fatigue, nasopharyngitis, arthralgia, and dysguesia.

Read the entire FDA prescribing information for Epanova (Omega-3-carboxylic Acids Soft-gelatin Capsules) »

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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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