"June 10, 2015 -- A new class of medications can lower "bad" LDL cholesterol to unheard-of levels, and it may be on the horizon.
The new class is called PCSK9 inhibitors. An FDA advisory panel on Tuesday recommended that the agency approve t"...
Omtryg Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Omtryg (omega-3-acid ethyl esters A) 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 belching, changes in the sense of taste, and indigestion.
The daily dose of Omtryg is 4 capsules per day taken as a single dose or as 2 capsules given twice daily, taken with meals. Omtryg may interact with anticoagulants, or other drugs affecting coagulation, such as anti-platelet agents. Tell your doctor all medications and supplements you use. During pregnancy, Omtryg should be taken only if prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding.
Our Omtryg (omega-3-acid ethyl esters A) 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.
Omtryg FDA Prescribing 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 to 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 patients treated with omega-3-acid ethyl esters based on pooled data across 23 clinical studies are listed in Table 1.
Table 1: Adverse Reactions Occurring at Incidence
≥ 3% and Greater than Placebo in Clinical Studies of Omega-3-Acid Ethyl
|Omega-3-Acid Ethyl Esters†
(N = 655)
(N = 370)
|Taste perversion||27||4||1||< 1|
|*Studies included subjects with HTG and severe HTG.
† OMTRYG and omega-3-acid ethyl esters each contain, among other components, at least 900 mg per capsule of ethyl esters from omega-3 fatty acids sourced from fish oils.
Additional adverse reactions from clinical studies are listed below:
Digestive System: Constipation, gastrointestinal disorder and vomiting.
Metabolic and Nutritional Disorders: Increased ALT and increased AST.
Skin: Pruritus and rash.
The following adverse reactions have been identified during post-approval use of omega-3-acid ethyl esters. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following events have been reported: anaphylactic reaction, hemorrhagic diathesis.
Read the entire FDA prescribing information for Omtryg (Omega-3-Acid Ethyl Esters A Capsules)
Additional Omtryg Information
Report Problems to the Food and Drug Administration
Tips to keep it under control.