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 Omtryg (omega-3-acid ethyl esters a capsules) Side Effects Center for a complete guide to possible side effects
Anticoagulants Or Other Drugs Affecting Coagulation
Some studies with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical studies have not been done to thoroughly examine the effect of OMTRYG and concomitant anticoagulants. Patients receiving treatment with OMTRYG and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
Drug Abuse And Dependence
OMTRYG does not have any known drug abuse or withdrawal effects.
Last reviewed on RxList: 5/5/2014
This monograph has been modified to include the generic and brand name in many instances.
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