OMEGA-3 ACID ETHYL ESTERS (omega-3 acid ethyl esters)

There are 0 contraindications.

There are 0 severe contraindications.

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Atrial fibrillation
Disease of liver

There are 4 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Hemorrhage Increased alanine transaminase Increased aspartate transaminase

There are 9 less severe adverse reactions.

More Frequent	Less Frequent
None.	Dysgeusia Dyspepsia Eructation Skin rash

Rare/Very Rare
Abnormal hepatic function tests Constipation Pruritus of skin Urticaria Vomiting

Available data are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes with the use of omega-3-acid ethyl esters in pregnant women. No teratogenic or adverse developmental effects have been observed in animal reproduction studies.

Omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been detected in human milk. Higher levels of omega-3 fatty acids have been observed in the milk of lactating women receiving omega-3 fatty acid supplementation. There are no data on the effects of omega-3 fatty acid ethyl esters on the breast-fed infant or on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for omega-3-acid ethyl esters and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

Experience in patients >65 years of age is limited. No substantial differences in safety and efficacy were observed between patients >60 years of age and younger patients.