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Omega-3-Acid Ethyl Esters Capsules

Also known as: Omega-3-Acid Ethyl Esters

Route: Oral

Check Omega-3-Acid Ethyl Esters Capsules Interactions →

2 interactions on record

Omega-3-Acid Ethyl Esters Capsules has 2 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Anti-Platelet Agents, Oral Anticoagulants. Patients taking Omega-3-Acid Ethyl Esters Capsules should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Moderate: 2

Moderate (2)

Omega-3-Acid Ethyl Esters Capsules + Anti-Platelet Agents— Omega-3-acid ethyl esters may prolong bleeding time. Patients taking concomitant anti-platelet agents should be monitore…
Omega-3-Acid Ethyl Esters Capsules + Oral Anticoagulants— Omega-3-acid ethyl esters may prolong bleeding time. Patients taking concomitant anticoagulants should be monitored peri…

Omega-3-Acid Ethyl Esters Capsules + Anti-Platelet Agents🟡Moderate

Omega-3-acid ethyl esters may prolong bleeding time. Patients taking concomitant anti-platelet agents should be monitored periodically.

Omega-3-Acid Ethyl Esters Capsules + Oral Anticoagulants🟡Moderate

Omega-3-acid ethyl esters may prolong bleeding time. Patients taking concomitant anticoagulants should be monitored periodically.

Contraindications

4 CONTRAINDICATIONS Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters capsules or any of its components. Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters capsules or any of its components. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary The available data from published case reports and the pharmacovigilance database on the use of omega-3-acid ethyl esters capsules in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, omega-3-acid ethyl esters given orally to female rats prior to mating through lactation did not have adverse effects on reproduction or development when given at doses 5 times the maximum recommended human dose (MRHD) of 4 grams/day, based on a body surface area comparison. Omega-3-acid ethyl esters given orally to rats and rabbits during organogenesis was not teratogenic at clinically relevant exposures, based on body surface area comparison (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: In female rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) beginning 2 weeks prior to mating through lactation, no adverse effects were observed at 2,000 mg/kg/day (5 times the MRHD based on body surface area [mg/m 2 ]). In a dose-ranging study, female rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) beginning 2 weeks prior to mating through Postpartum Day 7 had decreased live births (20% reduction) and pup survival to Postnatal Day 4 (40% reduction) at or greater than 3,000 mg/kg/day in the absence of maternal toxicity at 3,000 mg/kg/day (7 times the MRHD based on body surface area [mg/m 2 ]). In pregnant rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses at a maternally toxic dose (increased food consumption) of 6,000 mg/kg/da

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.