Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
OMACOR vs LIPIDIL
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Omega-3-acid ethyl esters (EPA and DHA) reduce hepatic triglyceride synthesis by inhibiting acyl-Co A:1,2-diacylglycerol acyltransferase and increasing beta-oxidation. They also decrease very-low-density lipoprotein (VLDL) secretion and enhance triglyceride clearance from circulating VLDL particles.
LIPIDIL (fenofibrate) is a fibric acid derivative that activates peroxisome proliferator-activated receptor-alpha (PPAR-alpha), leading to increased lipolysis and clearance of triglyceride-rich particles, and increased synthesis of apolipoproteins A-I and A-II.
FDA: Adjunct to diet for reduction of triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/d L).,Off-label: Secondary prevention of cardiovascular events in patients with hypertriglyceridemia or high cardiovascular risk.
Primary hypercholesterolemia or mixed dyslipidemia (as adjunct to diet),Severe hypertriglyceridemia,Prevention of pancreatitis in patients with hypertriglyceridemia
4 g orally once daily or 2 g orally twice daily, taken with meals. Each capsule contains 1 g of omega-3-acid ethyl esters (approximately 465 mg eicosapentaenoic acid and 375 mg docosahexaenoic acid).
130 mg orally once daily.
Terminal elimination half-life: ~55–75 hours for EPA and DHA (beta-phase). Clinical context: steady-state achieved after 4–8 weeks; half-life supports once-daily dosing.
Terminal elimination half-life of fenofibric acid is approximately 20 hours (range 15-25 hours). This supports once-daily dosing; steady-state is achieved after ~5 days.
Omega-3-acid ethyl esters are primarily hydrolyzed by pancreatic lipase to free fatty acids (EPA and DHA), which are then absorbed and incorporated into chylomicrons. They undergo hepatic metabolism via beta-oxidation. CYP450 involvement is minimal.
Fenofibrate is metabolized primarily by glucuronidation; fenofibric acid is further metabolized via reduction to benzhydrol metabolite. Minor involvement of CYP450 enzymes, predominantly CYP3A4.
Primarily fecal as unchanged drug and metabolites; <5% renal. Biliary excretion accounts for ~90% of elimination via feces, with minimal urinary excretion (0.5–2%).
Primarily renal excretion of glucuronide conjugates; approximately 70% of a single oral dose is recovered in urine (mostly as fenofibric acid glucuronide), and about 6% is excreted in feces.
Highly protein-bound (>99%) primarily to albumin.
Fenofibric acid is highly bound to plasma proteins, primarily albumin, with >99% binding.
Vd: ~0.2–0.3 L/kg (EPA), ~2–3 L/kg (DHA). Clinical meaning: extensive tissue distribution, especially in adipose and cardiac tissues.
Apparent volume of distribution (Vd/F) is approximately 0.9 L/kg, indicating distribution into total body water.
Oral: 50–100% (enhanced with fatty meal; absolute bioavailability not determined).
Absolute bioavailability of fenofibrate (prodrug) is not determined; fenofibrate is rapidly converted to fenofibric acid with a relative bioavailability of approximately 81-96% compared to the micronized formulation when taken with food. Absorption is enhanced when taken with meals.
No dose adjustment required for any degree of renal impairment. Use caution in patients with renal disease due to potential for increased bleeding risk.
GFR 30-89 m L/min: 130 mg once daily; GFR <30 m L/min: contraindicated.
Contraindicated in patients with Child-Pugh class C (severe) hepatic impairment. For Child-Pugh A or B, no dose adjustment is recommended, but monitor liver function tests periodically.
Child-Pugh class A: 130 mg once daily; Child-Pugh class B or C: contraindicated.
Safety and efficacy not established in pediatric patients. Not recommended for use in children.
Not recommended for use in pediatric patients.
No specific dose adjustment recommended. Monitor for potential drug interactions, especially with anticoagulants, due to increased bleeding risk. Start at lower end of dosing range if elderly patient has significant comorbidity or polypharmacy.
No dose adjustment required, but monitor renal function due to age-related decline.
No FDA black box warning.
There is no FDA black box warning for LIPIDIL.
Increased bleeding risk (monitor patients on anticoagulants).,Atrial fibrillation in patients with prior history or at high risk.,Persistent elevations of ALT or AST, especially with other hepatotoxic drugs.,Hypersensitivity reactions including anaphylaxis.,Fish allergy (capsules contain fish oil).
Hepatotoxicity: elevated liver enzymes reported; monitor liver function,Myopathy/rhabdomyolysis: increased risk when combined with statins or in renal impairment,Renal impairment: dose adjustment required; avoid in severe renal impairment,Cholelithiasis: increased bile cholesterol saturation may lead to gallstones, Pancreatitis: despite triglyceride reduction, pancreatitis can occur
Hypersensitivity to omega-3-acid ethyl esters or any component.,Acute pancreatitis with marked hypertriglyceridemia (consider if triglycerides >500 mg/d L and chylomicronemia).
Severe renal impairment (e GFR < 30 m L/min),Active liver disease including primary biliary cirrhosis,Pre-existing gallbladder disease,Hypersensitivity to fenofibrate or any component,Nursing mothers (due to potential for tumorigenicity in animal studies)
Avoid high-fat meals as they may increase triglyceride levels. No specific food interactions known, but consistency in timing with meals is recommended.
Take with food to enhance absorption. Avoid high-fat meals that may exacerbate hypertriglyceridemia. Grapefruit juice has minimal interaction but caution is advised with statin combinations. Alcohol should be limited or avoided due to potential for elevated triglycerides and hepatotoxicity.
FDA Pregnancy Category C. No evidence of teratogenicity in animal studies at doses up to 10 times the human dose. There are no adequate and well-controlled studies in pregnant women. Use only if potential benefit justifies potential risk to fetus. Omega-3-acid ethyl esters may inhibit prostaglandin synthesis and delay labor. Third trimester use may increase risk of bleeding in mother and neonate.
Lipidil (fenofibrate) is contraindicated in pregnancy. Animal studies show fetal toxicity at high doses. Human data are insufficient, but risk cannot be excluded. First trimester: possible embryotoxicity; second and third trimesters: potential for fetal harm due to interference with lipid metabolism.
Not recommended during breastfeeding. Omega-3 fatty acids are excreted in human milk; M/P ratio not established. Potential for adverse effects in nursing infant. Consider alternative treatment or discontinue nursing.
Contraindicated during breastfeeding. Fenofibrate is excreted in breast milk in animal studies; M/P ratio unknown in humans. Potential for serious adverse effects in breastfed infants, including interference with fatty acid metabolism.
No specific dose adjustments recommended for pregnancy-induced pharmacokinetic changes. Use with caution as pregnancy may alter lipid profiles; monitor triglyceride levels and adjust dose accordingly.
Lipidil is contraindicated in pregnancy; no dose adjustment recommended. Therapy should be discontinued upon conception or if pregnancy is planned. There are no established dose adjustments for pregnant women due to lack of safety data.
Omacor (omega-3-acid ethyl esters) is indicated as an adjunct to diet for severe hypertriglyceridemia (≥500 mg/d L). Monitor LDL-C levels as they may increase during therapy; adjust statin dose if needed. Administer with meals to enhance absorption and reduce gastrointestinal side effects. Avoid use in patients with fish or shellfish allergy. May prolong bleeding time; monitor in patients on anticoagulants.
Lipidil (fenofibrate) is a PPARα agonist used primarily for severe hypertriglyceridemia and mixed dyslipidemia. Monitor renal function at baseline and periodically; reduce dose in CKD (e GFR <60 m L/min). Avoid in severe hepatic impairment or gallbladder disease. Combines with statins but increases risk of myopathy; monitor for muscle symptoms. May raise serum creatinine and homocysteine levels. Tablet should be swallowed whole; do not crush or chew.
Take with food to improve absorption and reduce burping or fishy taste.,Do not take if you have an allergy to fish or shellfish.,Report unusual bleeding or bruising, especially if you are on blood thinners.,Do not substitute with over-the-counter fish oil supplements as they are not equivalent.,Continue dietary modifications and exercise as part of your treatment plan.
Take with food to improve absorption and reduce stomach upset.,Avoid alcohol as it can worsen triglyceride levels and liver effects.,Report unexplained muscle pain, tenderness, or weakness immediately.,Inform your doctor if you have kidney or liver disease, or gallbladder problems.,This medication may increase the effects of blood thinners (warfarin); monitor INR closely.,Do not take if you are pregnant or breastfeeding without consulting your doctor.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about OMACOR vs LIPIDIL, answered by our medical review team.
OMACOR is a Antilipemic that works by Omega-3-acid ethyl esters (EPA and DHA) reduce hepatic triglyceride synthesis by inhibiting acyl-Co A:1,2-diacylglycerol acyltransferase and increasing beta-oxidation. They also decrease very-low-density lipoprotein (VLDL) secretion and enhance triglyceride clearance from circulating VLDL particles.. LIPIDIL is a Fibrate Antilipemic that works by LIPIDIL (fenofibrate) is a fibric acid derivative that activates peroxisome proliferator-activated receptor-alpha (PPAR-alpha), leading to increased lipolysis and clearance of triglyceride-rich particles, and increased synthesis of apolipoproteins A-I and A-II.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between OMACOR and LIPIDIL depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of OMACOR is: 4 g orally once daily or 2 g orally twice daily, taken with meals. Each capsule contains 1 g of omega-3-acid ethyl esters (approximately 465 mg eicosapentaenoic acid and 375 mg docosahexaenoic acid).. The standard adult dose of LIPIDIL is: 130 mg orally once daily.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between OMACOR and LIPIDIL in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. OMACOR is classified as Category C. FDA Pregnancy Category C. No evidence of teratogenicity in animal studies at doses up to 10 times the human dose. There are no adequate and well-controlled studies in pregnant wome. LIPIDIL is classified as Category C. Lipidil (fenofibrate) is contraindicated in pregnancy. Animal studies show fetal toxicity at high doses. Human data are insufficient, but risk cannot be excluded. First trimester: . Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.