Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
LIPOFEN vs LIPIDIL
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Lipofen (fenofibrate) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It activates PPARα, which increases lipolysis and elimination of triglyceride-rich particles from plasma by stimulating lipoprotein lipase activity and reducing apolipoprotein C-III production. This leads to decreased triglyceride levels and increased HDL cholesterol.
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.
Adjunct to diet for treatment of hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia),Adjunct to diet for treatment of primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb) when statins are contraindicated or not tolerated
Primary hypercholesterolemia or mixed dyslipidemia (as adjunct to diet),Severe hypertriglyceridemia,Prevention of pancreatitis in patients with hypertriglyceridemia
For hypertriglyceridemia: 67-134 mg (as fenofibric acid) orally three times daily with meals. Maximum dose 200 mg/day.
130 mg orally once daily.
5-7 hours (prolonged in renal impairment; may exceed 24 hours in severe CKD).
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.
Primarily metabolized by glucuronidation via UDP-glucuronosyltransferases (UGT1A1, UGT1A3, UGT2B7) to fenofibric acid, the active metabolite. Minor CYP450 involvement (CYP3A4, CYP2C8, CYP2C19). Renal elimination of conjugates and unchanged drug.
Fenofibrate is metabolized primarily by glucuronidation; fenofibric acid is further metabolized via reduction to benzhydrol metabolite. Minor involvement of CYP450 enzymes, predominantly CYP3A4.
Primarily renal (90% as unchanged drug), with <5% fecal.
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.
>99% bound to albumin.
Fenofibric acid is highly bound to plasma proteins, primarily albumin, with >99% binding.
Approximately 0.5 L/kg (low, indicating minimal tissue distribution).
Apparent volume of distribution (Vd/F) is approximately 0.9 L/kg, indicating distribution into total body water.
Oral: 30% (first-pass effect; absorption increased with food).
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.
GFR 30-59 m L/min: reduce dose by 50% (e.g., 67 mg once daily). GFR <30 m L/min: contraindicated.
GFR 30-89 m L/min: 130 mg once daily; GFR <30 m L/min: contraindicated.
Child-Pugh Class A: no dose adjustment. Child-Pugh Class B or C: contraindicated due to risk of hepatotoxicity.
Child-Pugh class A: 130 mg once daily; Child-Pugh class B or C: contraindicated.
Not recommended in children <18 years; safety and efficacy not established.
Not recommended for use in pediatric patients.
Start at lower end of dosing range; monitor renal function and adjust accordingly.
No dose adjustment required, but monitor renal function due to age-related decline.
None.
There is no FDA black box warning for LIPIDIL.
Hepatotoxicity: Elevations of serum transaminases; monitor liver function. Discontinue if ALT > 3x ULN.,Cholelithiasis: Increases cholesterol excretion into bile, risk of gallstones.,Pancreatitis: Has been reported, especially during initiation or dose escalation.,Myopathy/Rhabdomyolysis: Risk increased when co-administered with statins.,Renal impairment: Dose adjustment required. Use with caution in patients with serum creatinine > 2.0 mg/d L.,Venothromboembolic disease: Increased risk of pulmonary embolism and deep vein thrombosis in some trials.
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
Severe renal impairment (e GFR < 30 m L/min/1.73 m²),Active liver disease including primary biliary cirrhosis and unexplained persistent liver function abnormalities,Pre-existing gallbladder disease,Known hypersensitivity to fenofibrate or any formulation components,Nursing mothers
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)
Take with food to enhance bioavailability. Avoid high-fat meals immediately before dosing as they may delay absorption. Grapefruit juice has no significant interaction. Alcohol should be limited or avoided due to potential for increased triglyceride levels and hepatotoxicity. No specific restriction on caffeine. Ensure adequate hydration to prevent renal complications.
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.
LIPOFEN (fenofibrate) is classified as FDA Pregnancy Category C. Animal studies have shown embryotoxicity and teratogenicity at high doses, but no adequate human studies exist. First trimester: potential risk of congenital anomalies cannot be ruled out. Second and third trimesters: may cause fetal skeletal abnormalities and growth retardation; risk of neonatal complications if used near term. Contraindicated in pregnancy unless clearly needed.
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.
Fenofibrate is excreted in breast milk in rats; no human data. M/P ratio unknown. Due to potential for adverse effects in nursing infants, avoid use during breastfeeding 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 are recommended due to lack of pharmacokinetic data in pregnancy. However, use is generally avoided; if deemed necessary, use lowest effective dose and monitor maternal and fetal status closely.
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.
LIPOFEN (fenofibrate) is a PPAR-alpha agonist that reduces triglycerides and increases HDL-C. Monitor renal function before initiation and periodically; dose adjustment required if e GFR <60 m L/min/1.73m2. Avoid use in severe renal impairment (e GFR <30). May increase serum creatinine transiently. Increases risk of cholelithiasis due to cholesterol supersaturation. Concomitant statin therapy increases risk of myopathy; monitor for muscle symptoms. Use with caution in patients with hepatic impairment; contraindicated in active liver disease. May potentiate effect of oral anticoagulants; monitor INR.
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 meals to improve absorption. Do not break, crush, or chew capsules.,Avoid alcohol consumption as it can increase triglyceride levels and risk of liver damage.,Report unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise.,Notify your doctor if you develop abdominal pain, nausea, or jaundice (yellowing of skin/eyes).,Maintain a low-fat diet and exercise regularly to maximize lipid-lowering benefits.,Do not take supplements containing red yeast rice or niacin without consulting your physician.
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 LIPOFEN vs LIPIDIL, answered by our medical review team.
LIPOFEN is a Fibrate Antilipemic that works by Lipofen (fenofibrate) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It activates PPARα, which increases lipolysis and elimination of triglyceride-rich particles from plasma by stimulating lipoprotein lipase activity and reducing apolipoprotein C-III production. This leads to decreased triglyceride levels and increased HDL cholesterol.. 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 LIPOFEN and LIPIDIL depend on the specific clinical indication. These are both Fibrate Antilipemic agents and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of LIPOFEN is: For hypertriglyceridemia: 67-134 mg (as fenofibric acid) orally three times daily with meals. Maximum dose 200 mg/day.. 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 LIPOFEN 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. LIPOFEN is classified as Category C. LIPOFEN (fenofibrate) is classified as FDA Pregnancy Category C. Animal studies have shown embryotoxicity and teratogenicity at high doses, but no adequate human studies exist. Fir. 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.