Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
LIPOFEN vs TRICOR (MICRONIZED)
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.
Tricor (micronized fenofibrate) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist that increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apolipoprotein C-III.
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
Adjunctive therapy to diet for adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb),Adjunctive therapy to diet for adult patients with severe hypertriglyceridemia (Fredrickson types IV and V),Fenofibrate is indicated as an adjunct to diet to reduce elevated LDL-C, total-C, triglycerides, and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia,Reduction of triglycerides in patients with hypertriglyceridemia (types IV and V hyperlipidemia)
For hypertriglyceridemia: 67-134 mg (as fenofibric acid) orally three times daily with meals. Maximum dose 200 mg/day.
Initial 48 mg (1 tablet) orally once daily with meals. May increase to 96 mg (2 tablets) once daily with meals. Maximum dose 96 mg/day.
5-7 hours (prolonged in renal impairment; may exceed 24 hours in severe CKD).
Terminal elimination half-life is approximately 20 hours (range 15-25 hours) in patients with normal renal function. Half-life is prolonged in renal impairment, requiring dose adjustment when e GFR < 30 m L/min/1.73 m².
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 a prodrug that is rapidly hydrolyzed by esterases to the active metabolite, fenofibric acid. Fenofibric acid is further metabolized by glucuronidation and excreted in urine. Major metabolic pathways involve hepatic glucuronidation via UGT1A1 and UGT1A3, with minor CYP-mediated metabolism (CYP3A4, CYP2C9).
Primarily renal (90% as unchanged drug), with <5% fecal.
Primarily renal excretion of glucuronide conjugate, accounting for approximately 60-70% of elimination; fecal excretion accounts for about 25%. Minimal unchanged drug in urine.
>99% bound to albumin.
Highly protein-bound (>99%), primarily to albumin.
Approximately 0.5 L/kg (low, indicating minimal tissue distribution).
Apparent volume of distribution is approximately 0.5 L/kg (range 0.2-0.9 L/kg). This moderate Vd indicates limited extravascular distribution, primarily intravascular and interstitial fluid spaces.
Oral: 30% (first-pass effect; absorption increased with food).
Oral bioavailability is approximately 66% (range 50-90%) after administration of micronized fenofibrate capsules taken with food. Absorption is enhanced by food; bioavailability is reduced when taken on an empty stomach.
GFR 30-59 m L/min: reduce dose by 50% (e.g., 67 mg once daily). GFR <30 m L/min: contraindicated.
Contraindicated in severe renal impairment (e GFR <30 m L/min/1.73 m²). For mild to moderate impairment (e GFR 30-80 m L/min/1.73 m²), reduce dose to 48 mg once daily. Not to exceed 48 mg/day.
Child-Pugh Class A: no dose adjustment. Child-Pugh Class B or C: contraindicated due to risk of hepatotoxicity.
Contraindicated in active liver disease or unexplained persistent liver function abnormalities. For Child-Pugh class A or B, avoid use due to potential risk; no specific dose adjustment recommendations, but cautious use only if benefit outweighs risk. Contraindicated in Child-Pugh class C.
Not recommended in children <18 years; safety and efficacy not established.
Safety and effectiveness in pediatric patients have not been established; use not recommended in children.
Start at lower end of dosing range; monitor renal function and adjust accordingly.
Select dose cautiously starting at the lower end of dosing range (48 mg once daily) due to possible decreased renal function and increased risk of adverse effects. Monitor renal function and adjust accordingly.
None.
There is no FDA black box warning for Tricor (micronized fenofibrate).
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: elevations of serum transaminases; monitor liver function tests,Cholelithiasis: fenofibrate may increase cholesterol excretion into bile, leading to gallstones,Pancreatitis: risk may be increased, especially in patients with severe hypertriglyceridemia,Myopathy/rhabdomyolysis: risk increased when used with HMG-Co A reductase inhibitors (statins) or other fibrates,Renal impairment: dose adjustment required; contraindicated in severe renal impairment (e GFR <30 m L/min/1.73 m²)
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/1.73 m²) or end-stage renal disease,Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities,Pre-existing gallbladder disease,Known hypersensitivity to fenofibrate or any component of the formulation,Breastfeeding (due to potential for serious adverse reactions in nursing infants)
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 grapefruit juice. Limit alcohol intake. Maintain a low-fat diet as part of triglyceride management.
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.
FDA Pregnancy Category C. First trimester: No adequate human studies; animal studies show fetal skeletal variations at high doses. Second and third trimesters: Avoid due to potential fetal harm and insufficient data. Use only if benefit outweighs risk.
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.
No data on milk concentration or M/P ratio. Not recommended due to potential for adverse effects in nursing infant; alternatives should be considered.
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.
No established dosing adjustments. Pharmacokinetics may be altered due to increased plasma volume and renal clearance; monitor efficacy and safety. Consider therapy discontinuation.
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.
Monitor renal function before and during therapy; reduce dose in e GFR 30-59 m L/min; contraindicated in severe renal impairment (e GFR <30 m L/min). May increase serum creatinine and transaminases. Avoid in active liver disease or unexplained persistent transaminase elevation. Risk of myopathy increases when coadministered with statins, especially in renal impairment. Can be used in combination with statins but monitor for muscle symptoms. Dose adjustment not required in mild to moderate hepatic impairment but use with caution.
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 GI side effects.,Swallow capsules whole; do not crush, chew, or open.,Avoid consuming grapefruit juice as it may increase drug levels.,Report unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise.,May cause gallstones; report right upper abdominal pain, nausea, or vomiting.,Avoid alcohol as it may increase triglyceride levels and liver effects.,This medication is not a substitute for a healthy diet and exercise; continue lifestyle modifications.,Inform your doctor if you have kidney or liver disease, diabetes, or if you are pregnant or breastfeeding.
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 TRICOR (MICRONIZED), 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.. TRICOR (MICRONIZED) is a Fibrate Antilipemic that works by Tricor (micronized fenofibrate) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist that increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apolipoprotein C-III.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between LIPOFEN and TRICOR (MICRONIZED) 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 TRICOR (MICRONIZED) is: Initial 48 mg (1 tablet) orally once daily with meals. May increase to 96 mg (2 tablets) once daily with meals. Maximum dose 96 mg/day.. 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 TRICOR (MICRONIZED) 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. TRICOR (MICRONIZED) is classified as Category C. FDA Pregnancy Category C. First trimester: No adequate human studies; animal studies show fetal skeletal variations at high doses. Second and third trimesters: Avoid due to potenti. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.