Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
FENOFIBRIC ACID vs LIPOFEN
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Fenofibric acid is a peroxisome proliferator-activated receptor alpha (PPARα) agonist that increases lipolysis and clearance of triglyceride-rich lipoproteins and reduces apolipoprotein C-III production, leading to decreased triglycerides and increased HDL cholesterol.
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.
Adjunct to diet for treatment of severe hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia),Adjunct to diet for reduction of LDL-C, total-C, triglycerides, and Apo B in primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb)
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
135 mg orally once daily
For hypertriglyceridemia: 67-134 mg (as fenofibric acid) orally three times daily with meals. Maximum dose 200 mg/day.
Terminal elimination half-life is approximately 20 hours (range 15-25 h) for fenofibric acid, supporting once-daily dosing. In renal impairment, half-life may be prolonged.
5-7 hours (prolonged in renal impairment; may exceed 24 hours in severe CKD).
Primarily hepatic via glucuronidation; minor CYP3A4 involvement. Excreted as glucuronide conjugates in urine and feces.
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.
Primarily renal as unchanged drug and glucuronide conjugate (approximately 60-70% of dose); remainder eliminated via biliary/fecal routes (~25%).
Primarily renal (90% as unchanged drug), with <5% fecal.
Highly bound to serum albumin (approximately 99%).
>99% bound to albumin.
Approximately 0.4 L/kg (range 0.2-0.6 L/kg), indicating distribution mainly in extracellular fluid.
Approximately 0.5 L/kg (low, indicating minimal tissue distribution).
Oral bioavailability of fenofibric acid is approximately 100% when administered as the choline salt; the capsule formulation has high bioavailability relative to tablet. Food may reduce rate but not extent of absorption.
Oral: 30% (first-pass effect; absorption increased with food).
If e GFR 30-59 m L/min: reduce dose to 45 mg orally once daily. If e GFR <30 m L/min: contraindicated.
GFR 30-59 m L/min: reduce dose by 50% (e.g., 67 mg once daily). GFR <30 m L/min: contraindicated.
Contraindicated in Child-Pugh class B or C; no dose adjustment defined for Child-Pugh A (use with caution).
Child-Pugh Class A: no dose adjustment. Child-Pugh Class B or C: contraindicated due to risk of hepatotoxicity.
Not approved for use in pediatric patients.
Not recommended in children <18 years; safety and efficacy not established.
No specific dose adjustment required; consider renal function and potential for decreased renal clearance in elderly.
Start at lower end of dosing range; monitor renal function and adjust accordingly.
None
None.
Hepatotoxicity: elevation of serum transaminases; contraindicated in active liver disease.,Myopathy/rhabdomyolysis risk, especially with statins or in patients with renal impairment, hypothyroidism, or alcohol abuse.,Cholelithiasis: risk of gallstones due to increased cholesterol excretion into bile.,Pancreatitis: reported in hypertriglyceridemia patients.,Renal impairment: dose adjustment required; avoid in severe renal disease.,Venothromboembolic events: increased risk in clinical trials.
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.
Active liver disease including primary biliary cirrhosis and unexplained persistent liver function abnormalities.,Known gallbladder disease (cholelithiasis).,Severe renal impairment (e GFR <30 m L/min/1.73 m²).,Hypersensitivity to fenofibrate or fenofibric acid.
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
Take with food to enhance absorption and reduce gastrointestinal intolerance. Avoid high-fat meals as they may exacerbate hypertriglyceridemia and reduce drug efficacy.
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.
Pregnancy Category C. First trimester: Data insufficient to assess risk; animal studies show embryotoxicity and teratogenicity at high doses. Second/third trimesters: Avoid use due to potential fetal harm; no well-controlled human studies.
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.
Excreted in breast milk in rats; human data unknown. Use caution, especially in preterm or jaundiced infants. M/P ratio not established.
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.
Avoid use during pregnancy; no established safe dose. Pharmacokinetic changes (increased volume of distribution, clearance) may reduce efficacy; dose adjustments not recommended due to potential fetal risk.
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.
Fenofibric acid is a PPARα agonist that reduces triglycerides by 30-50% and increases HDL; monitor renal function as dose adjustment required for Cr Cl 30-59 m L/min; contraindicated in severe renal impairment (Cr Cl <30 m L/min) and active liver disease; may increase serum creatinine; use with caution in patients with gallbladder disease; can potentiate warfarin effect (monitor INR).
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.
Take with food to reduce GI side effects.,Report unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise.,Avoid alcohol as it can increase triglyceride levels and worsen liver effects.,This medication is not a substitute for diet and exercise; continue lifestyle modifications.,Notify your doctor if you develop abdominal pain (possible gallstones).
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.
"Fenofibric acid, a peroxisome proliferator-activated receptor alpha (PPARα) agonist, may reduce the therapeutic efficacy of ursodeoxycholic acid (UDCA) by increasing the biliary excretion of cholesterol and altering bile acid composition, thereby counteracting the beneficial effects of UDCA in dissolving cholesterol gallstones and improving cholestatic liver diseases. This interaction can lead to reduced clinical response, including incomplete stone dissolution or worsening of liver function tests in conditions such as primary biliary cholangitis."
"Glisoxepide may increase the hypoglycemic activities of Fenofibric acid."
"Colchicine may increase the myopathic rhabdomyolysis activities of Fenofibric acid."
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about FENOFIBRIC ACID vs LIPOFEN, answered by our medical review team.
FENOFIBRIC ACID is a Antilipemic that works by Fenofibric acid is a peroxisome proliferator-activated receptor alpha (PPARα) agonist that increases lipolysis and clearance of triglyceride-rich lipoproteins and reduces apolipoprotein C-III production, leading to decreased triglycerides and increased HDL cholesterol.. 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.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between FENOFIBRIC ACID and LIPOFEN 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 FENOFIBRIC ACID is: 135 mg orally once daily. 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.. 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 FENOFIBRIC ACID and LIPOFEN 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. FENOFIBRIC ACID is classified as Category C. Pregnancy Category C. First trimester: Data insufficient to assess risk; animal studies show embryotoxicity and teratogenicity at high doses. Second/third trimesters: Avoid use due. 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. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.