Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
FENOFIBRIC ACID vs TRILIPIX
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.
TRILIPIX (fenofibric acid) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase, and reduces production of apoprotein C-III.
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)
Adjunctive therapy to diet for severe hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia),Primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb)
135 mg orally once daily
135 mg orally once daily, not to exceed 135 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.
Terminal elimination half-life of fenofibric acid is approximately 20 hours (range 10-35 hours), allowing once-daily dosing.
Primarily hepatic via glucuronidation; minor CYP3A4 involvement. Excreted as glucuronide conjugates in urine and feces.
Fenofibric acid is primarily metabolized via glucuronidation. It is not metabolized by cytochrome P450 (CYP) enzymes.
Primarily renal as unchanged drug and glucuronide conjugate (approximately 60-70% of dose); remainder eliminated via biliary/fecal routes (~25%).
Primarily renal excretion as glucuronide conjugate and unchanged drug; ~60% of dose excreted in urine as fenofibric acid and its glucuronide, ~25% in feces.
Highly bound to serum albumin (approximately 99%).
Fenofibric acid is highly bound to plasma albumin (>99%).
Approximately 0.4 L/kg (range 0.2-0.6 L/kg), indicating distribution mainly in extracellular fluid.
Apparent volume of distribution (Vd/F) is approximately 0.9 L/kg, indicating distribution into extracellular fluid.
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.
Absolute bioavailability of fenofibric acid from TRILIPIX is not determined; relative bioavailability compared to micronized fenofibrate is approximately 100% after oral administration.
If e GFR 30-59 m L/min: reduce dose to 45 mg orally once daily. If e 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 30-59 m L/min/1.73 m²), maximum dose is 67 mg daily.
Contraindicated in Child-Pugh class B or C; no dose adjustment defined for Child-Pugh A (use with caution).
Contraindicated in Child-Pugh Class B and C hepatic impairment. No dose adjustment specified for Child-Pugh Class A; use with caution.
Not approved for use in pediatric patients.
Safety and efficacy not established in pediatric patients.
No specific dose adjustment required; consider renal function and potential for decreased renal clearance in elderly.
No specific dose adjustment recommended; select dose cautiously due to age-related renal function decline.
None
There is no FDA-required black box warning for TRILIPIX.
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.
Risk of myopathy/rhabdomyolysis, especially in patients with renal impairment or those taking statins,Elevations in serum transaminases, possibly leading to cholelithiasis,Hepatocellular and obstructive jaundice have been reported,Monitor renal function prior to and during therapy,Not recommended in patients with 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.,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 unexplained persistent liver function abnormalities),Pre-existing gallbladder disease,Known hypersensitivity to fenofibric acid, fenofibrate, or any component of the formulation
Take with food to enhance absorption and reduce gastrointestinal intolerance. Avoid high-fat meals as they may exacerbate hypertriglyceridemia and reduce drug efficacy.
Avoid high-fat meals during administration as they can alter fenofibric acid absorption. Avoid grapefruit juice as it may increase drug exposure. Alcohol consumption should be limited (no more than 1 drink per day for women, 2 for men) due to potential hepatotoxicity and worsening of hypertriglyceridemia.
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.
Pregnancy category C. First trimester: No adequate studies in humans; animal studies show fetal toxicity at high doses. Second and third trimesters: Use only if benefit outweighs risk; may cause fetal harm due to maternal hypertriglyceridemia or drug effects.
Excreted in breast milk in rats; human data unknown. Use caution, especially in preterm or jaundiced infants. M/P ratio not established.
Not recommended. M/P ratio unknown; fenofibric acid is excreted in rat milk; potential for serious adverse reactions in nursing infants.
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 established dosing adjustments; pharmacokinetics in pregnancy unknown. Use lowest effective dose if necessary; avoid in third trimester unless essential.
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).
TRILIPIX (fenofibric acid) is a fibric acid derivative used as an adjunct to diet for severe hypertriglyceridemia. Monitor renal function prior to initiation and periodically; dose reduction required for e GFR 30-59 m L/min/1.73m². Contraindicated in severe renal impairment (e GR <30) and active liver disease. May increase serum creatinine; typically reversible. Co-administration with statins increases risk of myopathy/rhabdomyolysis; avoid in patients with predisposing factors. Not recommended for primary prevention of coronary heart disease.
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 TRILIPIX with or without food, but avoid taking with a high-fat meal as it may increase absorption variability.,Report unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise.,Inform your healthcare provider if you have kidney disease, liver disease, or a history of gallbladder problems.,Do not take this medication if you are pregnant or breastfeeding without consulting your doctor.,Alcohol consumption should be minimized or avoided as it can increase triglyceride levels and liver stress.
"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 TRILIPIX, 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.. TRILIPIX is a Fibrate Antilipemic that works by TRILIPIX (fenofibric acid) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase, and reduces production of apoprotein C-III.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between FENOFIBRIC ACID and TRILIPIX 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 TRILIPIX is: 135 mg orally once daily, not to exceed 135 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 TRILIPIX 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. TRILIPIX is classified as Category C. Pregnancy category C. First trimester: No adequate studies in humans; animal studies show fetal toxicity at high doses. Second and third trimesters: Use only if benefit outweighs r. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.