pharmacopeia
GET
/api/v1/drug/fenofibrate
2D structure
propan-2-yl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate
SMILES CC(C)OC(=O)C(C)(C)OC1=CC=C(C=C1)C(=O)C2=CC=C(C=C2)Cl
InChIKey YMTINGFKWWXKFG-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

The active moiety of fenofibrate is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through oral administration of fenofibrate.

Peroxisome Proliferator-activated Receptor alpha

Indications

Sourced from openFDA
  • Fenofibrate tablet USP is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1 ). For treatment of adult patients with severe hypertriglyceridemia ( 1.2 ).ICD-10: E78.00, E78.1, E78.2

Contraindications

Sourced from openFDA
  • Severe renal dysfunction, including dialysis patients ( 4 , 8.6 , 12.3 ). Active liver disease ( 4 , 5.3 ).contraindicated

Dosage & administration

Sourced from openFDA

Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 160 mg once daily ( 2.2 ). Severe hypertriglyceridemia: Initial dose of 54 to 160 mg once daily. Maximum dose is 160 mg ( 2.3 ). Renally impaired patients: Initial dose of 54 mg once daily ( 2.4 ). Geriatric patients: Select the dose on the basis of renal function ( 2.5 ). Should be given with meals ( 2.1 ). 2.1 General Considerations Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablet USP, and should continue this diet during treatment with fenofibrate tablet USP. Fenofibrate tablets USP should be given with meals, thereby optimizing the bioavailability of the medication. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

Warnings & precautions

Sourced from openFDA

Hepatotoxicity : Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibrate. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, atbaseline and periodically for the duration of therapy. Discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist ( 5.2 ). Myopathy and rhabdomyolysis: Have been reported in patients taking fenofibrate. Risks are increased during co-administration with a statin (with a significantly higher rate observed for gemfibrozil), particularly in elderly patients and patients with diabetes, renal failure, or hypothyroidism ( 5.3 ). Serum creatinine: Fenofibrate can reversibly increase serum creatinine levels ( 5.4 ). Monitor renal function periodically in patients with renal impairment ( 8.6 ). Cholelithiasis: Fenofibrate increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated ( 5.5 ). Coumarin anticoagulants: Use caution in concomitant treatment with oral coumarin anticoagulants. Adjust the dosage of coumarin anticoagulant to maintain the prothrombin time/INR at the desired level to prevent bleeding complications ( 5.6 ). Hypersensitivity Reactions: Acute hypersensitivity reactions, including anaphylaxis and angioedema, and delayed hypersensitivity reactions, including severe cutaneous adverse drug reactions have been reported postmarketing. Some cases were life-threatening and required emergency treatment.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described below and elsewhere in the labeling: •Mortality and coronary heart disease morbidity [see WARNINGS AND PRECAUTIONS ( 5.1 )] •Hepatoxicity [see WARNINGS AND PRECAUTIONS ( 5.2 )] •Pancreatitis [see WARNINGS AND PRECAUTIONS ( 5.7 )] •Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS ( 5.9 )] • Venothromboembolic disease [see WARNINGS AND PRECAUTIONS ( 5.10 )] Adverse reactions > 2% and at least 1% greater than placebo: Abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse events reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials, regardless of causality, are listed in Table 1 below. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double- blind trials. Table 1.

Use in specific populations

Sourced from openFDA

Geriatric Use: Determine dose selection based on renal function ( 8.5 ). Renal Impairment: Avoid use in severe renal impairment patients. Dose reduction is required in mild to moderate renal impairment patients ( 8.6 ). 8.1 Pregnancy Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 160 mg daily, based on body surface area (mg/m 2 ). Adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see Data). Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Fenofibrate is a pro-drug of the active chemical moiety fenofibric acid. Fenofibrate is converted by ester hydrolysis in the body to fenofibric acid which is the active constituent measurable in the circulation.

Overdosage

Sourced from openFDA

There is no specific treatment for overdose with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered.

Approval history

Sourced from openFDA
  • Apr 9, 2002ANDAANDA075753Rhodes Pharms
  • Nov 30, 2004NDANDA021695Lupin
  • May 13, 2005ANDAANDA076433Rhodes Pharms
  • Jan 11, 2006NDANDA021612Cipher Pharms Inc
  • Mar 26, 2008ANDAANDA076509Impax Labs
  • Dec 23, 2011ANDAANDA090856Lupin Ltd
  • Mar 1, 2012ANDAANDA090859Chartwell Rx
  • Dec 7, 2012ANDAANDA202856Mylan Pharms Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
34,577 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue2,1346.2%
  2. 2Diarrhoea2,0676.0%
  3. 3Nausea2,0025.8%
  4. 4Drug Ineffective1,7385.0%
  5. 5Headache1,5334.4%
  6. 6Dyspnoea1,4844.3%
  7. 7Pain1,3573.9%
  8. 8Dizziness1,3523.9%
  9. 9Off Label Use1,3443.9%
  10. 10Fall1,3423.9%
  11. 11Asthenia1,2953.7%
  12. 12Acute Kidney Injury1,2283.6%
  13. 13Vomiting1,2083.5%
  14. 14Arthralgia1,1433.3%
  15. 15Pruritus1,1243.3%

Literature

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Recent PubMed references pinned to Fenofibrate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 224 ClinicalTrials.gov registrations naming Fenofibrate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Fenofibrate work?
The active moiety of fenofibrate is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through oral administration of fenofibrate.
What is Fenofibrate used for?
According to FDA labeling, Fenofibrate carries indications including: Fenofibrate tablet USP is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1 ). For treatment of adult patients with severe hypertriglyceridemia ( 1.2 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Fenofibrate?
Fenofibrate is classified as Fibrates, Peroxisome Proliferator-activated Receptor alpha Agonist, Peroxisome Proliferator-activated Receptor alpha Agonists, Increased Lipolysis.
What are the brand names for Fenofibrate?
Fenofibrate is marketed under brand names including Antara, Fenoglide, Fibricor, Lipofen, Tricor, Trilipix.
What are the contraindications for Fenofibrate?
Fenofibrate labeling lists contraindications including: Severe renal dysfunction, including dialysis patients ( 4 , 8.6 , 12.3 ). Active liver disease ( 4 , 5.3 ).. Always consult the full prescribing information and a clinician.
Note. Data for fenofibrate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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