Generic Name

Fenofibrate

Brand Names
Lipofen, Tricor
FDA approval date: April 09, 2002
Classification: Peroxisome Proliferator Receptor alpha Agonist
Form: Tablet, Capsule

What is Lipofen (Fenofibrate)?

High cholesterol and triglyceride levels are common health challenges that silently increase the risk of heart disease and stroke. For many people, lifestyle changes alone may not be enough to bring lipid levels under control. That’s where Fenofibrate comes in, a long-established, clinically proven medication designed to help lower harmful fats in the blood and improve heart health.

Fenofibrate belongs to a group of medicines known as fibrates. It works by reducing triglycerides and “bad” cholesterol (LDL) while increasing “good” cholesterol (HDL). Often used as part of a broader treatment plan alongside diet and exercise, Fenofibrate is especially helpful for individuals with mixed dyslipidemia or severe hypertriglyceridemia. It has been in medical use for decades, making it a trusted option in cardiovascular risk reduction.

What does Fenofibrate do?

Fenofibrate is primarily prescribed to lower triglyceride levels and manage cholesterol in adults with high lipid levels (hyperlipidemia). It is often used:

  • To reduce triglycerides in patients at risk of pancreatitis due to very high triglyceride levels.
  • Alongside statins (such as atorvastatin or simvastatin) for patients needing further lipid control.
  • To increase HDL cholesterol, which helps remove excess cholesterol from arteries.

According to clinical studies, Fenofibrate can reduce triglyceride levels by 30–50% and raise HDL cholesterol by 10–20%, depending on the individual’s baseline values and lifestyle factors (Mayo Clinic, 2024).

In patients with metabolic syndrome or type 2 diabetes, lowering triglycerides and improving HDL can significantly reduce long-term cardiovascular risk. However, it is usually prescribed along with lifestyle changes such as a healthy diet, weight control, and regular physical activity.

How does Fenofibrate work?

Fenofibrate works by activating an enzyme system in the body called PPAR-alpha (peroxisome proliferator-activated receptor alpha). This activation leads to a series of beneficial metabolic effects:

  • It increases the breakdown of triglyceride-rich particles in the blood.
  • It enhances the removal of LDL (“bad”) cholesterol from circulation.
  • It boosts HDL (“good”) cholesterol production.
  • It reduces the production of very-low-density lipoproteins (VLDL), which are rich in triglycerides.

In simpler terms, Fenofibrate helps the body burn and clear fat more efficiently, keeping blood vessels healthier and reducing the risk of plaque buildup (atherosclerosis).

Clinically, these effects help prevent complications such as heart attack, stroke and pancreatitis caused by uncontrolled lipid levels.

Fenofibrate side effects

Like all medications, Fenofibrate can cause side effects, though most people tolerate it well when taken as prescribed. Understanding what to expect helps patients use it confidently and safely.

Common side effects include:

  • Stomach discomfort, nausea or mild diarrhea
  • Headache or dizziness
  • Joint or back pain
  • Mild increases in liver enzymes detected on routine blood tests

Less common but potentially serious side effects:

  • Muscle pain, tenderness, or weakness, especially when used with statins — these may signal muscle inflammation or breakdown (myopathy or rhabdomyolysis).
  • Liver problems, indicated by symptoms such as fatigue, dark urine, yellowing of the skin or eyes (jaundice), or upper abdominal pain.
  • Gallstones (cholelithiasis), due to changes in bile composition.
  • Allergic reactions, such as rash, swelling, or difficulty breathing (rare).

Who should avoid Fenofibrate: Fenofibrate is not recommended for individuals with severe liver disease, gallbladder disease or significant kidney impairment. It should also be used cautiously in older adults, as kidney function naturally declines with age (MedlinePlus, 2024).

When to seek medical help: Contact a healthcare provider immediately if you notice unexplained muscle pain, severe fatigue, yellowing of the skin or dark urine, as these may be signs of a serious reaction.

Fenofibrate dosage

Fenofibrate is available in tablet and capsule forms, typically taken once daily with food to improve absorption. Patients should always follow their doctor’s specific dosing instructions and not adjust doses on their own.

Because Fenofibrate affects liver and kidney function, regular monitoring is a crucial part of therapy. Doctors may recommend:

  • Liver function tests before and during treatment
  • Kidney function tests to ensure safe drug clearance
  • Lipid panels to check progress and guide adjustments
  • Muscle enzyme (CK) tests if symptoms of muscle pain occur

For patients with mild kidney impairment, a lower dose may be prescribed. Those with advanced kidney disease are typically advised to avoid the drug.

If used with a statin, careful monitoring is essential to minimize the risk of muscle-related side effects. Patients should report any unusual symptoms promptly.

Does Fenofibrate have a generic version?

Yes. Fenofibrate is available as a generic medication, approved by the FDA and widely used worldwide. Generic versions, such as Tricor, Antara, Lipofen, Lofibra, and Triglide, are as safe and effective as their brand-name counterparts, containing the same active ingredient.

Because multiple generic options exist, Fenofibrate is affordable and accessible, making it a practical long-term treatment for patients needing lipid control.

Conclusion

Fenofibrate is a time-tested and effective medication for managing high cholesterol and triglycerides. By improving the body’s fat metabolism and promoting healthier lipid levels, it plays a crucial role in reducing the risk of heart disease and pancreatitis in at-risk individuals.

When prescribed and monitored by a qualified healthcare provider, Fenofibrate offers a powerful tool for cardiovascular protection and long-term wellness. Patients can feel reassured knowing it’s a trusted therapy supported by decades of clinical experience and strong evidence.

Taking Fenofibrate as part of a comprehensive heart-healthy plan including balanced nutrition, exercise, and regular checkups can make a meaningful difference in protecting your heart and improving quality of life.

References

  1. Mayo Clinic. (2024). Fenofibrate (oral route). https://www.mayoclinic.org/drugs-supplements/fenofibrate-oral-route/description/drg-20068427
  2. MedlinePlus. (2024). Fenofibrate. https://medlineplus.gov/druginfo/meds/a686017.html
  3. FDA. (2024). Drug Safety and Availability — Fenofibrate Information. https://www.fda.gov

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Brand Information

    Lipofen (fenofibrate)
    1INDICATIONS AND USAGE
    LIPOFEN is indicated as adjunctive therapy to diet:
    • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).
    • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.
    2DOSAGE FORMS AND STRENGTHS
    • 50 mg: Size 3 white opaque gelatin capsule imprinted "G 246" and "50" in black ink.
    • 150 mg: Size 1 white opaque gelatin capsule imprinted "G 248" and "150" in green ink.
    3CONTRAINDICATIONS
    LIPOFEN is contraindicated in patients with:
    • Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis
    • Active liver disease, including those with unexplained persistent liver function abnormalities
    • Pre-existing gallbladder disease
    • Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients in LIPOFEN. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with fenofibrate
    4ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in the labeling:
    • Mortality and coronary heart disease morbidity
    • Hepatoxicity
    • Myopathy and Rhabdomyolysis
    • Increases in Serum Creatinine
    • Cholelithiasis
    • Increased Bleeding Risk with Coumarin Anticoagulants
    • Pancreatitis
    • Hematologic Changes
    • Hypersensitivity reactions
    • Venothromboembolic disease
    • Paradoxical Decreases in HDL Cholesterol Levels
    4.1Clinical Trials Experience
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
    The safety of LIPOFEN has been established in adults with hypertriglyceridemia or primary hyperlipidemia based on adequate and well-controlled trials of other formulations of fenofibrate, referenced below as "fenofibrate"
    Adverse reactions reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials are listed in Table 1 below. Adverse reactions led to discontinuation of treatment in 5% of patients treated with fenofibrate and in 3% 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.
    4.2Postmarketing Experience
    The following adverse reactions have been identified during post-approval use of fenofibrate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
    Blood: Anemia, white blood cell decreases
    Gastrointestinal: Pancreatitis
    General: Asthenia
    Hepatobiliary: Increased total bilirubin, hepatitis, cirrhosis
    Immune System: Anaphylaxis, angioedema
    Lipid Disorders: Severely depressed HDL-cholesterol levels
    Musculoskeletal: Myalgia, muscle spasms, rhabdomyolysis, arthralgia
    Renal and Urinary: Acute renal failure
    Respiratory: Interstitial lung disease
    Skin and Subcutaneous Tissue: Photosensitivity reactions, days to months after initiation. This may occur in patients who report a prior photosensitivity reaction to ketoprofen.
    5DRUG INTERACTIONS
    Table 2 presents clinically important drug interactions with LIPOFEN.
    6OVERDOSAGE
    In the event of an overdose of LIPOFEN, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
    There is no specific treatment for overdose with LIPOFEN. 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.
    7DESCRIPTION
    LIPOFEN
    Chemical Structure
    The empirical formula is C
    LIPOFEN (fenofibrate capsules, USP) meets USP Dissolution Test 2.
    Inactive Ingredients: Each hard gelatin capsule contains Gelucire 44/14 (lauroyl macrogol glyceride type 1500), polyethylene glycol 20,000, polyethylene glycol 8000, hydroxypropylcellulose, sodium starch glycolate, gelatin, titanium dioxide, shellac, propylene glycol, may also contain black iron oxide, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, D&C Yellow #10.
    8HOW SUPPLIED/STORAGE AND HANDLING
    LIPOFEN
    9PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label
    NDC 62559-305-90
    Lipofen
    50 mg
    Rx Only
    ani
    90 Capsules
    PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label
    10PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Label
    NDC 62559-306-90
    Lipofen
    150 mg
    Rx Only
    ani
    90 Capsules
    PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Label
    Lipofen has been selected.