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Fenofibrate

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Fenofibrate 40 mg/ 120 mg

Fenofibrate 40 mg/ 120 mg

Fenofibrate Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Fenofibrate (brand names: Antara, Fenoglide, Lipofen, Lofibra, TriCor, Triglide) is used to treat high cholesterol and high triglyceride (fatty acid) levels. It is in the fibrate class of drugs. Fenofibrate is a generic drug. Infrequent side effects include gallstones and liver problems. Call your doctor if you experience unlikely but serious side effects including severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine. Rare but serious side effect of the muscles may occur. Contact your doctor if you have unusual muscle pain, tenderness, or weakness especially if accompanied by fever or flu-like symptoms.

The initial dose of Fenofibrate tablets ranges from 40 to 120 mg per day. Dosage is individualized according to patient response. Fenofibrate may interact with blood thinners, cyclosporine, or other cholesterol-lowering medicines. Tell your doctor all medications you are taking. Fenofibrate is not recommended for use during pregnancy. Consult your doctor. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended.

Our Fenofibrate (brand names: Antara, Fenoglide, Lipofen, Lofibra, TriCor, Triglide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Fenofibrate in Detail - Patient Information: Side Effects

Fenofibrate has been associated with a rare but serious side effect of the muscles. Contact your doctor at once if you have unusual muscle pain, tenderness, or weakness especially if accompanied by fever or flu-like feeling.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fenofibrate and call your doctor at once if you have any of these serious side effects:

  • severe stomach pain;
  • nausea, vomiting;
  • unusual weakness; or
  • fever.

Less serious side effects may include:

  • joint pain;
  • indigestion;
  • bloating or gas; or
  • a rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fenofibrate (Fenofibrate) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Fenofibrate FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies 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 rates observed in clinical practice.

Adverse reactions reported by 2% or more of patients treated with fenofibrate (fenofibrate (fenofibrate) ) and greater than placebo during double-blind, placebo-controlled trials are listed in Table 1. Adverse reactions led to discontinuation of treatment in 5.0% of patients treated with fenofibrate (fenofibrate (fenofibrate) ) and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of fenofibrate (fenofibrate (fenofibrate) ) treatment in 1.6% of patients in double-blind trials.

Table 1. Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate (fenofibrate (fenofibrate) ) and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

BODY SYSTEM
Adverse Reaction
Fenofibrate*
(N=439)
Placebo
(N=365)
BODY AS A WHOLE    
  Abdominal Pain 4.6% 4.4%
  Back Pain 3.4% 2.5%
  Headache 3.2% 2.7%
DIGESTIVE    
  Nausea 2.3% 1.9%
  Constipation 2.1% 1.4%
INVESTIGATIONS    
  Abnormal Liver Tests 7.5% 1.4%
  Increased AST 3.4% 0.5%
  Increased ALT 3.0% 1.6%
  Increased Creatine Phosphokinase 3.0% 1.4%
RESPIRATORY    
  Respiratory Disorder 6.2% 5.5%
  Rhinitis 2.3% 1.1%
* Dosage equivalent to 130 mg fenofibrate

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate (fenofibrate (fenofibrate) ) : myalgia, rhabdomyolysis, increased creatinine phosphokinase, pancreatitis, increased alanine aminotransaminase, increased aspartate aminotransaminase, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, nausea, abdominal pain, anemia, headache, arthralgia, and asthenia. 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 casual relationship to drug exposure.

Read the entire FDA prescribing information for Fenofibrate (Fenofibrate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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