February 27, 2017
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Fenofibrate

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Fenofibrate 40 mg/ 120 mg




Fenofibrate Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/5/2016

Fenofibrate (brand names: Antara, Fenoglide, Lipofen, Lofibra, TriCor, Triglide) is a fibrate drug used to treat high cholesterol and high triglyceride (fatty acid) levels. Fenofibrate is a generic drug. Common side effects of fenofibrate include:

Infrequent side effects of fenofibrate include:

Call your doctor if you experience unlikely but serious side effects of fenofibrate including:

  • severe stomach/abdominal pain,
  • persistent nausea/vomiting,
  • yellowing eyes or skin (jaundice),
  • dark urine,
  • 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, breastfeeding 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

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

In rare cases, fenofibrate can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Stop using fenofibrate and call your doctor at once if you have:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • mild stomach pain;
  • back pain;
  • headache; or
  • runny or stuffy nose.

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 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 rate observed in clinical practice.

Adverse reactions 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: Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

BODY SYSTEM
Adverse Event
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
Abnormal Liver Function T ests 7.5%** 1.4%
Nausea 2.3% 1.9%
Constipation 2.1% 1.4%
METABOLIC AND NUTRITIONAL DISORDERS
Increased ALT 3.0% 1.6%
Creatine Phosphokinase Increased 3.0% 1.4%
Increased AST 3.4%** 0.5%
RESPIRATORY
Respiratory Disorder 6.2% 5.5%
Rhinitis 2.3% 1.1%
* Dosage equivalent to 150 mg fenofibrate
** Significantly different from placebo

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, acute renal failure, muscle spasm, hepatitis, cirrhosis, anemia, arthralgia, decreases in hemoglobin, decreases in hematocrit, white blood cell decreases, asthenia, and severely depressed HDL cholesterol levels. 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.

Read the entire FDA prescribing information for Fenofibrate (Fenofibrate)

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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