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Fenoglide

Last reviewed on RxList: 3/7/2017
Fenoglide Side Effects Center

Last reviewed on RxList 4/11/2016

Fenoglide (fenofibrate) is a lipid-regulating agent, which helps reduce cholesterol and triglycerides (fatty acids) in the blood used to treat high cholesterol and high triglyceride levels. Common side effects of Fenoglide include:

To treat hyperlipidemia and mixed dyslipidemia, the initial dose of Fenoglide is 120 mg per day. To treat hypertriglyceridemia, the initial dose is 40 to 120 mg per day. Fenoglide may interact with blood thinners, cyclosporine, or other cholesterol-lowering medicines. Tell your doctor all medications and supplements you use. During pregnancy, Fenoglide should be used only if prescribed. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Fenoglide should not be used while breastfeeding.

Our Fenoglide (fenofibrate) 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.

Fenoglide Consumer Information

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 Fenoglide (Fenofibrate Tablets)

Fenoglide Professional Information

SIDE EFFECTS

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 rates observed in clinical practice.

Adverse reactions reported by 2% or more of patients treated with 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 and in 3.0% treated with placebo. Increases in liver 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 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: 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 Fenoglide (Fenofibrate Tablets)

Related Resources for Fenoglide

© Fenoglide Patient Information is supplied by Cerner Multum, Inc. and Fenoglide Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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