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Fenoglide

Last reviewed on RxList: 4/1/2019
Fenoglide Side Effects Center

Last reviewed on RxList 4/1/2019

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.

QUESTION

What is cholesterol? See Answer
Fenoglide Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

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, or dark colored urine.

Also call your doctor at once if you have:

  • sharp stomach pain spreading to your back or shoulder blade;
  • loss of appetite, stomach pain just after eating a meal;
  • jaundice (yellowing of the skin or eyes);
  • fever, chills, weakness, sore throat, mouth sores, unusual bruising or bleeding;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • swelling, warmth, or redness in an arm or leg.

Common side effects may include:

  • runny nose, sneezing; or
  • abnormal laboratory tests.

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)

SLIDESHOW

Lower Your Cholesterol, Save Your Heart See Slideshow
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 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 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%
METABOLIC AND NUTRITIONAL DISORDERS
  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

Urticaria was seen in 1.1 vs. 0% and rash in 1.4 vs. 0.8% of fenofibrate and placebo patients respectively in controlled trials.

Postmarketing 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:

myalgia, rhabdomyolysis, pancreatitis, acute renal failure, muscle spasms, hepatitis, cirrhosis, anemia, arthralgia, decreases in hematocrit, white blood cell decreases, asthenia, and severely depressed HDL cholesterol levels. Photosensitivity reactions have occurred days to months after initiation; in some of these cases, patients reported a prior photosensitivity reaction to ketoprofen.

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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