Fenoglide

Last updated on RxList: 6/18/2021
Fenoglide Side Effects Center

What Is Fenoglide?

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.

What Are Side Effects of Fenoglide?

Common side effects of Fenoglide include:

Dosage for Fenoglide

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.

What Drugs, Substances, or Supplements Interact with Fenoglide?

Fenoglide may interact with blood thinners, cyclosporine, or other cholesterol-lowering medicines. Tell your doctor all medications and supplements you use.

Fenoglide During Pregnancy or Breastfeeding

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.

Additional Information

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.

SLIDESHOW

How to Lower Your Cholesterol & Save Your Heart See Slideshow
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)

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Fenoglide Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

  • Mortality and coronary heart disease morbidity [see WARNINGS AND PRECAUTIONS]
  • Hepatoxicity [see WARNINGS AND PRECAUTIONS]
  • Pancreatitis [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Venothromboembolic Disease [see WARNINGS AND PRECAUTIONS]

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.

Increases In Liver Enzymes

In a pooled analysis of 10 placebo-controlled trials, increases to > 3 times the upper limit of normal in ALT occurred in 5.3% of patients taking fenofibrate at doses equivalent to 87 mg to 130 mg fenofibrate daily (at the highest dose, comparable to FENOGLIDE, 120 mg) versus 1.1% of patients treated with placebo. In an 8-week study, the incidence of ALT or AST elevations ≥ 3 times the upper limit of normal was 13% in patients receiving dosages equivalent to 87 mg to 130 mg fenofibrate daily and was 0% in those receiving dosages equivalent to 43 mg or less fenofibrate daily or placebo.

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, increased total bilirubin, anemia, arthralgia, decreases in hematocrit, white blood cell decreases, asthenia, severely depressed HDL cholesterol levels, and interstitial lung disease. Photosensitivity reactions have occurred days to months after initiation; in some of these cases, patients reported a prior photosensitivity reaction to ketoprofen.

DRUG INTERACTIONS

Coumarin Anticoagulants

Caution should be exercised when coumarin anticoagulants are given in conjunction with FENOGLIDE. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the prothrombin time/INR has stabilized [see WARNINGS AND PRECAUTIONS].

Immunosuppressants

Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including FENOGLIDE, there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using FENOGLIDE with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed and renal function monitored.

Bile-Acid Binding Resins

Since bile acid resins may bind other drugs given concurrently, patients should take FENOGLIDE at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.

Colchicine

Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine.

Read the entire FDA prescribing information for Fenoglide (Fenofibrate Tablets)

© 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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