Navigation

Tricor

Tricor (Fenofibrate) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Tricor Side Effects Center

What Is Tricor?

Tricor (fenofibrate) is an antilipemic agent and fibric acid prescribed for reducing "bad" cholesterol and fats (for example, LDL and triglycerides) and for raising "good" cholesterol (HDL) in the blood. Tricor is available as a generic drug.

What Are Side Effects of Tricor?

Common side effects of Tricor include:

Dosage for Tricor

Tricor usual adult dose is 48-154 mg/day.

What Drugs, Substances, or Supplements Interact with Tricor?

Tricor may interact with blood thinners, medicines to treat a bowel disorder, medications to prevent organ transplant rejection, antiviral medications, chemotherapy, pain or arthritis medicines (including aspirin, acetaminophen, ibuprofen, and naproxen), or injected antibiotics. Tell your doctor all medications and supplements you use.

Tricor During Pregnancy and Breastfeeding

There are no adequate studies of Tricor in pregnant women. Tricor passes into breast milk and may harm a nursing baby. Breastfeeding while taking Tricor is not recommended. Use during pregnancy is not recommended unless the potential benefit outweighs the potential unknown risk to the fetus.

Additional Information

Our Tricor Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. articles.

 

Tricor 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 Tricor (Fenofibrate)

 

Tricor 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 the rates observed in practice.

Adverse events 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 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 Function Tests 7.5%** 1.4%
Increased ALT 3.0% 1.6%
Increased CPK 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 145 mg TRICOR.
** Significantly different from Placebo.

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 96 mg to 145 mg TRICOR daily versus 1.1% of patients treated with placebo [see WARNINGS AND PRECAUTIONS]. 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 96 mg to 145 mg TRICOR daily and was 0% in those receiving dosages equivalent to 48 mg or less TRICOR daily or placebo.

Postmarketing Experience

The following adverse reactions have been identified during postapproval 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 spasm, hepatitis, cirrhosis, increased total bilirubin, anemia, arthralgia, decreases in hemoglobin, 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

Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR.

Caution should be exercised when coumarin anticoagulants are given in conjunction with TRICOR. 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 PT/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 TRICOR, there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using TRICOR (fenofibrate tablets) 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 binding resins may bind other drugs given concurrently, patients should take TRICOR 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 Tricor (Fenofibrate)

&Copy; Tricor Patient Information is supplied by Cerner Multum, Inc. and Tricor Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.