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Tricor

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Tricor

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 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 4.60% 4.40%
Back Pain 3.40% 2.50%
Headache 3.20% 2.70%
DIGESTIVE
Nausea 2.30% 1.90%
Constipation 2.10% 1.40%
METABOLIC AND NUTRITIONAL DISORDERS
Abnormal Liver Function Tests 7.5%** 1.40%
Increased ALT 3.00% 1.60%
Increased CPK 3.00% 1.40%
Increased AST 3.4%** 0.50%
RESPIRATORY
Respiratory Disorder 6.20% 5.50%
Rhinitis 2.30% 1.10%
* Dosage equivalent to 145 mg TRICOR.
** 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 Tricor (fenofibrate) Side Effects Center for a complete guide to possible side effects

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

Immunosuppessants 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.

Last reviewed on RxList: 2/22/2013
This monograph has been modified to include the generic and brand name in many instances.

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Tricor - User Reviews

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