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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 AS A WHOLE|
|METABOLIC AND NUTRITIONAL DISORDERS|
|Abnormal Liver Function Tests||7.5%**||1.4%|
|* Dosage equivalent to 160 mg
** Significantly different from Placebo.
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
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].
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.
Prescribing Document Revised: December 2014This monograph has been modified to include the generic and brand name in many instances.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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