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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rate observed in clinical practice.
Adverse reactions 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 Event||Fenofibrate*
|BODY AS A WHOLE|
|Abnormal Liver Function Tests||7.5%**||1.4%|
|METABOLIC AND NUTRITIONAL DISORDERS|
|Creatine Phosphokinase Increased||3.0%||1.4%|
|* Dosage equivalent to 150 mg LIPOFEN
** 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 Lipofen (fenofibrate) Side Effects Center for a complete guide to possible side effects
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when LIPOFEN is given in conjunction with coumarin anticoagulants. LIPOFEN may potentiate the anticoagulant effect of these agents resulting in prolongation of the PT/INR. To prevent bleeding complications, frequent monitoring of PT/INR and dose adjustment of the oral anticoagulant as recommended until the PT/INR has stabilized [see WARNINGS AND PRECAUTIONS].
Immunosuppressant agents such as cyclosporine and tacrolimus can impair renal function and because renal excretion is the primary elimination route of fibrate drugs including LIPOFEN, there is a risk that an interaction will lead to deterioration of renal function. When immunosuppressants and other potentially nephrotoxic agents are co-administered with LIPOFEN, the lowest effective dose of LIPOFEN should be employed and renal function should be monitored.
Bile-Acid Binding Resins
Since bile-acid binding resins may bind other drugs given concurrently, patients should take LIPOFEN at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.
Last reviewed on RxList: 2/1/2013
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