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Fenofibrate 40 mg/ 120 mg
Clinical Studies 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 (fenofibrate (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 (fenofibrate (fenofibrate) ) and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of fenofibrate (fenofibrate (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 (fenofibrate (fenofibrate) ) and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM
|BODY AS A WHOLE|
|Abnormal Liver Tests||7.5%||1.4%|
|Increased Creatine Phosphokinase||3.0%||1.4%|
|* Dosage equivalent to 130 mg fenofibrate|
The following adverse reactions have been identified during postapproval use of fenofibrate (fenofibrate (fenofibrate) ) : myalgia, rhabdomyolysis, increased creatinine phosphokinase, pancreatitis, increased alanine aminotransaminase, increased aspartate aminotransaminase, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, nausea, abdominal pain, anemia, headache, arthralgia, and asthenia. 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 casual relationship to drug exposure.
Read the Fenofibrate 40 mg/ 120 mg (fenofibrate) Side Effects Center for a complete guide to possible side effects
Caution should be exercised when coumarin anticoagulants are given in conjunction with fenofibrate (fenofibrate (fenofibrate) ) . The dosage of the anticoagulants should be reduced to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. Frequent prothrombin time/INR determinations are advisable until it has been definitely determined that the prothrombin time/INR has stabilized. [see Concomitant Coumarin Anticoagulants.]
Because cyclosporine 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 fenofibrate (fenofibrate (fenofibrate) ) , there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using fenofibrate (fenofibrate (fenofibrate) ) with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.
HMG-CoA Reductase Inhibitors
The combined use of fenofibric acid derivatives, particularly gemfibrozil, and HMG-CoA reductase inhibitors results in an increased risk of rhabdomyolysis and myoglobinuria leading in a high proportion of cases to acute renal failure. [See Concomitant HMG-CoA Reductase Inhibitors]
The combined use of fenofibrate (fenofibrate (fenofibrate) ) and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination.
In a single-dose drug interaction study in 23 healthy adults the concomitant administration of fenofibrate (fenofibrate (fenofibrate) ) and pravastatin resulted in no clinically important difference in the pharmacokinetics of fenofibric acid, pravastatin, or its active metabolite 3α-hydroxy iso-pravastatin when compared to either drug given alone.
Since bile acid sequestrants may bind other drugs given concurrently, patients should take Fenofibrate (fenofibrate (fenofibrate) ) Tablets at least 1 hour before or 4-6 hours after a bile acid binding resin to avoid impeding its absorption.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/7/2007
Additional Fenofibrate 40 mg/ 120 mg Information
Report Problems to the Food and Drug Administration
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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