Does Antara (fenofibrate) cause side effects?
Antara (fenofibrate) is a derivative of fibric acid used with dietary modifications to treat lipid disorders. It helps reduce levels of LDL-C, total cholesterol, triglycerides, and apolipoprotein B, and increase HDL-C. Antara is prescribed to patients with primary hypercholesterolemia or mixed dyslipidemia, and hypertriglyceridemia.
Common side effects of Antara include
Less common side effects of Antara include
- high blood pressure (hypertension),
- upset stomach,
- urinary tract infections (UTIs),
- muscle pain,
- kidney problems, and
- respiratory tract infections.
- Antara may increase the adverse effects of colchicine on muscle tissue.
- Cyclosporine may increase the toxic effects of Antara on the kidney while Antara may decrease blood levels of cyclosporine.
- Antara may increase the adverse effects associated with ezetimibe, HMG-CoA reductase inhibitors (statins), and sulfonylureas.
- Antara may increase the anticoagulation (blood-thinning) benefits of warfarin.
What are the important side effects of Antara (fenofibrate)?
Less common side effects are:
Antara (fenofibrate) side effects list for healthcare professionals
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 rates observed in clinical practice.
- Adverse events reported by 2% or more of patients treated with fenofibrate and greater than placebo during double-blind, placebo-controlled trials, regardless of causality, are listed in Table 1.
- Adverse reactions 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*
|Body As A Whole|
|Abnormal Liver Function Tests||7.5%**||1.4%|
|Metabolic and Nutritional Disorders|
|Increased Creatine Phosphokinase||3.0%||1.4%|
|* Dosage equivalent to 130 mg
**Significantly different from placebo
The following adverse reactions have been identified during post approval 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:
- renal failure,
- muscle spasms,
- acute renal failure,
- asthenia, and
- severely depressed HDL-cholesterol levels.
What drugs interact with Antara (fenofibrate)?
- 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 Antara.
- 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.
- Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decrease in creatinine clearance and because renal excretion is the primary elimination route of fibrate drugs including Antara, there is a risk that an interaction will lead to deterioration of renal function.
- The benefits and risks of using Antara with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.
Bile-Acid Binding Resins
- Since bile acid binding resins may bind other drugs given concurrently, patients should take Antara at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.
- Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine.
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Medications & Supplements
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.