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Antara

Antara (Fenofibrate) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Antara Side Effects Center

What Is Antara?

Antara (fenofibrate) is a lipid-regulating agent called a fibrate used to treat high cholesterol and high triglyceride levels. Antara is available in generic form. Many people using Antara do not have serious side effects.

What Are Side Effects of Antara?

Side effects of Antara may include:

Antara may infrequently cause gallstones and liver problems. Tell your doctor if you notice unlikely but serious side effects of Antara such as:

  • severe stomach or abdominal pain,
  • fast heart rate,
  • persistent nausea or vomiting,
  • yellowing eyes or skin,
  • dark urine,
  • easy bruising,
  • unusual bleeding,
  • purple or red pinpoint spots under your skin,
  • chest pain,
  • sudden cough,
  • wheezing rapid breathing,
  • coughing up blood, or
  • pain/swelling/warmth/redness in one or both legs.

Dosage for Antara?

The adult starting dose of Antara to treat primary hypercholesterolemia or mixed hyperlipidemia is 130 mg per day. The adult starting dose of Antara to treat hypertriglyceridemia is 43 to 130 mg per day, based on blood lipid levels measured every 4 to 8 weeks.

What Drugs, Substances, or Supplements Interact with Antara?

Antara may interact with blood thinners, cyclosporine, or other cholesterol-lowering medicines.

Antara During Pregnancy and Breastfeeding

Tell your doctor all medications you use. Antara is not recommended for use during pregnancy. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Additional Information

Our Antara (fenofibrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Antara Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

In rare cases, fenofibrate can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Also call your doctor at once if you have:

  • sharp stomach pain spreading to your back or shoulder blade;
  • loss of appetite, stomach pain just after eating a meal;
  • jaundice (yellowing of the skin or eyes);
  • fever, chills, weakness, sore throat, mouth sores, unusual bruising or bleeding;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • swelling, warmth, or redness in an arm or leg.

Common side effects may include:

  • runny nose, sneezing; or
  • abnormal laboratory tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Antara (Fenofibrate)

 

Antara Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

  • Mortality and coronary heart disease morbidity [see WARNINGS AND PRECAUTIONS]
  • Hepatoxicity [see WARNINGS AND PRECAUTIONS]
  • Pancreatitis [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Venothromboembolic disease [see WARNINGS AND PRECAUTIONS]

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* (N=439) Placebo (N=365)
Body As A Whole
  Abdominal Pain 4.6% 4.4%
  Back Pain 3.4% 2.5%
  Headache 3.2% 2.7%
Digestive
  Abnormal Liver Function Tests 7.5%** 1.4%
  Nausea 2.3% 1.9%
  Constipation 2.1% 1.4%
Metabolic and Nutritional Disorders
  Increased AST 3.4%** 0.5%
  Increased ALT 3.0% 1.6%
  Increased Creatine Phosphokinase 3.0% 1.4%
Respiratory
  Respiratory Disorder 6.2% 5.5%
  Rhinitis 2.3% 1.1%
* Dosage equivalent to 90 mg fenofibrate
**Significantly different from placebo

Urticaria was seen in 1.1 vs. 0%, and rash in 1.4 vs. 0.8% of fenofibrate and placebo patients, respectively, in controlled trials.

Increases In Liver Enzymes

In a pooled analysis of 10 placebo-controlled trials, increases to >3 times the upper limit of normal in ALT occurred in 5.3% of patients taking fenofibrate at doses equivalent to 90 mg Antara daily versus 1.1% of patients treated with placebo.

Postmarketing Experience

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: myalgia, rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, increased total bilirubin, anemia, arthralgia, asthenia, severely depressed HDL-cholesterol levels, and interstitial lung disease. Photosensitivity reactions have occurred days to months after initiation; in some of these cases, patients reported a prior photosensitivity reaction to ketoprofen.

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 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 [see WARNINGS AND PRECAUTIONS].

Immunosuppressants

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.

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.

Read the entire FDA prescribing information for Antara (Fenofibrate)

&Copy; Antara Patient Information is supplied by Cerner Multum, Inc. and Antara Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.