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Last reviewed on RxList: 10/20/2017
Antara Side Effects Center

Last reviewed on RxList 10/20/2017

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. 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.

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

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

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.

Antara Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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, and dark colored urine.

Stop using fenofibrate and call your doctor at once if you have:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • mild stomach pain;
  • back pain;
  • headache; or
  • runny or stuffy nose.

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


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
  Abdominal Pain 4.6% 4.4%
  Back Pain 3.4% 2.5%
  Headache 3.2% 2.7%
  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 Disorder 6.2% 5.5%
  Rhinitis 2.3% 1.1%
* Dosage equivalent to 90 mg fenofibrate
**Significantly different from placebo

Postmarketing Experience

The following adverse reactions have been identified during post approval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, arthralgia, 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 casual relationship to drug exposure.

Read the entire FDA prescribing information for Antara (Fenofibrate)

Related Resources for Antara

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© 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.

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