Recommended Topic Related To:

Antara

"Robert Lowes
WebMD Health News

Nov. 1, 2013 -- The cholesterol-lowering drug Crestor (rosuvastatin) was the nation's most prescribed drug in the past 12 months, according to a new report from research firm IMS Health. New "...

Antara

Antara Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Antara (fenofibrate) is used to treat high cholesterol and high triglyceride levels. It is a lipid-regulating agent called a fibrate. This medication is available in generic form. Many people using this medication do not have serious side effects. This medication may infrequently cause gallstones and liver problems. If you notice unlikely but serious side effects such as severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, or dark urine, tell your doctor.

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, breast-feeding 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Antara in Detail - Patient Information: Side Effects

Fenofibrate has been associated with a rare but serious side effect of the muscles. Contact your doctor at once if you have unusual muscle pain, tenderness, or weakness especially if accompanied by fever or flu-like feeling.

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

Stop using fenofibrate and call your doctor at once if you have any of these serious side effects:

  • severe stomach pain;
  • nausea, vomiting;
  • unusual weakness; or
  • fever.

Less serious side effects may include:

  • joint pain;
  • indigestion;
  • bloating or gas; or
  • a rash.

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) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Antara FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 4.60% 4.40%
  Back Pain 3.40% 2.50%
  Headache 3.20% 2.70%
Digestive
  Abnormal Liver Function Tests 7.5%** 1.40%
  Nausea 2.30% 1.90%
  Constipation 2.10% 1.40%
Metabolic and Nutritional Disorders
  Increased AST 3.4%** 0.50%
  Increased ALT 3.00% 1.60%
  Increased Creatine Phosphokinase 3.00% 1.40%
Respiratory
  Respiratory Disorder 6.20% 5.50%
  Rhinitis 2.30% 1.10%
* 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) »

A A A

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.


Cholesterol Management

Tips to keep it under control.