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Fibricor

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Fibricor

Fibricor Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Fibricor (fenofibric acid) is indicated as an adjunctive therapy to diet for treatment of severe hypertriglyceridemia and in patients with primary hypercholesterolemia or mixed dyslipidemia. Most common adverse reactions seen with the use of Fibricor are increases in liver function tests, abdominal pain, back pain, and headache.

Fibricor may be taken with or without meals. Fibricor is available in two strengths: 35 mg and 105 mg. For severe hypertriglyceridemia the recommended dose is 35 to 105 mg/day, though the dose should be adjusted according to patient response. Patients with primary hyperlipidemia or mixed dyslipidemia should receive 105 mg/day.

Safety in pregnant women has not been established, and Fibricor should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fibricor should not be used by nursing mothers. A decision should be made whether to discontinue nursing or to discontinue the drug.

Our Fibricor 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.

Fibricor in Detail - Patient Information: Side Effects

In rare cases, fenofibric acid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking fenofibric acid and 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.

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

Stop using fenofibric acid and call your doctor at once if you have a serious side effect such as:

  • sharp stomach pain spreading to your back or shoulder blade;
  • stomach pain just after eating a meal;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pain, swelling, warmth, or redness in one or both legs; or
  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate.

Less serious side effects may include:

  • headache, dizziness;
  • back pain;
  • joint pain;
  • diarrhea, upset stomach; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 Fibricor (Fenofibric Acid) »

What is Prescribing information?

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

Fibricor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adverse reactions reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials are listed in Table 1. Adverse reactions led to discontinuation of treatment in 5% of patients treated with fenofibrate and in 3% 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* During the Double-Blind, Placebo-Controlled Trials

BODY SYSTEM
Adverse Reactions
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 ALT 3.00% 1.60%
  Increased CPK 3.00% 1.40%
  Increased AST 3.4%** 0.50%

RESPIRATORY

  Respiratory Disorder 6.20% 5.50%
  Rhinitis 2.30% 1.10%
* Fenofibric acid is the active moiety of fenofibrate; Fenofibrate dosage equivalent to 105 mg fenofibric acid.
** Significantly different from Placebo.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, muscle spasm, acute renal failure, hepatitis, cirrhosis, anemia, headache, arthralgia, decreases in hemoglobin, decreases in hematocrit, white blood cell decreases, 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 causal relationship to drug exposure.

Read the entire FDA prescribing information for Fibricor (Fenofibric Acid) »

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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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