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Fibricor

Fibricor (Fenofibric Acid) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Fibricor Side Effects Center

What Is Fibricor?

Fibricor (fenofibric acid) is a lipid-regulating agent indicated as an adjunctive therapy to diet for treatment of severe hypertriglyceridemia and in patients with primary hypercholesterolemia or mixed dyslipidemia.

What Are Side Effects of Fibricor?

Common side effects of Fibricor include:

Dosage for Fibricor?

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.

What Drugs, Substances, or Supplements Interact with Fibricor?

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.

Fibricor During Pregnancy and Breastfeeding

Fibricor may interact with cyclosporine, blood thinners, diuretics (water pills), birth control pills or hormone replacement therapy, or beta-blockers. Tell your doctor all medications and supplements you use. 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 while breastfeeding. A decision should be made whether to discontinue nursing or to discontinue the drug.

Additional Information

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

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. Fibricor may interact with cyclosporine, blood thinners, diuretics (water pills), birth control pills or hormone replacement therapy, or beta-blockers. Tell your doctor all medications and supplements you use. 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 while breastfeeding. 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.

 

Fibricor 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, fenofibric acid 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 Fibricor (Fenofibric Acid)

 

Fibricor 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 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		 Fenofibrate1
(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%2 1.4%
Nausea 2.3% 1.9%
Constipation 2.1% 1.4%
METABOLIC AND NUTRITIONAL DISORDERS
Increased ALT 3.0% 1.6%
Increased CPK 3.0% 1.4%
Increased AST 3.4%2 0.5%
RESPIRATORY
Respiratory Disorder 6.2% 5.5%
Rhinitis 2.3% 1.1%
1Fenofibric acid is the active moiety of fenofibrate; Fenofibrate dosage equivalent to 105 mg fenofibric acid.
2Significantly 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 versus 1.1% of patients treated with placebo. In an 8-week study, the incidence of ALT or AST elevations ≥ 3 times the upper limit of normal was 13% in patients receiving dosages equivalent to 35 mg to 105 mg FIBRICORdailyandwas0%inthosereceivingdosages equivalentto35mgor less FIBRICORdailyor 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, muscle spasm, acute renal failure, hepatitis, cirrhosis, increased total bilirubin, anemia, headache, arthralgia, decreases in hemoglobin, decreases in hematocrit, white blood cell decreases, 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 FIBRICOR. The dosage of the anticoagulants should be reduced to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. Frequent prothrombin time/INR determinations are advisable until it has been definitely determined that the prothrombin time/INR has stabilized [see WARNINGS AND PRECAUTIONS].

Bile-Acid Binding Resins

Since bile-acid binding resins may bind other drugs given concurrently, patients should take FIBRICOR at least 1 hour before or 4 to 6 hours after taking a bile-acid binding resin to avoid impeding its absorption.

Immunosuppressants

Immunosuppressant agents such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs, including FIBRICOR, there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using FIBRICOR with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed and renal function monitored.

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 Fibricor (Fenofibric Acid)

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