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Tricor

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Tricor

Tricor

Tricor Side Effects Center

Pharmacy Editor: Eni Williams, PharmD, PhD

Tricor (fenofibrate) is a medication that belongs to the drug class known as antilipemic agents and fibric acids. Tricor is available as a generic drug, and is prescribed for reducing "bad" cholesterol and fats (for example, LDL and triglycerides) and for raising "good" cholesterol (HDL) in the blood. Common side effects of Tricor include abdominal pain, nausea, vomiting, yellowing eyes/skin, dark urine, rash, itching, and swelling.

Tricor usual adult dose is 48-154 mg/day. Drug interactions include warfarin (Coumadin) and ezetimibe (Zetia). There are no adequate studies of Tricor in pregnant women and it is not known if Tricor is secreted in human breast milk. Use during pregnancy is not recommended unless the potential benefit outweighs the potential unknown risk to the fetus.

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

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.

Tricor 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 Tricor (Fenofibrate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Tricor Overview - Patient Information: Side Effects

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may infrequently cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor immediately: severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

Tell your doctor immediately if any of these rare but serious side effects occur: easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), unusual tiredness, chest pain, pain/redness/swelling of arms or legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Tricor (Fenofibrate)»

What is Prescribing information?

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

Tricor 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 the rates observed in practice.

Adverse events reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials, regardless of causality, are listed in Table 1 below. Adverse events 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
Nausea 2.30% 1.90%
Constipation 2.10% 1.40%
METABOLIC AND NUTRITIONAL DISORDERS
Abnormal Liver Function Tests 7.5%** 1.40%
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%
* Dosage equivalent to 145 mg TRICOR.
** Significantly different from Placebo.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, acute renal failure, muscle spasm, hepatitis, cirrhosis, anemia, 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 Tricor (Fenofibrate) »

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Tricor - User Reviews

Tricor User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Tricor sorted by most helpful. Patient Discussions FAQs

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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