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Lipofen

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Lipofen

Lipofen

Lipofen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lipofen (fenofibrate) is used to treat high cholesterol and high triglyceride levels. It helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries). Many people using this medication do not have serious side effects. It may infrequently cause gallstones and liver problems. Tell your doctor if severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, or dark urine occurs.

The dose of Lipofen ranges from 50 mg to 150 mg taken once daily, with meals. Lipofen may interact with blood thinners, cyclosporine, or other cholesterol-lowering medicines. Tell your doctor all medications and supplements you use. Lipofen 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 Lipofen (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.

Lipofen 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 Lipofen (Fenofibrate) »

What is Prescribing information?

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

Lipofen 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 rate 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, 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 Event Fenofibrate*
(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%** 1.4%
Nausea 2.3% 1.9%
Constipation 2.1% 1.4%
METABOLIC AND NUTRITIONAL DISORDERS
Increased ALT 3.0% 1.6%
Creatine Phosphokinase Increased 3.0% 1.4%
Increased AST 3.4%** 0.5%
RESPIRATORY
Respiratory Disorder 6.2% 5.5%
Rhinitis 2.3% 1.1%
* Dosage equivalent to 150 mg LIPOFEN
** 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 Lipofen (Fenofibrate) »

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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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