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Lipofen

Last reviewed on RxList: 12/17/2018
Lipofen Side Effects Center

Last reviewed on RxList 12/17/2018

Lipofen (fenofibrate) is a lipid-regulating agent available that helps reduce cholesterol and triglycerides (fatty acids) in the blood used to treat high cholesterol and high triglyceride levels. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries). Many people using Lipofen do not have serious side effects. Side effects of Lipofen include:

  • mild stomach or abdominal pain,
  • back pain,
  • headache,
  • runny or stuffy nose,
  • nausea,
  • constipation,
  • respiratory problems, and infrequently,
  • gallstones and liver problems.

Tell your doctor if you experience serious side effects of Lipofen including:

  • severe stomach or abdominal pain,
  • persistent nausea or vomiting,
  • yellowing eyes or skin,
  • dark urine,
  • easy bruising,
  • unusual bleeding (nose, mouth, vagina, or rectum),
  • purple or red pinpoint spots under your skin,
  • chest pain,
  • sudden cough,
  • wheezing,
  • rapid breathing,
  • coughing up blood, or
  • pain/swelling/warmth/redness in one or both legs.

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.

QUESTION

What is cholesterol? See Answer
Lipofen 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, fenofibrate 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 Lipofen (Fenofibrate)

SLIDESHOW

Lower Your Cholesterol, Save Your Heart See Slideshow
Lipofen Professional Information

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 Fenofibrate* Placebo
Adverse Event (N=439) (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

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.

Post Marketing 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, 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. Photosensitivity reactions have occurred days to months after initiation; in some of these cases, patients reported a prior photosensitivity reaction to ketoprofen.

Read the entire FDA prescribing information for Lipofen (Fenofibrate)

Related Resources for Lipofen

© Lipofen Patient Information is supplied by Cerner Multum, Inc. and Lipofen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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