Lipofen
- Generic Name: fenofibrate
- Brand Name: Lipofen
- Drug Class: Fibric Acid Agents
Lipofen (Fenofibrate) side effects drug center
Lipofen Side Effects Center
What Is Lipofen?
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.
What Are Side Effects of Lipofen?
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.
Dosage for Lipofen?
The dose of Lipofen ranges from 50 mg to 150 mg taken once daily, with meals.
What Drugs, Substances, or Supplements Interact with Lipofen?
Lipofen may interact with blood thinners, cyclosporine, or other cholesterol-lowering medicines. Tell your doctor all medications and supplements you use.
Lipofen During Pregnancy and Breastfeeding
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.
Additional Information
Our Lipofen (fenofibrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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)
Lipofen 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 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% | 1.4% |
| 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.
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 at doses equivalent to 100 mg to 150 mg LIPOFEN daily versus 1.1% of patients treated with 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, acute renal failure, muscle spasm, hepatitis, cirrhosis, increased total bilirubin, anemia, 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 effect has been observed with prolongation of the PT/INR.
Caution should be exercised when LIPOFEN is given in conjunction with coumarin anticoagulants. LIPOFEN may potentiate the anticoagulant effect of these agents resulting in prolongation of the PT/INR. To prevent bleeding complications, frequent monitoring of PT/INR and dose adjustment of the oral anticoagulant as recommended until the PT/INR has stabilized [see WARNINGS AND PRECAUTIONS].
Immunosuppressants
Immunosuppressant agents such as cyclosporine and tacrolimus can impair renal function and because renal excretion is the primary elimination route of fibrate drugs including LIPOFEN, there is a risk that an interaction will lead to deterioration of renal function. When immunosuppressants and other potentially nephrotoxic agents are co-administered with LIPOFEN, the lowest effective dose of LIPOFEN should be employed and renal function should be monitored.
Bile-Acid Binding Resins
Since bile-acid binding resins may bind other drugs given concurrently, patients should take LIPOFEN at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.
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 Lipofen (Fenofibrate)
&Copy; 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.