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Fenofibrate belongs to a group of drugs known as "fibrates." 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).
Fenofibrate is used along with a proper diet to help to treat high cholesterol and high triglyceride levels.
In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help fenofibrate work better include exercising, losing weight if overweight, and stopping smoking.
You should not take fenofibrate if you have liver disease, gallbladder disease, severe kidney disease, or if you are breast-feeding a baby.
Fenofibrate can cause the breakdown of muscle tissue, which can lead 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 urine.
You should not take fenofibrate if you are allergic to it, or if you have:
severe kidney disease (or if you are on dialysis);
liver disease; or
gallbladder disease.
Do not breast-feed while using this medicine, and for at least 5 days after your last dose.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
kidney disease;
liver disease; or
gallbladder problems.
Fenofibrate can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, or people who have kidney disease, diabetes, or poorly controlled hypothyroidism (underactive thyroid).
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Fenofibrate is not approved for use by anyone younger than 18 years old.
Take fenofibrate exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Some brands of fenofibrate should be taken with meals to help your body better absorb the medicine. Other brands may be taken with or without food. Follow the directions on your medicine label.
Swallow the tablet or capsule whole and do not crush, chew, dissolve, or open it.
You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.
Fenofibrate is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.
Store at room temperature away from moisture, heat, and light.
Usual Adult Dose of Fenofibrate for Hyperlipoproteinemia Type IIa (Elevated LDL):
Tricor: 145 mg orally once a day.
Lofibra and others: 160 mg to 200 mg orally once a day with food.
Antara: 130 mg orally once a day.
Triglide: 160 mg orally once a day.
Lipofen: 150 mg orally once a day with food.
Fenoglide: 120 mg orally once a day with food.
Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL):
Tricor: 145 mg orally once a day.
Lofibra and others: 160 mg to 200 mg orally once a day with food.
Antara: 130 mg orally once a day.
Triglide: 160 mg orally once a day.
Lipofen: 150 mg orally once a day with food.
Fenoglide: 120 mg orally once a day with food.
Usual Adult Dose of Fenofibrate for Hyperlipoproteinemia Type IV (Elevated VLDL):
Tricor: 48 to 145 mg orally once a day.
Lofibra and others: 54 mg to 200 mg orally once a day with food.
Antara: 43 mg to 130 mg orally once a day.
Triglide: 50 mg to 160 mg orally once a day.
Lipofen: 50 mg to 150 mg orally once a day with food.
Fenoglide: 40 mg to 120 mg orally once a day with food.
Usual Adult Dose for Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL):
Tricor: 48 to 145 mg orally once a day.
Lofibra and others: 54 mg to 200 mg orally once a day with food.
Antara: 43 mg to 130 mg orally once a day.
Triglide: 50 mg to 160 mg orally once a day.
Lipofen: 50 mg to 150 mg orally once a day with food.
Fenoglide: 40 mg to 120 mg orally once a day with food.
Usual Geriatric Dose of Fenofibrate for Hyperlipoproteinemia:
Tricor: 48 mg orally once a day. Increases in dosage should occur only after evaluating the effects on renal function and lipid levels at this dose, with a maximum recommended dose of 145 mg/24 hours.
Lofibra and others: 54 mg to 67 mg orally once a day with food. Individualize dosage according to patient response and adjust if necessary following repeat lipid determinations at 4 to 8 week intervals.
Antara: 43 mg orally once a day. Individualize dosage according to patient response and adjust if necessary following repeat lipid determinations at 4 to 8 week intervals.
Triglide: 50 mg orally once a day. Individualize dosage according to patient response and adjust if necessary following repeat lipid determinations at 4 to 8 week intervals.
Lipofen: 50 mg orally once a day with food. Individualize dosage according to patient response and adjust if necessary following repeat lipid determinations at 4 to 8 week intervals.
Fenoglide: 40 mg to 120 mg orally once a day with food
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid eating foods high in fat or cholesterol, or fenofibrate will not be as effective.
Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.
Get emergency medical help if you have signs of an allergic reaction to fenofibrate (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 fenofibrate 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.
Some medicines can make fenofibrate much less effective when taken at the same time. If you take any of the following medicines, take your dose 1 hour before or 4 to 6 hours after you take the other medicine.
cholestyramine;
colesevelam; or
colestipol.
Tell your doctor about all your other medicines, especially:
other cholesterol lowering medicines;
colchicine;
a blood thinner such as warfarin, Coumadin, Jantoven; or
drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.
This list is not complete. Other drugs may affect fenofibrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use fenofibrate only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Fenofibrate (www.drugs.com/fenofibrate.html).
Commonly reported side effects of fenofibrate include: increased serum aspartate aminotransferase and increased serum alanine aminotransferase. Other side effects include: abnormal hepatic function tests, increased creatine phosphokinase in blood specimen, and increased serum transaminases. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to fenofibrate: oral capsule, oral tablet
Along with its needed effects, fenofibrate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking fenofibrate:
Less common
Rare
Incidence not known
Some side effects of fenofibrate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Incidence not known
For Healthcare Professionals
Applies to fenofibrate: oral capsule, oral tablet
GeneralThe most frequently reported side effects have included abnormal liver tests, increased transaminases (ALT and AST), increased creatine phosphokinase (CPK), and rhinitis.
HepaticDuring clinical trials, transaminase increases to greater than 3 times the upper limit of normal (3 x ULN) occurred in 5.3% of patients taking fenofibrate compared with 1.1% of those on placebo; the incidence of increased transaminases appeared to be dose-related.
Common (1% to 10%): Liver function tests abnormal, AST increased, ALT increased
Uncommon (0.1% to 1%): Cholelithiasis
Rare (less than 0.1%): Hepatitis
Postmarketing reports: Cirrhosis, liver fatty deposit, cholecystitis, jaundice, cholangitis, biliary colic
RespiratoryVery common (10% or more): Rhinitis (up to 23.2%), bronchitis (16.4%)
Common (1% to 10%): Respiratory disorder, pharyngitis, sinusitis
Uncommon (0.1% to 1%): Pulmonary embolism
Very rare (less than 0.01%): Interstitial pneumopathy
Frequency not reported: Cough increased, dyspnea, asthma, pneumonia, laryngitis
Postmarketing reports: Interstitial lung disease
MusculoskeletalVery common (10% or more): Arthralgia (up to 25.1%), back pain (up to 15%)
Common (1% to 10%): Back pain, myalgia
Uncommon (0.1% to 1%): Diffuse myalgia, myositis, muscle cramp, muscle weakness
Very rare (less than 0.01%): Rhabdomyolysis
Frequency not reported: Arthritis, tenosynovitis, joint disorder, arthrosis, leg cramp, bursitis, myasthenia
Postmarketing reports: Muscle spasm
GastrointestinalVery common (10% or more): Abdominal pain (up to 15.9%)
Common (1% to 10%): Nausea, constipation, diarrhea, vomiting, flatulence
Uncommon (0.1% to 1%): Pancreatitis
Frequency not reported: Dyspepsia, gastroenteritis, rectal disorder, esophagitis, gastritis, colitis, tooth disorder, gastrointestinal disorder, duodenal ulcer, peptic ulcer, rectal hemorrhage, eructation, gamma glutamyl transpeptidase, dry mouth
Nervous systemCommon (1% to 10%): Headache, dizziness
Rare (less than 0.1%): Peripheral neuropathy
Frequency not reported: Migraine, paresthesia, hypertonia, neuralgia, somnolence
DermatologicPhotosensitivity reactions have been reported days to months after initiation; in some cases, a prior photosensitivity reaction to ketoprofen had been reported.
Common (1% to 10%): Rash, pruritus, urticaria
Uncommon (0.1% to 1%): Photosensitivity reaction
Rare (0.01% to 0.1%): Alopecia
Very rare (less than 0.01%): Cutaneous photosensitivity with erythema, vesiculation, nodulation
Frequency not reported: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eczema, acne, sweating, fungal dermatitis, skin disorder, contact dermatitis, maculopapular rash, nail disorder, skin ulcer
Postmarketing reports: Ecchymosis
CardiovascularUncommon (0.1% to 1%): Deep vein thrombosis
Frequency not reported: Angina pectoris, hypertension, vasodilatation, coronary artery disorder, electrocardiogram abnormal, extrasystole, myocardial infarct, peripheral vascular disorder, varicose vein, cardiovascular disorder, hypotension, palpitation, arrhythmia, phlebitis, tachycardia, atrial fibrillation
OcularCommon (1% to 10%): Conjunctivitis
Frequency not reported: Eye disorder, amblyopia, abnormal vision, cataract specified, refraction disorder
OtherVery common (10% or more): Accidental injury (up to 18.4%), flu syndrome (up to 17.9%), chest pain (up to 10.1%)
Common (1% to 10%): Creatine phosphokinase increased, malaise, vertigo, fatigue
Uncommon (0.1% to 1%): Serum creatinine increased, urea increased
Rare (less than 0.1%): Sexual asthenia
Frequency not reported: Pain, infection, cyst, hernia, fever, peripheral edema, ear pain, otitis media, herpes zoster, herpes simplex, weight gain, weight loss, edema
Postmarketing reports: Asthenia
GenitourinaryUncommon (0.1% to 1%): Sexual dysfunction
Frequency not reported: Urinary frequency, prostatic disorder, dysuria, gynecomastia, vaginal moniliasis, cystitis
HematologicRare (less than 0.1%): Hemoglobin decreased, leukopenia
Frequency not reported: Eosinophilia, lymphadenopathy, thrombocytopenia, anemia
Postmarketing reports: Hematocrit decreased
MetabolicFrequency not reported: Appetite increased, anorexia, diabetes mellitus, hypoglycemia, gout, hyperuricemia
Postmarketing reports: High-density lipoprotein cholesterol levels severely depressed
RenalFrequency not reported: Kidney function abnormal, urolithiasis
Postmarketing reports: Renal failure, acute renal failure
PsychiatricCommon (1% to 10%): Insomnia
Frequency not reported: Depression, libido decreased, anxiety, nervousness
EndocrineFrequency not reported: Diabetes mellitus
HypersensitivityRare (less than 0.1%): Hypersensitivity reaction
Frequency not reported: Allergic reaction
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Fenofibrate (www.drugs.com/fenofibrate.html).
November 24, 2020
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