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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 1/3/2022.
Source: Drugs.com Fenofibrate (www.drugs.com/fenofibrate.html).
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