Fenofibrate

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.

Applies 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

• Chills or fever
• hives, itching, or skin rash
• muscle aches and pains
• nausea or vomiting

Rare

• Chronic indigestion
• dark urine
• muscle cramps, pain, stiffness, swelling, or weakness
• troubled breathing
• unusual bleeding or bruising
• unusual tiredness
• yellow eyes or skin

Incidence not known

• Agitation
• bloating
• bloody urine
• decreased frequency or amount of urine
• lower back or side pain
• pains in the stomach, side, or abdomen, possibly radiating to the back
• swelling of the face, fingers, or lower legs
• swollen joints
• upper right abdominal or stomach pain

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

• Runny nose
• sneezing
• stuffy nose

Less common

• Back pain
• diarrhea
• eye irritation
• gas
• increased sensitivity of the skin to sunlight

Incidence not known

• Lack or loss of strength

Applies to fenofibrate: oral capsule, oral tablet

The most frequently reported side effects have included abnormal liver tests, increased transaminases (ALT and AST), increased creatine phosphokinase (CPK), and rhinitis.

During 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

Very 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

Very 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

Very 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

Common (1% to 10%): Headache, dizziness

Rare (less than 0.1%): Peripheral neuropathy

Frequency not reported: Migraine, paresthesia, hypertonia, neuralgia, somnolence

Photosensitivity 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

Uncommon (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

Common (1% to 10%): Conjunctivitis

Frequency not reported: Eye disorder, amblyopia, abnormal vision, cataract specified, refraction disorder

Very 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

Uncommon (0.1% to 1%): Sexual dysfunction

Frequency not reported: Urinary frequency, prostatic disorder, dysuria, gynecomastia, vaginal moniliasis, cystitis

Rare (less than 0.1%): Hemoglobin decreased, leukopenia

Frequency not reported: Eosinophilia, lymphadenopathy, thrombocytopenia, anemia

Postmarketing reports: Hematocrit decreased

Frequency not reported: Appetite increased, anorexia, diabetes mellitus, hypoglycemia, gout, hyperuricemia

Postmarketing reports: High-density lipoprotein cholesterol levels severely depressed

Frequency not reported: Kidney function abnormal, urolithiasis

Postmarketing reports: Renal failure, acute renal failure

Common (1% to 10%): Insomnia

Frequency not reported: Depression, libido decreased, anxiety, nervousness

Frequency not reported: Diabetes mellitus

Rare (less than 0.1%): Hypersensitivity reaction

Frequency not reported: Allergic reaction