Fenofibrate Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 16, 2024.

Applies to fenofibrate: oral capsule, oral tablet.

Common side effects of fenofibrate

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:

Serious side effects of fenofibrate

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:

For Healthcare Professionals

Applies to fenofibrate: oral capsule, oral tablet.

General

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

Hepatic

• 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, elevated total bilirubin, serious drug-induced liver injury including liver transplantation and death^[Ref]

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.^[Ref]

Respiratory

• 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^[Ref]

Musculoskeletal

• 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^[Ref]

Gastrointestinal

• 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^[Ref]

Nervous system

• Common (1% to 10%): Headache, dizziness
• Rare (less than 0.1%): Peripheral neuropathy
• Frequency not reported: Migraine, paresthesia, hypertonia, neuralgia, somnolence^[Ref]

Dermatologic

• 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: Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), ecchymosis^[Ref]

Photosensitivity reactions have been reported days to months after initiation; in some cases, a prior photosensitivity reaction to ketoprofen had been reported.^[Ref]

Cardiovascular

• 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^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Frequency not reported: Eye disorder, amblyopia, abnormal vision, cataract specified, refraction disorder^[Ref]

Other

• 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^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Sexual dysfunction
• Frequency not reported: Urinary frequency, prostatic disorder, dysuria, gynecomastia, vaginal moniliasis, cystitis^[Ref]

Hematologic

• Rare (less than 0.1%): Hemoglobin decreased, leukopenia
• Frequency not reported: Eosinophilia, lymphadenopathy, thrombocytopenia, anemia
• Postmarketing reports: Hematocrit decreased^[Ref]

Metabolic

• Frequency not reported: Appetite increased, anorexia, diabetes mellitus, hypoglycemia, gout, hyperuricemia
• Postmarketing reports: High-density lipoprotein cholesterol levels severely depressed^[Ref]

Renal

• Frequency not reported: Kidney function abnormal, urolithiasis
• Postmarketing reports: Renal failure, acute renal failure^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia
• Frequency not reported: Depression, libido decreased, anxiety, nervousness^[Ref]

Endocrine

• Frequency not reported: Diabetes mellitus^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Hypersensitivity reaction
• Frequency not reported: Allergic reaction^[Ref]

Further information

Fenofibrate side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer