Note: This document contains side effect information about fenofibrate. Some dosage forms listed on this page may not apply to the brand name Lipofen.

Summary

Common side effects of Lipofen 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. Continue reading for a comprehensive list of adverse effects.

Applies to fenofibrate: oral fenofibrate capsules, oral fenofibrate tablets, oral fenofibric acid delayed-release capsules.

Side effects include:

Fenofibrate (the active ingredient contained in Lipofen) Abnormal liver function tests (e.g., increased ALT and/or AST), respiratory disorder, abdominal pain, back pain, headache, increased CK concentrations, diarrhea, nausea, rhinitis, constipation, asthenia, flu syndrome.

Fenofibric acid (alone or in combination with a statin): Headache, back pain, nasopharyngitis, nausea, myalgia, diarrhea, upper respiratory tract infection.

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

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

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]

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]