Lofibra Side Effects

Generic Name: triglide,fenofibrate

Please note - some side effects for Lofibra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Lofibra Side Effects - for the Professional

Lofibra

Clinical

Adverse events reported by 2% or more of patients treated with fenofibrate during the double-blind, placebo-controlled trials, regardless of causality, are listed in the table below. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

Additional adverse events reported by three or more patients in placebo-controlled trials or reported in other controlled or open trials, regardless of causality are listed below.

Body as a Whole: Chest pain, pain (unspecified), infection, malaise, allergic reaction, cyst, hernia, fever, photosensitivity reaction, and accidental injury.

Cardiovascular System: Angina pectoris, hypertension, vasodilatation, coronary artery disorder, electrocardiogram abnormal, ventricular extrasystoles, myocardial infarct, peripheral vascular disorder, migraine, varicose vein, cardiovascular disorder, hypotension, palpitation, vascular disorder, arrhythmia, phlebitis, tachycardia, extrasystoles, and atrial fibrillation.

Digestive System: Dyspepsia, flatulence, nausea, increased appetite, gastroenteritis, cholelithiasis, rectal disorder, esophagitis, gastritis, colitis, tooth disorder, vomiting, anorexia, gastrointestinal disorder, duodenal ulcer, nausea and vomiting, peptic ulcer, rectal hemorrhage, liver fatty deposit, cholecystitis, eructation, gamma glutamyl transpeptidase, and diarrhea.

Endocrine System: Diabetes mellitus

Hemic and Lymphatic System: Anemia, leukopenia, ecchymosis, eosinophilia, lymphadenopathy, and thrombocytopenia.

Metabolic and Nutritional Disorders: Creatinine increased, weight gain, hypoglycemia, gout, weight loss, edema, hyperuricemia, and peripheral edema.

Musculoskeletal System: Myositis, myalgia, arthralgia, arthritis, tenosynovitis, joint disorder, arthrosis, leg cramps, bursitis, and myasthenia.

Nervous System: Dizziness, insomnia, depression, vertigo, libido decreased, anxiety, paresthesia, dry mouth, hypertonia, nervousness, neuralgia, and somnolence.

Respiratory System: Pharyngitis, bronchitis, cough increased, dyspnea, asthma, pneumonia, laryngitis, and sinusitis.

Skin and Appendages: Rash, pruritus, eczema, herpes zoster, urticaria, acne, sweating, fungal dermatitis, skin disorder, alopecia, contact dermatitis, herpes simplex, maculopapular rash, nail disorder, and skin ulcer.

Special Senses: Conjunctivitis, eye disorder, amblyopia, ear pain, otitis media, abnormal vision, cataract specified, and refraction disorder.

Urogenital System: Urinary frequency, prostatic disorder, dysuria, kidney function abnormal, urolithiasis, gynecomastia, unintended pregnancy, vaginal moniliasis, and cystitis.

Lofibra Capsules

CLINICAL

Adverse events reported by 2% or more of patients treated with fenofibrate during the double-blind, placebo-controlled trials, regardless of causality, are listed in the table below. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

BODY AS A WHOLE: Chest pain, pain (unspecified), infection, malaise, allergic reaction, cyst, hernia, fever, photosensitivity reaction, and accidental injury.

CARDIOVASCULAR SYSTEM: Angina pectoris, hypertension, vasodilatation, coronary artery disorder, electrocardiogram abnormal, ventricular extrasystoles, myocardial infarct, peripheral vascular disorder, migraine, varicose vein, cardiovascular disorder, hypotension, palpitation, vascular disorder, arrhythmia, phlebitis, tachycardia, extrasystoles, and atrial fibrillation.

DIGESTIVE SYSTEM: Dyspepsia, flatulence, nausea, increased appetite, gastroenteritis, cholelithiasis, rectal disorder, esophagitis, gastritis, colitis, tooth disorder, vomiting, anorexia, gastrointestinal disorder, duodenal ulcer, nausea and vomiting, peptic ulcer, rectal hemorrhage, liver fatty deposit, cholecystitis, eructation, gamma glutamyl transpeptidase, and diarrhea.

ENDOCRINE SYSTEM: Diabetes mellitus.

HEMIC AND LYMPHATIC SYSTEM: Anemia, leukopenia, ecchymosis, eosinophilia, lymphadenopathy, and thrombocytopenia.

METABOLIC AND NUTRITIONAL DISORDERS: Creatinine increased, weight gain, hypoglycemia, gout, weight loss, edema, hyperuricemia, and peripheral edema.

MUSCULOSKELETAL SYSTEM: Myositis, myalgia, arthralgia, arthritis, tenosynovitis, joint disorder, arthrosis, leg cramps, bursitis, and myasthenia.

NERVOUS SYSTEM: Dizziness, insomnia, depression, vertigo, libido decreased, anxiety, paresthesia, dry mouth, hypertonia, nervousness, neuralgia, and somnolence.

RESPIRATORY SYSTEM: Pharyngitis, bronchitis, cough increased, dyspnea, asthma, pneumonia, laryngitis, and sinusitis.

SKIN AND APPENDAGES: Rash, pruritus, eczema, herpes zoster, urticaria, acne, sweating, fungal dermatitis, skin disorder, alopecia, contact dermatitis, herpes simplex, maculopapular rash, nail disorder, and skin ulcer.

SPECIAL SENSES: Conjunctivitis, eye disorder, amblyopia, ear pain, otitis media, abnormal vision, cataract specified, and refraction disorder.

UROGENITAL SYSTEM: Urinary frequency, prostatic disorder, dysuria, kidney function abnormal, urolithiasis, gynecomastia, unintended pregnancy, vaginal moniliasis, and cystitis.

4

*Dosage equivalent to 200 mg Lofibra® [Fenofibrate capsules (micronized)]

5

**Significantly different from Placebo

Side Effects by Body System

General

Body as a whole effects probably related to fenofibrate or where causality has not yet been established include weight loss and fever.

General total body symptoms have included asthenia/fatigue or flu-like symptoms (5%) and infection (18%). During clinical studies, 6% of patients discontinued fenofibrate because of drug-related adverse effects. The most common reason for discontinuation of fenofibrate was skin rash in 2% of patients.

Hepatic

In clinical studies, 6% of patients receiving 134 mg to 200 mg fenofibrate daily experienced transaminase levels greater than 3 times the upper limits of normal. No such incidences occurred in patients receiving dosages of 34 mg to 67 mg daily. Hepatotoxicity can occur following weeks or years of therapy and is dose related. Cirrhosis associated with chronic active hepatitis has been reported.

Hepatic side effects have included significant increases in serum transaminase levels.

Musculoskeletal

Musculoskeletal side effects have included arthralgias (3%). In addition, the use of fibrate derivatives, including fenofibrate occasionally has been associated with myositis. Rhabdomyolysis has occurred rarely and generally in association with impaired renal function. Myopathy should be considered in the presence of symptoms of diffuse myalgias, muscle tenderness or weakness, and/or significant increase in serum creatine kinase. Combination therapy with HMG-CoA reductase inhibitors may increase the potential for myositis. Elevations in serum creatinine have also been associated with fenofibrate therapy.

Patients should be instructed to report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and, if elevated, fenofibrate should be discontinued.

Gemfibrozil is associated with a higher incidence of myotoxicity (i.e., rhabdomyolysis) than fenofibrate when used in combination with any HMG CoA reductase inhibitor (statin). Fenofibrate is primarily metabolized by glucuronidation, whereas gemfibrozil undergoes extensive oxidative metabolism which results in higher plasma levels of statins. This pharmacokinetic difference may account for the differences in the rates of myotoxicity.

A patient with auto-immune thyroiditis induced hypothyroidism developed acute renal failure secondary to simvastatin/fenofibrate combination therapy induced rhabdomyolysis. Following discontinuation of simvastatin/fenofibrate therapy and thyroid replacement, symptoms (i.e., muscle pain, oliguria) resolved and renal function returned to normal within 14 days.

Gastrointestinal

Gastrointestinal side effects having occurred during fenofibrate therapy where causality has not yet been established have included hematemesis.

Gastrointestinal side effects included dyspepsia (5%), nausea/vomiting (4%), flatulence, abdominal pain, constipation, or diarrhea (3%), and eructation (1%). In addition, an increased incidence of gallbladder disease/surgeries and pancreatitis occurred during clinical studies. Fibrate derivatives, including fenofibrate may increase cholesterol excretion into bile and result in cholelithiasis.

Dermatologic

Dermatologic side effects have included pruritus (3%) and rash (6%). During clinical studies, 2% of patients discontinued fenofibrate therapy because of rashes.

Dermatologic side effects possibly related to fenofibrate or where causality has not yet been established have included: photosensitivity, eczema, lupus-like syndrome, ichthyosis, telangiectasis, and alopecia.

Renal

Renal side effects have included acute renal failure. The accumulation of fenofibric acid in the presence of preexisting renal dysfunction causes an increase in levels of fenofibric acid, the main metabolite of fenofibrate. Renal side effects of fenofibric acid accumulation include acute renal failure associated with myositis and rhabdomyolysis.

Cardiovascular

Cardiovascular effects which have occurred during fenofibrate therapy where causality has not yet been established include facial and peripheral edema, angina, palpitations, tachycardia, migraine and epistaxis.

Cardiovascular side effects have included arrhythmia (1%) and pulmonary embolus (PE).

Nervous system

Nervous system side effects have included decreased libido (2%) and insomnia (1%).

Nervous system effects probably related to fenofibrate or where causality has not yet been established include dry mouth, vertigo, anxiety, sleep disorders, and confusion.

Respiratory

Respiratory side effects have included cough or sinusitis (1%) and rhinitis (4%).

Respiratory effects probably related to fenofibrate or where causality has not yet been established include allergic pulmonary alveolitis and congestion.

Ocular

Ocular side effects have included eye irritation (2%), eye floaters, blurred vision, or conjunctivitis (1%).

Other

Otic side effects have included earache (1%).

Genitourinary

Genitourinary side effects have included polyuria or vaginitis (1%).

Genitourinary effects occurring during fenofibrate where causality has not yet been established have included decreased male fertility and renal lithiasis.

Hypersensitivity

Hypersensitivity side effects have included severe skin rashes (requiring hospitalization and steroid therapy), urticaria and less severe rashes.

Hematologic

Hematologic side effects have included mild to moderate decreases in hemoglobin and hematocrit and white blood cells, rare incidences of thrombocytopenia and agranulocytosis, and deep vein thrombosis (DVT).

Oncologic

Oncologic effects of tumor growth in rodents have been associated with many lipid-lowering drugs. Fenofibrate has been associated with liver, pancreatic and testicular tumors in rats. Long-term clinical trials are needed to define the risk of cancer in humans.

Endocrine

Endocrine side effects include at least one case of fenofibrate-induced gynecomastia that resolved following discontinuation and recurred upon rechallenge.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.