ADVERSE REACTIONS
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 SYSTEM
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Fenofibrate*
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Placebo
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* Dosage equivalent to 145 mg TRICOR.
** Significantly different from Placebo.
|
Adverse Event
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(N=439)
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(N=365)
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BODY AS A WHOLE
|
|
|
Abdominal Pain |
4.6% |
4.4% |
Back Pain |
3.4% |
2.5% |
Headache |
3.2% |
2.7% |
Asthenia |
2.1% |
3.0% |
Flu Syndrome |
2.1% |
2.7% |
DIGESTIVE
|
|
|
Liver Function Tests Abnormal |
7.5%** |
1.4% |
Diarrhea |
2.3% |
4.1% |
Nausea |
2.3% |
1.9% |
Constipation |
2.1% |
1.4% |
METABOLIC AND NUTRITIONAL DISORDERS
|
|
SGPT Increased |
3.0% |
1.6% |
Creatine Phosphokinase Increased |
3.0% |
1.4% |
SGOT Increased |
3.4% ** |
0.5% |
RESPIRATORY
|
|
|
Respiratory Disorder |
6.2% |
5.5% |
Rhinitis |
2.3% |
1.1% |
Additional adverse events reported during post-marketing surveillance or 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
Accidental injury, allergic reaction, chest pain, cyst, fever, hernia, infection, malaise and pain (unspecified).
Cardiovascular System
Angina pectoris, arrhythmia, atrial fibrillation, cardiovascular disorder, coronary artery disorder, electrocardiogram abnormal, extrasystoles, hypertension, hypotension, migraine, myocardial infarct, palpitation, peripheral vascular disorder, phlebitis, tachycardia, varicose vein, vascular disorder, vasodilatation, venous thromboembolic events (deep vein thrombosis, pulmonary embolus) and ventricular extrasystoles.
Digestive System
Anorexia, cholecystitis, cholelithiasis, colitis, diarrhea, duodenal ulcer, dyspepsia, eructation, esophagitis, flatulence, gastritis, gastroenteritis, gastrointestinal disorder, increased appetite, jaundice, liver fatty deposit, nausea, pancreatitis, peptic ulcer, rectal disorder, rectal hemorrhage, tooth disorder and vomiting.
Endocrine System
Diabetes mellitus.
Hemic and Lymphatic System
Anemia, ecchymosis, eosinophilia, leukopenia, lymphadenopathy, and thrombocytopenia.
Laboratory Investigations
Alkaline phosphatase increased, bilirubin increased, blood urea nitrogen increased, serum creatinine increased, gamma glutamyl transpeptidase increased, lactate dehydrogenase increased, SGOT and SGPT increased.
Metabolic and Nutritional Disorders
Edema, gout, hyperuricemia, hypoglycemia, peripheral edema, weight gain, and weight loss.
Musculoskeletal System
Arthralgia, arthritis, arthrosis, bursitis, joint disorder, leg cramps, myalgia, myasthenia, myositis, rhabdomyolysis and tenosynovitis.
Nervous System
Anxiety or nervousness, depression, dizziness, dry mouth, hypertonia, insomnia, libido decreased, neuralgia, paresthesia, somnolence and vertigo.
Respiratory System
Allergic pulmonary alveolitis, asthma, bronchitis, cough increased, dyspnea, laryngitis, pharyngitis, pneumonia and sinusitis.
Skin and Appendages
Acne, alopecia, contact dermatitis, eczema, fungal dermatitis, herpes simplex, herpes zoster, maculopapular rash, nail disorder, photosensitivity reaction, pruritus, rash, sweating, skin disorder, skin ulcer and urticaria.
Special Senses
Abnormal vision, amblyopia, cataract specified, conjunctivitis, ear pain, eye disorder, otitis media and refraction disorder.
Urogenital System
Abnormal kidney function, cystitis, dysuria, gynecomastia, prostatic disorder, unintended pregnancy, urinary frequency, urolithiasis and vaginal moniliasis.
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