Tricor Side Effects
Generic Name: Fenofibrate
Please note - some side effects for Tricor 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).
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For the consumer For the professional
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Side Effects of Tricor - for the consumer
Tricor
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tricor:
Seek medical attention right away if any of these SEVERE side effects occur when using Tricor:Headache; nausea.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills or sore throat; dark urine; fever; muscle pain, tenderness, or weakness; pale stools; red, swollen, blistered or peeling skin; severe or persistent nausea, vomiting, or stomach pain; unusual bruising or bleeding; yellowing of the skin or eyes.
For the professional
Tricor
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.
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BODY SYSTEM |
Fenofibrate* | Placebo |
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| Adverse Event | (N=439) | (N=365) |
| 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 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, allergic pulmonary alveolitis, 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, abnormal kidney function, urolithiasis, gynecomastia, unintended pregnancy, vaginal moniliasis, and cystitis.
TopMore resources:
Tricor - Includes detailed dosage instructions.
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