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Tricor (Fenofibrate) - Side Effects and 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.

Fenofibrate* Placebo

*   Dosage equivalent to 145 mg TRICOR.

**   Significantly different from Placebo.

Adverse Event (N=439) (N=365)
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%
Liver Function Tests Abnormal 7.5%** 1.4%
Diarrhea 2.3% 4.1%
Nausea 2.3% 1.9%
Constipation 2.1% 1.4%
SGPT Increased 3.0% 1.6%
Creatine Phosphokinase Increased 3.0% 1.4%
SGOT Increased 3.4% ** 0.5%
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.


Below is a sample of reports where side effects / adverse reactions may be related to Tricor. The information is not vetted and should not be considered as verified clinical evidence.

Possible Tricor side effects / adverse reactions in 35 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-11

Patient: 35 year old female weighing 71.7 kg (157.7 pounds)

Reactions: Pancreatitis, Nervousness

Suspect drug(s):

Possible Tricor side effects / adverse reactions in 65 year old female

Reported by a physician from United States on 2011-10-20

Patient: 65 year old female weighing 90.7 kg (199.6 pounds)

Reactions: Vomiting, Malaise, Diarrhoea, Pain, Prothrombin Time Prolonged, Abdominal Pain Upper, Muscle Spasms

Suspect drug(s):

Possible Tricor side effects / adverse reactions in 72 year old male

Reported by a consumer/non-health professional from United States on 2011-10-21

Patient: 72 year old male

Reactions: Lung Neoplasm Malignant

Adverse event resulted in: death, hospitalization

Suspect drug(s):

See index of all Tricor side effect reports >>

Drug label data at the top of this Page last updated: 2009-11-18

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