Tricor (Fenofibrate) - Side Effects and Adverse Reactions

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	Fenofibrate*	Placebo
*   Dosage equivalent to 145 mg TRICOR. **   Significantly different from Placebo.
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 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.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO TRICOR

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

Reported by a consumer/non-health professional from United States on 2007-01-29

Patient: 65 year old male

Reactions: Flushing, Medication Error, Drug Interaction, Myocardial Infarction

Adverse event resulted in: death

Suspect drug(s):
Wellbutrin
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Depression

Lanoxin
    Dosage: .375mg per day
    Administration route: Oral
    Indication: Tachyarrhythmia

Niaspan
    Dosage: 1000mg single dose
    Administration route: Oral
    Start date: 2006-07-11
    End date: 2006-07-11

Trazodone HCL
    Dosage: 200mg per day
    Administration route: Oral
    Indication: Depression

Tenormin
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Tachyarrhythmia

Glucophage
    Dosage: 1000mg twice per day
    Administration route: Oral
    Indication: Diabetes Mellitus

Glucotrol XL
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Diabetes Mellitus

Actos
    Dosage: 45mg per day
    Administration route: Oral
    Indication: Diabetes Mellitus

Tricor
    Dosage: 160mg per day
    Administration route: Oral

Lantus
    Dosage: 70u per day
    Indication: Diabetes Mellitus

Lipitor
    Indication: Drug USE FOR Unknown Indication

Effexor
    Dosage: 150mg per day
    Administration route: Oral
    Indication: Depression

Lorazepam
    Dosage: 2mg per day
    Administration route: Oral
    Indication: Depression

Risperdal
    Dosage: 3mg per day
    Administration route: Oral

Multi-Vitamins

Other drugs received by patient: NO Concurrent Medications

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

Reported by a physician from United States on 2007-01-31

Patient: 65 year old male weighing 94.8 kg (208.6 pounds)

Reactions: Cardio-Respiratory Arrest, Myocardial Infarction

Adverse event resulted in: death

Suspect drug(s):
Actos
    Dosage: 45 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2003-07-01
    End date: 2006-06-11

Niaspan
    Dosage: 1000 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2006-06-11
    End date: 2006-06-11

Niaspan
    Dosage: 1000 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2006-06-11
    End date: 2006-06-11

Wellbutrin
    Dosage: 300 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Depression
    End date: 2006-06-11

Effexor
    Dosage: 150 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Depression
    End date: 2006-06-11

Lorazepam
    Dosage: 2 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Depression
    End date: 2006-06-11

Trazodone HCL
    Dosage: 200 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Depression
    End date: 2006-06-11

Tenormin
    Dosage: 100 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Tachyarrhythmia
    End date: 2006-06-11

Lanoxin
    Dosage: 0.375 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Tachyarrhythmia
    End date: 2006-06-11

Glucophage
    Dosage: 1000 mg, 2 in 1 d, per oral
    Administration route: Oral
    Indication: Diabetes Mellitus
    End date: 2006-06-11

Glucotrol XL
    Dosage: 10 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Diabetes Mellitus
    End date: 2006-06-11

Tricor
    Dosage: 160 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Dyslipidaemia
    End date: 2006-06-11

Lantus
    Dosage: see image
    Indication: Diabetes Mellitus
    End date: 2006-06-09

Lantus
    Dosage: see image
    Indication: Diabetes Mellitus
    Start date: 2006-06-09
    End date: 2006-06-11

Lipitor
    End date: 2006-06-11

Multivitamin
    End date: 2006-06-11

Risperdal
    Dosage: 3 mg, per oral
    Administration route: Oral
    End date: 2006-06-11

Possible Tricor side effects / adverse reactions in 37 year old female

Reported by a physician from United States on 2007-02-05

Patient: 37 year old female

Reactions: Liver Injury, Cytomegalovirus Antibody Positive, Abdominal Pain, Jaundice, Hepatitis C Antibody Positive, Nausea, Drug Toxicity, Myalgia, Fatigue, Hepatitis A Antibody Positive

Suspect drug(s):
Tricor