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Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in clinical practice.

Adverse events reported by 2% or more of patients treated with fenofibrate and greater than placebo during double-blind, placebo-controlled trials, regardless of causality, are listed in Table 1. Adverse reactions 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.

Table 1 : Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

Body System Adverse Reaction Fenofibrate*
(N=439)
Placebo
(N=365)
Body As A Whole
  Abdominal Pain 4.60% 4.40%
  Back Pain 3.40% 2.50%
  Headache 3.20% 2.70%
Digestive
  Abnormal Liver Function Tests 7.5%** 1.40%
  Nausea 2.30% 1.90%
  Constipation 2.10% 1.40%
Metabolic and Nutritional Disorders
  Increased AST 3.4%** 0.50%
  Increased ALT 3.00% 1.60%
  Increased Creatine Phosphokinase 3.00% 1.40%
Respiratory
  Respiratory Disorder 6.20% 5.50%
  Rhinitis 2.30% 1.10%
* Dosage equivalent to 90 mg fenofibrate
**Significantly different from placebo

Postmarketing Experience

The following adverse reactions have been identified during post approval use of fenofibrate: myalgia, rhabdomyolysis, , pancreatitis, , renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, arthralgia, asthenia and severely depressed HDL-cholesterol levels. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.