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*
|Body As A Whole|
|Abnormal Liver Function Tests||7.5%**||1.40%|
|Metabolic and Nutritional Disorders|
|Increased Creatine Phosphokinase||3.00%||1.40%|
|* Dosage equivalent to 90 mg fenofibrate
**Significantly different from placebo
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.