ADVERSE REACTIONS
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
|
4.6%
|
4.4%
|
Back Pain
|
3.4%
|
2.5%
|
Headache
|
3.2%
|
2.7%
|
Digestive
|
|
|
Abnormal Liver Function Tests
|
7.5%
|
1.4%
|
Nausea
|
2.3%
|
1.9%
|
Constipation
|
2.1%
|
1.4%
|
Metabolic
and
Nutritional
Disorders
|
|
|
Increased AST
|
3.4%
|
0.5%
|
Increased ALT
|
3.0%
|
1.6%
|
Increased Creatine Phosphokinase
|
3.0%
|
1.4%
|
Respiratory
|
|
|
Respiratory Disorder
|
6.2%
|
5.5%
|
Rhinitis
|
2.3%
|
1.1%
|
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.
|