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Antara (Fenofibrate) - Side Effects and Adverse Reactions

 
 



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 1
( N = 439 )
Placebo
( N = 365 )
Body  As  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% 2
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%

1 Dosage equivalent to 130 mg fenofibrate
2 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.

Drug label data at the top of this Page last updated: 2014-09-02

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