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Lipofen (Fenofibrate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials Experience

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

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

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

* Dosage equivalent to 150 mg LIPOFEN
** Significantly different from placebo

BODY SYSTEM
Adverse Event
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 ALT 3.0% 1.6%
Creatine Phosphokinase Increased 3.0% 1.4%
Increased AST 3.4%** 0.5%
RESPIRATORY
Respiratory Disorder 6.2% 5.5%
Rhinitis 2.3% 1.1%

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, acute renal failure, muscle spasm, hepatitis, cirrhosis, anemia, arthralgia, decreases in hemoglobin, decreases in hematocrit, white blood cell decreases, 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 causal relationship to drug exposure.



REPORTS OF SUSPECTED LIPOFEN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Lipofen. The information is not vetted and should not be considered as verified clinical evidence.

Possible Lipofen side effects / adverse reactions in 51 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-28

Patient: 51 year old female weighing 77.1 kg (169.6 pounds)

Reactions: Nausea, Feeling Abnormal, Influenza Like Illness

Adverse event resulted in: hospitalization

Suspect drug(s):
Lipofen
    Dosage: 150 mg;1x;po
    Administration route: Oral
    Start date: 2011-11-22
    End date: 2011-12-13

Livalo
    Dosage: 1x;po
    Administration route: Oral
    Start date: 2011-11-22
    End date: 2011-12-13

Other drugs received by patient: Zofran; Effexor XR; Seroquel; Lamictal; Bentyl; Synthroid



Possible Lipofen side effects / adverse reactions in 64 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-24

Patient: 64 year old male

Reactions: Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased

Suspect drug(s):
Lipofen
    Dosage: 150 mg; po
    Administration route: Oral
    Start date: 2011-08-09

Livalo
    Dosage: 4mg;1x;po : ;1mg;1x;po
    Administration route: Oral
    Start date: 2011-08-01
    End date: 2011-10-01

Other drugs received by patient: Methadone HCL; Morphine Sulfate



Possible Lipofen side effects / adverse reactions in 51 year old female

Reported by a individual with unspecified qualification from United States on 2012-03-06

Patient: 51 year old female weighing 77.3 kg (170.1 pounds)

Reactions: Nausea, Influenza

Adverse event resulted in: hospitalization

Suspect drug(s):
Livalo
    Start date: 2011-11-22
    End date: 2011-12-13

Lipofen
    Dosage: 150mg, daily, oral
    Administration route: Oral
    Start date: 2011-11-22
    End date: 2011-12-13

Other drugs received by patient: Synthroid; Seroquel; Effexor; Bentyl; Zofran; Lamictal



See index of all Lipofen side effect reports >>

Drug label data at the top of this Page last updated: 2013-01-29

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