Effexor XR - Side Effects & Drug Interactions

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Table 2

Common Adverse Events Leading to Discontinuation of Treatment in Placebo-Controlled Trials 1

Percentage of Patients Discontinuing Due to Adverse Event

Adverse Event Major Depressive

Disorder Indication 2

GAD Indication 3,4 Social Anxiety

Disorder Indication

Effexor XR

n = 357

Placebo

n = 285

Effexor XR

n = 1381

Placebo

n = 555

Effexor XR

n = 277

Placebo

n = 274

Body as a Whole Asthenia ----

3 < 1 1% < 1

Headache --------2% < 1

Digestive System Nausea

4 < 1 8% < 1 4% 0%

Anorexia 1 < 1 --------Dry

Mouth 1 0 2 < 1 ----Vomiting

----1% < 1% ----Nervous

System Dizziness

2 1 ----2% 0%

Insomnia 1 < 1 3 < 1 3% < 1

Somnolence 2 < 1 3 < 1 2% < 1

Nervousness ----2 < 1 ----Tremor

----1 0 ----Anxiety

--------1% < 1

Skin Sweating ----

2 < 1 1% 0%

Urogenital System Impotence 5 --------3% 0%

1 Two of the major depressive disorder studies were flexible dose and one was fixed dose. Four of the GAD studies were fixed dose and one was flexible dose. Both of the Social Anxiety Disorder studies were flexible dose.

2 In U. S. placebo-controlled trials for major depressive disorder, the following were also common events leading to discontinuation and were considered to be drug-related for Effexor XR-treated patients (% Effexor XR [n = 192], % Placebo [n = 202]): hypertension (1 , < 1 ); diarrhea (1 ,0 ); paresthesia (1 ,0 ); tremor (1 ,0 ); abnormal vision, mostly

blurred vision (1 ,0 ); and abnormal, mostly delayed, ejaculation (1 ,0 ).

3 In two short-term U. S. placebo-controlled trials for GAD, the following were also common events leading to discontinuation and were considered to be drug-related for Effexor XR-treated patients ( Effexor XR [n = 476]), % Placebo [n = 201]: headache (4%, < 1%); vasodilatation (1%, 0%); anorexia (2%, < 1%); dizziness (4%, 1%); thinking abnormal (1%, 0%); and abnormal

vision (1%, 0%).

4 In long-term placebo-controlled trials for GAD, the following was also a common event

leading to discontinuation and was considered to be drug-related for Effexor XR-treated patients

(% Effexor XR [n = 535], % Placebo [n = 257]): decreased libido (1%, 0%).