Effexor XR

[venlafaxine hydrochloride]

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%).

Text Continues Below

---

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%).

Page:  << Prev | 1 | 2 | 3 | 4 | 5 | Next >>