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In the two U. S. placebo-controlled trials, the following additional events occurred in at least 5 of Effexor XR-treated patients (n = 192) and at a rate at least twice that of the placebo group: Abnormalities of sexual function (impotence in men, anorgasmia in women, and libido decreased),
gastrointestinal complaints (constipation and flatulence),
CNS complaints (insomnia, nervousness, and tremor),
problems of special senses (abnormal vision), cardiovascular effects (hypertension and vasodilatation), and yawning. Generalized Anxiety Disorder Text Continues Below
Note in particular the following adverse events that occurred in at least 5 of the Effexor XR patients and at a rate at least twice that of the placebo group for all placebo-controlled trials for the GAD indication (Table 4): Abnormalities of sexual function (abnormal ejaculation and impotence), gastrointestinal complaints (nausea, dry mouth, anorexia, and constipation), problems of special senses (abnormal vision), and sweating. Social Anxiety Disorder Note in particular the following adverse events that occurred in at least 5% of the Effexor XR patients and at a rate at least twice that of the placebo group for the 2 placebo-controlled trials for the Social Anxiety Disorder indication (Table 5): Asthenia, gastrointestinal complaints (anorexia, dry mouth, nausea), CNS complaints (anxiety, insomnia, libido decreased, nervousness, somnolence, dizziness), abnormalities of sexual function (abnormal ejaculation, orgasmic dysfunction, impotence), yawn, sweating, and abnormal vision. Table 3
Treatment-Emergent Adverse Event Incidence in Short-Term Placebo-Controlled
Effexor XR Clinical Trials in Patients with Major Depressive Disorder 1,2
% % % % Reporting Event Body System
Preferred Term
Effexor XR
(n = 357)
Placebo
(n = 285)
Body as a Whole
Asthenia 8 7
Cardiovascular System
Vasodilatation 3 4 2
Hypertension 4 1
Digestive System
Nausea 31 12
Constipation 8 5
Anorexia 8 4
Vomiting 4 2
Flatulence 4 3
Metabolic/ Nutritional Weight Loss
3 0
Nervous System Dizziness
20 9
Somnolence 17 8%
Insomnia 17% 11
Dry Mouth 12 6
Nervousness 10 5
Abnormal Dreams 4 7 2
Tremor 5 2
Depression 3 < 1
Paresthesia 3 1
Libido Decreased 3 < 1
Agitation 3 1
Respiratory System Pharyngitis
7 6
Yawn 3 0
Skin Sweating
14 3 % % % % Reporting Event Body System
Preferred Term
Effexor XR
(n = 357)
Placebo
(n = 285)
Special Senses Abnormal Vision 5
4 < 1
Urogenital System Abnormal Ejaculation
16 < 1
(male) 6,7
Impotence 7 4 < 1
Anorgasmia (female) 8,9 3 < 1 1
Incidence, rounded to the nearest % , for events reported by at least 2 of patients treated with Effexor XR, except the following events which had an incidence equal to or less than placebo: Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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