Effexor XR - Side Effects & Drug Interactions

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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

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