EFFEXOR: COMMON SIDE EFFECTS
TABLE 1
Treatment-Emergent Adverse Experience Incidence in 4- to 8-Week Placebo-Controlled Clinical Trials1
Body System
|
Preferred Term
|
Effexor
(n=1033) |
Placebo
(n=609) |
Body as a Whole |
Headache |
25% |
24% |
Asthenia |
12% |
6% |
|
Infection |
6% |
5% |
|
Chills |
3% |
¾ |
|
Chest pain |
2% |
1% |
|
Trauma |
2% |
1% |
|
Cardiovascular |
Vasodilatation |
4% |
3% |
Increased blood |
|||
pressure/hypertension |
2% |
¾ |
|
Tachycardia |
2% |
¾ |
|
Postural hypotension |
1% |
¾ |
|
Dermatological |
Sweating |
12% |
3% |
Rash |
3% |
2% |
|
Pruritus |
1% |
¾ |
|
Gastrointestinal |
Nausea |
37% |
11% |
Constipation |
15% |
7% |
|
Anorexia |
11% |
2% |
|
Diarrhea |
8% |
7% |
|
Vomiting |
6% |
2% |
|
Dyspepsia |
5% |
4% |
|
Flatulence |
3% |
2% |
|
Metabolic |
Weight loss |
1% |
¾ |
Nervous System |
Somnolence |
23% |
9% |
Dry mouth |
22% |
11% |
|
Dizziness |
19% |
7% |
|
Insomnia |
18% |
10% |
|
Nervousness |
13% |
6% |
|
Anxiety |
6% |
3% |
|
Tremor |
5% |
1% |
|
Abnormal dreams |
4% |
3% |
|
Hypertonia |
3% |
2% |
|
Paresthesia |
3% |
2% |
|
Libido decreased |
2% |
¾ |
|
Agitation |
2% |
¾ |
|
Confusion |
2% |
1% |
|
Thinking abnormal |
2% |
1% |
|
Depersonalization |
1% |
¾ |
|
Depression |
1% |
¾ |
|
Urinary retention |
1% |
¾ |
|
Twitching |
1% |
¾ |
|
Respiration |
Yawn |
3% |
¾ |
Special Senses |
Blurred vision |
6% |
2% |
Taste perversion |
2% |
¾ |
|
Tinnitus |
2% |
¾ |
|
Mydriasis |
2% |
¾ |
|
Urogenital System
|
Abnormal ejaculation/
orgasm |
12%2 |
¾2 |
Impotence |
6%2 |
¾2 |
|
Urinary frequency |
3% |
2% |
|
Urination impaired |
2% |
¾ |
|
Orgasm disturbance |
2%3 |
¾3 |
1 Events reported by at least 1% of patients treated with Effexor (venlafaxine hydrochloride) tablets are included, and are rounded to the nearest %. Events for which the Effexor incidence was equal to or less than placebo are not listed in the table, but included the following: abdominal pain, pain, back pain, flu syndrome, fever, palpitation, increased appetite, myalgia, arthralgia, amnesia, hypesthesia, rhinitis, pharyngitis, sinusitis, cough increased, and dysmenorrhea 3 .
¾ Incidence less than 1%.
2 Incidence based on number of male patients.
3 Incidence based on number of female patients
