Venlafaxine Hydrochloride (Page 9 of 14)

Incidence in Controlled Trials

Commonly Observed Adverse Events in Controlled Clinical Trials

The most commonly observed adverse events associated with the use of venlafaxine hydrochloride (incidence of 5% or greater) and not seen at an equivalent incidence among placebo-treated patients (i.e., incidence for venlafaxine hydrochloride at least twice that for placebo), derived from the 1% incidence table below, were asthenia, sweating, nausea, constipation, anorexia, vomiting, somnolence, dry mouth, dizziness, nervousness, anxiety, tremor, and blurred vision as well as abnormal ejaculation/orgasm and impotence in men.

Adverse Events Occurring at an Incidence of 1% or More Among Venlafaxine Hydrochloride-Treated Patients

The table that follows enumerates adverse events that occurred at an incidence of 1% or more, and were more frequent than in the placebo group, among venlafaxine hydrochloride-treated patients who participated in short-term (4 to 8 week) placebo-controlled trials in which patients were administered doses in a range of 75 to 375 mg/day. This table shows the percentage of patients in each group who had at least one episode of an event at some time during their treatment. Reported adverse events were classified using a standard COSTART-based Dictionary terminology.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.

TABLE 2: Treatment-Emergent Adverse Experience Incidence in 4 to 8 Week Placebo-Controlled Clinical Trials *
— Incidence less than 1%.
*
Events reported by at least 1% of patients treated with venlafaxine hydrochloride are included, and are rounded to the nearest %. Events for which the venlafaxine hydrochloride 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 dysmenorrhea3.
Incidence based on number of male patients.
Incidence based on number of female patients.

Body System

Preferred Term

Venlafaxine Hydrochloride (n = 1033)

Placebo (n = 609)

Body as a Whole

Headache

25%

24%

Asthenia

12%

6%

Infection

6%

5%

Chills

3%

Chest pain

2%

1%

Trauma

2%

1%

Cardiovascular

Vasodilatation

4%

3%

Increased blood pressure/hypertension

2%

Tachycardia

2%

Postural hypotension

1%

Dermatological

Sweating

12%

3%

Rash

3%

2%

Pruritus

1%

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%

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%

Agitation

2%

Confusion

2%

1%

Thinking abnormal

2%

1%

Depersonalization

1%

Depression

1%

Urinary retention

1%

Twitching

1%

Respiration

Yawn

3%

Special Senses

Blurred vision

6%

2%

Taste perversion

2%

Tinnitus

2%

Mydriasis

2%

Urogenital System

Abnormal ejaculation/orgasm

12%

Impotence

6%

Urinary frequency

3%

2%

Urination impaired

2%

Orgasm disturbance

2%

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