Venlafaxine Hydrochloride (Page 10 of 14)

Dose Dependency of Adverse Events

A comparison of adverse event rates in a fixed-dose study comparing venlafaxine hydrochloride 75, 225, and 375 mg/day with placebo revealed a dose dependency for some of the more common adverse events associated with venlafaxine hydrochloride use, as shown in the table that follows. The rule for including events was to enumerate those that occurred at an incidence of 5% or more for at least one of the venlafaxine groups and for which the incidence was at least twice the placebo incidence for at least one venlafaxine hydrochloride group. Tests for potential dose relationships for these events (Cochran-Armitage Test, with a criterion of exact 2 sided p-value ≤ 0.05) suggested a dose-dependency for several adverse events in this list, including chills, hypertension, anorexia, nausea, agitation, dizziness, somnolence, tremor, yawning, sweating, and abnormal ejaculation.

TABLE 3: Treatment-Emergent Adverse Experience Incidence in a Dose Comparison Trial

Venlafaxine Hydrochloride (mg/day)

Body System/Preferred Term

Placebo (n = 92)

75 (n = 89)

225 (n = 89)

375 (n = 88)

Body as a Whole

Abdominal pain

3.3%

3.4%

2.2%

8%

Asthenia

3.3%

16.9%

14.6%

14.8%

Chills

1.1%

2.2%

5.6%

6.8%

Infection

2.2%

2.2%

5.6%

2.3%

Cardiovascular System

Hypertension

1.1%

1.1%

2.2%

4.5%

Vasodilatation

0%

4.5%

5.6%

2.3%

Digestive System

Anorexia

2.2%

14.6%

13.5%

17%

Dyspepsia

2.2%

6.7%

6.7%

4.5%

Nausea

14.1%

32.6%

38.2%

58%

Vomiting

1.1%

7.9%

3.4%

6.8%

Nervous System

Agitation

0%

1.1%

2.2%

4.5%

Anxiety

4.3%

11.2%

4.5%

2.3%

Dizziness

4.3%

19.1%

22.5%

23.9%

Insomnia

9.8%

22.5%

20.2%

13.6%

Libido decreased

1.1%

2.2%

1.1%

5.7%

Nervousness

4.3%

21.3%

13.5%

12.5%

Somnolence

4.3%

16.9%

18.0%

26.1%

Tremor

0%

1.1%

2.2%

10.2%

Respiratory System

Yawn

0%

4.5%

5.6%

8%

Skin and Appendages

Sweating

5.4%

6.7%

12.4%

19.3%

Special Senses

Abnormality of accommodation

0%

9.1%

7.9%

5.6%

Urogenital System

Abnormal ejaculation/orgasm

0%

4.5%

2.2%

12.5%

Impotence

0%

5.8%

2.1%

3.6%

(Number of men)

(n = 63)

(n = 52)

(n = 48)

(n = 56)

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