Venlafaxine Hydrochloride (Page 11 of 16)

Adverse Events Occurring at an Incidence of 2% or More Among Venlafaxine Hydrochloride Extended-Release Capsule-Treated Patients

Tables 7 and 10 enumerate the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of major depressive disorder (up to 12 weeks; dose range of 75 to 225 mg/day), and of panic disorder (up to 12 weeks; dose range of 37.5 to 225 mg/day), respectively, in 2% or more of patients treated with venlafaxine hydrochloride extended-release capsules where the incidence in patients treated with venlafaxine hydrochloride extended-release capsules was greater than the incidence for the respective placebo-treated patients. The 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.

Commonly Observed Adverse Events From Tables 7 and 10

Major Depressive Disorder

Note in particular the following adverse events that occurred in at least 5% of the venlafaxine hydrochloride extended-release capsule patients and at a rate at least twice that of the placebo group for all placebo-controlled trials for the major depressive disorder indication (Table 7): Abnormal ejaculation, gastrointestinal complaints (nausea, dry mouth, and anorexia), CNS complaints (dizziness, somnolence, and abnormal dreams), and sweating. In the two U.S. placebo-controlled trials, the following additional events occurred in at least 5% of venlafaxine hydrochloride extended-release capsule-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.

Panic Disorder

Note in particular the following adverse events that occurred in at least 5% of the venlafaxine hydrochloride extended-release capsule patients and at a rate at least twice that of the placebo group for 4 placebo-controlled trials for the panic disorder indication (Table 10): gastrointestinal complaints (anorexia, constipation, dry mouth), CNS complaints (somnolence, tremor), abnormalities of sexual function (abnormal ejaculation), and sweating.

Table 7: Treatment-Emergent Adverse Event Incidence in Short-Term Placebo-Controlled Venlafaxine Hydrochloride Extended-Release Capsule Clinical Trials in Patients With Major Depressive Disorder *
*
Incidence, rounded to the nearest %, for events reported by at least 2% of patients treated with venlafaxine hydrochloride extended-release capsules, except the following events which had an incidence equal to or less than placebo: abdominal pain, accidental injury, anxiety, back pain, bronchitis, diarrhea, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, pain, palpitation, rhinitis, and sinusitis.
< 1% indicates an incidence greater than zero but less than 1%.
Mostly “hot flashes.”
§
Mostly “vivid dreams,” “nightmares,” and “increased dreaming.”
Mostly “blurred vision” and “difficulty focusing eyes.”
#
Mostly “delayed ejaculation.”
Þ
Incidence is based on the number of male patients.
ß
Mostly “delayed orgasm” or “anorgasmia.”
à
Incidence is based on the number of female patients.

Body System

% Reporting Event

Venlafaxine Hydrochloride Extended-Release Capsules

Placebo

Preferred Term

(n = 357)

(n = 285)

Body as a Whole

Asthenia

8%

7%

Cardiovascular System

Vasodilatation

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 §

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%

Special Senses

Abnormal Vision

4%

< 1%

Urogenital System

Abnormal Ejaculation (male)#,Þ

16%

< 1%

Impotence Þ

4%

< 1%

Anorgasmia (female)ß,à

3%

< 1%

Table 10: Treatment-Emergent Adverse Event Incidence in Short-Term Placebo-Controlled Venlafaxine Hydrochloride Extended-Release Capsule Clinical Trials in Panic Disorder Patients *
*
Adverse events for which the venlafaxine hydrochloride extended-release capsules reporting rate was less than or equal to the placebo rate are not included. These events are: abdominal pain, abnormal vision, accidental injury, anxiety, back pain, diarrhea, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, nervousness, pain, paresthesia, pharyngitis, rash, rhinitis, and vomiting.
< 1% means greater than zero but less than 1%.
Mostly “hot flushes.”
§
Mostly “decreased appetite” and “loss of appetite.”
Includes “delayed or retarded ejaculation” and “anorgasmia.”
#
Percentage based on the number of males (venlafaxine hydrochloride extended-release capsules = 335, placebo = 238).
Þ
Includes “anorgasmia” and “delayed orgasm.”
ß
Percentage based on the number of females (venlafaxine hydrochloride extended-release capsules = 666, placebo = 424).

% Reporting Event

Body System

Preferred Term

Venlafaxine Hydrochloride Extended-Release Capsules

(n = 1001)

Placebo

(n = 662)

Body as a Whole

Asthenia

10%

8%

Cardiovascular System

Hypertension

4%

3%

Vasodilatation

3%

2%

Digestive System

Nausea

21%

14%

Dry Mouth

12%

6%

Constipation

9%

3%

Anorexia §

8%

3%

Nervous System

Insomnia

17%

9%

Somnolence

12%

6%

Dizziness

11%

10%

Tremor

5%

2%

Libido Decreased

4%

2%

Skin

Sweating

10%

2%

Urogenital System

Abnormal Ejaculation ,#

8%

< 1%

Impotence #

4%

< 1%

Orgasmic Dysfunction Þ,ß

2%

< 1%

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