ABILIFY (Page 9 of 24)

6.1 Clinical Trials Experience

Adult Patients with Schizophrenia

The following findings are based on a pool of five placebo-controlled trials (four 4-week and one 6-week) in which oral ABILIFY was administered in doses ranging from 2 to 30 mg/day.

Commonly Observed Adverse Reactions

The only commonly observed adverse reaction associated with the use of ABILIFY in patients with schizophrenia (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) was akathisia (ABILIFY 8%; placebo 4%).

Adult Patients with Bipolar Mania

Monotherapy

The following findings are based on a pool of 3-week, placebo-controlled, bipolar mania trials in which oral ABILIFY was administered at doses of 15 or 30 mg/day.

Commonly Observed Adverse Reactions

Commonly observed adverse reactions associated with the use of ABILIFY in patients with bipolar mania (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 16.

Table 16:Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Adult Patients with Bipolar Mania Treated with Oral ABILIFY Monotherapy

Percentage of Patients Reporting Reaction

ABILIFY

Placebo

Preferred Term

(n=917)

(n=753)

Akathisia

13

4

Sedation

8

3

Restlessness

6

3

Tremor

6

3

Extrapyramidal Disorder

5

2

Less Common Adverse Reactions in Adults

Table 17 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (up to 6 weeks in schizophrenia and up to 3 weeks in bipolar mania), including only those reactions that occurred in 2% or more of patients treated with ABILIFY (doses ≥2 mg/day) and for which the incidence in patients treated with ABILIFY was greater than the incidence in patients treated with placebo in the combined dataset.

Table 17:Adverse Reactions in Short-Term, Placebo-Controlled Trials in Adult Patients Treated with Oral ABILIFY

Percentage of Patients Reporting Reactiona

System Organ Class

ABILIFY

Placebo

Preferred Term

(n=1843)

(n=1166)

Eye Disorders

Blurred Vision

3

1

Gastrointestinal Disorders

Nausea

15

11

Constipation

11

7

Vomiting

11

6

Dyspepsia

9

7

Dry Mouth

5

4

Toothache

4

3

Abdominal Discomfort

3

2

Stomach Discomfort

3

2

General Disorders and Administration Site Conditions

Fatigue

6

4

Pain

3

2

Musculoskeletal and Connective Tissue Disorders

Musculoskeletal Stiffness

4

3

Pain in Extremity

4

2

Myalgia

2

1

Muscle Spasms

2

1

Nervous System Disorders

Headache

27

23

Dizziness

10

7

Akathisia

10

4

Sedation

7

4

Extrapyramidal Disorder

5

3

Tremor

5

3

Somnolence

5

3

Psychiatric Disorders

Agitation

19

17

Insomnia

18

13

Anxiety

17

13

Restlessness

5

3

Respiratory, Thoracic, and Mediastinal Disorders

Pharyngolaryngeal Pain

3

2

Cough

3

2

a Adverse reactions reported by at least 2% of patients treated with oral ABILIFY, except adverse reactions which had an incidence equal to or less than placebo.

An examination of population subgroups did not reveal any clear evidence of differential adverse reaction incidence on the basis of age, gender, or race.

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