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 aripiprazole 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 aripiprazole in patients with schizophrenia (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) was akathisia (aripiprazole 8%; placebo 4%).
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 upto 3 weeks in another indication), including only those reactions that occurred in 2% or more of patients treated with aripiprazole (doses ≥2 mg/day) and for which the incidence in patients treated with aripiprazole was greater than the incidence in patients treated with placebo in the combined dataset.
|System Organ Class Preferred Term|
|Percentage of Patients Reporting Reaction *|
|General Disorders and Administration Site Conditions|
|Musculoskeletal and Connective Tissue Disorders|
|Pain in Extremity||4||2|
|Nervous System Disorders|
|Respiratory, Thoracic, and Mediastinal Disorders|
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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