ARIPIPRAZOLE (Page 5 of 13)
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 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 * | ||
Aripiprazole | Placebo | |
(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 |
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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