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.
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.
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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