It's a new drug and the side effects are completely insane!!!
WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS
See full prescribing information for complete boxed warning.
• Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. ABILIFY is not approved for the
treatment of patients with dementia-related psychosis. (5.1)
• Children, adolescents, and young adults taking antidepressants for Major
Depressive Disorder (MDD) and other psychiatric disorders are at increased
risk of suicidal thinking and behavior. (5.2)
– – – – – – – – – – – – – WARNINGS AND PRECAUTIONS – – – – – – – – – – – – – – –
• Elderly Patients with Dementia-Related Psychosis: Increased incidence of
cerebrovascular adverse events (eg, stroke, transient ischemic attack, including
fatalities) (5.1)
• Suicidality and Antidepressants: Increased risk of suicidality in children,
adolescents, and young adults with Major Depressive Disorder (5.2)
• Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and
close monitoring (5.3)
• Tardive Dyskinesia: Discontinue if clinically appropriate (5.4)
• Hyperglycemia and Diabetes Mellitus: Monitor glucose regularly in patients with
and at risk for diabetes (5.5)
• Orthostatic Hypotension: Use with caution in patients with known cardiovascular
or cerebrovascular disease (5.6)
• Seizures/Convulsions: Use cautiously in patients with a history of seizures or with
conditions that lower the seizure threshold (5.7)
• Potential for Cognitive and Motor Impairment: Use caution when operating
machinery (5.8)
• Suicide: The possibility of a suicide attempt is inherent in Schizophrenia and
Bipolar Disorder. Closely supervise high-risk patients (5.10)
– – – – – – – – – – – – – – – – – ADVERSE REACTIONS – – – – – – – – – – – – – – – – – –
Commonly observed adverse reactions (incidence ≥5% and at least twice that for
placebo) were (6.2):
• Adult patients with Schizophrenia: akathisia
• Pediatric patients (13 to 17 years) with Schizophrenia: extrapyramidal disorder,
somnolence, and tremor
• Adult patients (monotherapy) with Bipolar Mania: akathisia, sedation, restlessness,
tremor, and extrapyramidal disorder
• Adult patients (adjunctive therapy with lithium or valproate) with Bipolar Mania:
akathisia, insomnia, and extrapyramidal disorder
• Pediatric patients (10 to 17 years) with Bipolar Mania: somnolence, extrapyramidal
disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion,
and dizziness
• Adult patients with Major Depressive Disorder (adjunctive treatment to antidepressant
therapy): akathisia, restlessness, insomnia, constipation, fatigue, and
blurred vision
• Adult patients with agitation associated with Schizophrenia or Bipolar Mania:
nausea
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at
1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS
See full prescribing information for complete boxed warning.
• Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. ABILIFY is not approved for the
treatment of patients with dementia-related psychosis. (5.1)
• Children, adolescents, and young adults taking antidepressants for Major
Depressive Disorder (MDD) and other psychiatric disorders are at increased
risk of suicidal thinking and behavior. (5.2)
– – – – – – – – – – – – – WARNINGS AND PRECAUTIONS – – – – – – – – – – – – – – –
• Elderly Patients with Dementia-Related Psychosis: Increased incidence of
cerebrovascular adverse events (eg, stroke, transient ischemic attack, including
fatalities) (5.1)
• Suicidality and Antidepressants: Increased risk of suicidality in children,
adolescents, and young adults with Major Depressive Disorder (5.2)
• Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and
close monitoring (5.3)
• Tardive Dyskinesia: Discontinue if clinically appropriate (5.4)
• Hyperglycemia and Diabetes Mellitus: Monitor glucose regularly in patients with
and at risk for diabetes (5.5)
• Orthostatic Hypotension: Use with caution in patients with known cardiovascular
or cerebrovascular disease (5.6)
• Seizures/Convulsions: Use cautiously in patients with a history of seizures or with
conditions that lower the seizure threshold (5.7)
• Potential for Cognitive and Motor Impairment: Use caution when operating
machinery (5.8)
• Suicide: The possibility of a suicide attempt is inherent in Schizophrenia and
Bipolar Disorder. Closely supervise high-risk patients (5.10)
– – – – – – – – – – – – – – – – – ADVERSE REACTIONS – – – – – – – – – – – – – – – – – –
Commonly observed adverse reactions (incidence ≥5% and at least twice that for
placebo) were (6.2):
• Adult patients with Schizophrenia: akathisia
• Pediatric patients (13 to 17 years) with Schizophrenia: extrapyramidal disorder,
somnolence, and tremor
• Adult patients (monotherapy) with Bipolar Mania: akathisia, sedation, restlessness,
tremor, and extrapyramidal disorder
• Adult patients (adjunctive therapy with lithium or valproate) with Bipolar Mania:
akathisia, insomnia, and extrapyramidal disorder
• Pediatric patients (10 to 17 years) with Bipolar Mania: somnolence, extrapyramidal
disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion,
and dizziness
• Adult patients with Major Depressive Disorder (adjunctive treatment to antidepressant
therapy): akathisia, restlessness, insomnia, constipation, fatigue, and
blurred vision
• Adult patients with agitation associated with Schizophrenia or Bipolar Mania:
nausea
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at
1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
