ABILIFY (Page 11 of 24)

Pediatric Patients (6 to 17 years) with Autistic Disorder

The following findings are based on two 8-week, placebo-controlled trials in which oral ABILIFY was administered in doses of 2 to 15 mg/day.

Adverse Reactions Associated with Discontinuation of Treatment

The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated pediatric patients (6 to 17 years) was 10% and 8%, respectively.

Commonly Observed Adverse Reactions

Commonly observed adverse reactions associated with the use of ABILIFY in pediatric patients with autistic disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 20.

Table 20:Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Pediatric Patients (6 to 17 years) with Autistic Disorder Treated with Oral ABILIFY

	Percentage of Patients Reporting Reaction
	ABILIFY	Placebo
Preferred Term	(n=212)	(n=101)
Sedation	21	4
Fatigue	17	2
Vomiting	14	7
Somnolence	10	4
Tremor	10	0
Pyrexia	9	1
Drooling	9	0
Decreased Appetite	7	2
Salivary Hypersecretion	6	1
Extrapyramidal Disorder	6	0
Lethargy	5	0

Pediatric Patients (6 to 18 years) with Tourette’s Disorder

The following findings are based on one 8-week and one 10-week, placebo-controlled trials in which oral ABILIFY was administered in doses of 2 to 20 mg/day.

Adverse Reactions Associated with Discontinuation of Treatment

The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated pediatric patients (6 to 18 years) was 7% and 1%, respectively.

Commonly Observed Adverse Reactions

Commonly observed adverse reactions associated with the use of ABILIFY in pediatric patients with Tourette’s disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 21.

Table 21:Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Pediatric Patients (6 to 18 years) with Tourette’s Disorder Treated with Oral ABILIFY

	Percentage of Patients Reporting Reaction
	ABILIFY	Placebo
Preferred Term	(n=121)	(n=72)
Sedation	13	6
Somnolence	13	1
Nausea	11	4
Headache	10	3
Nasopharyngitis	9	0
Fatigue	8	0
Increased Appetite	7	1

Less Common Adverse Reactions in Pediatric Patients (6 to 18 years) with Schizophrenia, Bipolar Mania, Autistic Disorder, or Tourette’s Disorder

Table 22 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (up to 6 weeks in schizophrenia, up to 4 weeks in bipolar mania, up to 8 weeks in autistic disorder, and up to 10 weeks in Tourette’s disorder), including only those reactions that occurred in 2% or more of pediatric 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.

Table 22:Adverse Reactions in Short-Term, Placebo-Controlled Trials of Pediatric Patients (6 to 18 years) Treated with Oral ABILIFY

	Percentage of Patients Reporting Reactiona
System Organ Class	ABILIFY	Placebo
Preferred Term	(n=732)	(n=370)
Eye Disorders
Blurred Vision	3	0
Gastrointestinal Disorders
Abdominal Discomfort	2	1
Vomiting	8	7
Nausea	8	4
Diarrhea	4	3
Salivary Hypersecretion	4	1
Abdominal Pain Upper	3	2
Constipation	2	2
General Disorders and Administration Site Conditions
Fatigue	10	2
Pyrexia	4	1
Irritability	2	1
Asthenia	2	1
Infections and Infestations
Nasopharyngitis	6	3
Investigations
Weight Increased	3	1
Metabolism and Nutrition Disorders
Increased Appetite	7	3
Decreased Appetite	5	4
Musculoskeletal and Connective Tissue Disorders
Musculoskeletal Stiffness	2	1
Muscle Rigidity	2	1
Nervous System Disorders
Somnolence	16	4
Headache	12	10
Sedation	9	2
Tremor	9	1
Extrapyramidal Disorder	6	1
Akathisia	6	4
Drooling	3	0
Lethargy	3	0
Dizziness	3	2
Dystonia	2	1
Respiratory, Thoracic, and Mediastinal Disorders
Epistaxis	2	1
Skin and Subcutaneous Tissue Disorders
Rash	2	1
a Adverse reactions reported by at least 2% of pediatric patients treated with oral ABILIFY, except adverse reactions which had an incidence equal to or less than placebo.