uncontrolled) has shown that approximately 5 to 10% of pediatric patients experienced potentially clinically important changes in heart rate (≥20 beats per min) or blood pressure (≥15 to 20 mm Hg) [see Contraindications (4) and Warnings and Precautions (5)].
Table 2: Common Treatment–Emergent Adverse Reactions Associated with the Use of STRATTERA in Acute (up to 18 weeks) Child and Adolescent Trials
a Reactions reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following reactions did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: blood pressure increased, early morning awakening (terminal insomnia), flushing, mydriasis, sinus tachycardia, asthenia, palpitations, mood swings, constipation, and dyspepsia. The following reactions were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: pharyngolaryngeal pain, insomnia (insomnia includes the terms, insomnia, initial insomnia, middle insomnia). The following reaction did not meet this criterion but shows a statistically significant dose relationship: pruritus.
b Abdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.
c Somnolence includes the terms: sedation, somnolence.
Adverse Reactiona Percentage of Patients Reporting Reaction
STRATTERA
(N=1597) Placebo
(N=934)
Gastrointestinal Disorders
Abdominal painb 18 10
Vomiting 11 6
Nausea 10 5
General Disorders and Administration Site Conditions
Fatigue 8 3
Irritability 6 3
Therapeutic response unexpected 2 1
Investigations
Weight decreased 3 0
Metabolism and Nutritional Disorders
Decreased appetite 16 4
Anorexia 3 1
Nervous System Disorders
Headache 19 15
Somnolencec 11 4
Dizziness 5 2
Skin and Subcutaneous Tissue Disorders
Rash 2 1
Table 3: Common Treatment-Emergent Adverse Reactions Associated with the Use of STRATTERA in Acute (up to 18 weeks) Child and Adolescent Trials
a Abdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.
b Constipation didn't meet the statistical significance on Breslow-Day test but is included in the table because of pharmacologic plausibility.
c Mood swings didn't meet the statistical significance on Breslow-Day test at 0.05 level but p-value was <0.1 (trend).
Adverse Reaction Percentage of Patients
Reporting Reaction from
BID Trials Percentage of Patients
Reporting Reaction from
QD Trials
STRATTERA
(N=715) Placebo
(N=434) STRATTERA
(N=882) Placebo
(N=500)
Gastrointestinal Disorders&n
