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: peripheral coldness, tachycardia, prostatitis, testicular pain, orgasm abnormal, flatulence, asthenia, feeling cold, muscle spasm, dysgeusia, agitation, restlessness, micturition urgency, pollakiuria, pruritus, urticaria, flushing, tremor, menstruation irregular, rash, and urinary retention. The following reactions were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: anxiety, diarrhea, back pain, headache, and oropharyngeal pain.
b Abdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.
c Somnolence includes the terms: sedation, somnolence.
d Insomnia includes the terms: insomnia, initial insomnia, middle insomnia, and terminal insomnia.
e Urinary hesitation includes the terms: urinary hesitation, urine flow decreased.
f Based on total number of males (STRATTERA, N=943; placebo, N=869).
g Based on total number of females (STRATTERA, N=754; placebo, N=691).
Adverse Reactiona Percentage of Patients Reporting Reaction
System Organ Class/Adverse Reaction STRATTERA
(N=1697) Placebo
(N=1560)
Cardiac Disorders
Palpitations 3 1
Gastrointestinal Disorders
Dry mouth 20 5
Nausea 26 6
Constipation 8 3
Abdominal painb 7 4
Dyspepsia 4 2
Vomiting 4 2
General Disorders and Administration Site Conditions
Fatigue 10 6
Chills 3 0
Feeling jittery 2 1
Irritability 5 3
Thirst 2 1
Investigations
Weight decreased 2 1
Metabolism and Nutritional Disorders
Decreased appetite 16 3
Nervous System Disorders
Dizziness 8 3
Somnolencec 8 5
Paraesthesia 3 0
Psychiatric Disorders
Abnormal dreams 4 3
Insomniad 15 8
Libido decreased 3 1
Sleep disorder 3 1
Renal and Urinary Disorders
Urinary hesitatione 6 1
Dysuria 2 0
Reproductive System and Breast Disorders
Erectile dysfunctionf 8 1
Dysmenorrheag 3 2
Ejaculation delayedf and/or ejaculation disorderf 4 1
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis 4 1
Vascular Disorders
Hot flush 3 0
The following adverse events occurred in at least 2% of adult CYP2D6 poor metaboliser (PM) patients and were st
