Table 4.

Treatment-Emergent Adverse Events Reported by at Least 5% of Patients in Any Treatment Group (Arranged in Decreasing Frequency of the Total Population)

EventPlacebo
(n = 83)
n (%)
Atomoxetine (mg/kg/day)
0.5
(n = 44)
n (%)
1.2
(n = 84)
n (%)
1.8
(n = 83)
n (%)
Headache19 (22.9)11 (25.0)20 (23.8)20 (24.1)
Rhinitis18 (21.7)7 (15.9)10 (11.9)12 (14.5)
Abdominal pain9 (10.8)5 (11.4)12 (14.3)12 (14.5)
Pharyngitis12 (14.5)4 (9.1)9 (10.7)9 (10.8)
Anorexia4 (4.8)3 (6.8)10 (11.9)10 (12.0)
Vomiting5 (6.0)3 (6.8)6 (7.1)9 (10.8)
Cough increased4 (4.8)6 (13.6)6 (7.1)7 (8.4)
Somnolence3 (3.6)2 (4.5)6 (7.1)9 (10.8)
Insomnia5 (6.0)4 (9.1)5 (6.0)4 (4.8)
Rash3 (3.6)3 (6.8)5 (6.0)7 (8.4)
Nausea5 (6.0)2 (4.5)6 (7.1)4 (4.8)
Nervousness4 (4.8)3 (6.8)5 (6.0)5 (6.0)
Fever5 (6.0)1 (2.3)7 (8.3)3 (3.6)
Pain5 (6.0)4 (9.1)2 (2.4)5 (6.0)
Accidental injury7 (8.4)1 (2.3)3 (3.6)3 (3.6)
Asthenia4 (4.8)3 (6.8)2 (2.4)4 (4.8)
Infection1 (1.2)05 (6.0)6 (7.2)
Dizziness1 (1.2)4 (9.1)*2 (2.4)4 (4.8)
Diarrhea5 (6.0)04 (4.8)0
Depression5 (6.0)1 (2.3)0 (0.0)*2 (2.4)
Pruritus001 (1.2)5 (6.0)
  • All patients who took at least 1 dose of the study medication are included.

  • *P < .05, pairwise versus placebo.

  • P < .10 test for dose-response trend.

  • P < .05 test for dose-response trend.