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Table 3 Summary of Treatment-Emergent Adverse Events Reported by at Least 5% of Subjects in Either Age Group

From: Acute atomoxetine treatment of younger and older children with ADHD: A meta-analysis of tolerability and efficacy

 

6- and 7-Year Olds

 

8- to 12-Year Olds

  
 

ATX

PBO

 

ATX

PBO

  
 

N = 183

N = 95

 

N = 542

N = 316

  

Event

n (%)

(n) %

p Valuea

(n) %

(n) %

p Valuea

p Valueb

Abdominal pain upper

34 (18.6)

6 (6.3)

.006

83 (15.3)

40 (12.7)

.313

.044

Decreased appetite

30 (16.4)

3 (3.2)

< .001

82 (15.1)

17 (5.4)

< .001

.331

Headache

25 (13.7)

8 (8.4)

.243

90 (16.6)

54 (17.1)

.850

.214

Vomiting

25 (13.7)

2 (2.1)

.001

51 (9.4)

18 (5.7)

.068

.053

Cough

18 (9.8)

6 (6.3)

.375

18 (3.3)

28 (8.9)

< .001

.007

Nausea

13 (7.1)

2 (2.1)

.097

42 (7.7)

20 (6.3)

.496

.186

Fatigue

12 (6.6)

2 (2.1)

.150

39 (7.2)

8 (2.5)

.003

.918

Somnolence

12 (6.6)

1 (1.1)

.040

50 (9.2)

14 (4.4)

.010

.294

Irritability

9 (4.9)

2 (2.1)

.342

33 (6.1)

9 (2.8)

.034

.924

Pyrexia

9 (4.9)

2 (2.1)

.342

15 (2.8)

17 (5.4)

.062

.058

Nasopharyngitis

8 (4.4)

4 (4.2)

1.00

26 (4.8)

24 (7.6)

.098

.442

Upper respiratory tract infection

8 (4.4)

3 (3.2)

.754

16 (3.0)

17 (5.4)

.096

.206

Pharyngolaryngeal pain

2 (1.1)

3 (3.2)

.342

26 (4.8)

29 (9.2)

.014

.687

  1. Abbreviations: ATX = atomoxetine; N, n = number; PBO = placebo.
  2. aP values comparing ATX and PBO within each subgroup are based on Fisher's exact test.
  3. bP values comparing odds ratios between children and adolescent