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Table 3 Adverse events and adverse drug reactions occurring in ≥0.5% of patients

From: Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance

 

Adverse Events* n = 510

Adverse Drug Reactions* n = 510

125 (24.5%)

116 (22.7%)

Somnolence

48 (9.4%)

48 (9.4%)

Weight increased

18 (3.5%)

17 (3.3%)

Headache

8 (1.6%)

6 (1.2%)

Nausea

7 (1.4%)

7 (1.4%)

Increased appetite

6 (1.2%)

6 (1.2%)

Obesity

5 (1.0%)

5 (1.0%)

Insomnia

4 (0.8%)

3 (0.6%)

Tic disorders

4 (0.8%)

4 (0.8%)

Akathisia

4 (0.8%)

4 (0.8%)

Constipation

4 (0.8%)

4 (0.8%)

Malaise

4 (0.8%)

4 (0.8%)

Irritability

3 (0.6%)

3 (0.6%)

Dizziness

3 (0.6%)

3 (0.6%)

Vomiting

3 (0.6%)

3 (0.6%)

  1. *: MedDRA/J version (22.1)