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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)