Table IV.

ADRs that were significantly higher in pediatric patients than in adults

Drugs	Age range of pediatric patients	Patient number in pediatric clinical trials	Patient number in adult clinical trials	ADRs (pediatric patients > adults)
Aripiprazole	6–18 y	732 (pooled)	1843 (pooled)	Abdominal pain, diarrhea, salivary hypersecretion, fatigue, pyrexia, decreased appetite, increased appetite, sedation
Duloxetine	7–17 y	476	4797 (pooled)	Abdominal pain, vomiting, weight increased, decreased appetite, headache, oropharyngeal pain
Paliperidone	12–17 y	150 (pooled)	850 (pooled)	Sedation
Lurasidone 40 mg	13–17 y	110	487	Respiratory tract infection
Lurasidone 80 mg	13–17 y	104	538	Respiratory tract infection
Escitalopram	12–17 y	234	715	Abdominal pain, vomiting, inflicted injury, respiratory tract infection, headache, menstrual cramps
Risperidone (bipolar I disorder)	10–17 y	111	448	Blurred vision, abdominal pain, diarrhea, dyspepsia, nausea, vomiting, fatigue, increased appetite, dizziness, sedation, pharyngolaryngeal pain
Risperidone (schizophrenia)	13–17 y	106	564	Salivary hypersecretion, extrapyramidal disorder, sedation,
Asenapine	10–17 y	302	620	Blurred vision, abdominal pain, oral hypoesthesia, irritability, dehydration, dyspnea, fatigue, increased appetite, myalgia, headache, dysmenorrhea, sedation, anger, pharyngolaryngeal pain, rhinitis, rash, tachycardia