Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children – a prospective observational cohort study of 6,601 admissions

Table 3 Severe reactions (Hartwig scale ≥4) by reaction type and medication implicated

Severity level	ADR type (count)	Medication implicated (count)	Admission to PICU/ HDU (if > once)
4	Cardiac failure (1)	Bisoprolol (1), Carvedilol (1)^a	HDU
	Sedation withdrawal (1)^b	Fentanyl (1), Midazolam (1), Promethazine (1) , Chloral hydrate (1)	PICU
	Raised INR and hemorrhage (1)	Warfarin (1)	HDU
	Pulmonary edema (1)	Diazoxide (1)	HDU
	Respiratory depression (5)	Fentanyl (4), Ketamine (2), Midazolam (1),	PICU (3)^c HDU (2)
	Respiratory arrest (2)	Fentanyl (2), Sevoflurane (1), Isoflurane (1), Ketamine (1)	PICU, HDU
5	Peripheral neuropathy (1)	Vincristine (1)	N/A

^aBoth drugs caused significant fluid retention in this patient; ^bthis patient had been on sedating drugs for 10 days by the time withdrawal became clinically significant; ^cADR was not the only factor leading to PICU admission; other clinical factors may also have contributed. ADR adverse drug reaction, HDU high dependency unit, INR international normalized ratio, PICU pediatric ICU.

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