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

Table 4 Common ADR types observed

Reaction type	All reactions		Reaction following GA^b
	N	% of all reactions^a	N	% of reaction types, where reaction followed GA
Nausea and/or vomiting	400	27.5%	295	73.8%
Pruritus	243	16.7%	232	95.5%
Constipation	155	10.6%	107	69.0%
Diarrhea (9/88 with vomiting)	88	6.0%	0	0.0%
Somnolence (without cardio-respiratory symptoms)	50	3.4%	34	68.0%
Respiratory depression (41)/arrest (3)	44	3.0%	43	97.7%
Candidiasis	41	2.8%	0	0.0%
Urinary retention	40	2.7%	37	92.5%
Rash	31	2.1%	3	9.7%
Hypokalemia	25	1.7%	0	0.0%
Hypotension	22	1.5%	9	40.9%
Hepatotoxicity(6)/increased transaminases (12)^c	18	1.2%	1	5.6%
Stomatitis	16	1.1%	0	0.0%
Myoclonus	15	1.0%	14	93.3%
Pancytopenia	13	<1%	0	0.0%
Hyperglycemia	12	<1%	0	0.0%
Hypertension	11	<1%	2	18.2%
Allergic reactions	10	<1%	3	30.0%
Pain (4/10 pain in jaw, 2/10 back pain)	10	<1%	0	0.0%
Other reactions ( occurred <10 times)	213	14.6%	65	30.5%
Total	1,457		845	58.0%

^aIf the same patient experienced two types of reactions to the same medication(s) at the same time this would have been reported as one ADR case but will be listed here as two reaction types, for example, a patient with respiratory depression and bradycardia = one ADR case, but is listed as two reactions; ^breaction occurred post theater AND drugs given in theater and/or used in post-operative pain management were implicated; ^ctransaminases were raised in all cases. Additionally, if other parameters of liver function such as bilirubin and INR were also raised, we classified this as hepatotoxicity. ADR, adverse drug reaction, GA general anesthesia; N number, INR international normalized ratio.

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