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Table 3 Medicines course frequency administered, implicated and off-label, unlicensed or unknown (only medicines with > 100 courses shown, n = 7,007)

From: Adverse drug reactions and off-label and unlicensed medicines in children: a nested case?control study of inpatients in a pediatric hospital

 

Medicine (number of courses)

Number of courses off-label or unlicensed (%)a

Number of authorized courses implicated in at least one PD ADR (%)

Number of off-label or unlicensed courses implicated in at least one PD ADR (%)

Number of courses unknown

Medicines with only authorized courses

Cefuroxime (245)

0 (0%)

15 (6.5%)

-

1

Cefotaxime (388)

0 (0%)

40 (10.3%)

-

0

Medicines with off-label courses

Chlorphenamine (339)

1 (0.3%)

1 (0.3%)

0

1

Diazepam (107)

1 (1.9%)

1 (1.0%)

0

0

Ibuprofen (545)

26 (4.8%)

4 (0.8%)

1 (3.8%)

0

Lactulose (272)

13 (4.8%)

7 (2.7%)

1 (0.1%)

0

Cefalexin (148)

9 (6.1%)

8 (5.8%)

1 (11.0%)

0

Metronidazole (257)

21 (8.2%)

19 (8.0%)

3 (14.3%)

0

Furosemide (110)

13 (11.8%)

13 (13.4%)

2 (15.4%)

0

Paracetamol (1786)

596 (33.4%)

1 (0.1%)

0 (0%)

2

Ondansetron (550)

290 (52.7%)

18 (8.5%)

14 (2.5%)

48

Salbutamol (146)

84 (57.5%)

3(4.8%)

10 (11.9%)

0

Ranitidine (109)

65 (59.6%)

1 (2.3%)

0 (0%)

0

Dexamethasone (166)

107 (64.5%)

7(13.5%)

3 (2.8%)

7

Fentanyl (150)

149 (99.3%)

0 (0%)

72 (48%)

0

Medicines with unlicensed courses

Fentanyl and Levobupivicaine epidural (106)

106 (100.0%)

-

47 (44.3%)

0

Medicines with off-label and unlicensed courses

Codeine Phosphate (752)

12 (1.6%)

49 (10.1%)

0 (0%)

257

Morphine (500)

198 (39.8%)

86 (28.5%)

89 (44.9%)

0

Diclofenac (331)

149 (45.0%)

2 (8.7%)

3 (2.0%)

159

  1. aDrugs within each category listed in ascending order of % off-label or unlicensed. PD ADR, probable or definite adverse drug reaction.