Table 1.

Adverse drug reactions (ADRs) reported for systemic antibacterials (ATC group J01) by medicines, age group, seriousness (italic) and labelling status (1998 to 2007)

Age groups (years)
Medicines	DDD*	<1	1<2	2<3	3<4	4<5	5<6	6<7	7<8	8<9	9<10	10<11	11<12	12<13	13<14	14<15	15<16	16<17	17<18	Total (n)	Serious ADRs	Labelled (+/−)
Amoxicillin	12.3	2	2	2	0	0	2	0	0	0	0	0	0	1	0	0	0	0	0	9	NR	NR
Azithromycin	4.4	3(2)	0	0	8(8)	0	0	0	4(2)	0	0	0	2	0	0	1	0	4(3)	0	22(15)	Cerebral palsy	−
																					Diarrhoea	+
																					Hypersensitivity	+
																					Dizziness	+
																					Syncope	+
																					Affective disorder	+
																					Aggression	+
																					Anxiety	+
																					Confusion	+
																					Restlessness	+
																					Hallucination	−
																					Mental disorder	+
																					Psychotic disorder	+
																					Photosensitivity reaction	+
Ceftriaxone	0.1	0	0	1	0	0	1(1)	4	0	0	0	0	0	0	0	0	0	0	0	6(1)	Cholelithiasis	−
Ciprofloxacin	3.2	0	0	0	0	1(1)	0	0	0	0	0	0	0	0	0	1(1)	0	2(2)	2(2)	6(6)	Leukopenia	+
																					Tachycardia	+
																					Stomatitis	+
																					Nausea	+
																					Hepatic enzymes increased	+
																					Tendonitis	+
Dicloxacillin	9.2	0	0	0	0	0	0	7(7)	0	0	0	1(1)	0	0	0	0	3 (1)	1(1)	1(1)	13(11)	Urticaria	+
																					Abdominal pain	+
																					Diarrhoea	+
																					Vomiting	+
																					Enterocolitis haemorrhagic	+
																					Pyrexia	+
																					Anaphylactic shock	+
																					Anxiety	−
																					Hallucination	−
																					Rash	+
Erythromycin	10.5	2(2)	1	0	0	0	0	1(1)	0	0	0	0	0	2	1(1)	5	2	0	0	14(4)	Chest pain	−
																					Hepatic cirrhosis	+
																					Anorexia	−
																					Erythema multiforme	+
Fleroxacin	NA	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	2	NR	NR
Lymecycline	2.4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	2	NR	NR
Oxytetracycline	1.7	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	6(6)	8(6)	Decreased appetite	−
																					Depression	−
																					Dizziness	−
																					Palpitations	−
																					Tympanic membrane perforation	−
																					Vomiting	+
Pivampicillin	7.3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	8(8)	0	0	0	8(8)	Vomiting	+
																					Death	−
																					Carnitine decreased	+
																					Fatigue	+
																					Restlessness	+
Phenoxymethylpenicillin	52.5	0	1	0	0	0	2	1	0	0	0	0	3(3)	0	0	0	0	0	0	7(3)	Haemolysis	+
																					Pancytopenia	−
																					Pyrexia	+
Sulfamethizole	3.9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1(1)	1(1)	Haemolytic anaemia	+
Spiramycin	NA	1(1)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1(1)	Dental caries	−
Sulfamethoxazole/Trimethoprim	1.4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	NR	NR
Tetracycline	11.8	0	0	0	0	0	0	0	0	0	0	0	0	0	0	7(6)	0	0	0	7(6)	Oesophagal ulcer haemorrhage	+
																					Benign intracranial hypertension	+
																					Headache	+
																					Papilloedema	+
																					Visual disturbance	+
																					Vomiting	+
Trimethoprim	4	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	NR	NR
Vancomycin	NA	2(2)	0	0	0	0	0	0	0	2(2)	0	1(1)	0	0	0	0	0	0	0	5(5)	Neutropenia	+
																					Bradycardia	+
																					Pyrexia	+
																					Convulsion	+
																					Apnoea	+
Total		10(7)	5	3	8(8)	1(1)	5(1)	13(8)	6(2)	2(2)	0	2(2)	5(3)	3	1(1)	22 (15)	5 (1)	10(6)	12 (10)	113(67)

NA, not available; NR, not relevant;

^*DDD = defined daily dosage per 1000 inhabitants per day.