Table 5 Age- and sex-stratified analysis of drug substances and their ADRs most frequently reported

0–1 month

(n = 2451)

1. venlafaxine (5.7%; n = 56)

atrial septal defect (32.1%; n = 18)

neonatal respiratory distress syndrome (17.9%; n = 10)

patent ductus arteriosus (16.1%; n = 9)

ventricular septal defect (16.1%; n = 9)

1. venlafaxine (6.9%; n = 92)

atrial septal defect (20.7%; n = 19)

neonatal respiratory distress syndrome (18.5%; n = 17)

drug withdrawal syndrome neonatal (14.1%; n = 13)

small for dates baby (14.1%; n = 13)

2. lamotrigine

(5.6%; n = 55)

atrial septal defect (40.0%; n = 22)

foetal exposure during pregnancy (20.0%; n = 11)

selective eating disorder (16.4%; n = 9)

2. lamotrigine

(5.4%; n = 72)

atrial septal defect (18.1%; n = 13)

foetal exposure during pregnancy (16.7%; n = 12)

neonatal respiratory distress syndrome (9.7%; n = 7)

3. citalopram

(5.3%; n = 52)

foetal exposure during pregnancy (26.9%; n = 14)

atrial septal defect (25.0%; n = 13)

small for dates baby (19.2%; n = 10)

ventricular septal defect (19.2%; n = 10)

2. citalopram

(5.4%; n = 72)

foetal exposure during pregnancy (37.5%; n = 27)

atrial septal defect (19.4%; n = 14)

small for dates baby (19.4%; n = 14)

2 month-1 year

(n = 2302)

1. palivizumab ^b

(16.6%; n = 149)

respiratory syncytial virus infection (38.3%; n = 57)

respiratory syncytial virus bronchiolitis (14.8%; n = 22)

bronchitis (10.7%; n = 16)

1. palivizumab ^b

(17.0%; n = 206)

respiratory syncytial virus infection (38.8%; n = 80)

respiratory syncytial virus bronchiolitis (18.0%; n = 37)

bronchitis (8.7%; n = 18)

2. levetiracetam

(3.5%; n = 31)

foetal exposure during pregnancy (51.6%; n = 16)

premature baby (19.4%; n = 6)

small for dates baby (16.1%; n = 5)

2. levetiracetam

(2.6%; n = 32)

foetal exposure during pregnancy (53.1%; n = 17)

atrial septal defect (15.6%; n = 5)

exposure during pregnancy (12.5%; n = 4)

premature baby (12.5%; n = 4),

3. topiramate

(2.3%; n = 21)

off-label use (19.0%; n = 4)

seizure (14.3%; n = 3)

3. octocog alfa (2.5%; n = 30)

factor VIII inhibition (70.0%; n = 21),

anti factor VIII antibody positive (23.3%; n = 7)

2–3 years

(n = 1537)

1. amoxicillin

(3.9%; n = 26)

tooth discolouration (26.7%; n = 7)

rash (11.5%; n = 3)

1. ibuprofen

(4.5%; n = 35)

urticaria (20.0%; n = 7)

crying (11.4%; n = 4)

angioedema (8.6%; n = 3),

diarrhoea (8.6%; n = 3)

eyelid oedema (8.6%; n = 3)

lip swelling (8.6%; n = 3)

vomiting (8.6%; n = 3)

2. valproinic acid (3.4%; n = 23)

seizure (17.4%; n = 4)

electroencephalogram abnormal (13.0%; n = 3)

fatigue (13.0%; n = 3)

liver disorder (13.0%; n = 3)

2. amoxicillin

(4.0%; n = 31)

rash (19.4%; n = 6)

vomiting (16.1%; n = 5)

dizziness (9.7%; n = 3)

urticaria (9.7%; n = 3)

3. cefaclor

(3.1%; n = 21)

tooth discolouration (19.0%; n = 4)

urticaria (19.0%; n = 4)

confusional state (14.3%; n = 3)

joint swelling (14.3%; n = 3)

vomiting (14.3%; n = 3)

3. cefaclor

(3.1%; n = 24)

rash (16.7%; n = 4)

urticaria (16.7%; n = 4)

dyspnoea (12.5%; n = 3)

erythema (12.5%; n = 3)

pruritus (12.5%; n = 3)

vomiting (12.5%; n = 3)

4–6 years

(n = 1929)

1. ibuprofen

(3.6%; n = 28)

urticaria (21.4%; n = 6)

nausea (14.3%; n = 4)

vomiting (14.3%; n = 4)

1. methylphenidate

(5.0%; n = 52)

blood creatine phosphokinase increased (13.5%; n = 7)

leukopenia (9.6%; n = 5)

weight decreased (7.7%; n = 4)

2. valproinic acid (3.3%; n = 26)

condition aggravated (15.4%; n = 4)

blood creatinine phosphokinase increased (11.5%; n = 3)

decreased level of consciousness (11.5%; n = 3)

dystonia (11.5%; n = 3)

encephalopathy (11.5%; n = 3)

epilepsy (11.5%; n = 3)

hyperthermia (11.5%; n = 3)

movement disorder (11.5%; n = 3)

myoclonus (11.5%; n = 3)

2. ibuprofen

(4.1%; n = 43)

swelling face (16.3%; n = 7)

urticaria (16.3%; n = 7)

angioedema (11.6%; n = 5)

eyelid oedema (11.6%; n = 5)

3. oxcarbazepine

(2.5%; n = 20)

hyponatraemia (35.0%; n = 7)

fatigue (15.0%; n = 3)

3. montelukast (2.7%; n = 28)

aggression (25.0%; n = 7)

seizure (14.3%; n = 4)

abdominal pain (10.7%; n = 3)

hallucination (10.7%; n = 3)

nightmare (10.7%; n = 3)

pyrexia (10.7%; n = 3)

restlessness (10.7%; n = 3)

vomiting (10.7%; n = 3)

7–12 years

(n = 5384)

1. methylphenidate

(5.8%; n = 118)

decreased appetite (5.9%; n = 7)

cerebral infarction (5.1%; n = 6)

leukopenia (5.1%; n = 6)

1. methylphenidate (15.4%; n = 490)

tic (6.7%; n = 33)

decreased appetite (6.3%; n = 31)

headache (5.9%; n = 29)

2. etanercept

(4.4%; n = 90)

injection site pain (24.4%; n = 22)

condition aggravated (7.8%; n = 7)

headache (5.6%; n = 5)

injection site erythema (5.6%; n = 5)

juvenile idiopathic arthritis (5.6%; n = 5)

2. atomoxetine (6.2%; n = 197)

suicidal ideation (18.3%; n = 36)

aggression (14.2%; n = 28)

nausea (7.6%; n = 15)

3. insulin aspart

(2.3%; n = 47)

blood glucose increased (63.8%; n = 30)

product leakage (46.8%; n = 22)

diabetic ketoacidosis (23.4%; n = 11)

3. allergens (2.2%; n = 71)

anaphylactic reaction (29.6%; n = 21)

urticaria (29.6%; n = 21)

dyspnoea (26.8%; n = 19)

13–17 years

(n = 7251)

1. dienogest

(4.7%; n = 187)

pulmonary embolism (21.9%; n = 41)

deep vein thrombosis (15.0%; n = 28)

pelvic thrombosis (9.6%; n = 18)

1. methylphenidate (10.1%; n = 315)

headache (5.4%; n = 17)

suicide attempt (4.1%; n = 13)

nausea (3.8%; n = 12)

2. levonorgestrel

(4.7%; n = 185)

drug ineffective (9.7%; n = 18)

abdominal pain (7.6%; n = 14)

headache (6.5%; n = 12)

2. isotretinoin (5.2%; n = 163)

blood creatine phosphokinase increased (12.9%; n = 21)

depression (11.0%; n = 18)

acne (6.1%; n = 10)

headache (6.1%; n = 10)

3. paracetamol

(3.3%; n = 130)

suicide attempt (57.7%; n = 75)

intentional overdose (35.4%; n = 46)

vomiting (21.5%; n = 28)

3. atomoxetine (3.8%; n = 117)

suicidal ideation (11.1%; n = 13)

nausea (10.3%; n = 12)

aggression (9.4%; n = 11)