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

From: Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs

Age groups Females: rank of drug substances a Females: the three drug substances reported most frequently as suspected and their three ADRs reported most frequently in brackets Males: rank of drug substances a Males: the three drug substances reported most frequently reported and their three ADRs reported most frequently in brackets
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)
  1. a presented are the three drugs substances and their three related ADRs most frequently reported (PT-level) stratified by age and sex. Single drug substances and their combination products (if available) were summarized. Listed are only those ADRs for which more than two ADR reports were available. One ADR report may contain information about more than one drug substance and more than one ADR, therefore, the numbers of reported drug substances and ADRs may exceed that of the ADR reports
  2. b ADR reports for palivizumab were mostly related to a lack of efficacy
  3. Table 5 presents the three drugs substances and their ADRs most frequently reported stratified by age and sex