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Table 4 Age-stratified analysis of demographical parameters and the five drug substances and ADRs reported most frequently

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

Age groups 0–1 month
(n = 2451)
2 month-1 year
(n = 2302)
2–3 years
(n = 1537)
4–6 years
(n = 1929)
7–12 years
(n = 5384)
13–17 years
(n = 7251)
Demographical parameters
 female 40.2% (n = 986) 39.0% (n = 898) 43.5% (n = 669) 40.8% (n = 787) 37.9% (n = 2042) 54.8% (n = 3972)
 male 54.2% (n = 1329) 52.6% (n = 1212) 50.4% (n = 775) 54.5% (n = 1049) 59.2% (n = 3186) 43.0% (n = 3119)
 unknown 5.5% (n = 136) 8.3% (n = 192) 6.1% (n = 93) 4.8% (n = 93) 2.9% (n = 156) 2.2% (n = 160)
The five drug substances most frequently reported as suspected in the respective age group a
 1. venlafaxine (6.2%; n = 152) palivizumab b (16.3%; n = 376) ibuprofen (3.7%; n = 57) ibuprofen (3.7%; n = 71) methylphenidate (11.6%; n = 625) methylphenidate (6.1%; n = 440)
 2. lamotrigine (5.5%; n = 134) levetiracetam (2.9%; n = 66) amoxicillin (3.1%; n = 48) methylphenidate (3.3%; n = 64) atomoxetine (4.5%; n = 241) isotretinoin (2.8%; n = 204)
 3. citalopram (5.1%; n = 124) ibuprofen (2.3%; n = 52) cefaclor (3.0%; n = 46) valproinic acid (2.7%; n = 53) etanercept (2.6%; n = 138) etanercept (2.6%; n = 190)
 4. quetiapine (4.2%; n = 104) valproinic acid (2.0%; n = 45) salbutamol (2.9%; n = 45) oxcarbazepine (2.3%; n = 44) insulin aspartate (1.8%; n = 96) dienogest (2.6%; n = 187)
 5. sertraline (4.0%; n = 98) topiramate (1.9%; n = 44) valproinic acid (2.8%; n = 43) amoxicillin (2.2%; n = 43) ibuprofen (1.8%; n = 96) levonorgestrel (2.6%; n = 185)
The five ADRs most frequently reported in the respective age group a
 1. foetal exposure during pregnancy (16.3%; n = 400) foetal exposure during pregnancy (6.8%; n = 156) vomiting (9.3%, n = 143) vomiting (8.0%; n = 155) urticaria (6.6%; n = 358) suicide attempt (6.7%; n = 487)
 2. atrial septal defect (14.4%; n = 352) respiratory syncytial virus infection (6.6%; n = 151) accidental exposure to product by child (8.3%; n = 127) urticaria (6.6%; n = 127) dyspnoea (6.2%; n = 334) nausea (5.8; n = 419)
 3. premature baby (12.2%; n = 298) vomiting (5.7%; n = 131) accidental overdose (5.9%; n = 91) pyrexia (5.0%; n = 97) vomiting (5.5%; n = 296) dyspnoea(5.4%; n = 395)
 4. small for dates baby (9.7%; n = 238) accidental exposure to product by child (4.1%; n = 95) pyrexia (5.3%; n = 82) rash (4.9%; n = 95) nausea (5.2%; n = 279) intentional overdose (5.3%; n = 387)
 5. neonatal respiratory distress syndrome (6.9%; n = 169) pyrexia (4.1%; n = 94) urticaria (5.3%; n = 82) pruritus (4.7%; n = 91) anaphylactic reaction (4.4%; n = 239) vomiting (5.1%; n = 368)
  1. a presented are the five drugs substances and the five ADRs (PT-level) most frequently reported. Single drug substances and their combination products (if available) were summarized. 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 4 presents the demographical parameters, the drug substances and ADRs most frequently reported in the age-stratified analysis of the complete data set