Skip to main content

Table 6 Reporting rates of the five drug substances most frequently reported stratified by age and sex

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

Rank 2 month-1 year [number of ADR reports per 100,000 drug prescriptions] a 2–3 years [number of ADR reports per 100,000 drug prescriptions] a 4–6 years [number of ADR reports per 100,000 drug prescriptions] a 7–12 years [number of ADR reports per 100,000 drug prescriptions] a 13–17 years [number of ADR reports per 100,000 drug prescriptions] a
1. topiramat: 379.4 valproinic acid: 47.8 oxcarbazepine: 27.9 etanercept: 542.2 etanercept: 505.5
female: 481.6 female: 48.9 female: 26.1 female: 503.9 female: 503.3
male: 262.5 male: 40.6 male: 29.3 male: 575.6 male: 452.8
2. levetiracetam: 250.7 amoxicillin: 1.3 methylphenidate: 22.8 insulin aspartat: 47.8 isotretinoin: 22.5
female: 237.3 female: 1.0 female: 19.3 female: 46.6 female: 14.8
male: 245.3 male: 1.4 male: 22.6 male: 48.9 male: 25.3
3. valproinic acid: 161.0 cefaclor: 1.0 valproinic acid: 19.5 atomoxetine: 19.1 methylphenidate: 6.0
female: 80.9 female: 0.8 female: 25.5 female: 14.9 female: 9.7
male: 204.1 male: 1.2 male: 15.2 male: 19.4 male: 4.8
4. palivizumab: 87.7 b salbutamol: 0.5 amoxicillin: 0.8 methylphenidate: 5.2 dienogest: 4.6
female: 72.7
male: 88.4
female: 0.4
male: 0.5
female: 0.7
male: 1.0
female: 4.9
male: 5.0
female: 4.6
male: 0
5. ibuprofen: 0.7 ibuprofen: 0.3 ibuprofen: 0.3 ibuprofen: 0.4 levonorgestrel: 2.8
female: 0.5 female: 0.2 female: 0.2 female: 0.2 female: 2.8
male: 0.7 male: 0.4 male: 0.4 male: 0.5 male: 0
  1. apresented are the five drug substances most frequently reported. Single drug substances and their combination products (if available) were summarized
  2. bADR reports for palivizumab were mostly related to a lack of efficacy
  3. Table 6 presents the ranking of the reporting rates (number of ADR reports/number of drug prescriptions) for the five drug substances most frequently reported in the age-stratified analysis of the complete data set (see Table 4)) as well as the reporting rates for females and males. The number of ADR reports for the respective drugs was determined for the time period 01/01/2009–28/02/2019, since substance-specific exposure data were only available for this time