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Table 8 Analysis of ADR reports referring to “off-label use”

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

  ADR reports referring to “off-label use” (3.5%, n = 722*)
The five drug substances most frequently reported a  
 1. aripiprazole (5.0%; 36/722)
 2. levetiracetam (3.0%; 22/722)
 3. methylphenidate (2.6%; 19/722)
 4. eculizumab (2.2%; 16/722)
 5. valproinic acid (2.2%; 16/722)
The five ADRs most frequently reported (except PTs coding for off-label use) a  
 1. drug ineffective (4.0%; 29/722)
 2. seizure (3.9%; 28/722)
 3. fatigue (3.7%; 27/722)
 4. vomiting (3.5%; 25/722)
 5. nausea (2.9%; 21/722)
  1. * in only 3.5% of the ADR reports an “off-label use” was coded. Hence, the ranking of the most frequently reported drug substances and ADRs in the remaining data set (complete data set excluding ADR reports referring to off-label use) remains the same as for the complete data set (see Table 1)
  2. a one ADR report may contain information about more than one drug substance and more than one ADR. Therefore, the number of reported drug substances and ADRs exceeds that of the ADR reports. Single drug substances and their combination products (if available) were summarized