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Table 2 Drug-stratified analysis

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

Drug substances Methylphenidate a
(5.5%; n = 1151)
Ibuprofen a
(2.3%; n = 470)
Palivizumab a,b
(2.0%; n = 411)
Atomoxetine a
(2.0%; n = 407)
Etanercept a
(1.9%; n = 389)
Patients demographics
 Mean age (+/− standard deviation) [years] 11.2 (+/−3.4) 7.9 (+/−6.0) 0.2 (+/− 0.5) 11.4 (+/− 3.1) 11.4 (+/− 4.5)
 Median age (interquartile range) [years] 11.0 (9.0–14.0) 7.0 (2.0–14.0) 0.0 (0.0–0.0) 12.0 (9.0–14.0) 12.0 (9.0–15.0)
 Male/female ratio 3.5:1.0 1.0:1.0 1.3:1.0 4.2:1.0 0.5:1.0
 Serious 77.5% 76.6% 96.4% 87.7% 39.6%
ADRs most frequently reported
 1. headache (5.3%; n = 61) suicide attempt (13.8%; n = 65) respiratory syncytial virus infection (40.1%; n = 165) suicidal ideation (14.0%; n = 57) injection site pain (16.7%; n = 65)
 2. decreased appetite (4.7%; n = 54) intentional overdose (11.3%; n = 53) respiratory syncytial virus bronchiolitis (16.1%; n = 66) aggression (12.5%; n = 51) condition aggravated (6.9%; n = 27)
 3. tachycardia (4.2%; n = 48) vomiting (10.4%; n = 49) bronchitis (8.5%; n = 35) nausea (7.9%; n = 32) injection site erythema (5.1%; n = 20)
 4. tic (4.0%; n = 46) urticaria (8.3%; n = 39) pneumonia (7.3%; n = 30) tachycardia (6.1%; n = 25) drug ineffective (4.6%; n = 18)
 5. leukopenia (3.6%; n = 41) nausea (6.4%; n = 6.4%) respiratory failure (6.8%; n = 28) fatigue (5.4%; n = 22) nasopharyngitis (4.6%; n = 18)
  1. asingle 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 2 presents the patients’ demographics and ADRs reported most frequently for the five drugs reported most frequently in the complete data set