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Table 7 Sex-stratified analysis of ADRs most frequently reported

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

Rank The ten ADRs reported most frequently in ADR reports referring to females (n = 9354) a The ten ADRs reported most frequently in ADR reports referring to males (n = 10,670) a
1. vomiting (6.2%; n = 581)
OR: 1.3 [1.0–1.7]
urticaria (5.3%; n = 563)
OR: 0.8 [0.6–1.0]
2. nausea (4.7%; n = 443)
OR 1.5 [1.1–2.1]
vomiting (4.8%; n = 515)
OR: 1.3 [1.0–1.7]
3. dyspnoea (4.2%; n = 390)
OR: 0.9 [0.7–1.2]
dyspnoea (4.5%; n = 481)
OR: 0.9 [0.7–1.2]
4. suicide attempt (4.1%; n = 385)
OR: 4.3 [2.7–7.0]
nausea (3.2%; n = 342)
OR: 1.5 [1.1–2.1]
5. urticaria (4.1%; n = 382)
OR: 0.8 [0.6–1.0]
rash (3.2%; n = 340)
OR: 0.9 [0.7–1.3]
6. intentional overdose (3.3%; n = 312)
OR: 5.0 [2.8–8.8]
anaphylactic reaction (3.2%; n = 339)
OR: 0.6 [0.4–0.9]
7. headache (3.2%; n = 303)
OR: 1.2 [0.8–1.8]
foetal exposure during pregnancy (3.1%; n = 326)
OR: 0.7 [0.5–1.1]
8. tachycardia (3.2%; n = 301)
OR: 1.3 [0.9–1.8]
pruritus (3.0%; n = 323)
OR: 1.0 [0.7–1.4]
pyrexia (3.0%; n = 323)
OR: 0.9 [0.7–1.4]
9. fatigue (3.2%; n = 300)
OR: 1.3 [0.9–1.9]
seizure (2.8%; n = 297)
OR: 1.0 [0.7–1.4]
10. dizziness (3.1%; n = 386)
1.4 [0.9–2.0]
headache (2.7%; n = 285)
OR: 1.2 [0.8–1.8]
  1. OR = 1 no differences in sex-stratified analysis, OR > 1 ADR is more often reported for females, OR < 1 ADR is more often reported for males
  2. a one ADR report may contain information about more than one ADR, therefore, the number of reported ADRs exceeds that of the ADR reports
  3. Table 7 shows the absolute and relative number of the ten most frequently reported ADRs on PT-level of the MedDRA terminology [25] stratified by sex and their calculated ORs with Bonferroni adjusted CI for females versus males