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

Table 7 Sex-stratified analysis of ADRs most frequently reported

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]

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
^a one ADR report may contain information about more than one ADR, therefore, the number of reported ADRs exceeds that of the ADR reports
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

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