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] |