| SOC | HLGT | PT | Male | Female | ROR (95% CI) | PRR (95% CI) |
| Psychiatric disorders | Various dissociative disorders | Dissociation | 398 | 221 | 1.32 (1.11, 1.56) | 1.32 (1.11, 1.56) | Various acts of suicide and self-harm (not classified) | Suicidal ideation | 202 | 113 | 1.30 (1.03, 1.64) | 1.30 (1.03, 1.64) | Depressive mood disorders and confusion | Depression | 142 | 84 | 1.22 (1.13, 1.61) | 1.22 (1.13, 1.61) | Anxiety disorders and symptoms | Anxiety | 130 | 64 | 1.48 (1.09, 1.99) | 1.48 (1.09, 1.99) | Various acts of suicide and self-harm (not classified) | Suicide attempt | 72 | 41 | 1.27 (0.86, 1.87) | 1.27 (0.86, 1.87) |
| Nervous system disorders | Neurological diseases (not otherwise classified) | Sedation | 294 | 165 | 1.30 (1.07, 1.58) | 1.30 (1.07, 1.58) | Neurological diseases (not otherwise classified) | Dizziness | 113 | 78 | 2.25 (1.78, 2.90) | 2.25 (1.78, 2.90) | Headache of all kinds | Headache | 75 | 24 | 2.27 (1.43, 3.60) | 2.27 (1.43, 3.60) | Neurological diseases (not otherwise classified) | Somnolence | 43 | 26 | 1.19 (0.73, 1.95) | 1.19 (0.73, 1.95) |
| Vomiting | Signs and symptoms of gastrointestinal system | Nausea | 162 | 86 | 1.37 (1.05, 1.78) | 1.37 (1.05, 1.78) | Signs and symptoms of gastrointestinal system | Vomiting | 136 | 78 | 1.26 (0.95, 1.67) | 1.26 (0.95, 1.67) | Signs and symptoms of gastrointestinal system | Abdominal pain upper | 19 | 4 | 3.43 (1.17, 10.10) | 3.43 (1.17, 10.10) | Oral soft tissue diseases | Hypoaesthesia oral | 12 | 5 | 1.73 (0.61, 4.92) | 1.73 (0.61, 4.92) |
| Inappropriate schedule of product administration | Off-specification use and intentional misuse/use of products | Off-label use | 86 | 85 | 0.73 (0.54, 0.98) | 0.73 (0.54, 0.98) | Medication errors and other product use errors and problems | Product dose omission issue | 83 | 29 | 2.08 (1.36, 3.18) | 2.08 (1.36, 3.18) | Various injuries (not otherwise classified) | Fall | 23 | 10 | 1.66 (0.79, 3.50) | 1.66 (0.79, 3.50) | Medication errors and other product use errors and problems | Product dose omission issue | 23 | 18 | 0.92 (0.50, 1.71) | 0.92 (0.50, 1.71) | Overdose and underdose (not classified separately) | Underdose | 23 | 11 | 1.51 (0.74, 3.10) | 1.51 (0.74, 3.10) |
| Hypotension | Vascular hypertensive disease | Hypotension | 92 | 55 | 1.21 (0.86, 1.69) | 1.21 (0.86, 1.69) | Decreased blood pressure and abnormal blood pressure of unknown nature and shock | Hypotension | 22 | 22 | 0.72 (0.40, 1.30) | 0.72 (0.40, 1.30) |
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