Table 4.
Type of serious adverse drug reaction (sADR)
| Type of ADR | Description of sADR | n = 54 |
|---|---|---|
| Cardiovascular ADR | QTc time prolongation (> 450 ms) | 20 |
| Nervous system ADR | EPS: Rigor, tremor, akinesia, gaze spasm, tongue or gullet spasm, akathisia, myoclonus, gait disturbance | 8 |
| Epileptic seizure | 2 | |
| Gastrointestinal ADR | Nausea, vomiting, abdominal pain with diarrhea | 3 |
| Increased salivation | 3 | |
| Weight gain (> 10 kg) | 4 | |
| Blood count change | Leukopenia | 1 |
| Aplastic anemia | 1 | |
| Liver value increase | 3 | |
| Psychiatric ADR | Suicidality | 3 |
| Psychosis | 3 | |
| (Auto-)aggression | 2 | |
| Delirium | 1 |
ADR adverse drug reaction