Table 2.
Adverse drug reaction (ADR) characteristics for ADR being reported at least four times, categorization into nervous system disorders, cardiovascular disorders, and other ADRs. Multiple reported ADRs in single ICSR are possible
| Reactions/MedDRA terms reported at least four times | ||
|---|---|---|
| MedDRA terms | Frequency (n) | Number of serious ADRs (%) |
| Nervous system disorders | ||
| Fatigue | 7 | 2 (28.6) |
| Hallucination | 7 | 4 (57.1) |
| Somnolence | 7 | 2 (28.6) |
| Fall | 5 | 2 (40.0) |
| Coma | 4 | 3 (75.0) |
| Disorientation | 4 | 4 (100.0) |
| Dizziness | 4 | 3 (75.0) |
| Loss of consciousness | 4 | 2 (50.0) |
| Unresponsive to stimuli | 4 | 4 (100.0) |
| Cardiovascular disorders | ||
| Hypotension | 25 | 16 (64.0) |
| Bradycardia | 6 | 5 (83.3) |
| Hypertension | 4 | 2 (50.0) |
| Others | ||
| Drug interaction | 23 | 14 (60.9) |
| Asthenia | 8 | 6 (75.0) |
| Urinary tract infection | 8 | 4 (50.0) |
| Gait disturbance | 6 | 4 (66.7) |
| Drug hypersensitivity | 6 | 1 (16.7) |
| Labelled drug-drug interaction medication | 6 | 3 (50.0) |
| Abdominal pain upper | 4 | 2 (50.0) |
| Acute kidney injury | 4 | 4 (100.0) |
| Decreased appetite | 4 | 2 (50.0) |
| Hepatitis | 4 | 3 (75.0) |
| Muscular weakness | 4 | 3 (75.0) |