Table 6.
Event | Number reported (percentage of 813) | Comment |
---|---|---|
Generalized tonic-clonic seizure | 1 (0.1%) | Underlying seizure disorder |
Vomiting | 2 (0.2%) | One patient received ipecac |
Significant hypertension* | 1 (0.1%) | Total dose 1.2 mg |
SBP increases > 30 mmHg | 7 (0.9%) | Systolic blood pressure (SBP) between 100 and 160 mmHg |
Significant hypotension** | 2 (0.2%) |
No patient had ventricular tachycardia, fibrillation, or asystole; pulmonary edema was not assessed.
If SBP increased by more than 30 mmHg and above 160 mmHg.
If SBP decreased to less than 120 mmHg and dropped by 30 mmHg.