Table 3 ADRs involving systematic and clinical manifestations (N = 392)
ADRs | Mild | Moderate | Severe | |||
|---|---|---|---|---|---|---|
Number of patients, n (%) | Number of cases | Number of patients, n (%) | Number of cases | Number of patients, n (%) | Number of cases | |
Total ADRs | 58 (14.8) | 96 | 33 (8.4) | 46 | 1 (0.3) | 1 |
Neurological disorders | 52 (13.3) | 71 | 26 (6.6) | 32 | 0 (0) | 0 |
Akathisia | 28 (7.1) | 28 | 11 (2.8) | 11 | 0 (0) | 0 |
Tremor | 17 (4.3) | 18 | 5 (1.3) | 5 | 0 (0) | 0 |
Dystonia | 7 (1.8) | 7 | 5 (1.3) | 6 | 0 (0) | 0 |
Parkinsonism | 8 (2.0) | 9 | 4 (1.0) | 4 | 0 (0) | 0 |
Investigations | 9 (2.3) | 9 | 4 (1.0) | 5 | 1 (0.3) | 1 |
Weight gain | 3 (0.8) | 3 | 2 (0.5) | 2 | 0(0) | 0 |
Blood prolactin increased | 2 (0.5) | 2 | 1 (0.3) | 1 | 1 (0.3) | 1 |
Increased heart rate | 1 (0.3) | 1 | 1(0.3) | 1 | 0(0) | 0 |
elevated transaminase level | 2 (0.5) | 2 | 0 (0) | 0 | 0 (0) | 0 |
White blood cell count decreased | 0 (0) | 0 | 1 (0.3) | 1 | 0 (0) | 0 |
Blood glucose increased | 1 (0.3) | 1 | 0 (0) | 0 | 0 (0) | 0 |
Gastrointestinal disorders | 2 (0.5) | 3 | 2 (0.5) | 2 | 0 (0) | 0 |
Eye disorders | 1 (0.3) | 3 | 1 (0.3) | 1 | 0 (0) | 0 |
Psychiatric disorders | 1 (0.3) | 1 | 1 (0.3) | 1 | 0 (0) | 0 |
Kidney and urinary disorders | 1 (0.3) | 1 | 0 (0) | 0 | 0 (0) | 0 |