All-cause treatment-emergent adverse events.
| Placebo, n (%) N = 184 | Pregabalin 300 mg/day, n (%) N = 184 | Pregabalin 450 mg/day, n (%) N = 182 | Pregabalin 600 mg/day, n (%) N = 186 | All Pregabalin, n (%) N = 552 | |
|---|---|---|---|---|---|
| Summary | |||||
| Any adverse event | 135 (73.4) | 155 (84.7) | 164 (90.1) | 171 (91.9) | 490 (88.9) |
| Serious adverse events | 4 (2.2) | 2 (1.1) | 8 (4.4) | 4 (2.2) | 14 (2.5) |
| Severe adverse events | 12 (6.5) | 33 (17.9) | 26 (14.3) | 30 (16.1) | 89 (16.1) |
| Adverse events/preferred term* | |||||
| Dizziness | 28 (15.2) | 68 (37.0) | 76 (41.8) | 93 (50.0) | 237 (42.9) |
| Somnolence | 11 (6.0) | 37 (20.1) | 24 (13.2) | 34 (18.3) | 95 (17.2) |
| Peripheral edema | 7 (3.8) | 19 (10.3) | 15 (8.2) | 27 (14.5) | 61 (11.1) |
| Weight increase | 6 (3.3) | 24 (13.0) | 24 (13.2) | 24 (12.9) | 72 (13.0) |
| Dry mouth | 4 (2.2) | 16 (8.7) | 20 (11.0) | 20 (10.8) | 56 (10.1) |
| Fatigue | 15 (8.2) | 14 (7.6) | 26 (14.3) | 17 (9.1) | 57 (10.3) |
| Headache | 30 (16.3) | 27 (14.7) | 25 (13.7) | 16 (8.6) | 68 (12.3) |
| Constipation | 8 (4.3) | 18 (9.8) | 12 (6.6) | 15 (8.1) | 45 (8.2) |
| Vertigo | 4 (2.2) | 13 (7.1) | 12 (6.6) | 15 (8.1) | 40 (7.2) |
| Disturbance in attention | 4 (2.2) | 10 (5.4) | 12 (6.6) | 15 (8.1) | 37 (6.7) |
| Blurred vision | 1 (0.5) | 6 (3.3) | 9 (4.9) | 13 (7.0) | 28 (5.1) |
| Nausea | 20 (10.9) | 22 (12.0) | 6 (3.3) | 12 (6.5) | 40 (7.2) |
| Influenza | 6 (3.3) | 5 (2.7) | 7 (3.8) | 10 (5.4) | 22 (4.0) |
| Diarrhea | 12 (6.5) | 7 (3.8) | 6 (3.3) | 8 (4.3) | 21 (3.8) |
| Nasopharyngitis | 7 (3.8) | 7 (3.8) | 10 (5.5) | 6 (3.2) | 23 (4.2) |
| Arthralgia | 8 (4.3) | 10 (5.4) | 7 (3.8) | 5 (2.7) | 22 (4.0) |
↵* Reported by ≥ 5% of patients in any treatment group and ordered by decreasing frequency in the 600 mg/day treatment group.