Table 3. Adverse Events related to Gastrointestinal System.
SD - Single Dose, OD - Once Daily, BID - Twice Daily
| Study | Constipation, n (%) | Nausea, n (%) | Gastroenteritis, n (%) | Increased alanine aminotransferase level, n (%) | Vomiting, n (%) | Diarrhea, n (%) | Abdominal discomfort, n (%) |
|---|---|---|---|---|---|---|---|
| Ankrom et al.9 | |||||||
| 60 mg OD | 3 (11.5) | 0 | - | - | - | 3 (11.5) | - |
| Goadsby et al.10 | |||||||
| 10 mg OD | 1 (1) | 3 (3) | - | - | - | - | - |
| 30 mg OD | 10 (5) | 10 (5) | - | - | - | - | - |
| 60 mg OD | 8 (4) | 11 (6) | - | - | - | - | - |
| 30 mg BID | 3 (3) | 5 (6) | - | - | - | - | - |
| 60 mg BID | 4 (4) | 8 (9) | - | - | - | - | - |
| Placebo | 2 (1) | 5 (3) | - | - | - | - | - |
| Min et al.11 | |||||||
| 170 mg | 2 (8.7) | 3 (13.0) | - | - | - | 2 (8.7) | 2 (8.7) |
| Placebo | 0 | 1 (9.1) | - | - | - | 0 | 0 |
| Boinpally et al.12 | |||||||
| 300 mg SD | 0 | 0 | - | - | 0 | 0 | 0 |
| Placebo | 1 (1.7) | 0 | - | - | 0 | 1 (1.7) | 0 |
| Ailani et al.13 | |||||||
| 10 mg OD | 17 (7.7) | 11 (5.0) | 3 (1.4) | 3 (1.4) | - | - | - |
| 30 mg OD | 16 (7.0) | 10 (4.4) | 2 (0.9) | 2 (0.9) | - | - | - |
| 60 mg OD | 16 (6.9) | 14 (6.1) | 2 (0.9) | 2 (0.9) | - | - | - |
| Placebo | 1 (0.5) | 4 (1.8) | 6 (2.7) | 6 (2.7) | - | - | - |
| Klein et al.16 | |||||||
| 60 mg OD | 23 (3.4) | 23 (3.4) | 15 (2.2) | 4 (0.6) | 14 (2.0) | - | - |
| Ashina et al.17 | |||||||
| 60 mg OD | 39 (7.2) | 34 (6.3) | 13 (2.4) | 11 (2.0) | - | - | - |