| Summary of results C: Adverse events with different doses of pregabalin in fibromyalgia | ||||||
| Outcome ‐ daily dose | Number of | Per cent with outcome | Relative risk (95% CI) | NNH (95% CI) | ||
| Studies | Participants | Pregabalin | Placebo | |||
| Any adverse event | ||||||
| 150 mg* | 1 | 263 | 78 | 77 | 1.01 (0.89 to 1.2) | Not calculated |
| 300 mg | 4 | 1275 | 85 | 74 | 1.2 (1.1 to 1.2) | 9.0 (6.5 to 15) |
| 450 mg | 5 | 1874 | 90 | 73 | 1.2 (1.18 to 1.3) | 5.9 (4.9 to 7.4) |
| 600 mg | 3 | 1122 | 91 | 74 | 1.2 (1.17 to 1.3) | 5.7 (4.6 to 7.5) |
| Serious adverse event | ||||||
| 300 mg | 2 | 735 | 1 | 2 | 0.7 (0.2 to 2.4) | Not calculated |
| 450 mg | 3 | 1238 | 2 | 1 | 1.9 (0.8 to 4.6) | Not calculated |
| 600 mg | 2 | 742 | 2 | 2 | 1.0 (0.3 to 3.0) | Not calculated |
| Specific adverse events ‐ 150 mg | ||||||
| Somnolence* | 1 | 263 | 16 | 5 | 3.5 (1.5 to 8.3) | Not calculated |
| Dizziness* | 1 | 263 | 23 | 11 | 2.1 (1.2 to 3.8) | Not calculated |
| Weight gain* | 1 | 263 | 8 | 2 | 5.0 (1.1 to 22) | Not calculated |
| Peripheral oedema* | 1 | 263 | 5 | 1 | 7.0 (0.9 to 56) | Not calculated |
| Specific adverse events ‐ 300 mg | ||||||
| Somnolence | 4 | 1375 | 20 | 5 | 4.0 (2.8 to 5.8) | 6.7 (5.5 to 8.7) |
| Dizziness | 4 | 1375 | 32 | 10 | 3.1 (2.4 to 3.9) | 4.6 (3.9 to 5.7) |
| Weight gain | 4 | 1375 | 11 | 2 | 4.6 (2.7 to 7.9) | 12 (9.1 to 17) |
| Peripheral oedema | 4 | 1375 | 7 | 2 | 3.0 (1.7 to 5.3) | 23 (15 to 45) |
| Specific adverse events ‐ 450 mg | ||||||
| Somnolence | 5 | 1874 | 28 | 8 | 3.3 (2.6 to 4.1) | 5.2 (4.5 to 6.4) |
| Dizziness | 5 | 1874 | 39 | 9 | 4.2 (3.4 to 5.2) | 3.4 (3 to 3.8) |
| Weight gain | 5 | 1874 | 12 | 3 | 4.5 (2.9 to 6.8) | 11 (8.6 to 14) |
| Peripheral oedema | 5 | 1874 | 7 | 2 | 3.5 (2.1 to 5.8) | 21 (15 to 34) |
| Specific adverse events ‐ 600 mg | ||||||
| Somnolence | 3 | 1122 | 23 | 5 | 4.5 (3.1 to 6.7) | 5.7 (4.6 to 7.3) |
| Dizziness | 3 | 1122 | 46 | 10 | 4.4 (3.4 to 5.8) | 2.8 (2.5 to 3.2) |
| Weight gain | 3 | 1122 | 13 | 3 | 5.4 (3.1 to 9.4) | 9.1 (7.1 to 13) |
| Peripheral oedema | 3 | 1122 | 11 | 3 | 4.2 (2.4 to 7.5) | 12 (9.1 to 19) |
| Specific adverse events ‐ all doses combined | ||||||
| Somnolence | 5 | 3256 | 23 | 10 | 2.4 (1.9 to 3) | 7.4 (6.1 to 9.2) |
| Dizziness | 5 | 3256 | 38 | 11 | 3.5 (2.3 to 4.3) | 3.7 (3.3 to 4.2) |
| Weight gain | 5 | 3256 | 9 | 3 | 2.8 (1.8 to 4.1) | 18 (14 to 26) |
| Peripheral oedema | 5 | 3256 | 8 | 2 | 3.4 (2.1 to 5.5) | 19 (14 to 26) |
| *Information from a single study, included to examine a general dose‐response relationship and should be interpreted with caution. CI: confidence interval; NNH: number needed to harm | ||||||
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