Summary of most frequently reported treatment-emergent adverse events. Adverse events were reported by at least 5% of patients in the milnacipran 200 mg/day group.
| Adverse Event, n (%) | Placebo, n = 223 | Milnacipran 100 mg/day, n = 224 | Milnacipran 200 mg/day, n = 441 |
|---|---|---|---|
| Nausea | 47 (21.1) | 73 (32.6) | 177 (40.1) |
| Headache | 26 (11.7) | 35 (15.6) | 78 (17.7) |
| Constipation | 6 (2.7) | 41 (18.3) | 63 (14.3) |
| Hyperhidrosis | 5 (2.2) | 22 (9.8) | 55 (12.5) |
| Dizziness | 15 (6.7) | 26 (11.6) | 50 (11.3) |
| Hot flush | 6 (2.7) | 22 (9.8) | 46 (10.4) |
| Insomnia | 15 (6.7) | 24 (10.7) | 41 (9.3) |
| Vomiting | 4 (1.8) | 11 (4.9) | 36 (8.2) |
| Sinusitis | 18 (8.1) | 11 (4.9) | 32 (7.3) |
| Heart rate increased | 5 (2.2) | 12 (5.4) | 32 (7.3) |
| Dry mouth | 6 (2.7) | 13 (5.8) | 31 (7.0) |
| Upper respiratory tract infection | 16 (7.2) | 20 (8.9) | 30 (6.8) |
| Palpitations | 2 (0.9) | 18 (8.0) | 25 (5.7) |
| Diarrhea | 16 (7.2) | 10 (4.5) | 23 (5.2) |