Table 4 Treatment-emergent adverse events
| Â | Randomized withdrawal study | Extension study | ||
|---|---|---|---|---|
Open-label | Double-blind | |||
Milnacipran | Placebo | Milnacipran | Milnacipran | |
Patients, n (%) | n = 116 | n = 6 | n = 14 | N = 57 |
Any TEAEa | 91 (78.4) | 4 (66.7) | 6 (42.9) | 42 (73.7) |
Nausea | 38 (32.8) | 0 | 0 | 10 (17.5) |
Vomiting | 16 (13.8) | 0 | 0 | 5 (8.8) |
Headache | 12 (10.3) | 1 (16.7) | 0 | 4 (7.0) |
Dizziness | 10 (8.6) | 0 | 0 | 3 (5.3) |
Fatigue | 7 (6.0) | 0 | 0 | 1 (1.8) |
Hot flush | 7 (6.0) | 0 | 0 | 2 (3.5) |
Tachycardiab | 7 (6.0) | 0 | 1 (7.1) | 6 (10.5) |
Decreased appetite | 5 (4.3) | 0 | 0 | 6 (10.5) |
Hyperhidrosis | 5 (4.3) | 0 | 0 | 1 (1.8) |
Insomnia | 5 (4.3) | 0 | 0 | 1 (1.8) |
Upper respiratory tract infection | 5 (4.3) | 0 | 1 (7.1) | 0 |
Urinary tract infection | 5 (4.3) | 0 | 0 | 5 (8.8) |
Abdominal pain | 4 (3.4) | 0 | 0 | 4 (7.0) |
Gastroenteritis | 4 (3.4) | 0 | 0 | 1 (1.8) |
Heart rate increasedb | 4 (3.4) | 0 | 0 | 4 (7.0) |
Nasopharyngitis | 4 (3.4) | 0 | 0 | 2 (3.5) |
Diarrhea | 3 (2.6) | 0 | 0 | 1 (1.8) |
Dysmenorrhea | 3 (2.6) | 0 | 0 | 0 |
Irritability | 3 (2.6) | 0 | 0 | 0 |
Palpitations | 3 (2.6) | 0 | 0 | 1 (1.8) |
Rash | 3 (2.6) | 0 | 0 | 0 |
Tremor | 3 (2.6) | 0 | 0 | 1 (1.8) |