Table 4.
Treatment-emergent adverse events
| 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) |
aReported in ≥2 % of patients during the open-label period of the randomized withdrawal study; coded by MedDRA preferred term
bTachycardia refers to an increase in heart rate that is greater than the age-corrected upper limit of normal. Heart rate increased refers to any increase, whether or not within the normal age-corrected range
TEAE = treatment-emergent adverse event