Table 3.
Most common treatment-emergent adverse events (≥5 % of patients) during open-label treatment (safety population) of levomilnacipran ER 40–120 mg/day (n = 825)
| TEAEs | n (%) | Related to levomilnacipran ERa [n (%)] |
|---|---|---|
| Patients with ≥1 TEAE | 712 (86.3) | 557 (67.5) |
| Headache | 183 (22.2) | 116 (14.1) |
| Nausea | 134 (16.2) | 100 (12.1) |
| Upper respiratory tract infection | 109 (13.2) | 1 (0.1) |
| Hyperhidrosis | 90 (10.9) | 86 (10.4) |
| Constipation | 79 (9.6) | 61 (7.4) |
| Nasopharyngitis | 70 (8.5) | 2 (0.2) |
| Dizziness | 67 (8.1) | 54 (6.5) |
| Insomnia | 66 (8.0) | 47 (5.7) |
| Tachycardia | 65 (7.9) | 63 (7.6) |
| Dry mouth | 59 (7.2) | 54 (6.5) |
| Heart rate increased | 55 (6.7) | 53 (6.4) |
| Hypertension | 53 (6.4) | 35 (4.2) |
| Back pain | 46 (5.6) | 3 (0.4) |
| Erectile dysfunctionb | 16 (5.6) | 15 (5.2) |
| Blood pressure increased | 44 (5.3) | 37 (4.5) |
ER extended-release, TEAE treatment-emergent adverse event
aPercentage of safety population with TEAE possibly or probably related to levomilnacipran ER as determined by investigator assessment
bPercentage relative to the number of male patients (n = 286)