Common treatment-emergent adverse events (≥ 5% of patients in any treatment group), safety population
| Group; % | |||
|---|---|---|---|
| Adverse event | Placebo, n = 186 | Levomilnacipran ER, 40 mg/day, n = 188 | Levomilnacipran ER, 80 mg/day, n = 188 |
| Nausea | 5.9 | 14.4 | 15.4 |
| Headache | 8.6 | 11.7 | 13.3 |
| Dry mouth | 3.8 | 10.1 | 9.6 |
| Hyperhidrosis | 0 | 3.7 | 9.6 |
| Constipation | 2.2 | 6.9 | 6.4 |
| Dizziness | 0.5 | 3.7 | 6.4 |
| Urinary hesitation | 0 | 3.2 | 6.4 |
| Increased heart rate | 3.2 | 9.0 | 13.8 |
| Erectile dysfunction* | 1.4 | 5.6 | 14.1 |
| Upper respiratory tract infection | 5.9 | 5.3 | 4.3 |
| Diarrhea | 5.4 | 3.7 | 3.7 |
| Testicular pain* | 0 | 4.2 | 7.8 |
ER = extended-release.
↵* Percentages are relative to the number of male patients (placebo, n = 70; 40 mg/day, n = 71; 80 mg/day, n = 64).