Table 3.
Adverse events observed with dapoxetine (60 mg and 100 mg) and placebo
| Adverse effects | Placebo (n = 140) | Dapoxetine 60 mg (n = 139) | Dapoxetine 100 mg (n = 145) |
|---|---|---|---|
| Total # of pts 1 AE | 21 (15.0%) | 41 (29.5%) | 57 (39.3%) |
| Nausea | 1 (0.7%) | 8 (5.8%) | 24 (16.6%) |
| Headache | 0 | 6 (4.3%) | 8 (5.5%) |
| Upper respiratory tract infection | 1 (0.7%) | 3 (2.2%) | 2 (1.4%) |
| Diarrhea | 1 (0.7%) | 7 (5.0%) | 10 (6.9%) |
| Dizziness | 0 | 3 (2.2%) | 2 (1.4%) |
| Rhinitis | 1 (0.7%) | 6 (4.3%) | 1 (0.7%) |
| ED | 0 | 0 | 2 (1.4%) |
| Somnolence | 1 (0.7%) | 4 (2.9%) | 2 (1.4%) |
| Insomnia | 1 (0.7%) | 5 (3.6%) | 9 (6.2%) |
| Dyspepsia | 0 | 4 (2.9%) | 3 (2.1%) |
| Nervousness | 0 | 5 (3.6%) | 5 (3.4%) |
| Dropouts | 1 | 0 | 9 |
Derived from Hellstrom (2004), Hellstrom et al (2005).
Abbreviations: AE, adverse events; ED, erectile dysfunction.