Table 3.
Treatment-emergent adverse events occurring in at least 2% of subjects in pooled phase III data [Buvat et al. 2009; Kaufman et al. 2009; McMahon et al. 2010; Pryor et al. 2006].
| Adverse event n (%) | Placebo (n = 1857) | Dapoxetine 30 mg as needed (n = 1616) | Dapoxetine 60 mg as needed (n = 2106) | Dapoxetine 60 mg daily (n = 502) | Total dapoxetine (n = 4224) |
|---|---|---|---|---|---|
| Nausea | 41 (2.2) | 178 (11.0) | 467 (22.2) | 86 (17.1) | 731 (17.3) |
| Dizziness | 40 (2.2) | 94 (5.8) | 230 (10.9) | 75 (14.9) | 399 (9.4) |
| Headache | 89 (4.8) | 91 (5.6) | 185 (8.8) | 56 (11.2) | 332 (7.9) |
| Diarrhoea | 32 (1.7) | 56 (3.5) | 145 (6.9) | 47 (9.4) | 248 (5.9) |
| Somnolence | 10 (0.5) | 50 (3.1) | 98 (4.7) | 18 (3.6) | 166 (3.9) |
| Fatigue | 23 (1.2) | 32 (2.0) | 86 (4.1) | 46 (9.2) | 164 (3.9) |
| Insomnia | 28 (1.5) | 34 (2.1) | 83 (3.9) | 44 (8.8) | 161 (3.8) |
| Nasopharyngitis | 43 (2.3) | 51 (3.2) | 61 (2.9) | 17 (3.4) | 129 (3.1) |