Table 2.
Proportion of Participants Who Experienced at Least 1 Adverse Effect by Treatment Group
| No. (%) of Participants |
|||
|---|---|---|---|
| Escitalopram (n = 85) |
Placebo (n = 92) |
P Valuea |
|
| ≥1 Adverse effect | 65 (76.5) | 59 (64) | .10 |
|
| |||
| Withdrew due to adverse effects | 3 (3.5) | 4 (4.3) | .99 |
|
| |||
| Most common adverse effects | |||
| Fatigue or somnolence | 35 (41.1) | 10 (10.9) | <.001 |
|
| |||
| Gastrointestinal upset | 22 (25.9) | 26 (28.3) | .73 |
|
| |||
| Headache | 13 (15.3) | 7 (7.6) | .15 |
|
| |||
| Sleep disturbance | 12 (14.1) | 2 (2.2) | .004 |
|
| |||
| Sweating | 11 (12.9) | 5 (5.4) | .11 |
|
| |||
| Sexual | 9 (10.6) | 3 (3.3) | .07 |
|
| |||
| Urinary symptomsb | 8 (9.4) | 0 | .002 |
|
| |||
| Increased anxiety or depression | 7 (8.2) | 9 (9.8) | .80 |
|
| |||
| Light-headedness | 7 (8.2) | 7 (7.6) | .99 |
|
| |||
| Tremor | 7 (8.2) | 2 (2.2) | .09 |
|
| |||
| Aches | 5 (5.9) | 14 (15.2) | .05 |
|
| |||
| Rash or pruritus | 5 (5.9) | 6 (6.5) | .99 |
a
Two-tailed Fisher exact tests.
b
Increased or decreased frequency and urgency.