Table 2.
Number (%) of Patients Reporting Treatment-Emergent Adverse Eventsa During the On-Therapy Period of 3 Short-Term, Double-Blind, Placebo-Controlled Studies of Desvenlafaxine 50 and 100 mg/d for MDD, by Most Common Event
| Desvenlafaxine |
|||
| Adverse Eventb | Placebo | 50 mg/d | 100 mg/d |
| From Liebowitz et al,19 Study 332 | |||
| (n = 152) | (n = 151) | (n = 148) | |
| Dizziness | 6 (4) | 25 (17) | 10 (7) |
| Dry mouth | 6 (4) | 15 (10) | 23 (16) |
| Constipation | 5 (3) | 14 (9) | 16 (11) |
| Insomnia | 4 (3) | 14 (9) | 15 (10) |
| Decreased appetite | 7 (5) | 8 (5) | 15 (10) |
| Hyperhidrosis | 4 (3) | 10 (7) | 14 (10) |
| Fatigue | 5 (3) | 9 (6) | 10 (7) |
| Abdominal pain | 4 (3) | 9 (6) | 5 (3) |
| Anxiety | 1 (1) | 5 (3) | 7 (5) |
| Vision blurred | 2 (1) | 7 (5) | 5 (3) |
| From Boyer et al,17 Study 333 | |||
| (n = 161) | (n = 166) | (n = 158) | |
| Nausea | 17 (11) | 44 (27) | 48 (30) |
| Dizziness | 6 (4) | 17 (10) | 11 (7) |
| Insomnia | 7 (4) | 13 (8) | 14 (9) |
| Constipation | 7 (4) | 13 (8) | 8 (5) |
| Fatigue | 5 (3) | 12 (7) | 11 (7) |
| Anxiety | 5 (3) | 4 (2) | 9 (6) |
| Decreased appetite | 1 (1) | 8 (5) | 7 (4) |
| From Tourian et al,26 Study 335 | |||
| Desvenlafaxine |
||||
| Adverse Eventb | Placebo (n = 161) | 50 mg/d (n = 148) | 100 mg/d (n = 150) | Duloxetine, 60 mg/d (n = 157) |
| Nausea | 14 (9) | 33 (22) | 35 (23) | 49 (31) |
| Insomnia | 5 (3) | 16 (11) | 21 (14) | 29 (19) |
| Decreased appetite | 5 (3) | 14 (10) | 14 (9) | 29 (19) |
| Somnolence | 4 (3) | 9 (6) | 17 (11) | 23 (15) |
| Fatigue | 6 (4) | 12 (8) | 15 (10) | 19 (12) |
| Constipation | 4 (3) | 9 (6) | 10 (7) | 17 (11) |
| Hyperhidrosis | 3 (2) | 7 (5) | 9 (6) | 16 (10) |
| Vomiting | 3 (2) | 2 (1) | 6 (4) | 13 (8) |
| Vision blurred | 1 (1) | 6 (4) | 7 (5) | 2 (1) |
| Abnormal dreams | 2 (1) | 2 (1) | 3 (2) | 8 (5) |
| Yawning | 0 | 2 (1) | 1 (1) | 7 (5) |
a
Events reported by at least 5% of patients at twice the rate of placebo in any active treatment group during the double-blind period, excluding taper, safety population (all randomly assigned patients who took at least 1 dose of double-blind test medication).
b
Classification of adverse events is based on the Medical Dictionary for Regulatory Activities.33