Table 3.
Most Common Treatment-Emergent Adverse Events During the On-Therapy Period of All Short-Term, Double-Blind, Placebo-Controlled Studies of Desvenlafaxine for MDD, Safety Populationa
| All Short-Term Studies |
All 5 Fixed-Dose Studies |
||||||
| Desvenlafaxine |
|||||||
| Adverse Eventb | Placebo (n = 1,116) | Desvenlafaxine, 50 to 400 mg/d (n = 1,834) | Placebo (n = 636) | 50 mg/d (n = 317) | 100 mg/d (n = 424) | 200 mg/d (n = 307) | 400 mg/d (n = 317) |
| Nausea | 117 (11) | 585 (32) | 66 (10) | 69 (22) | 112 (26) | 110 (36) | 129 (41) |
| Dry mouth | 93 (8) | 361 (20) | 57 (9) | 36 (11) | 70 (17) | 63 (21) | 78 (25) |
| Hyperhidrosis | 46 (4) | 276 (15) | 28 (4) | 30 (10) | 47 (11) | 56 (18) | 66 (21) |
| Dizziness | 71 (6) | 241 (13) | 33 (5) | 42 (13) | 41 (10) | 47 (15) | 50 (16) |
| Insomnia | 71 (6) | 226 (12) | 40 (6) | 27 (9) | 49 (12) | 42 (14) | 47 (15) |
| Constipation | 41 (4) | 197 (11) | 24 (4) | 27 (9) | 37 (9) | 31 (10) | 43 (14) |
| Somnolence | 43 (4) | 161 (9) | 23 (4) | 11 (4) | 36 (9) | 37 (12) | 37 (12) |
| Decreased appetite | 18 (2) | 167 (9) | 13 (2) | 16 (5) | 34 (8) | 30 (10) | 33 (10) |
| Fatigue | 47 (4) | 152 (8) | 22 (4) | 21 (7) | 28 (7) | 30 (10) | 35 (11) |
| Erectile dysfunctionc | 4 (1) | 53 (7) | 3 (1) | 3 (3) | 9 (6) | 10 (8) | 17 (11) |
| Vomiting | 26 (2) | 105 (6) | 18 (3) | 9 (3) | 15 (4) | 19 (6) | 27 (9) |
| Tremor | 17 (2) | 105 (6) | 11 (2) | 6 (2) | 13 (3) | 26 (9) | 28 (9) |
| Mydriasis | 1 (< 1) | 68 (4) | 1 (< 1) | 5 (2) | 7 (2) | 19 (6) | 18 (6) |
| Anorgasmia | 0 | 41 (2) | 0 | 1 (< 1) | 7 (2) | 6 (2) | 18 (6) |
Data from Clayton et al.32
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). Classification of adverse events is based on the Medical Dictionary for Regulatory Activities.33
Percentage based on number of men. All studies: placebo, n = 403; desvenlafaxine, n = 723; fixed-dose studies: placebo, n = 239; desvenlafaxine 50 mg/d, n = 108; 100 mg/d, n = 157; 200 mg/d, n = 131; 400 mg/d, n = 154.
Abbreviations: MDD = major depressive disorder, TEAEs = treatment-emergent adverse events.