eived doses of 50 to 200 mg/day. Patients in the PMDD study with daily dosing throughout the menstrual cycle received doses of 50 to 150 mg/day, and in the PMDD study with dosing during the luteal phase of the menstrual cycle received doses of 50 to 100 mg/day. Table 3 enumerates treatment-emergent adverse events that occurred in 2% or more of adult patients treated with ZOLOFT and with incidence greater than placebo who participated in controlled clinical trials comparing ZOLOFT with placebo in the treatment of major depressive disorder/other*, OCD, panic disorder, PTSD, PMDD and social anxiety disorder. Table 3 provides combined data for the pool of studies that are provided separately by indication in Table 2.
TABLE 2 MOST COMMON TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Percentage of Patients Reporting Event
Major Depressive Disorder/Other* OCD Panic Disorder PTSD
Body System/Adverse Event ZOLOFT
(N=861) Placebo
(N=853) ZOLOFT
(N=533) Placebo
(N=373) ZOLOFT
(N=430) Placebo
(N=275) ZOLOFT
(N=374) Placebo
(N=376)
*
Major depressive disorder and other premarketing controlled trials.
†
Primarily ejaculatory delay. Denominator used was for male patients only (N=271 ZOLOFT major depressive disorder/other*; N=271 placebo major depressive disorder/other*; N=296 ZOLOFT OCD; N=219 placebo OCD; N=216 ZOLOFT panic disorder; N=134 placebo panic disorder; N=130 ZOLOFT PTSD; N=149 placebo PTSD; No male patients in PMDD studies; N=205 ZOLOFT social anxiety disorder; N=153 placebo social anxiety disorder).
‡
The luteal phase and daily dosing PMDD trials were not designed for making direct comparisons between the two dosing regimens. Therefore, a comparison between the two dosing regimens of the PMDD trials of incidence rates shown in Table 2 should be avoided.
Autonomic Nervous System Disorders
Ejaculation Failure† 7 <1 17 2 19 1 11 1
Mouth Dry 16 9 14 9 15 10 11 6
Sweating Increased 8 3 6 1 5 1 4 2
Center. & Periph. Nerv. System Disorders
Somnolence 13 6 15 8 15 9 13 9
Tremor 11 3 8 1 5 1 5 1
Dizziness 12 7 17 9 10 10 8 5
General
Fatigue 11 8 14 10 11 6 10 5
Pain 1 2 3 1 3 3 4 6
Malaise <1 1 1 1 7 14 10 10
Gastrointestinal Disorders
Abdominal Pain 2 2 5 5 6 7 6 5
Anorexia 3 2 11 2 7 2 8 2
Constipation 8 6 6 4 7 3 3 3
Diarrhea/Loose Stools 18 9 24 10 20 9 24 15
Dyspepsia 6 3 10 4 10 8 6 6
Nausea 26 12 30 11 29 18 21 11
Psychiatric Disorders
Agitation 6 4 6 3 6 2 5 5
Insomnia 16 9 28 12 25 18 20 11
Libido Decreased 1 <1 11 2 7 1 7 2
PMDD
Daily Dosing PMDD
Luteal Phase Dosing‡ Social Anxiety Disorder
Body System/Adverse Event ZOLOFT
(N=121) Placebo
(N=122) ZOLOFT
(N=136) Placebo
(N=127) ZOLOFT
(N=344) Placebo
(N=268)
Autonomic Nervous System Disorders
Ejaculation Failure† N/A N/A N/A N/A 14 -
Mouth Dry 6 3 10 3 12 4
Sweatin
