g Increased 6 <1 3 0 11 2
Center. & Periph. Nerv. System Disorders
Somnolence 7 <1 2 0 9 6
Tremor 2 0 <1 <1 9 3
Dizziness 6 3 7 5 14 6
General
Fatigue 16 7 10 <1 12 6
Pain 6 <1 3 2 1 3
Malaise 9 5 7 5 8 3
Gastrointestinal Disorders
Abdominal Pain 7 <1 3 3 5 5
Anorexia 3 2 5 0 6 3
Constipation 2 3 1 2 5 3
Diarrhea/Loose Stools 13 3 13 7 21 8
Dyspepsia 7 2 7 3 13 5
Nausea 23 9 13 3 22 8
Psychiatric Disorders
Agitation 2 <1 1 0 4 2
Insomnia 17 11 12 10 25 10
Libido Decreased 11 2 4 2 9 3
TABLE 3 TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Percentage of Patients Reporting Event Major Depressive Disorder/Other *, OCD, Panic Disorder, PTSD, PMDD and Social Anxiety Disorder combined Body System/Adverse Event† ZOLOFT
(N=2799) Placebo
(N=2394)
Major depressive disorder and other premarketing controlled trials.
†
Included are events reported by at least 2% of patients taking ZOLOFT except the following events, which had an incidence on placebo greater than or equal to ZOLOFT: abdominal pain, back pain, flatulence, malaise, pain, pharyngitis, respiratory disorder, upper respiratory tract infection.
‡
Primarily ejaculatory delay. Denominator used was for male patients only (N=1118 ZOLOFT; N=926 placebo).
Autonomic Nervous System Disorders
Ejaculation Failure‡ 14 1
Mouth Dry 14 8
Sweating Increased 7 2
Center. & Periph. Nerv. System Disorders
Somnolence 13 7
Dizziness 12 7
Headache 25 23
Paresthesia 2 1
Tremor 8 2
Disorders of Skin and Appendages
Rash 3 2
Gastrointestinal Disorders
Anorexia 6 2
Constipation 6 4
Diarrhea/Loose Stools 20 10
Dyspepsia 8 4
Nausea 25 11
Vomiting 4 2
General
Fatigue 12 7
Psychiatric Disorders
Agitation 5 3
Anxiety 4 3
Insomnia 21 11
Libido Decreased 6 2
Nervousness 5 4
Special Senses
Vision Abnormal 3 2
Associated with Discontinuation in Placebo-Controlled Clinical Trials
Table 4 lists the adverse events associated with discontinuation of ZOLOFT (sertraline hydrochloride) treatment (incidence at least twice that for placebo and at least 1% for ZOLOFT in clinical trials) in major depressive disorder/other*, OCD, panic disorder, PTSD, PMDD and social anxiety disorder.
TABLE 4 MOST COMMON ADVERSE EVENTS ASSOCIATED WITH DISCONTINUATION IN PLACEBO-CONTROLLED CLINICAL TRIALS Adverse Event Major Depressive Disorder/Other*, OCD, Panic Disorder, PTSD, PMDD and Social Anxiety Disorder combined
(N=2799) Major Depressive Disorder/ Other*
(N=861) OCD
(N=533) Panic Diso
