Table 2 enumerates the most common treatment-emergent adverse events associated with the use of sertraline (incidence of at least 5% for sertraline and at least twice that for placebo within at least one of the indications) for the treatment of adult patients with major depressive disorder/other*, OCD, panic disorder, PTSD, PMDD and social anxiety disorder in placebo-controlled clinical trials. Most patients in major depressive disorder/other*, OCD, panic disorder, PTSD and social anxiety disorder studies received 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 sertraline and with incidence greater than placebo who participated in controlled clinical trials comparing sertraline 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.

  1. Primarily ejaculatory delay. Denominator used was for male patients only (N=271 sertraline major depressive disorder/other*; N=271 placebo major depressive disorder/other*; N=296 sertraline OCD; N=219 placebo OCD; N=216 sertraline panic disorder; N=134 placebo panic disorder; N=130 sertraline PTSD; N=149 placebo PTSD; No male patients in PMDD studies; N=205 sertraline social anxiety disorder; N=153 placebo social anxiety disorder). *Major depressive disorder and other premarketing controlled trials.  

  2. 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. 


  1. Primarily ejaculatory delay. Denominator used was for male patients only (N=271 sertraline major depressive disorder/other*; N=271 placebo major depressive disorder/other*; N=296 sertraline OCD; N=219 placebo OCD; N=216 sertraline panic disorder; N=134 placebo panic disorder; N=130 sertraline PTSD; N=149 placebo PTSD; No male patients in PMDD studies; N=205 sertraline social anxiety disorder; N=153 placebo social anxiety disorder). *Major depressive disorder and other premarketing controlled trials.  

  2. 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. 


  1. Primarily ejaculatory delay. Denominator used was for male patients only (N=271 sertraline major depressive disorder/other*; N=271 placebo major depressive disorder/other*; N=296 sertraline OCD; N=219 placebo OCD; N=216 sertraline panic disorder; N=134 placebo panic disorder; N=130 sertraline PTSD; N=149 placebo PTSD; No male patients in PMDD studies; N=205 sertraline social anxiety disorder; N=153 placebo social anxiety disorder). *Major depressive disorder and other premarketing controlled trials.  

  2. 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. 


  1. Primarily ejaculatory delay. Denominator used was for male patients only (N=1118 sertraline; N=926 placebo). *Major depressive disorder and other premarketing controlled trials. **Included are events reported by at least 2% of patients taking sertraline except the following events, which had an incidence on placebo greater than or equal to sertraline: abdominal pain, back pain, flatulence, malaise, pain, pharyngitis, respiratory disorder, upper respiratory tract infection.