Table 1 ~ Table 2 ~ Table 3

TABLE 1 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 PMDD
Daily Dosing 		PMDD
Luteal Phase Dosing (2) 		Social Anxiety
Disorder
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) 		ZOLOFT
(N=121) 		Placebo
(N=122) 		ZOLOFT
(N=136) 		Placebo
(N=127) 		ZOLOFT
(N=344) 		Placebo
(N=268)
Autonomic Nervous System Disorders
       
Ejaculation Failure (1)
 7 <1 17  2 19  1 11  1 N/A N/A N/A N/A 14 -
Mouth Dry
 16  9 14  9 15 10 11  6  6  3 10  3 12  4
Sweating Increased
  8  3  6  1  5  1  4  2  6 <1  3  0 11  2
Centr. & Periph. Nerv. System Disorders
Somnolence
13  6 15  8 15  9 13  9  7 <1 2  0  9  6
Tremor
11  3  8  1  5  1  5  1  2  0 <1 <1  9  3
Dizziness
12  7 17  9 10 10  8  5  6  3  7  5 14  6
General
Fatigue
11  8 14 10 11  6 10  5 16  7 10 <1 12  6
Pain
 1  2  3  1  3  3  4  6  6 <1  3  2  1  3
Malaise
<1  1  1  1  7 14 10 10  9  5  7  5  8  3
Gastrointestinal Disorders
Abdominal Pain
 2  2  5  5  6  7  6  5  7 <1  3  3  5  5
Anorexia
 3  2 11  2  7  2  8  2  3  2  5  0  6  3
Constipation
 8  6  6  4  7  3  3  3  2  3  1  2  5  3
Diarrhea/
Loose Stools
18  9 24 10 20  9 24 15 13  3 13  7 21  8
Dyspepsia
  6  3 10  4 10  8  6  6  7  2  7  3 13  5
Nausea
26 12 30 11 29 18 21 11 23  9 13  3 22  8
Psychiatric Disorders
Agitation
 6  4  6  3  6  2  5  5  2 <1  1  0  4  2
Insomnia
16  9 28 12 25 18 20 11 17 11 12 10 25 10
Libido Decreased
  1 <1 11  2  7  1  7  2 11  2  4  2  9  3
(1) 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).
*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 1 should be avoided.
 

TABLE 2 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)
Autonomic Nervous System Disorders
 Ejaculation Failure (1)
14  1
 Mouth Dry
14  8
 Sweating Increased
 7  2
Centr. & 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
(1) Primarily ejaculatory delay. Denominator used was for male patients only (N=1118 ZOLOFT; N=926 placebo).
*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.

 

TABLE 3 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
Disorder
(N=430) 		PTSD
(N=374) 		PMDD Daily Dosing
(N=121) 		PMDD Luteal Phase Dosing
(N=136) 		Social Anxiety Disorder
(N=344)
Abdominal Pain
- - - - - - - 1%
Agitation
- 1% - 2% - - - -
Anxiety
- - - - - - - 2%
Diarrhea/Loose Stools
2% 2% 2% 1% - 2% - -
Dizziness
- - 1% - - - - -
Dry Mouth
- 1% - - - - - -
Dyspepsia
- - - 1% - - - -
Ejaculation Failure (1)
1% 1% 1% 2% - N/A N/A 2%
Fatigue
- - - - - - - 2%
Headache
1% 2% - - 1% - - 2%
Hot Flushes
- - - - - - 1% -
Insomnia
2% 1% 3% 2% - - 1% 3%
Nausea
3% 4% 3% 3% 2% 2% 1% 2%
Nervousness
- - - - - 2% - -
Palpitation
- - - - - - 1% -
Somnolence
1% 1% 2% 2% - - - -
Tremor
- 2% - - - - - -
(1) Primarily ejaculatory delay. Denominator used was for male patients only (N=271 major depressive disorder/other*; N=296 OCD; N=216 panic disorder; N=130 PTSD; No male patients in PMDD studies; N=205 social anxiety disorder).
*Major depressive disorder and other premarketing controlled trials.

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