Zoloft Withdrawal Symptoms
Table 3 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 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 |
¾ |
¾ |
¾ |
¾ |
¾ |
¾ |
¾ |
1% |
Agitation |
¾ |
1% |
¾ |
2% |
¾ |
¾ |
¾ |
¾ |
Anxiety |
¾ |
¾ |
¾ |
¾ |
¾ |
¾ |
¾ |
2% |
Diarrhea/
Loose Stools |
2% |
2% |
2% |
1% |
¾ |
2% |
¾ |
¾ |
Dizziness |
¾ |
¾ |
1% |
¾ |
¾ |
¾ |
¾ |
¾ |
Dry Mouth |
¾ |
1% |
¾ |
¾ |
¾ |
¾ |
¾ |
¾ |
Dyspepsia |
¾ |
¾ |
¾ |
1% |
¾ |
¾ |
¾ |
¾ |
Ejaculation
Failure(1) |
1% |
1% |
1% |
2% |
¾ |
N/A |
N/A |
2% |
Fatigue |
¾ |
¾ |
¾ |
¾ |
¾ |
¾ |
¾ |
2% |
Headache |
1% |
2% |
¾ |
¾ |
1% |
¾ |
¾ |
2% |
Hot Flushes |
¾ |
¾ |
¾ |
¾ |
¾ |
¾ |
1% |
¾ |
Insomnia |
2% |
1% |
3% |
2% |
¾ |
¾ |
1% |
3% |
Nausea |
3% |
4% |
3% |
3% |
2% |
2% |
1% |
2% |
Nervousness |
¾ |
¾ |
¾ |
¾ |
¾ |
2% |
¾ |
¾ |
Palpitation |
¾ |
¾ |
¾ |
¾ |
¾ |
¾ |
1% |
¾ |
Somnolence |
1% |
1% |
2% |
2% |
¾ |
¾ |
¾ |
¾ |
Tremor |
¾ |
2% |
¾ |
¾ |
¾ |
¾ |
¾ |
¾ |
(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.
