rder
(N=430) PTSD
(N=374) PMDD
Daily Dosing
(N=121) PMDD
Luteal Phase Dosing
(N=136) Social Anxiety Disorder
(N=344)
*
Major depressive disorder and other premarketing controlled trials.
†
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).
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% 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% – – – – – –
Male and Female Sexual Dysfunction with SSRIs
Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence.
Table 5 below displays the incidence of sexual side effects reported by at least 2% of patients taking ZOLOFT in placebo-controlled trials.
TABLE 5 Adverse Event ZOLOFT Placebo
*
Denominator used was for male patients only (N=1118 ZOLOFT; N=926 placebo)
†
Denominator used was for male and female patients (N=2799 ZOLOFT; N=2394 placebo)
Ejaculation failure*
(primarily delayed ejaculation) 14% 1%
Decreased libido† 6% 1%
There are no adequate and well-controlled studies examining sexual dysfunction with sertraline treatment.
Priapism has been reported with all SSRIs.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.
Other Adverse Events in Pediatric Patients
In over 600 pediatric patients treated with ZOLOFT, the overall profile of adverse events was generally similar to that seen in adult studies. However, the following adverse events, from controlled trials, not appearing in Tables 2 and 3, were reported at an in
