Sertraline Hydrochloride: Package Insert and Label Information (Page 5 of 8)
Adverse Reactions III
Associated with Discontinuation in Placebo-Controlled Clinical Trials
Table 4 lists the adverse events associated with discontinuation of Sertraline hydrochloride treatment (incidence at least twice that for placebo and at least 1% for Sertraline hydrochloride in clinical trials) in major depressive disorder/other*, OCD, panic disorder, PTSD, PMDD, and social anxiety disorder.
| (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. | ||||||||
| Adverse Event | Major Depressive Disorder/Other*, OCD, panic Disorder, PSTD, 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% | – | – | – | – | – | – |
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 Sertraline hydrochloride in placebo-controlled trials.
| *Denominator used was for male patients only (N=1118 Sertraline hydrochloride; N=926 placebo) | |||||||||||
| **Denominator used was for male and female patients (N=2799 Sertraline hydrochloride; N=2394 placebo) | |||||||||||
| Adverse Event | Sertraline | 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 Sertraline hydrochloride, 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 incidence of at least 2% and occurred at a rate of at least twice the placebo rate (N=281 patients treated with Sertraline hydrochloride): fever, hyperkinesia, urinary incontinence, aggressive reaction, sinusitis, epistaxis and purpura.
Other Events Observed During the Premarketing Evaluation of Sertraline hydrochloride –Following is a list of treatment-emergent adverse events reported during premarketing assessment of Sertraline hydrochloride in clinical trials (over 4000 adult subjects) except those already listed in the previous tables or elsewhere in labeling.
In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of Sertraline hydrochloride who experienced an event of the type cited on at least one occasion while receiving Sertraline hydrochloride. All events are included except those already listed in the previous tables or elsewhere in labeling and those reported in terms so general as to be uninformative and those for which a causal relationship to Sertraline hydrochloride treatment seemed remote. It is important to emphasize that although the events reported occurred during treatment with Sertraline hydrochloride, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients. Events of major clinical importance are also described in the PRECAUTIONS section.
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