Suicide ideation was reported by 3 sertraline-treated patients and no placebo-treated patients however the difference was not statistically significant. Suicide attempt was reported in the same number of patients in the sertraline (2 out of 189) and placebo (2 out of 184) groups. In clinical trials in children and adolescents aged 6 to 17 years with major depressive disorder, agitation was reported at a frequency of at least 2% and at least twice that of placebo. In a 12-week placebo-controlled study in pediatric patients with OCD, side effects observed at an incidence of at least 5% and at a statistically significant increased level for sertraline compared with placebo were insomnia and agitation in 6 to 12 year olds, and insomnia in 13 to 17 year olds. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder ( MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.Īdult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Postmarketing reports: Depressive symptoms, intense dreams, manic reaction, psychosis, sleep disturbances, withdrawal syndrome Īntidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Rare (less than 0.1%): Conversion disorder, drug dependence, paranoia, psychotic disorder, sleep walking, suicide behaviorįrequency not reported: Psychomotor hyperactivity, irritability
Uncommon (0.1% to 1%): Abnormal dreams, Abnormal thinking, apathy, euphoria/euphoric mood, hallucination Very common (10% or more): Insomnia (up to 21%)Ĭommon (1% to 10%): Affect/emotional lability, aggravated depression, aggressive reaction, aggression, agitation, anxiety, bruxism/teeth grinding, decreased libido, depersonalization, depression, nervousness, nightmare, mania, paroniria, suicidal ideation, suicide attempt In clinical trials in children and adolescents aged 6 to 17 years with major depressive disorder, the incidence of discontinuation due to side effects was reported at 9% the most common reactions leading to discontinuation were agitation, suicidal ideation, hyperkinesia, suicide attempt, and aggravated depression. Fever, hyperkinesia, urinary incontinence, aggressive reaction, sinusitis, epistaxis, and purpura were reported in clinical trials in pediatric patients at an incidence of at least 2% and at a rate of at least twice that of placebo. The overall profile of side effects in pediatric clinical trials was generally similar to that seen in adult studies. The most common side effects associated with discontinuation of sertraline (the active ingredient contained in Zoloft) treatment at an incidence at least twice that for placebo and at least 1% for sertraline in clinical trials included abdominal pain, agitation, diarrhea, dizziness, dry mouth, dyspepsia, ejaculation failure, fatigue, headache, hot flushes, insomnia, nausea, nervousness, palpitation, somnolence, and tremor. The most commonly reported side effect was nausea, which was dose dependent and often transient in nature. (See Pediatric Use under Cautions.) For Healthcare ProfessionalsĪpplies to sertraline: oral capsule, oral concentrate, oral tablet. Nausea, diarrhea/loose stools, dyspepsia, dry mouth, somnolence, dizziness, insomnia, tremor, ejaculatory delay, sweating.Īdverse effects in children are similar to those reported in adults. 1 304 305 310 344 (See Worsening of Depression and Suicidality Risk under Cautions.)
1 304 305 310 344Īppropriately monitor and closely observe all patients who are started on sertraline therapy for clinical worsening, suicidality, or unusual changes in behavior involve family members and/or caregivers in this process.
1 235 (See Pediatric Use under Cautions.) 1 304 305 344 Sertraline is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder. Antidepressants increased risk of suicidal thinking and behavior (suicidality) compared with placebo in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders balance this risk with clinical need.
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