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Cautions

Contraindications

• Concomitant use with pimozide or an MAO inhibitor. (See Interactions.)
• Concomitant use of sertraline oral concentrate solution (contains alcohol 12%) and disulfiram or other agents likely to produce disulfiram-like reactions (e.g., metronidazole).
• Known hypersensitivity to sertraline or any ingredient in the formulation.

Warnings/Precautions

Warnings

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patientswith major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs. However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

Appropriately monitor and closely observe patients receiving sertraline for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments. (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or maniamay be precursors to emerging suicidality. Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms. If decision is made to discontinue therapy, taper sertraline dosage as rapidly as is feasible but consider risks of abrupt discontinuance. (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, OCD) and nonpsychiatric disorders.

Drug Interactions

Concomitant use with MAO inhibitors associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS). (See Serotonin Syndrome under Cautions and also see Contraindications.)

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) and other serotonergic drugs (e.g., 5-HT₁ receptor agonists [“triptans”]) or drugs that impair serotonin metabolism (e.g., MAO inhibitors). Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea). (See Interactions.)

Bipolar Disorder

May unmask bipolar disorder. (See Activation of Mania/Hypomania under Cautions.) Sertraline is not approved for use in treating bipolar depression.

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.

Fetal/Neonatal Morbidity and Mortality

Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care, in neonates exposed to sertraline, other SSRIs, or SNRIs late in the third trimester; may arise immediately upon delivery.

Increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants exposed to SSRIs during late pregnancy; PPHN is associated with substantial neonatal morbidity and mortality.

Carefully consider potential risks and benefits of treatment when used during third trimester of pregnancy. Consider cautiously tapering dosage during third trimester prior to delivery. (See Pregnancy under Cautions.)

Sensitivity Reactions

Latex Sensitivity

Dropper dispenser provided with oral concentrate solution contains natural latex proteins in the form of dry natural rubber; possible sensitivity reactions in susceptible individuals.

General Precautions

Activation of Mania/Hypomania

Possible activation of mania or hypomania. Use with caution in patients with history of mania or hypomania. (See Bipolar Disorder under Cautions.)

Weight Loss

Possible anorexia and weight loss. Use with caution in patients who may be adversely affected (e.g., underweight patients).

Seizures

Limited experience in patients with a history of seizures; use with caution in such patients.

Uricosuric Effect

Decrease in serum uric acid concentrations possible. Use with caution in patients who may be adversely affected (e.g., those at risk for acute renal failure).

Concomitant Illnesses

Experience in patients with concomitant diseases is limited. Patients with recent history of MI or unstable heart disease generally were excluded from premarketing clinical studies, but a postmarketing controlled study suggests that sertraline therapy is well tolerated in these patients.

Use with caution in patients with altered metabolism or hemodynamics.

Hyponatremia

Reported principally in geriatric patients, those receiving concomitant therapy with a diuretic, and in volume depleted patients; reversible following discontinuance of the drug. May be due to SIADH secretion. Monitor serum sodium concentration periodically in geriatric patients.

Abnormal Bleeding

Possible increased risk of bleeding, including upper GI bleeding; use with caution.

Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk. (See Interactions.)

Endocrine Effects

Possible hypothyroidism, elevated serum thyrotropin, and/or reduced serum thyroxine concentrations. Monitor thyroid function periodically in patients with thyroid disease.

Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT have not been systematically evaluated.

Specific Populations

Pregnancy

Category C. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.

Lactation

Distributed into milk; use with caution.

Pediatric Use

Safety and efficacy for OCD not established in children <6 years of age.

Safety and efficacy for other disorders (e.g., major depressive disorder, panic disorder, PTSD, PMDD, social phobia) not established in pediatric patients. Results of 2 placebo-controlled trials in children and adolescents with major depressive disorder did not support a claim of efficacy for use of sertraline in pediatric patients with this condition.

Adverse effect profile generally similar to that seen in adults. Weight loss, usually slight, reported in children and adolescents receiving sertraline for major depressive disorder; manufacturer recommends periodic monitoring of weight and growth during long-term therapy with sertraline and other SSRIs.

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others). However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation. No suicides occurred in these pediatric trials.

Carefully consider these findings when assessing potential benefits and risks of sertraline for any clinical use. (See Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out. (See Hyponatremia under Cautions.)

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo. (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Hepatic Impairment

Decreased clearance; use with caution. (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Nausea, diarrhea/loose stools, dyspepsia, dry mouth, somnolence, dizziness, insomnia, tremor, ejaculatory delay, sweating.

Adverse effects in children are similar to those reported in adults. (See Pediatric Use under Cautions.)