Black Box Warning

BLACK BOX WARNING — Suicidal ideation in young patients: Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients and young adults (up to age 24); this risk must be balanced against clinical need; monitor all patients closely for clinical worsening, agitation, unusual behavior, or suicidality, especially during the first 4 weeks

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Zoloft.

Other warnings & precautions

Serotonin syndrome: Do not use sertraline with MAO inhibitors or within 14 days of stopping an MAOI. Allow 14 days after stopping sertraline before starting an MAOI. Serotonin syndrome can be life-threatening; discontinue immediately if suspected
Screening for bipolar disorder: Prior to initiating treatment, screen patients for personal or family history of bipolar disorder, mania, or hypomania; sertraline monotherapy may precipitate a manic episode in undiagnosed bipolar patients
Angle-closure glaucoma: Sertraline can cause pupillary dilation (mydriasis) that may trigger an acute angle-closure attack in patients with narrow-angle anatomy; evaluate patients for this risk before initiating
Hyponatremia: SIADH and hyponatremia have been reported, primarily in elderly patients and those receiving diuretics; discontinue if symptomatic hyponatremia occurs
Bleeding risk: Impaired platelet aggregation can result in abnormal bleeding events ranging from bruising to severe GI hemorrhage; the risk is compounded by concurrent use of NSAIDs, aspirin, or anticoagulants
Activation or worsening of anxiety: Some patients may experience increased anxiety, agitation, or panic attacks early in treatment; lower initial doses (25 mg) can help mitigate this in anxiety disorders
Discontinuation syndrome: Do not abruptly stop sertraline; gradually taper the dose over several weeks to minimize the risk of discontinuation symptoms such as dizziness, paresthesias, irritability, and flu-like symptoms
Use in pregnancy (third trimester): Neonates exposed to SSRIs in late pregnancy may experience complications including respiratory distress, cyanosis, apnea, hypoglycemia, and neonatal withdrawal syndrome; weigh risks and benefits carefully
Hepatic impairment: Sertraline is extensively metabolized by the liver; use with caution in patients with hepatic impairment and use lower doses; avoid in severe hepatic impairment
Sexual dysfunction: Sertraline commonly causes sexual side effects including decreased libido, delayed ejaculation, and anorgasmia; these may persist and should be discussed with patients before starting treatment

Other warnings & precautions

Serotonin syndrome: Do not use sertraline with MAO inhibitors or within 14 days of stopping an MAOI. Allow 14 days after stopping sertraline before starting an MAOI. Serotonin syndrome can be life-threatening; discontinue immediately if suspected

Screening for bipolar disorder: Prior to initiating treatment, screen patients for personal or family history of bipolar disorder, mania, or hypomania; sertraline monotherapy may precipitate a manic episode in undiagnosed bipolar patients

Angle-closure glaucoma: Sertraline can cause pupillary dilation (mydriasis) that may trigger an acute angle-closure attack in patients with narrow-angle anatomy; evaluate patients for this risk before initiating

Hyponatremia: SIADH and hyponatremia have been reported, primarily in elderly patients and those receiving diuretics; discontinue if symptomatic hyponatremia occurs

Bleeding risk: Impaired platelet aggregation can result in abnormal bleeding events ranging from bruising to severe GI hemorrhage; the risk is compounded by concurrent use of NSAIDs, aspirin, or anticoagulants

Activation or worsening of anxiety: Some patients may experience increased anxiety, agitation, or panic attacks early in treatment; lower initial doses (25 mg) can help mitigate this in anxiety disorders

Discontinuation syndrome: Do not abruptly stop sertraline; gradually taper the dose over several weeks to minimize the risk of discontinuation symptoms such as dizziness, paresthesias, irritability, and flu-like symptoms

Use in pregnancy (third trimester): Neonates exposed to SSRIs in late pregnancy may experience complications including respiratory distress, cyanosis, apnea, hypoglycemia, and neonatal withdrawal syndrome; weigh risks and benefits carefully

Hepatic impairment: Sertraline is extensively metabolized by the liver; use with caution in patients with hepatic impairment and use lower doses; avoid in severe hepatic impairment

Sexual dysfunction: Sertraline commonly causes sexual side effects including decreased libido, delayed ejaculation, and anorgasmia; these may persist and should be discussed with patients before starting treatment

Zoloft Black Box Warning

Black Box Warning

Other warnings & precautions

Zoloft Black Box Warning

Black Box Warning

Other warnings & precautions