Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
Nausea (26%): most common, usually transient and improves after first 1–2 weeks
Diarrhea/loose stools (20%): often dose-dependent
Insomnia (21%): difficulty falling or staying asleep, particularly early in treatment
Dry mouth (16%): reduced salivary flow
Somnolence/drowsiness (13%): some patients experience sedation rather than insomnia
Dizziness (12%): may be postural; caution when rising quickly
Tremor (11%): fine hand tremor, usually mild
Sweating/hyperhidrosis (8%): night sweats are commonly reported
Sexual dysfunction (males 14%; females 3%): delayed ejaculation, decreased libido, difficulty achieving orgasm (anorgasmia)
Decreased appetite/weight loss (7%): particularly in early treatment
Headache (20%): often resolves within first few weeks
Fatigue/asthenia (11%): general tiredness, particularly during initiation
Dyspepsia/indigestion (10%): upper GI discomfort
Constipation (8%): less common than diarrhea but reported
Agitation/nervousness (8%): restlessness, particularly in early weeks
Suicidality — Black Box Warning: Increased risk of suicidal thinking and behavior in children, adolescents, and young adults (up to age 24) during initial treatment; monitor closely, especially in the first 1–4 weeks
Serotonin syndrome: Life-threatening condition caused by excess serotonergic activity; symptoms include hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes; risk increased with concomitant serotonergic agents
Activation of mania/hypomania: May precipitate a manic or mixed episode in patients with undiagnosed bipolar disorder; screen for bipolar disorder before initiating
Seizures: Sertraline lowers the seizure threshold; use with caution in patients with a seizure disorder or history of seizures
Hyponatremia/SIADH: Clinically significant hyponatremia reported, especially in elderly patients; may present as confusion, weakness, seizures
QTc prolongation: Rare but reported at high doses; caution in patients with cardiac risk factors or concomitant use of QT-prolonging drugs
Abnormal bleeding: Impaired platelet aggregation due to serotonin depletion; risk increased with concurrent NSAIDs, aspirin, or anticoagulants; can present as GI bleeding or ecchymosis
Discontinuation syndrome: Abrupt cessation may cause dizziness, sensory disturbances (electric shock sensations), irritability, anxiety, confusion, and flu-like symptoms; taper gradually
Angle-closure glaucoma: Pupillary dilation caused by sertraline may trigger acute angle-closure glaucoma in anatomically predisposed individuals
Pulmonary hypertension of the newborn (PPHN): Associated with SSRI use in late pregnancy; risk approximately 6 per 1,000 neonates
Stevens-Johnson syndrome/toxic epidermal necrolysis: Very rare severe cutaneous adverse reactions reported
Agranulocytosis/aplastic anemia: Extremely rare hematologic adverse events
Hepatotoxicity: Rare cases of clinically significant liver injury including hepatitis and elevated transaminases
Neuroleptic malignant syndrome (NMS)-like reactions: Rare; presents with hyperthermia, muscle rigidity, altered consciousness
Hallucinations/psychosis: Rare in patients without underlying psychotic disorder
Lupus-like syndrome: Rare autoimmune reaction with arthralgias, rash, and positive ANA
Like all medications, Zoloft can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: