Indicated for treatment of:

• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Posttraumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD)

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. 

Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.

Avoid use of antidepressants, including ZOLOFT, in patients with untreated anatomically narrow angles. The pupillary dilation that occurs following use of many antidepressant drugs including ZOLOFT may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including ZOLOFT. Cases with serum sodium lower than 110 mmol/L have been reported.

Cases of QTc prolongation and Torsade de Pointes (TdP) have been reported. ZOLOFT should be used with caution in patients with risk factors for QTc prolongation.

Both the recommended starting dosage and therapeutic range in patients with mild hepatic impairment (Child Pugh scores 5 or 6) are half the recommended daily dosage. The use of ZOLOFT in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10–15) is not recommended.

ZOLOFT has not been systematically evaluated in patients with seizure disorders. Patients with a history of seizures were excluded from clinical studies. ZOLOFT should be prescribed with caution in patients with a seizure disorder.

In patients with bipolar disorder, treating a depressive episode with ZOLOFT or another antidepressant may precipitate a mixed/manic episode. Prior to initiating treatment with ZOLOFT or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

Use of SSRIs, including ZOLOFT, may cause symptoms of sexual dysfunction in male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

The pupillary dilation that occurs following use of many antidepressant drugs including ZOLOFT may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including ZOLOFT, in patients with untreated anatomically narrow angles.

Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including ZOLOFT, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. Serotonin syndrome can also occur when these drugs are used alone.

Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures.

Drugs that interfere with serotonin reuptake inhibition, including ZOLOFT, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Inform patients of the increased risk of bleeding associated with the concomitant use of ZOLOFT and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.

ZOLOFT is contraindicated in patients taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome. At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of ZOLOFT. In addition, at least 14 days must elapse after stopping ZOLOFT before starting an MAOI antidepressant.

ZOLOFT is contraindicated in patients taking pimozide.

Pimozide is contraindicated for use with sertraline.

ZOLOFT oral solution is contraindicated in patients taking disulfiram. ZOLOFT oral solution contains alcohol, and concomitant use of ZOLOFT and disulfiram may result in a disulfiram-alcohol reaction.

The concomitant use of ZOLOFT with a CYP2D6 substrate (e.g., propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine) may increase the exposure of the CYP2D6 substrate.

ZOLOFT may increase phenytoin concentrations.

The risk of QTc prolongation and/or ventricular arrhythmias (e.g., TdP is increased with concomitant use of other drugs which prolong the QTc interval.Avoid the concomitant use of drugs known to prolong the QTc interval.

ZOLOFT is highly bound to plasma protein. The concomitant use of ZOLOFT with another drug that is highly bound to plasma protein may increase free concentrations of ZOLOFT or other tightly-bound drugs in plasma.

False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking ZOLOFT.

Neonates exposed to ZOLOFT and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Advise a pregnant woman of possible risks to the fetus when prescribing ZOLOFT.

ZOLOFT oral solution contains 12% alcohol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy.

Available data from published literature demonstrate low levels of sertraline and its metabolites in human milk.

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• Fibromyalgia, arthritis, chronic fatigue, multiple sclerosis, bipolar depression, lupus, headaches, irritable bowel syndrome, ADD/ADHD, eating disorders, neurocardiogenic syncope, tourette syndrome, premature ejaculation, generalized anxiety disorder, dementia and autistic spectrum disorders. GoToSource 

• Uremic pruritus. GoToSource

• Use in patients under the age of 6. GoToSource

Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions particularly when used with serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. GoToSource

Birth defects. GoToSource 

Increased risk of suicide ideation and behavior. GoToSource

Weight gain, upper gastrointestinal bleeding, agitation, headache and insomnia. GoToSource

Extrapyramidal symptoms (drug-induced movement disorders). GoToSource

Withdrawal syndrome. GoToSource

Increased cholesterol levels. GoToSource

Acute liver injury. GoToSource 

Hyponatraemia (low sodium level). GoToSource 

Sexual dysfunction. GoToSource 

Galactorrhea (milky nipple discharge). GoToSource 

Acute angle closure glaucoma. GoToSource

Rhabdomyolysis (breakdown of muscle tissue). GoToSource

Increased risk of bleeding. GoToSource

Ventricular tachycardia. GoToSource

Urinary hesitancy and retention. GoToSource

Lawsuits filed for birth defects, withdrawal symptoms, suicidal behavior and bone loss.