Zoloft

[Sertraline]

Side Effects & Drug Interactions
ADVERSE REACTIONS

Activation of Mania/Hypomania—

During premarketing testing, hypomania or mania occurred in approximately 0.4% of ZOLOFT® (sertraline hydrochloride) treated patients.

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Weight Loss—

Significant weight loss may be an undesirable result of treatment with sertraline for some patients, but on average, patients in controlled trials had minimal, 1 to 2 pound weight loss, versus smaller changes on placebo. Only rarely have sertraline patients been discontinued for weight loss.

Seizure—

ZOLOFT has not been evaluated in patients with a seizure disorder. These patients were excluded from clinical studies during the product's premarket testing. No seizures were observed among approximately 3000 patients treated with ZOLOFT in the development program for major depressive disorder. However, 4 patients out of approximately 1800 (220<18 years of age) exposed during the development program for obsessive-compulsive disorder experienced seizures, representing a crude incidence of 0.2%. Three of these patients were adolescents, two with a seizure disorder and one with a family history of seizure disorder, none of whom were receiving anticonvulsant medication. Accordingly, ZOLOFT should be introduced with care in patients with a seizure disorder.

Suicide—

The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high risk patients should accompany initial drug therapy. Prescriptions for ZOLOFT should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Because of the well-established comorbidity between OCD, panic disorder, PTSD, PMDD or social anxiety disorder and major depressive disorder, the same precautions observed when treating patients with major depressive disorder should be observed when treating patients with OCD, panic disorder, PTSD, PMDD or social anxiety disorder.

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