Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults especially within the first few months of treatment. Depression and certain other serious mental illnesses are important causes of suicidal thoughts and actions. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Anyone considering the use of ZOLOFT or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. ZOLOFT is not approved for use in pediatric patients except for patients with Obsessive-Compulsive Disorder (OCD).
Do not take the ZOLOFT liquid formulation if you take Antabuse® (disulfiram) due to the alcohol content of the liquid form of ZOLOFT.
Tell your physician about all the medicines that you take including prescription and nonprescription medicine, vitamins, and herbal supplements.
Call a physician right away if you or a person you know who is taking ZOLOFT has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety or panic attacks; feeling agitated, restless, angry or irritable; trouble sleeping; acting aggressive or violent; acting on dangerous impulses; an increase in activity or talking from what is normal for you (mania); or any other unusual changes in behavior or mood.
ZOLOFT can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how ZOLOFT affects you.
ZOLOFT should be used with caution if you have risk factors for a disturbance of the electrical activity of the heart known as QT/QTc prolongation or you are using concomitantly other drugs which prolong the QTc interval.
Drinking alcohol while taking ZOLOFT is not recommended.
Women who are pregnant, plan to become pregnant, or who are breastfeeding should not take ZOLOFT without consulting their physician.
The most commonly observed adverse reactions in patients treated with ZOLOFT (seen in 5% or more of patients and at least twice as high as the control group) were nausea (25%), delayed ejaculation (14%), shakiness (8%), increased sweating (7%), lack of appetite (6%), and reduced sexual desire (6%).
In children and adolescents treated with ZOLOFT, adverse reactions were generally similar to adults. However, the following additional adverse reactions were reported in 2% or more of children/adolescents and at least twice as high as the control group: fever, hyperactivity, bedwetting, aggressive reaction, sinusitis, nosebleeds, and a bleeding sign resembling a bruise.
Consult your physician before you stop taking ZOLOFT. Stopping ZOLOFT may cause serious symptoms including: anxiety, irritability, high or low mood, feeling restless or sleepy; headache, sweating, nausea, dizziness; electric shock-like sensations, tremor, and confusion.
ZOLOFT is approved by the FDA to treat in adults Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, Posttraumatic Stress Disorder (PTSD), Premenstrual Dysphoric Disorder (PMDD), and Social Anxiety Disorder. It is also approved to treat Obsessive-Compulsive Disorder (OCD) in children and adolescents aged 6-17 years.
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