IMPORTANT SAFETY INFORMATION AND INDICATIONS

Suicidality and Antidepressant Drugs
Antidepressant medicines 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 ZOLOFT if you:

  • Take a Monoamine Oxidase Inhibitor (MAOI), including linezolid or methylene blue, or if you stopped taking an MAOI in the last 2 weeks. Do not take an MAOI within 2 weeks of stopping ZOLOFT. Ask your doctor or pharmacist if you are not sure if your medicine is an MAOI
  • Take Orap® (pimozide)
  • Are allergic to sertraline or any of the inactive ingredients in ZOLOFT

Do not take the ZOLOFT liquid formulation if you take Antabuse® (disulfiram) due to the alcohol content of the liquid form of ZOLOFT.

Call a doctor 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.

Before taking ZOLOFT, tell your doctor and pharmacist about all prescription and over-the-counter medications and supplements you take or plan to take including: those to treat migraines, psychiatric disorders (including other antidepressants or amphetamines) to avoid a potentially life-threatening condition called serotonin syndrome; aspirin, other NSAID pain relievers, or blood thinners because they may increase the risk of bleeding.

Tell your doctor immediately if you:

  • Become severely ill and have some or all of these symptoms: agitation, hallucinations, coma or other changes in mental status; coordination problems or muscle twitching (overactive reflexes); racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle tightness, as these may be the symptoms of a life- threatening condition called Serotonin Syndrome
  • Have a rash, itchy welts (hives) or blisters, alone or with fever or joint pain; swelling of the face, tongue, eyes, or mouth; or trouble breathing, as these may be the symptoms of a severe allergic reaction
  • Have any increased or unusual bruising or bleeding, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin
  • Have a headache; weakness or feeling unsteady; confusion, problems concentrating, thinking, or remembering, as these may be the symptoms of low salt (sodium) levels in the blood (hyponatremia). Elderly people may be at greater risk for this

Some people are at risk for visual problems such as eye pain, changes in vision, or swelling or redness around the eye. You may want to undergo an eye examination to see if you are at risk and get preventative treatment if you are.

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.

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 doctor 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.

Indications for ZOLOFT

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.

Product names referenced herein are trademarks of their respective owners.

Please click here to see full Prescribing Information, including BOXED WARNING and Medication Guide.

Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

Pharmacy Finder

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Helpful Tips

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†You may pay less by receiving the generic.

‡This information is an estimate derived from the use of information under license from the following IMS Health Information service: IMS PayerTrak, June 2016 for commercial plans. IMS expressly reserves all rights, including rights of copying, distribution, and republication.