IMPORTANT SAFETY INFORMATION AND INDICATIONS

Suicidality and Antidepressant Drugs
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 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 physician 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.

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.

Tell your physician 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 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.

Indications for ZOLOFT

ZOLOFT is approved by the FDA to treat adults with 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.

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

About ZOLOFT

ZOLOFT has a range of indications

ZOLOFT is approved by the FDA to treat the following conditions in adults:

  • Major Depressive Disorder (MDD)
  • Obsessive-Compulsive Disorder (OCD)
  • Panic Disorder
  • Posttraumatic Stress Disorder (PTSD)
  • Social Anxiety Disorder
  • Premenstrual Dysphoric Disorder (PMDD)

ZOLOFT is also approved to treat the following condition in children and adolescents aged 6 to 17 years:

  • Obsessive-Compulsive Disorder (OCD)

ZOLOFT tablets are available in 25, 50, and 100 mg.

The time it takes for ZOLOFT to work is different for each individual and condition. Even if you don't feel better right away, it is important to keep taking ZOLOFT as directed by your doctor.

ZOLOFT Frequently Asked Questions
What is ZOLOFT?

ZOLOFT is a prescription medicine used to treat the following conditions in adults:

  • Major Depressive Disorder (MDD)
  • Obsessive Compulsive Disorder (OCD)
  • Panic Disorder
  • Posttraumatic Stress Disorder (PTSD)
  • Social Anxiety Disorder
  • Premenstrual Dysphoric Disorder (PMDD)

ZOLOFT is also indicated to treat OCD in children and adolescents.

It is important to talk with your doctor about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your doctor.

Talk to your doctor if you do not think that your condition is getting better with ZOLOFT treatment.

What is the most important information I should know about ZOLOFT?

ZOLOFT and other antidepressant medicines may cause serious side effects, including:

  • Suicidal thoughts or actions:
    ZOLOFT and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed
  • Serotonin Syndrome:
    a potentially life-threatening condition that may occur in treatment with SNRIs (serotonin and norepinephrine reuptake inhibitors) and SSRIs (selective serotonin reuptake inhibitors), including ZOLOFT, particularly when taken along with another drug that increases serotonin levels. Serotonin syndrome symptoms may include fever, sweating, muscle stiffness, trouble thinking clearly, a change in mental functioning, or change in your heartbeat and blood pressure. You should tell your doctor immediately if you experience any of these symptoms
    • Severe allergic reactions
    • Abnormal bleeding
    • Seizures or convulsions
    • Manic episodes
    • Changes in appetite or weight
    • Low salt (sodium) levels in the blood
    • Visual problems

Please see the Medication Guide for further information about these side effects.

Do not stop ZOLOFT without first talking to your doctor.

Stopping ZOLOFT too quickly may cause serious symptoms including:

  • anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
  • headache, sweating, nausea, dizziness
  • electric shock-like sensations, shaking, confusion
Is ZOLOFT approved for children?

ZOLOFT is approved for children and adolescents aged 6-17 years only for the treatment of Obsessive-Compulsive Disorder (OCD). Please see Important Safety Information and the Medication Guide for more information.

Who should not take ZOLOFT?

Do not take ZOLOFT if you:

  • are allergic to sertraline or any of the ingredients in ZOLOFT. See the Medication Guide for a complete list of ingredients in ZOLOFT
  • take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems
  • take Antabuse® (disulfiram) (if you are taking the liquid form of ZOLOFT) due to the alcohol content
  • take a monoamine oxidase inhibitor (MAOI). Ask your doctor or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid
  • Do not take an MAOI within 2 weeks of stopping ZOLOFT unless directed to do so by your doctor
  • stopped taking an MAOI in the last 2 weeks unless directed to do so by your doctor

People who take ZOLOFT close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms: high fever, uncontrolled muscle spasms, stiff muscles, rapid changes in heart rate or blood pressure, confusion, or loss of consciousness (pass out).

Can I take ZOLOFT with other medications?

Do not take ZOLOFT if you currently take, or have taken within the last 14 days, any medicine known as an MAOI (including intravenous methylene blue or the antibiotic linezolid). Allow 14 days after stopping ZOLOFT before starting an MAOI. Taking an MAOI with ZOLOFT can cause serious or even life-threatening side effects.

Before taking ZOLOFT, tell your healthcare professional about all prescription and over-the-counter medications, vitamins, and supplements you take or plan to take including: those to treat migraines or psychiatric disorders (including other antidepressants) to avoid serotonin syndrome, a potentially life-threatening condition; those to treat seizures, pain, type II diabetes, heartburn, control your heartbeat; aspirin, NSAID pain relievers, or blood thinners because they may increase the risk of bleeding.

Do not take ZOLOFT with other medicines containing sertraline (sertraline HCL, sertraline hydrochloride, etc.)

What should I tell my doctor before taking ZOLOFT?

Before starting ZOLOFT, tell your doctor about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ZOLOFT and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your doctor or pharmacist can tell you if it is safe to take ZOLOFT with your other medicines. Do not start or stop any medicine while taking ZOLOFT without talking to your doctor first.

You should also tell your doctor about any health conditions you have, including: liver, kidney, or heart problems; a history of seizures, convulsions, stroke, or bleeding problems; bipolar disorder or mania; low sodium levels in your blood; or high blood pressure.

Tell your doctor if you are pregnant, plan to become pregnant, are breast-feeding, or plan to breast-feed.

If you take ZOLOFT, you should not take any other medicines that contain sertraline (sertraline HCl, sertraline hydrochloride, etc.).

Please see the Medication Guide for further information.

How should I take ZOLOFT?

Take ZOLOFT exactly as prescribed. Your doctor may need to change the dose of ZOLOFT until it is the right dose for you.

ZOLOFT Oral Concentrate must be diluted before use:

  • Follow the instructions carefully
  • When diluting ZOLOFT Oral Concentrate, use ONLY water, ginger ale, lemon/lime soda, lemonade, or orange juice
  • If you are sensitive to latex, be careful when using the dropper to dispense the Oral Concentrate

ZOLOFT may be taken with or without food. If you miss a dose of ZOLOFT, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ZOLOFT at the same time.

If you take too much ZOLOFT, call your doctor or poison control center right away, or get emergency treatment.

What should I avoid while taking ZOLOFT?

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. Do not drink alcohol while using ZOLOFT.

What are the possible side effects of ZOLOFT?

ZOLOFT may cause serious side effects, including feeling anxious or having trouble sleeping.

Common possible side effects in people who take ZOLOFT include:

  • nausea, loss of appetite, diarrhea, or indigestion
  • change in sleep habits including increased sleepiness or insomnia
  • increased sweating
  • sexual problems including decreased libido and ejaculation failure
  • tremor or shaking
  • feeling tired or fatigued
  • agitation

Other side effects in children and adolescents include:

  • abnormal increase in muscle movement or agitation
  • nose bleed
  • urinating more often
  • urinary incontinence
  • aggressive reaction
  • heavy menstrual periods
  • possible slowed growth rate and weight change. Your child's height and weight should be monitored during treatment with ZOLOFT

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ZOLOFT. For more information, ask your doctor or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store ZOLOFT?

Store ZOLOFT at room temperature, between 59°F and 86°F (15°C to 30°C). Keep the bottle closed tightly, and make sure to keep ZOLOFT and all medicines out of the reach of children.

How long does it take to feel better with ZOLOFT?

The time it takes for ZOLOFT to work is different for each individual and condition. Even if you don't feel better right away, it is important to keep taking ZOLOFT as directed by your doctor.

*Terms & conditions apply.

You may pay less by receiving the generic.

Patients with commercial/private insurance with an out-of-pocket expense of more than $130 for a 30-day supply of ZOLOFT, Medicare Part D,§ or no insurance with an out-of-pocket expense of $130 or less for a 30-day supply of ZOLOFT.

§Patients with Medicare Part D must agree not to use any prescription benefits to purchase ZOLOFT.