IMPORTANT SAFETY INFORMATION AND INDICATIONS

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
ZOLOFT and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when ZOLOFT is started or when the dose is changed.

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) because this can cause serious heart problems
  • Are allergic to sertraline or any of the inactive ingredients in ZOLOFT
  • Take Antabuse® (disulfiram) (if you are taking the liquid form of ZOLOFT) 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:

  • Attempts to commit suicide
  • Acting aggressive or violent
  • New or worse depression
  • Feeling agitated, restless, angry, or irritable
  • An increase in activity or talking more than what is normal for you
  • Acting on dangerous impulses
  • Thoughts about suicide or dying
  • New or worse anxiety or panic attacks
  • Trouble sleeping
  • Other unusual changes in behavior or mood

Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

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 other 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, hives, swelling, or trouble breathing as these may be the symptoms of an allergic reaction
  • Have seizures or convulsions
  • 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

Do not stop ZOLOFT without first talking to your healthcare provider. 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, shaking, and confusion.

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 common side effects in adults treated with ZOLOFT include:

  • Nausea, loss of appetite, diarrhea, or indigestion
  • Increased sweating
  • Tremor or shaking
  • Agitation
  • Change in sleep habits including increased sleepiness or insomnia
  • Sexual problems including decreased libido and ejaculation failure
  • Feeling tired or fatigued
  • Anxiety

In children and adolescents treated with ZOLOFT, adverse reactions were generally similar to those seen in adults with the following additional side effects: abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change.

Indications

ZOLOFT is a prescription medication for the treatment, in adults, of 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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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.

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.

ZOLOFT is also available as an Oral Concentrate and Oral Solution.

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 children with OCD age 6 to 17 years.

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. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.

1. Suicidal thoughts or actions:

  • ZOLOFT and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
  • Pay particular attention to such changes when ZOLOFT is started or when the dose is changed.
  • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

  • attempts to commit suicide
  • acting aggressive or violent
  • new or worse depression
  • feeling agitated, restless, angry or irritable
  • an increase in activity or talking more than what is normal for you
  • acting on dangerous impulses
  • thoughts about suicide or dying
  • new or worse anxiety or panic attacks
  • trouble sleeping
  • other unusual changes in behavior or mood

2. Serotonin Syndrome. This condition can be life-threatening and symptoms may include:

  • agitation, hallucinations, coma, or other changes in mental status
  • racing heartbeat, high or low blood pressure
  • coordination problems or muscle twitching (overactive reflexes)
  • nausea, vomiting, or diarrhea
  • sweating or fever
  • muscle rigidity

3. Increased chance of bleeding: ZOLOFT and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

4. Manic episodes. Symptoms may include:

  • greatly increased energy
  • racing thoughts
  • unusually grand ideas
  • severe trouble sleeping
  • reckless behavior
  • excessive happiness or irritability
  • talking more or faster than usual

5. Seizures or convulsions.

6. Glaucoma (angle-closure glaucoma). Many antidepressant medicines including ZOLOFT may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

  • Headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking, or memory problems

Do not stop ZOLOFT without first talking to your healthcare provider. 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:

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

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
  • rapid changes in heart rate or blood pressure
  • uncontrolled muscle spasms
  • confusion
  • stiff muscles
  • 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 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.

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

Do not take ZOLOFT with the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.

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

What should I tell my healthcare provider before taking ZOLOFT?

Before starting ZOLOFT, tell your healthcare provider:

  • if you have:
  • liver problems
  • heart problems
  • bipolar disorder or mania
  • kidney problems
  • or have had seizures or convulsions
  • low sodium levels in your blood
  • a history of a stroke
  • high blood pressure
  • or have had bleeding problems
  • are pregnant or plan to become pregnant: Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking ZOLOFT during pregnancy.
  • are breastfeeding or plan to breastfeed. A small amount of ZOLOFT may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking ZOLOFT.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter 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 healthcare provider 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 healthcare provider first.

How should I take ZOLOFT?

  • Take ZOLOFT exactly as prescribed. Your healthcare provider may need to change the dose of ZOLOFT until it is the right dose for you.
  • ZOLOFT Tablets may be taken with or without food.
  • ZOLOFT Oral Concentrate and Oral Solution may look cloudy or hazy after mixing, this is normal.
  • ZOLOFT Oral Concentrate and Oral Solution must be diluted before use:
  • Do not mix ZOLOFT until you are ready to take it.
  • When diluting ZOLOFT Oral Concentrate and Oral Solution, use only water, ginger ale, lemon/lime soda, lemonade, or orange juice.
  • The oral dropper contains latex. If you are sensitive or allergic to latex, ask your healthcare provider or pharmacist about the best way to measure your medicine.
  • 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 healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.

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 you take ZOLOFT.

What are the possible side effects of ZOLOFT?

ZOLOFT may cause serious side effects, including:

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

The most common side effects in adults who take ZOLOFT include:

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

The most common side effects in children and adolescents who take include abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child's height and weight should be monitored during treatment with ZOLOFT.

Tell your healthcare provider 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 healthcare provider 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, 68°F to 77°F (20°C to 25°C).
  • Keep ZOLOFT bottle closed tightly.

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.

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