Zyprexa has not been approved for use in children under 13 years of age. Zyprexa in combination with fluoxetine has not been approved for use in children under 10 years of age.

Zyprexa is a prescription medicine used to treat:

  • schizophrenia in people age 13 or older.
  • bipolar disorder, including:
    • manic or mixed episodes that happen with bipolar I disorderin people age 13 or older.
    • manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate, in adults.
    • long-term treatment of bipolar I disorder in adults.
  • episodes of depression that happen with bipolar I disorder, when used with the medicine fluoxetine (Prozac®) in people age 10 or older.
  • episodes of depression that do not get better after 2 other medicines, also called treatment resistant depression, when used with the medicine fluoxetine (Prozac), in adults.

What are the possible side effects of Zyprexa?

Serious side effects may happen when you take Zyprexa, including:

  • See “What is the most important information I should know about Zyprexa?”, which describes the increased risk of death in elderly people with dementia-related psychosis and the risks of high blood sugar, high cholesterol and triglyceride levels, and weight gain.
  • Increased incidence of stroke or “mini-strokes” called transient ischemic attacks (TIAs) in elderly people with dementia-related psychosis (elderly people who have lost touch with reality due to confusion and memory loss). Zyprexxa is not approved for these patients.
  • Neuroleptic Malignant Syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including Zyprexxa. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have any of these symptoms:
    • high fever
    • excessive sweating
    • rigid muscles
    • confusion
    • changes in your breathing, heartbeat, and blood pressure.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): DRESS can occur with Zyprexxa. Features of DRESS may include rash, fever, swollen glands and other internal organ involvement such as liver, kidney, lung and heart. DRESS is sometimes fatal; therefore, tell your doctor immediately if you experience any of these signs.
  • Tardive Dyskinesia: This condition causes body movements that keep happening and that you can not control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking Zyprexxa. It may also start after you stop taking Zyprexxa. Tell your doctor if you get any body movements that you can not control.
  • Decreased blood pressure when you change positions, with symptoms of dizziness, fast or slow heartbeat, or fainting.
  • Difficulty swallowing, that can cause food or liquid to get into your lungs.
  • Seizures: Tell your doctor if you have a seizure during treatment with Zyprexxa.
  • Problems with control of body temperature: You could become very hot, for instance when you exercise a lot or stay in an area that is very hot. It is important for you to drink water to avoid dehydration. Call your doctor right away if you become severely ill and have any of these symptoms of dehydration:
    • sweating too much or not at all
    • dry mouth
    • feeling very hot
    • feeling thirsty
    • not able to produce urine.

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Common side effects of Zyprexa include:

  • lack of energy,
  • dry mouth,
  • increased appetite,
  • sleepiness,
  • tremor (shakes),
  • having hard or infrequent stools,
  • dizziness,
  • changes in behavior, or
  • restlessness

Other common side effects in teenagers (13-17 years old) include:

  • headache,
  • stomach-area (abdominal) pain,
  • pain in your arms or legs, or
  • tiredness

Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness, as compared with adults

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects with Zyprexxa. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What is Zyprexa and how is it used? 3

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