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Important Safety Information About ZYPREXA® (olanzapine)
Please read the Medication Guide that comes with ZYPREXA before you start taking it and each time you get a refill.
What are the possible side effects of ZYPREXA?
ZYPREXA is associated with possible side effects. Tell your doctor about any side effect that concerns you.
ZYPREXA may be associated with the following serious risks:
- Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ZYPREXA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ZYPREXA is not approved for treating psychosis in the elderly with dementia.
- High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or even if you have never had diabetes. In rare cases, this could lead to ketoacidosis (build up of acid in the blood due to ketones), coma, or death. Your doctor should do lab tests to check your blood sugar before you start taking ZYPREXA and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when ZYPREXA is stopped. People with diabetes and some people who did not have diabetes before taking ZYPREXA need to take medicine for high blood sugar even after they stop taking ZYPREXA. If you have diabetes, follow your doctor's instructions about how often to check your blood sugar while taking ZYPREXA.
Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking ZYPREXA:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
- High cholesterol and triglyceride levels in the blood (fat in the blood). This may happen in people treated with ZYPREXA, especially in teenagers (13-17 years old). You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking ZYPREXA and during treatment.
- Increase in weight (weight gain). Weight gain is very common in people who take ZYPREXA. Teenagers (13-17 years old) are more likely to gain weight and to gain more weight than adults. Some people may gain a lot of weight while taking ZYPREXA, so your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.
- Increased risk in teenagers (13-17 years old): Possible serious risks of weight gain and increases in cholesterol and triglycerides are more common in teenagers than in adults. You and your doctor should decide if other available treatments should be used first. Before your teenager takes ZYPREXA, talk with your doctor about the possible long-term risks of teenagers taking ZYPREXA.
- Strokes and "mini-strokes" called transient ischemic attacks (TIAs). These are more common in elderly people with dementia-related psychosis (elderly people who have lost touch with reality due to confusion and memory loss). ZYPREXA 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 ZYPREXA. NMS can cause death and must be treated in a hospital. The symptoms include high fever; excessive sweating; rigid muscles; confusion; and changes in breathing, heartbeat, and blood pressure. Call your doctor right away if you become severely ill and have any of these symptoms.
- Tardive dyskinesia. This condition causes body movements that keep happening and that you cannot control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking ZYPREXA. It may also start after you stop taking ZYPREXA. Tell your doctor if you get any body movements that you cannot control.
- Decreased blood pressure when you change position, with symptoms of dizziness, fast or slow heart beat, or fainting.
- Decreases in white blood cells (infection fighting cells) have been reported in some patients taking antipsychotic agents, including ZYPREXA. Patients with a history of a significant decrease in white blood cell (WBC) count or who have experienced a low WBC count due to drug therapy should have their blood tested and monitored during the first few months of therapy.
- Trouble swallowing, that can cause food or liquid to get into your lungs.
- Seizures. Tell your doctor if you have a seizure during treatment with ZYPREXA.
- 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 some or all of these symptoms of dehydration: sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, not able to produce urine.
Common possible side effects of ZYPREXA include:
- Sleepiness
- Lack of energy
- Increased appetite
- Changes in behavior
- Dizziness
- Tremors (shakes)
- Dry mouth
- Restlessness
- Having hard or infrequent stools
Other common possible 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.
This is not a complete list of possible side effects. If you have questions or if you have any side effects that concern you, talk with your doctor and/or pharmacist.
Other important safety information
The symptoms of bipolar I disorder, treatment resistant depression, or schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away.
Tell your doctor if you are pregnant or may become pregnant while taking ZYPREXA. It is not known if ZYPREXA will harm your unborn baby. You should not breast-feed if you are taking ZYPREXA.
Tell your doctor if you are taking, or plan to take, any prescription or over-the-counter drugs including vitamins and herbal supplements. ZYPREXA and some medicines may interact with each other and may not work as well, or may cause possible serious side effects. Do not start or stop any medicine while taking ZYPREXA without talking to your doctor first.
ZYPREXA may not be right for you. Before starting ZYPREXA, tell your doctor about all of your medical conditions.
Take ZYPREXA exactly as prescribed. To prevent serious side effects, do not stop taking ZYPREXA suddenly. If you need to stop taking ZYPREXA, your doctor can tell you how to safely stop taking it.
ZYPREXA can cause sleepiness and 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 ZYPREXA affects you.
Avoid the use of alcohol while taking ZYPREXA.
ZYPREXA has been approved for use in adolescents (13-17 years old) to treat schizophrenia and manic or mixed episodes that happen with bipolar I disorder. ZYPREXA has not been approved for use in children under 13 years of age.
If you have any questions or concerns, or if you want to report any problems with the use of ZYPREXA, contact your doctor, pharmacist, or other healthcare provider. For more information, talk with your doctor or visit www.ZYPREXA.com or call 1-800-LillyRx.
