This is a summary of the most important information about Zyprexa. For details, talk to your healthcare professional.

What is Zyprexa?

• Zyprexa is in a class of medications called atypical antipsychotics. Antipsychotic medicines are approved to treat symptoms of schizophrenia that may include hearing voices, seeing things, or sensing things that are not there, mistaken beliefs or unusual suspiciousness.
• Zyprexa is approved to treat mixed or manic episodes in adults who have a condition called Bipolar I disorder.
• Zyprexa may also be used with lithium or valproate for short-term treatment of acute manic episodes of bipolar disorder.

What are The Risks?

The following are the risks and potential side effects of Zyprexa therapy. However, this list is not complete.

• Increased chance of death in elderly persons. Elderly patients treated with atypical antipsychotics, such as Zyprexa, for dementia had a higher chance for death than patients who did not take the medicine. Zyprexa is not approved for dementia.
   
• A life-threatening nervous system problem called neuroleptic malignant syndrome (NMS). NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS can affect your kidneys. NMS is a medical emergency. Call your healthcare professional right away if you experience these symptoms.
   
• A movement problem called tardive dyskinesia (TD). Call your healthcare professional right away if you get muscle movements that cannot be stopped.
   
• High blood sugar and diabetes. Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked often.
   
• Strokes have happened in older patients treated for mental illness from dementia. Zyprexa is not approved for this use.
   
• Other serious side effects include low blood pressure seen as dizziness, and possibly fainting; increased heart beat; seizures; liver problems; increased body temperature; and difficulty swallowing.
   
• The most common side effects include sleepiness, dry mouth, dizziness, restlessness, constipation, upset stomach, weight gain, increased appetite, and tremor.

What Should I Tell My Healthcare Professional?

Before you start taking Zyprexa, tell your healthcare professional if you:

• have or had heart problems

• have or had seizures

• have or had diabetes or increased blood sugar

• have or had liver disease

• are trying to become pregnant, are already pregnant, or are breast-feeding.

• drink alcohol

• have a condition called phenylketonuria

Are There Any Interactions With Drugs or Foods?

Because certain other medications can interact with Zyprexa, review all medications that you are taking with your healthcare professional, including those that you take without a prescription.

Your healthcare professional may have to adjust your dose or watch you more closely if you take the following medications:

• blood pressure medicines

• levodopa and other medicines called dopamine agonists

• omeprazole

• rifampin

• carbamazepine

• fluvoxamine

Avoid drinking alcohol while taking Zyprexa.

Is There Anything Else I Need to Know?

• Dizziness, and sometimes fainting, caused by a drop in blood pressure may happen with Zyprexa, especially when you first start taking this medicine or when the dose is increased.

• Zyprexa may impair judgment, thinking, or motor skills. You should be careful in operating machinery, including automobiles, until you know how Zyprexa affects you.

• It is important to avoid overheating and dehydration while taking Zyprexa. Zyprexa may make it harder to lower your body temperature.

Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570
Druginfo@fda.hhs.gov