ZYPREXA - olanzapine tablet 
ZYPREXA  ZYDIS - olanzapine tablet, orally disintegrating 
ZYPREXA  INTRAMUSCULAR - olanzapine injection, powder, for solution 
H2-Pharma LLC


Medication Guide






Tablet, Orally Disintegrating

Read the Medication Guide that comes with ZYPREXA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about ZYPREXA.

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

ZYPREXA may cause serious side effects, including:

  1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).
  2. High blood sugar (hyperglycemia).
  3. High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17.
  4. Weight gain, especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17.

These serious side effects are described below.

  1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). ZYPREXA is not approved for treating psychosis in elderly people with dementia.
  2. High blood sugar (hyperglycemia).High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:
    • a build up of acid in your blood due to ketones (ketoacidosis)
    • coma
    • death

    Your doctor should do 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 doctorif 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
  3. High fat levels in your blood (cholesterol and triglycerides). High fat levels may happen in people treated with ZYPREXA, especially in teenagers (13 to 17 years old), or when used in combination with fluoxetine in children (10 to 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.
  4. Weight gain. Weight gain is very common in people who take ZYPREXA. Teenagers (13 to 17 years old) are more likely to gain weight and to gain more weight than adults. Children (10 to 17 years old) are also more likely to gain weight and to gain more weight than adults when ZYPREXA is used in combination with fluoxetine. Some people may gain a lot of weight while taking ZYPREXA, so you and 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.

What is ZYPREXA?

ZYPREXA is a prescription medicine used to treat:

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.

The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn.

The symptoms of bipolar I disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.

The symptoms of treatment resistant depression include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior.

Some of your symptoms may improve with treatment. If you do not think you are getting better, call your doctor.

What should I tell my doctor before taking ZYPREXA?

ZYPREXA may not be right for you. Before starting ZYPREXA, tell your doctor if you have or had:

Tell your doctor if you exercise a lot or are in hot places often.

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 about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. ZYPREXA and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take ZYPREXA with your other medicines. Do not start or stop any medicine while taking ZYPREXA without talking to your doctor first.

How should I take ZYPREXA?

What should I avoid while taking ZYPREXA?

What are the possible side effects of ZYPREXA?

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

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 ZYPREXA. 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.

How should I store ZYPREXA?

Keep ZYPREXA and all medicines out of the reach of children.

General information about ZYPREXA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZYPREXA for a condition for which it was not prescribed. Do not give ZYPREXA to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about ZYPREXA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ZYPREXA that was written for healthcare professionals. For more information about ZYPREXA call 1-866-770-9010.

What are the ingredients in ZYPREXA?

Active ingredient: olanzapine

Inactive ingredients:

Tablets — carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains: Titanium Dioxide, FD&C Blue No. 2 Aluminum Lake, or Synthetic Red Iron Oxide.

ZYDIS — gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide revised October, 2023

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117, USA

Licensed by:
CHEPLAPHARM Registration GmbH
Weilerstr. 5e, 79540 Lörrach, Germany

CHEPLAPHARM Registration GmbH under the license of CHEPLAPHARM Schweiz GmbH

Revised: 10/2023
H2-Pharma LLC