QUETIAPINE FUMARATE- quetiapine fumarate tablet 
Golden State Medical Supply, Inc.


Medication Guide

Quetiapine Tablets, USP

(kwe tye′ a peen)

Rx only

Read this Medication Guide before you start taking quetiapine and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

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

Quetiapine may cause serious side effects, including:

  1. Risk of death in the elderly with dementia. Medicines like quetiapine can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine is not for treating psychosis in the elderly with dementia.
  2. Risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions).
  3. Talk to your or your family member’s healthcare provider about:
    • All risks and benefits of treatment with antidepressant medicines.
    • All treatment choices for depression or other serious mental illness.
  4. Antidepressant medications may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  5. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or suicidal thoughts or actions.
  6. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

      Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  7. Thoughts about suicide or dying
  8. Attempts to commit suicide
  9. New or worse depression
  10. New or worse anxiety
  11. Feeling very agitated or restless
  12. Panic attacks
  13. Trouble sleeping (insomnia)
  14. New or worse irritability
  15. Acting aggressive, being angry, or violent
  16. Acting on dangerous impulses
  17. An extreme increase in activity and talking (mania)
  18. Other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

What is quetiapine?

Quetiapine is a prescription medicine used to treat:

It is not known if quetiapine is safe and effective in children under 10 years of age.

What should I tell my healthcare provider before taking quetiapine?

Before you take quetiapine, tell your healthcare provider if you have or have had:

Tell the healthcare provider about all the medicines that you take or recently have taken including prescription medicines, over-the-counter medicines, herbal supplements and vitamins.

Quetiapine and other medicines may affect each other causing serious side effects. Quetiapine may affect the way other medicines work, and other medicines may affect how quetiapine works.

Tell your healthcare provider if you are having a urine drug screen because quetiapine may affect your test results. Tell those giving the test that you are taking quetiapine.

How should I take quetiapine?

What should I avoid while taking quetiapine?

What are possible side effects of quetiapine?

Quetiapine can cause serious side effects, including:

The most common side effects of quetiapine include:

In Adults:

In Children and Adolescents:

These are not all the possible side effects of quetiapine. For more information, ask your healthcare provider 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 quetiapine?

General information about the safe and effective use of quetiapine.

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

This Medication Guide summarizes the most important information about quetiapine. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine that is written for health professionals.

For more information, please call 1-800-962-8364.

What are the ingredients in Quetiapine Tablets, USP?

Active ingredient: quetiapine, USP

Inactive ingredients: The 25 mg tablet contains lactose, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate.

The 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg tablets contain colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate.

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

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922


Revised February 2022

Marketed by:

GSMS, Inc.

Camarillo, CA 93012 USA

Revised: 2/2024
Golden State Medical Supply, Inc.