QUETIAPINE FUMARATE- quetiapine fumarate tablet 



Quetiapine Tablets, USP


Read this Medication Guide before you start taking quetiapine tablets 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).

o all risks and benefits of treatment with antidepressant medicines.

o all treatment choices for depression or other serious mental illness

o 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.

o Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

o 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:

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 takenincluding 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:

Increases in blood sugar can happen in some people who take quetiapine. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes) your healthcare provider should check your blood sugar before you start quetiapine and during therapy. Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine:

o feel very thirsty

o need to urinate more than usual

o feel very hungry

o feel weak or tired

o feel sick to your stomach

o feel confused, or your breath smells fruity

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.

What are the ingredients in quetiapine? Active ingredient:quetiapine

Inactive ingredients:povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide.The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide.

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

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Revised: 3/2024