Page Highlights

• SEROQUEL XR is a medication used for the treatment of schizophrenia
• Patients taking SEROQUEL XR in clinical trials experienced improvements with the symptoms of schizophrenia
• SEROQUEL XR is approved for adult patients. It is not approved for patients who are under 18

This is not a complete summary of safety information. Please discuss the full Prescribing Information with your health care provider.

SEROQUEL XR is a once daily tablet approved to treat schizophrenia.

Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to placebo (sugar pill). SEROQUEL XR is not approved for treating these patients.

Antidepressants have increased the risk of suicidal thoughts and actions in some children, teenagers, and young adults. Patients of all ages starting treatment should be watched closely for worsening of depression, suicidal thoughts or actions, unusual changes in behavior, agitation, and irritability. Families and caregivers should watch patients daily and report these symptoms immediately to the physician. SEROQUEL XR is not approved to treat depression. SEROQUEL XR is not approved for patients under the age of 18 years.

• High blood sugar and diabetes have been reported with SEROQUEL XR and medicines like it. If you have diabetes or risk factors such as obesity or a family history of diabetes, ask your doctor about checking your blood sugar before starting SEROQUEL XR and regularly throughout treatment. If you develop symptoms of high blood sugar or diabetes, such as excessive thirst or hunger, increased urination, or weakness, contact your doctor. Complications from diabetes can be serious and even life threatening
• A rare, but potentially fatal, side effect reported with SEROQUEL XR and medicines like it is neuroleptic malignant syndrome (NMS). Tell your doctor if you have very high fever; rigid muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness because treatment should be stopped if you have NMS
• Another serious side effect reported with SEROQUEL XR and medicines like it is tardive dyskinesia (TD)—uncontrollable movements of the face, tongue, or other parts of the body. TD may become permanent, and the risk of TD is believed to increase as the length of time on and the amount of these medications increase. While TD can develop in patients taking low doses for short periods, this is much less common. There is no known treatment for TD, but it may go away partially or completely if treatment is stopped
• Before starting treatment, tell your doctor if you have high cholesterol or have a history of, or are at risk for, seizures or a low white blood cell (WBC) count. An eye exam for cataracts is recommended at the beginning of treatment and every 6 months thereafter. During treatment, tell your doctor if you feel dizzy or lightheaded upon standing. Suicidal thoughts or actions may occur in schizophrenia; tell your doctor if you have thoughts about death or suicide. Since drowsiness has been reported with SEROQUEL XR, you should not participate in activities such as driving or operating machinery until you know that you can do so safely. Avoid drinking alcohol while taking SEROQUEL XR because SEROQUEL XR increases the effects of alcohol. Avoid becoming overheated or dehydrated while taking SEROQUEL XR
• Common side effects: The most common side effects are drowsiness, dry mouth, constipation, upset stomach, dizziness, a sudden drop in blood pressure upon standing, weight gain, increased hunger, tiredness, difficulty speaking, and stuffy nose.

Talk to your doctor about prescription SEROQUEL XR.
Click here to see Prescribing Information, including Boxed Warnings.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.