Regulation and Commitment to Patient Safety

 

The information on this Web site should not take the place of patients talking with their doctor or health care professional about how to manage and treat bipolar disorder or schizophrenia. Patients should contact their doctor or health care professional if they have any questions about these conditions, or would like more information about SEROQUEL. Only health care professionals can decide if SEROQUEL is right for a particular patient.

Important Safety Information and Indications for SEROQUEL

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 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. Patients, families, and caregivers should watch for these symptoms and report them immediately to the doctor. SEROQUEL is not approved for patients under the age of 10 years.

• A rare, but potentially fatal, side effect reported with SEROQUEL 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

• High blood sugar and diabetes have been reported with SEROQUEL and medicines like it. If you have diabetes or risk factors such as obesity or a family history of diabetes, your doctor should check your blood sugar before you start taking SEROQUEL and also during therapy. 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

• Increases in triglycerides and in LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with SEROQUEL. Your doctor should check your cholesterol levels before you start SEROQUEL and during therapy

• Weight gain has been reported with SEROQUEL. Your doctor should check your weight regularly

• Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of a serious condition called tardive dyskinesia (TD). TD may not go away, even if you stop taking SEROQUEL. TD may also start after you stop taking SEROQUEL

• Other risks include feeling dizzy or lightheaded upon standing, or having trouble swallowing. Tell your doctor if you experience any of these

• Increases in blood pressure have been reported with SEROQUEL in children and adolescents. Your doctor should check blood pressure in children and adolescents before starting SEROQUEL and during therapy

• Before starting treatment, tell your doctor if you have or have had low white blood cell (WBC) count, seizures, abnormal thyroid tests, high prolactin levels, heart or liver problems, or cataracts. An eye exam for cataracts is recommended at the beginning of treatment and every 6 months thereafter

• Since drowsiness has been reported with SEROQUEL, you should not participate in activities such as driving or operating machinery until you know that you can do so safely. Avoid becoming overheated or dehydrated while taking SEROQUEL. Do not drink alcohol while taking SEROQUEL

• Tell your doctor if you are pregnant or intend to become pregnant. Avoid breast-feeding while taking SEROQUEL

• Common side effects: The most common side effects in adults are drowsiness, dry mouth, dizziness, constipation, weakness, abdominal pain, a sudden drop in blood pressure upon standing, sore throat, weight gain, sluggishness, abnormal liver tests, and upset stomach. The most common side effects in children and adolescents are drowsiness, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, rapid heartbeat, and weight gain

  
  

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

Indications

SEROQUEL is approved for (1) depressive episodes in bipolar disorder in adults; (2) manic episodes in bipolar disorder in adults when used alone or with lithium or divalproex; (3) manic episodes in bipolar disorder in children and adolescents ages 10 to 17 years; (4) long-term treatment of bipolar disorder in adults with lithium or divalproex; (5) schizophrenia in adults; and (6) schizophrenia in adolescents ages 13-17 years.

Click here to see the Prescribing Information for SEROQUEL, including Boxed Warnings.

Click here to see the Medication Guide for SEROQUEL.

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.