SEROQUEL is a mood-stabilizing medication approved by the FDA to treat both the
highs and lows of bipolar disorder.1 To learn more about the
effectiveness of SEROQUEL in bipolar disorder—click
here.
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The information on this Web site should not take the place of talking with your
doctor or health care professional about how to manage and treat bipolar
disorder. If you have any questions about your condition, or if you would like
more information about Seroquel, talk to your doctor or pharmacist. Only you
and your doctor can decide if Seroquel is right for you.
Important Safety Information about Seroquel XR and Seroquel 
This is not a complete summary of safety information. Please discuss the full Prescribing Information for SEROQUEL XR and SEROQUEL with your health care provider.
Seroquel XR is a once-daily tablet approved to treat acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or when added to lithium or divalproex; long-term maintenance of bipolar disorder when added to lithium or divalproex; and schizophrenia. Seroquel is approved for depressive episodes and acute manic episodes in bipolar disorder; long-term maintenance treatment of bipolar disorder in combination with lithium or divalproex; and 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 and Seroquel are 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 and Seroquel are not approved for patients under the age of 18 years.
- High blood sugar and diabetes have been reported with Seroquel XR, Seroquel, and medicines like them. 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 or Seroquel 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.
- Increases in cholesterol and triglycerides, and weight gain have been reported with Seroquel XR and Seroquel.
- A rare, but potentially fatal, side effect reported with Seroquel XR, Seroquel, and medicines like them 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, Seroquel, and medicines like them 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 prolactin levels 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; tell your doctor if you have thoughts about death or suicide. Since drowsiness has been reported with Seroquel XR and Seroquel, 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 or Seroquel because both drugs increase the effects of alcohol. Avoid becoming overheated or dehydrated while taking Seroquel XR or Seroquel.
- Common side effects: The most common side effects are drowsiness, dry mouth, increases in cholesterol and triglycerides, dizziness, increased hunger, increases in blood sugar, constipation, weakness, tiredness, weight gain, upset stomach, abdominal pain, a sudden drop in blood pressure upon standing, sore throat, difficulty speaking, stuffy nose, abnormal liver tests, and sluggishness.
Click here to see full Prescribing Information for SEROQUEL XR and SEROQUEL, including Boxed Warnings.
REFERENCES:
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Data on file, DA-SER-51, AstraZeneca Pharmaceuticals LP.
