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Prescribing Information
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This is not a complete summary of safety information. Please discuss the full
Prescribing Information with your health care provider.
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
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 is not approved for patients under the
age of 18 years.
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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, ask your doctor about checking your blood sugar before
starting 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
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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
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Another serious side effect reported with SEROQUEL 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
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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. Suicidal thoughts or actions may occur in
bipolar disorder and schizophrenia; tell your doctor if you have thoughts about
death or suicide. During treatment, tell your doctor if you feel dizzy or
lightheaded upon standing. 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 drinking alcohol while taking
SEROQUEL because SEROQUEL increases the effects of alcohol. Avoid becoming
overheated or dehydrated while taking SEROQUEL
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Common side effects: The most common side effects are dry mouth, sedation,
drowsiness, dizziness, constipation, weakness, abdominal pain, sudden drop in
blood pressure upon standing, sore throat, weight gain, sluggishness, high
blood sugar, nasal congestion, abnormal liver tests, and upset stomach
Talk to your doctor about prescription SEROQUEL.
Click here for full 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.