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.
Talk to your doctor about prescription SEROQUEL XR or SEROQUEL.
Click here to see full Prescribing Information for
SEROQUEL and
SEROQUEL XR, 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.