Important Safety Information about
SEROQUEL® (quetiapine fumarate) and SEROQUEL XR
This is not a complete summary of safety information. Please discuss the full Prescribing Information for SEROQUEL and SEROQUEL XR with your health care provider.
SEROQUEL is approved to treat the depressive episodes and the acute manic episodes in bipolar disorder and to treat schizophrenia. SEROQUEL XR is a once daily tablet approved only 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 and SEROQUEL XR 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 is not approved to treat depression; however, SEROQUEL is approved to treat bipolar depression. SEROQUEL and SEROQUEL XR are not approved for patients under the age of 18 years.
High blood sugar and diabetes have been reported with SEROQUEL, SEROQUEL XR, 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 or 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, SEROQUEL XR, 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, SEROQUEL XR, 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 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 bipolar disorder and schizophrenia; tell your doctor if you have thoughts about death or suicide. Since drowsiness has been reported with SEROQUEL and 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 or SEROQUEL XR because both drugs increase the effects of alcohol. Avoid becoming overheated or dehydrated while taking SEROQUEL or SEROQUEL XR.
The most common side effects are dry mouth, drowsiness, sedation, dizziness, high blood sugar, weakness, constipation, abdominal pain, sudden drop in blood pressure upon standing, sore throat, weight gain, abnormal liver tests, upset stomach, and sluggishness.
Please see Prescribing Information for SEROQUEL and SEROQUEL XR, including Boxed Warnings.