Side Effects Associated with SEROQUEL

Medicines have potential risks of side effects, and some patients may experience side effects while taking SEROQUEL
Patients should always discuss the risk of potential side effects with their health care professional

Common Side Effects Associated With SEROQUEL

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.

Prescription medicines, including SEROQUEL, have benefits and potential risks of side effects. Regulatory agencies such as the US Food & Drug Administration (FDA) evaluate every drug to determine whether the potential benefit outweighs the risk of potential side effects for FDA-approved uses. The FDA considers the severity of the disease being treated, the clinical need for new treatments, and the potential benefits and risk of the medication.

Important Information You Should Know About 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.

Serious Side Effects Have Been Reported With SEROQUEL Including:

Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Stop SEROQUEL and call your healthcare provider right away.
High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take SEROQUEL. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes) your healthcare provider should check your blood sugar before you start SEROQUEL and during therapy.

Call your healthcare provider if you have any of these symptoms of high blood sugar while taking SEROQUEL:

feel very thirsty
need to urinate more than usual
feel very hungry
feel weak or tired
feel sick to your stomach
feel confused, or your breath smells fruity.

High cholesterol and triglyceride levels in the blood (fat in the blood): Increases in total cholesterol, triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported in clinical trials with SEROQUEL. You may not have any symptoms, so your healthcare provider should do blood tests to check your cholesterol and triglyceride levels before you start taking SEROQUEL and during therapy.
Increase in weight (weight gain): Weight gain has been seen in patients who take SEROQUEL so you and your healthcare provider should check your weight regularly.
Tardive dyskinesia: Tell your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking SEROQUEL. Tardive dyskinesia may also start after you stop taking SEROQUEL.
Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting caused by a sudden change in heart rate and blood pressure when rising too quickly from a sitting or lying position.
Increases in blood pressure: reported in children and teenagers. Your healthcare provider should check blood pressure in children and adolescents before starting SEROQUEL and during therapy.
Low white blood cell count
Cataracts
Seizures
Abnormal thyroid tests: Your healthcare provider may do blood tests to check your thyroid hormone level.
Increases in prolactin levels: Your healthcare provider may do blood tests to check your prolactin levels.
Increases in liver enzymes: Your healthcare provider may do blood tests to check your liver enzyme levels.
Long lasting and painful erection
Difficulty swallowing

These are not all the possible side effects of SEROQUEL. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Contacting AstraZeneca

For SEROQUEL info:

1-800-236-9933
E-mail

For Media contact only:

Kirsten Evraire
E-mail
302-885-0435

Laura Woodin
E-mail
302-885-1087

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

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.

This product information is intended for US audiences only.

SEROQUEL is a registered trademark of AstraZeneca group of companies.

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