Seroquel XR is used to treat schizophrenia in adults and children who are at least 13 years old.

Seroquel XR is used alone or in combination with divalproex or lithium to treat manic episodes in adults with bipolar disorder.

Seroquel XR is also used to treat depressive episodes in adults with bipolar disorder.

Seroquel XR is also used alone to treat manic episodes in children at least 10 years old with bipolar disorder.

Seroquel XR extended release is used in combination with antidepressant medications to treat major depressive disorder in adults.

Seroquel XR may also be used for purposes not listed in this medication guide.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting Seroquel XR. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Seroquel XR may increase the risk of death in older adults with mental health problems related to dementia.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take Seroquel XR with or without food, but take it the same way each time.

Swallow the tablet whole and do not crush, chew, or break it.

Your blood may need to be checked on a regular basis, and you may need other medical tests.

Your blood pressure may need to be checked often.

Do not stop using Seroquel XR suddenly, your condition may get worse, or you could have unpleasant symptoms (such as trouble sleeping, nausea and vomiting). Ask your doctor before stopping the medicine.

This medicine may cause false results on a drug-screening urine test. Tell the laboratory staff that you use Seroquel XR.

Store at room temperature away from moisture and heat.

You should not use Seroquel XR if you are allergic to it.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you have or have ever had:

• a nervous system reaction associated with antipsychotic medication use;

• heart disease, a heart attack or stroke;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low blood levels of potassium or magnesium);

• high or low blood pressure;

• low white blood cell (WBC) counts;

• abnormal thyroid tests or prolactin levels;

• an enlarged prostate, constipation or urination problems;

• a seizure;

• glaucoma or cataracts;

• diabetes (in you or a family member);

• high cholesterol or triglycerides; or

• liver disease.

Seroquel XR may increase the risk of death in older adults with mental health problems related to dementia.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor's advice.

It may be harder for you to get pregnant while you are using Seroquel XR.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of quetiapine on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not drink alcohol. Dangerous side effects could occur.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how Seroquel XR will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of liquids while you are receiving Seroquel XR.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of quetiapine can cause a serious movement disorder that may not be reversible. The longer you use Seroquel XR, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Seroquel XR may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• breast swelling and tenderness, nipple discharge, impotence, missed menstrual periods;

• trouble swallowing, severe constipation;

• painful or difficult urination;

• high blood pressure, fast, slow or uneven heart rate;

• a light-headed feeling, sudden numbness or weakness, severe headache;

• blurred vision, eye pain or redness, seeing halos around lights;

• a seizure, feeling unusually hot or cold;

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• underactive thyroid--tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough.

Common side effects of Seroquel XR may include:

• speech problems;

• dizziness, drowsiness, tiredness;

• feeling like you might pass out;

• lack of energy;

• fast heartbeats;

• increased appetite, weight gain;

• upset stomach, vomiting, constipation;

• stomach pain, nausea;

• abnormal liver function tests, sore throat;

• stuffy nose, dry mouth; or

• difficulty moving.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Seroquel XR can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially:

• bronchodilator asthma medication;

• cold or allergy medicine (Benadryl and others);

• medicine to treat overactive bladder;

• medicine to treat Parkinson's disease; or

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

This list is not complete and many other drugs may affect Seroquel XR. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.