Generic Name: QUETIAPINE - ORAL
Pronounced: (kweh-TIE-ah-peen)

Seroquel Oral Warning

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure) when this medication is used in elderly patients with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

Seroquel Oral Side Effects

Constipation, drowsiness, dizziness, headache, stomach pain/upset, tiredness, weight gain, nasal congestion, or dry mouth may occur. If any of these side effects persist or worsen, notify your doctor.

Quetiapine may cause drowsiness and dizziness. This can increase your risk of falls. This is more likely to occur in the first few days after starting/restarting the drug or after your dose increases. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• fainting
• restlessness/constant need to move
• shakiness (tremor)
• slow/shuffling walk
• unusually fast/irregular heartbeat
• signs of infection (e.g., fever, persistent sore throat)
• mental/mood changes (e.g., increased anxiety, depression, suicidal thoughts)
• difficulty swallowing
• weakness
• swelling arms/legs/feet

Quetiapine may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

Tell your doctor immediately if any of these rare but very serious side effects occur:

• seizures
• vision changes

Quetiapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face, lips, mouth, tongue, arms or legs).

For males, in the very unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention, or permanent problems could occur.

This drug may infrequently cause a serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome). Seek immediate medical attention if you notice any of the following rare but very serious side effects: muscle stiffness, high fever, increased sweating, fast heartbeat, mental/mood changes, change in the amount of urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Seroquel Oral Precautions

Before taking quetiapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• Alzheimer's disease
• low blood pressure
• disease of the blood vessels in the brain (e.g., stroke)
• blood disorders (e.g., leukopenia, neutropenia)
• a severe loss of body water (dehydration)
• certain eye problems (cataracts)
• liver disease
• seizures
• trouble swallowing
• thyroid problems

Also tell your doctor or pharmacist if you or a family member has a history of the following:

• alcohol/drug abuse
• diabetes
• heart disease (e.g., ischemic heart disease, heart failure, heart rhythm problems)
• high blood cholesterol/triglyceride levels
• high blood pressure
• obesity

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects may increase your risk for developing heart disease, especially if you also have diabetes. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar such as unusual increased thirst/urination or vision changes. If you already have diabetes, be sure to check your blood sugar level regularly.

This drug can make you more likely to get heat stroke. Avoid activities that may cause you to overheat (e.g., strenuous work, exercising in hot weather, using hot tubs). Drink plenty of fluids, dress lightly, and stay in cool/air-conditioned areas when the weather is hot.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.