Patient Information Sheet
Quetiapine Tablets (marketed as Seroquel)

This is a summary of the most important information about Seroquel. For details, talk to your healthcare professional.

What is Seroquel?

• Seroquel is in a class of medications called atypical antipsychotics. Antipsychotic medicines are used to treat symptoms of schizophrenia that may include hearing voices, seeing things, or sensing things that are not there, mistaken beliefs or unusual suspiciousness.
• Seroquel may be used alone or with lithium or divalproex to treat acute manic episodes in adults who have a condition called Bipolar I disorder. Bipolar disorder is a mental illness that causes extreme mood swings.

What are The Risks?

The following are the risks and potential side effects of Seroquel therapy. However, this list is not complete.

• Increased chance of death in elderly persons. Elderly patients treated with atypical antipsychotics, such as Seroquel, for dementia had a higher chance for death than patients who did not take the medicine. Seroquel is not approved for dementia.
   
• A life-threatening nervous system problem called neuroleptic malignant syndrome (NMS). NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS can affect your kidneys. NMS is a medical emergency. Call your healthcare professional right away if you experience these symptoms.
   
• A movement problem called tardive dyskinesia (TD). Call your healthcare professional right away if you get muscle movements that cannot be stopped.
   
• High blood sugar and diabetes. Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked.
   
• Other serious side effects may include low blood pressure seen as dizziness, increased heart beat and possibly fainting, cataracts, seizures, low thyroid, elevated cholesterol or triglycerides, liver problems, persistent erection, increase or decrease in body temperature, and difficulty swallowing.
   
• The most common side effects include headache, agitation, dry mouth, constipation, pain, vomiting, upset stomach and weight gain.

What Should I Tell My Healthcare Professional?

Before you start taking Seroquel, tell your healthcare professional if you:

• have or had heart problems
• have or had cataracts
• have a thyroid disorder
• have high cholesterol or triglycerides
• have or had seizures.
• have or had diabetes or increased blood sugar
• have or had liver disease
• are trying to become pregnant, are already pregnant, or are breast-feeding.
• drink alcohol

Are There Any Interactions With Drugs or Foods?

Because certain other medications can interact with Seroquel, review all medications that you are taking with your health care professional, including those that you take without a prescription.

Your healthcare professional may have to adjust your dose or watch you more closely if you take the following medications:

• blood pressure medicines
• levodopa and medicines called dopamine agonists
• phenytoin
• thioridazine
• antifungal or antibiotic medicines such as ketoconazole, itraconazole, fluconazole and erythromycin
• lorazepam

Avoid drinking alcohol while taking Seroquel.

Is There Anything Else I Need to Know?

• Dizziness, and sometimes fainting, caused by a drop in blood pressure may happen with Seroquel, especially when you first start taking this medicine or when the dose is increased.
• Seroquel may impair judgment, thinking, or motor skills. You should be careful in operating machinery, including automobiles, until you know how Seroquel affects you.
• It is important to avoid overheating and dehydration while taking Seroquel. Seroquel may make it harder to lower your body temperature.
  

Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570

Date created: April 2005, updated September 6, 2006