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EmailGeneric Name: quetiapine
FDA Alerts-
Special Alerts:
[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html and http://www.fda.gov/cder/drug/antidepressants/default.htm.
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Before taking quetiapine, tell your doctor if you are taking any of the following medicines:
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cimetidine (Tagamet);
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lorazepam (Ativan);
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rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane, Rifater);
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steroids (prednisone and others);
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thioridazine (Mellaril);
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an antibiotic such as erythromycin (E-Mycin, E.E.S, Ery-Tab), fluconazole (Diflucan), ketoconazole (Nizoral), itraconazole (Sporanox);
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medicine for depression or mental illness, such as fluoxetine (Prozac), haloperidol (Haldol), imipramine (Tofranil), or risperidone (Risperdal);
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a medication to treat high blood pressure or a heart condition; or
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seizure medication such as carbamazepine (Tegretol), divalproex (Depakote), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), or valproate (Depakene).
This list is not complete and there may be other drugs that can interact with quetiapine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Get emergency medical help if you have any of these
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Other serious side effects include:
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fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
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jerky muscle movements you cannot control;
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sudden numbness or weakness, especially on one side of the body;
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sudden headache, confusion, problems with vision, speech, or balance;
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increased thirst, frequent urination, excessive hunger, or weakness;
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feeling like you might pass out; or
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urinating less than usual or not at all.
Less serious side effects may include:
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dizziness, drowsiness, or weakness;
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dry mouth, runny nose, sore throat;
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nausea, vomiting, stomach pain, constipation;
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blurred vision, headache, anxiety, agitation;
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breast swelling or discharge;
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missed menstrual periods; or
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weight gain.
This is not a complete list side effects and others may occur. Tell your doctor about unusual or bothersome side effect.