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Limited Use
[what does this mean?]
Generic drug name:
quetiapine
(KWE TYE a peen)
Brand name(s):
SEROQUEL,
SEROQUEL ER
GENERIC:
available
FAMILY:
Atypical Antipsychotics
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
Quetiapine (SEROQUEL) caused harm to developing fetuses in animal studies; instances included fetal and pup death. This drug should be used during pregnancy only for clear medical reasons. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.
The FDA updated the information for this entire class of antipsychotic drugs relating to their potential risk to newborns when used during pregnancy. The drugs’ product labels have been updated to include information stating that when mothers are treated with these drugs during the third trimester of pregnancy, there is a potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in their newborns.
Breast-feeding Warning
Quetiapine was excreted in the breast milk of treated rats. It is very likely that women taking quetiapine would also excrete the drug into their milk. Because of the potential for serious adverse effects, women taking quetiapine should not breast-feed their infants.
Safety Warnings For This Drug [top]
FDA BLACK BOX WARNING
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5 percent, compared to a rate of about 2.6 percent in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Seroquel is not approved for the treatment of patients with dementia-related psychosis.
Product Warnings
Ask a doctor or pharmacist before use if you are taking antibiotics.
When using this product, tiredness, drowsiness or dizziness may occur. Be careful driving or operating machinery.
Stop using and ask a doctor if symptoms get worse, diarrhea lasts more than two days or you get abdominal swelling or bulging. These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Older adults are especially sensitive to the harmful anticholinergic effects of this drug. Drugs in this family should not be used unless absolutely necessary.
Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention.
Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma.
Weight Gain
For a variety of reasons, including increased appetite, the newer (so-called “atypical”) antipsychotic drugs commonly cause a significant increase in weight that can be troublesome and dangerous for patients using these drugs. For various drugs in this group, the usual range of weight gain is from 5 to 20 pounds, but there are a large number of reports of people gaining much more than 20 pounds, especially with longer-term use of the drugs. In addition to and related to weight gain are metabolic disorders including elevated blood sugar, the onset of diabetes and abnormalities of fat metabolism such as elevated triglyceride levels. Patients should be informed of these effects to help prevent excessive body weight gain.[1]
Blood Sugar Elevation and Diabetes Mellitus
Elevations in blood sugar (glucose),[2],[3],[4] in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics that include aripiprazole (ABILIFY), clozapine (CLOZARIL), olanzapine (ZYPREXA), quetiapine (SEROQUEL), risperidone (RISPERDAL) and ziprasidone (GEODON).
The relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia (excessive thirst/drinking of liquids), polyuria (excessive urination), polyphagia (excessive eating) and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug.
Heat Stress Alert
This drug can affect your body’s ability to adjust to heat, putting you at risk of “heat stress.” If you live alone, ask a friend to check on you several times during the day. Early signs of heat stress are dizziness, lightheadedness, faintness, and slightly high temperature. Call your doctor if you have any of these signs. Drink more fluids (water, fruit and vegetable juices) than usual—even if you’re not thirsty—unless your doctor has told you otherwise. Do not drink alcohol.
Facts About This Drug [top]
Quetiapine (SEROQUEL, SEROQUEL ER) is an atypical antipsychotic approved to treat psychotic disorders such as schizophrenia. Refer to the drug product label for additional approved uses of quetiapine.
Quetiapine is not approved for the treatment of patients with dementia-related psychosis.
Public Citizen lists quetiapine as a Limited Use drug.
All antipsychotics usually improve symptoms such as agitation, delusions, hallucinations and suspiciousness. Atypical antipsychotics are...
Quetiapine (SEROQUEL, SEROQUEL ER) is an atypical antipsychotic approved to treat psychotic disorders such as schizophrenia. Refer to the drug product label for additional approved uses of quetiapine.
Quetiapine is not approved for the treatment of patients with dementia-related psychosis.
Public Citizen lists quetiapine as a Limited Use drug.
All antipsychotics usually improve symptoms such as agitation, delusions, hallucinations and suspiciousness. Atypical antipsychotics are different because they claim to improve “negative” symptoms, such as apathy, disorientation, emotional withdrawal and lack of pleasure, better than older antipsychotics do. However, there is no clear evidence that atypical antipsychotics are more effective or are better tolerated than the older conventional antipsychotics, such as haloperidol (HALDOL).[5]
Adverse effects
Generally, older people are more prone to develop adverse effects from antipsychotics. A common adverse effect is drowsiness. Quetiapine can cause dizziness and low blood pressure. More than 20% of people taking quetiapine experienced weight gain, and this was sometimes accompanied by an increase in cholesterol levels. Common anticholinergic effects include dry mouth (see the “Adverse effects of antipsychotic drugs” table in "Antipsychotic Drugs: Dangerously Overused").
Quetiapine can have serious adverse effects such as tardive dyskinesia. Early signs of tardive dyskinesia include tremor or unusual movements of the tongue or mouth. In these early stages, the condition may be reversible. If progressive, tardive dyskinesia may lead to uncontrollable movements of the arms, legs and tongue, for which there is no known effective treatment. Women and older people are more prone to tardive dyskinesia. Extrapyramidal effects from quetiapine, such as drug-induced Parkinsonism, may cause a shuffle when walking.
Neuroleptic malignant syndrome (NMS) is a rare but severe adverse effect of antipsychotic drugs. The symptoms of NMS can include fever; confusion; disorientation or other cognitive (thinking) function changes; muscle rigidity; profuse sweating; and unstable blood pressure, heart rate and gastrointestinal function. NMS can be life threatening; rapid recognition and treatment are important.[6] (Read more in the December 2010 Worst Pills, Best Pills News.)
Reports have suggested that newer atypical antipsychotic drugs such as quetiapine are associated with elevations in blood sugar that have led to the development of diabetes.[2],[4],[3]
Cardiac muscle disorders have been reported in patients treated with quetiapine. Heart muscle damage and inflammation can be fatal.[7]
An article in the Canadian Adverse Reaction Newsletter reviewed information on three published case reports (one Canadian and two international) that found a probable association between quetiapine use and acute liver failure. The article urged health care professionals to report suspected cases of liver injury due to quetiapine treatment.[8]
In one breed of dog (beagles), but not in any other animals, quetiapine caused cataracts. Until the effect of quetiapine on human eyes is determined, patients should have eye exams at initiation of treatment and every six months thereafter to detect the formation of cataracts.
Studies show …
In April 2011, the Office of Inspector General of the Department of Health and Human Services released a study titled “Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents,” with dismal results. The study was conducted at the request of Sen. Charles Grassley (R-Iowa) and evaluated the extent to which elderly nursing home residents receive newer, more expensive atypical antipsychotic drugs and the associated cost to the Medicare system. It also assessed the extent to which dangerous, off-label prescribing of these drugs was occurring. (Click here to read the August 2011 Worst Pills, Best Pills News article on the report.)
On May 24, 2013, the Centers for Medicare and Medicaid Services, as part of the National Partnership to Improve Dementia Care in Nursing Homes, issued new guidelines discouraging the use of antipsychotic drugs to treat dementia in nursing home patients. The recommendations belatedly follow the May 2011 report by the Inspector General of the Department of Health and Human Services, which found that 14% of nursing home residents had Medicare claims filed on their behalf for atypical antipsychotic medications, which have never been approved by the Food and Drug Administration (FDA) for managing dementia.
A study published in the British Medical Journal evaluated the risk of death associated with specific antipsychotic medications used in elderly residents in nursing homes. The study reviewed information relating to the risk of death when using different drug therapies and found that the risk of death varied according to the specific drug used. The authors of the study concluded:
“The evidence accumulated so far implies that use of haloperidol in this vulnerable population cannot be justified because of the excess harm. Quetiapine might be somewhat safer than other atypical drugs, but these findings will require replication in other studies.”[9]
A study published in Annals of Internal Medicine in 2014 showed that patients 65 years or older using quetiapine, risperidone (RISPERDAL) or olanzapine (ZYPREXA, ZYPREXA ZYDIS) have an increased risk of a sudden loss of kidney function known as acute kidney injury.[10]
In 2015, JAMA Internal Medicine published an article showing that use of atypical antipsychotic drugs was associated with an increased risk of falls and fractures in patients 65 and older.[11]
In 2015, a study published in the Journal of Clinical Psychiatry showed that aripiprazole (ABILIFY), olanzapine, quetiapine and risperidone had a high risk of adverse effects and a low rate of effectiveness when used in patients older than 40. [12]
Regulatory actions surrounding quetiapine
2003: In September, the FDA ordered that the product labeling for certain drugs warn that patients should be monitored for symptoms of diabetes.[13] The drugs requiring the new warning were quetiapine, aripiprazole (ABILIFY), clozapine (CLOZARIL), olanzapine, risperidone and ziprasidone (GEODON).[14]
2005: The FDA issued a public health advisory on April 11 to warn that atypical antipsychotic drugs are associated with an increased risk of death when used to treat dementia in elderly patients.
The atypical antipsychotics affected by the FDA advisory were quetiapine, aripiprazole, olanzapine, risperidone, clozapine and ziprasidone. None of these drugs is approved for the treatment of behavioral disorders in patients with dementia.[15]
2009: The FDA updated the product label of quetiapine to include information that increases in blood pressure in children and adolescents were observed in placebo-controlled trials involving patients with schizophrenia. Health care professionals should monitor blood pressure in these patients at the beginning of treatment and then periodically during treatment.[16]
2011: The FDA updated the information for all antipsychotic drugs relating to their potential risk to newborns when used during pregnancy. The drugs’ product labels have been updated to state that when mothers are treated with these drugs during the third trimester of pregnancy, there is a potential risk of abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in their newborns.[17]
In July 2011, the FDA requested that the product label for quetiapine be revised to warn against use with certain classes of drugs known to cause an arrhythmia (alteration in heartbeat rhythm). The classes of drugs that are listed in the revised label and that may have a risk of bad interactions with quetiapine include antiarrhythmics, antibiotics, anti-infectives, antipsychotics and opioids.
The revised label includes post-marketing study findings of QT prolongation in patients taking quetiapine along with medications known to cause electrolyte imbalance or increased QT intervals. Though this effect was seen in 17 patients who took more than the recommended dosage of the drug, the original label’s mentioning of a QT effect did not provide information on specific classes of drugs to avoid.[18],[19]
2016: Health Canada, an agency similar to the FDA, updated the product label of atypical antipsychotics to warn that the drugs are associated with an increased risk of sleep apnea (a disorder that causes breaks in breathing or very shallow breathing during sleep).[20]
2017: The FDA approved a new warning in the product label of quetiapine that stated that the drug may cause excessive sleepiness, low blood pressure upon sitting up or standing (postural hypotension) and problems with balance, all of which may increase the risk of falls and fractures in patients taking the drug.[21]
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:
Central nervous system depressant (CNS) drugs, including alcohol, antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics, sedatives, sleeping pills, and tranquilizers.
amiodarone, ATIVAN, BIAXIN, carbamazepine, cimetidine, clarithromycin, CORDARONE, CRIXIVAN, DELTASONE, DIFLUCAN, DILANTIN, EES, ERYTHROCIN, erythromycin, fluconazole, fluoxetine, fluvoxamine, FORTOVASE, indinavir, INVIRASE, itraconazole, ketoconazole, , levodopa, lorazepam, LUMINAL, LUVOX, MELLARIL, METICORTEN, METRETON, nefazodone, nelfinavir, NIZORAL, NORVIR, phenobarbital, phenytoin, prednisolone, prednisone, PROZAC, RIFADIN, rifampin, RIMACTANE, ritonavir, saquinavir, SERZONE, SOLFOTON, sparfloxacin, SPORANOX, TAGAMET, TAO, TEGRETOL, thioridazine, troleandomycin, VIRACEPT, ZAGAM.
Because of its potential for causing low blood pressure, quetiapine may enhance the effects of blood-pressure-lowering drugs.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Signs of overdose:
If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed July 31, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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