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Limited Use
[what does this mean?]
Generic drug name:
risperidone
(ris PER i done)
Brand name(s):
PERSERIS KIT,
RISPERDAL,
RISPERDAL CONSTA,
UZEDY
GENERIC:
not available
FAMILY:
Atypical Antipsychotics
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Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
Risperidone crosses the human placenta. Newborns exposed in utero to antipsychotic drugs (including risperidone) are at risk of drug-induced movement disorders and/or withdrawal symptoms including agitation, tremor, drowsiness, respiratory distress and feeding disorders.
Risperidone caused harm in animal studies including an increase in stillborn rat pups as well as pup deaths after birth. There was also an increase in tumors of the pituitary glands, mammary glands and pancreas. Women taking this drug should adopt a reliable form of birth control to prevent pregnancy. Tell your doctor if you are taking this drug and think you may be pregnant. Never stop taking an antipsychotic except under close supervision of a doctor.
Breast-feeding Warning
Risperidone is excreted in human breast milk. To avoid potential risks, women should talk with their doctor about discontinuing the drug or discontinuing nursing.
Safety Warnings For This Drug [top]
FDA BLACK-BOX WARNING
Elderly patients with dementia-related psychosis who are being treated with antipsychotic drugs are at an increased risk of death. Risperdal is not approved for the treatment of patients with dementia-related psychosis.
Decreased Sweating
This drug may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or in hot weather while you are taking this medication, since overheating may result in heatstroke. Also, hot baths or saunas may make you feel dizzy or faint when you are taking this medication.
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.
Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia
Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in clinical trials of the atypical antipsychotics in elderly patients with dementia-related psychosis.[5] In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with these drugs than in patients treated with placebo. The atypical antipsychotics are not approved for the treatment of patients with dementia-related psychosis.
Death has resulted when risperidone has been used to treat dementia in the elderly.
Risperidone is not approved by the FDA to treat patients with dementia, such as Alzheimer’s dementia in elderly patients.
Facts About This Drug [top]
Risperidone (RISPERDAL) is an atypical antipsychotic approved to treat psychotic disorders such as schizophrenia. In 2007, the Food and Drug Administration (FDA) approved risperidone for the treatment of schizophrenia in adolescents aged 13 to 17 and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents aged 10 to 17.[6] Refer to the drug product label for additional approved uses of risperidone.
Risperidone is not approved for the...
Risperidone (RISPERDAL) is an atypical antipsychotic approved to treat psychotic disorders such as schizophrenia. In 2007, the Food and Drug Administration (FDA) approved risperidone for the treatment of schizophrenia in adolescents aged 13 to 17 and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents aged 10 to 17.[6] Refer to the drug product label for additional approved uses of risperidone.
Risperidone is not approved for the treatment of patients with dementia-related psychosis.
Public Citizen lists risperidone 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).[7]
Information about the long-term effects of risperidone is still sparse. Continued use should be reassessed periodically.
The cost of risperidone is high compared with that of generic haloperidol. When switching from other drugs to risperidone, the time during which the drugs overlap should be minimal.
Adverse effects
Older people are at an increased risk of adverse effects. Some adverse effects can be averted by lowering the dose.
Reports have suggested that newer atypical antipsychotic drugs such as risperidone are associated with the development of drug-induced elevations in blood sugar that have led to the development of diabetes.[2],[4],[3]
Risperidone also can cause users to sunburn more readily and experience weight gain, dry mouth or excessive saliva. The latter two can cause cavities.
Neuroleptic malignant syndrome (NMS) is a rare yet 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.[8]
In 2013, Health Canada, an agency similar to the FDA, and Janssen Inc. informed the Canadian public of the risk of intraoperative floppy iris syndrome (IFIS) associated with the use of risperidone or paliperidone (INVEGA) in patients undergoing cataract surgery.[9]
In 2013, the Medicines and Healthcare products Regulatory Agency in the U.K. issued a similar advisory on the risk of IFIS associated with the use of risperidone or paliperidone in patients undergoing cataract surgery.[10]
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 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.”[11]
In March 2013, Prescrire International published an article on rhabdomyolysis (muscle damage) associated with use of risperidone. The article was based on information published by Health Canada on five case reports that occurred in patients without the presence of NMS.[12]
A study published in Annals of Internal Medicine in 2014 showed that patients 65 years or older using quetiapine (SEROQUEL, SEROQUEL XR), risperidone and olanzapine (ZYPREXA, ZYPREXA ZYDIS) have an increased risk of a sudden loss of kidney function known as acute kidney injury.[13]
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.[14]
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. [15]
Regulatory actions surrounding risperidone
2003: In September, the FDA ordered that the product labeling for certain drugs warn that patients should be monitored for symptoms of diabetes. The drugs requiring the new warning were risperidone, aripiprazole, clozapine (CLOZARIL), olanzapine, quetiapine and ziprasidone (GEODON).[16]
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 risperidone, aripiprazole, olanzapine, quetiapine, clozapine and ziprasidone. None of these drugs are approved for the treatment of behavioral disorders in patients with dementia.[17]
2009: The FDA updated the product label of risperidone to state that the agency had received reports of leukopenia/neutropenia (low white blood cell count). These reports were received in clinical trial and post-marketing reports, and the FDA called them short-term events “related to antipsychotic agents.” Agranulocytosis (failure of the bone marrow to make enough white blood cells) also had been reported.[18]
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.[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 risperidone 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]
In 2022, the Journal of Clinical Psychopharmacology published a study showing that antipsychotic drugs that caused a high or medium increase in the level of the hormone prolactin in women, which include risperidone, were associated with an increased risk of breast cancer . [22] See the July 2022 Worst Pills, Best Pills News article “Some Antipsychotics Elevate Breast Cancer Risk, a Large Study Confirms.”
Before You Use This Drug [top]
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:
AVELOX, bromocriptine, carbamazepine, clozapine, CLOZARIL, DILANTIN, fluoxetine, LARODOPA, levodopa, moxifloxacin, NORVIR, PARLODEL, phenobarbital, phenytoin, PROZAC, RIFADIN, rifampin, RIMACTANE, ritonavir, TEGRETOL.
Because risperidone may cause low blood pressure (hypotension), it may enhance the blood-pressure-lowering effects of drugs used to treat high blood pressure.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
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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