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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: risperidone (ris PER i done)
Brand name(s): PERSERIS KIT, RISPERDAL, RISPERDAL CONSTA
GENERIC: not available FAMILY: Atypical Antipsychotics
Find the drug label by searching at DailyMed.

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 compared with 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]

Before You Use This Drug [top]

Tell your doctor if you have or have had:

  • low blood pressure
  • breast cancer
  • dehydration
  • heart, kidney, or liver problems
  • hypovolemia
  • Parkinson’s disease
  • seizures or stroke
  • brain tumor
  • medication overdose
  • drug abuse or dependence
  • intestinal obstruction
  • Reye’s syndrome
  • slow heartbeat
  • pregnancy or are breast-feeding

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Until you know how you react to this drug, do not drive or perform other activities that require alertness. Risperidone can cause drowsiness, dizziness, and blurred vision.
  • When you first take risperidone, try to have someone stay with you in case you become very weak from the lowering of your blood pressure.
  • Do not drink alcohol or use other central nervous system (CNS) depressants, including antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics, sedatives, sleeping pills, and tranquilizers.
  • You may feel dizzy when rising from a lying or sitting position. When getting out of bed, hang your legs over the side of the bed for a few minutes, then get up slowly. When getting up from a chair, stay beside the chair until you are sure that you are not dizzy.
  • Protect yourself from sun. Use sunblock that protects against both UVA and UVB rays and/or wear wide-brim hats, sunglasses, long sleeves, and long slacks. Avoid sunlamps, tanning beds, and tanning booths.
  • Avoid heatstroke from exercise, hot baths, or hot weather. Drink adequate fluids during hot weather.
  • Chew sugarless gum, candy, or ice or use a saliva substitute if you develop dryness in your mouth. If dryness continues more than two weeks, check with your doctor or dentist.
  • Keep regular appointments with your doctor.
  • If you plan to have any surgery, including dental, tell your doctor that you take this drug.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Take with or without food.
  • Stir measured dose of oral solution into water, coffee, orange juice, or low-fat milk; do not use cola or tea.
  • Store both tablets and oral solution at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.
  • Do not suddenly stop taking this drug. Check with your doctor to find out if you need to taper off this drug.

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:

  • signs of parkinsonism: trouble speaking or swallowing, loss of balance, masklike face, shuffling walk, slowed movements, stiffness of arms or legs, trembling and shaking of hands and fingers
  • muscle spasms in face, neck, and back
  • restlessness
  • anxiety, nervousness
  • trouble sleeping
  • decrease in sexual function
  • decrease in appetite
  • weakness or stiffness in arms or legs
  • back pain
  • bleeding
  • irregular blood pressure
  • unusual secretion of milk
  • difficulty breathing
  • puffy cheeks
  • chest pain
  • dandruff
  • difficulty concentrating or remembering
  • dizziness
  • drowsiness
  • unusual facial expression
  • fever
  • trembling or shaking of hands or fingers
  • irregular heartbeat
  • lip smacking or puckering
  • menstrual changes
  • mood changes, including aggressive behavior or uncontrolled excitement
  • stiff muscles
  • painful or prolonged penis erection
  • restlessness, need to keep moving
  • seizures
  • decline in sexual desire
  • shuffling walk or loss of balance
  • itching, oily, or pale skin
  • bruises or rash
  • difficulty sleeping
  • uncontrolled movements of arms, back, face, legs, neck, or trunk
  • difficulty swallowing or speaking
  • extreme thirst
  • ticlike, twisting, or twitching movements of body
  • rapid or darting movement of tongue
  • difficulty urinating
  • blurred or changed vision
  • uncontrolled tiredness or weakness

Call your doctor if these symptoms continue:

  • tiredness or weakness
  • abdominal pain
  • constipation
  • cough
  • diarrhea
  • dry mouth
  • headache
  • heartburn
  • joint pain
  • nausea
  • runny nose
  • increase or decrease in saliva (watering of mouth)
  • dry or darkened skin
  • increased sleep and dreams
  • drowsiness
  • sore throat
  • sunburn
  • undesired weight gain or loss
  • vomiting

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • abnormal movement determinations

last reviewed January 31, 2021