Risperidone
Risperidone · Say it: ris-PER-ih-done
Risperidone is a prescription medicine used to treat schizophrenia, certain manic or mixed episodes of bipolar I disorder, and irritability linked to autistic disorder.
⬛ Boxed warning (the FDA's strongest warning)
Elderly people with dementia-related psychosis who take antipsychotic drugs have an increased risk of death. In studies of elderly patients with dementia-related psychosis, the risk of death in people taking these drugs was about 1.6 to 1.7 times the risk in people taking a placebo (an inactive pill). Risperidone is not approved for treating dementia-related psychosis.
Used for
Schizophrenia in adults and adolescents (ages 13 to 17)
Comes as
1 mg tablets (white, round, film-coated, engraved 'RI3' on one side); The label's description also lists 0.25 mg tablets (orange) and 0.5 mg tablets (orange) among its available strengths
Common side effects
Restlessness, stiffness, tremor, or abnormal muscle movements (parkinsonism, akathisia, dystonia, tremor), Sleepiness, sedation, dizziness, or tiredness, Anxiety
| Generic name | Risperidone |
|---|---|
| Brand names | — |
| Type of medicine | an atypical antipsychotic medicine |
| How it is sold | Prescription tablet taken by mouth |
| Comes as | 1 mg tablets (white, round, film-coated, engraved 'RI3' on one side); The label's description also lists 0.25 mg tablets (orange) and 0.5 mg tablets (orange) among its available strengths |
| Route | oral |
| Boxed warning | Yes, see below |
| Label date | 2026-06-25 |
💊 What is Risperidone used for?
- Schizophrenia in adults and adolescents (ages 13 to 17)
- Acute manic or mixed episodes linked to Bipolar I Disorder, used alone or together with lithium or valproate
- Irritability linked to autistic disorder in children and adolescents (ages 5 to 17), including aggression, self-injury, temper tantrums, and quickly changing moods
How it works
The label says risperidone works by blocking a brain signaling site called the D2 receptor. It is an antagonist of that receptor.
How it is usually taken
- Risperidone is taken by mouth. The label says it can be given once or twice a day. The label says the dose is often increased slowly, at intervals of at least 24 hours, and that slower increases may be used for some patients. Follow the instructions from your prescriber or pharmacist about how and when to take it.
Comes as
- 1 mg tablets (white, round, film-coated, engraved 'RI3' on one side)
- The label's description also lists 0.25 mg tablets (orange) and 0.5 mg tablets (orange) among its available strengths
⚠️ Risperidone side effects
Common side effects
- Restlessness, stiffness, tremor, or abnormal muscle movements (parkinsonism, akathisia, dystonia, tremor)
- Sleepiness, sedation, dizziness, or tiredness
- Anxiety
- Blurred vision
- Nausea, vomiting, stomach pain or discomfort, indigestion, diarrhea, or constipation
- Dry mouth or extra saliva
- Increased appetite or weight gain
- Rash
- Stuffy nose, upper respiratory infection, sore throat
Get medical help right away if
- Get medical help right away if you have signs of neuroleptic malignant syndrome (NMS), a potentially fatal reaction. Signs include high fever, muscle stiffness, confusion or altered mental status, and irregular pulse or blood pressure.
- Get medical help right away if you have a painful or prolonged erection (priapism).
- Contact your healthcare provider if you notice abnormal movements, which may be a sign of tardive dyskinesia.
- Contact your healthcare provider if you have symptoms of high blood sugar, such as increased thirst, frequent urination, increased hunger, or weakness.
- Seek medical attention if you have signs of high prolactin, such as missed or absent periods or milk discharge from the breasts in women, or erectile dysfunction or breast enlargement in men.
- Be aware of possible dizziness or fainting (orthostatic hypotension and syncope), especially when starting treatment, restarting treatment, or when the dose is increased.
- Stroke and other cerebrovascular events have been reported in elderly patients with dementia-related psychosis. Seek medical help right away for signs of a stroke.
🛑 Who should not take Risperidone, and who should be careful
The label says not to take it if
- You have a known allergy (hypersensitivity) to risperidone, paliperidone, or any of the other ingredients in the tablets. The label says hypersensitivity reactions, including anaphylaxis and angioedema, have been reported.
Tell your doctor before taking it if
- Tell your healthcare provider about all prescription and over-the-counter medicines you take or plan to take, because interactions are possible.
- Tell your provider if you have a history of seizures or conditions that lower the seizure threshold.
- Tell your provider if you have a low white blood cell count or a history of drug-induced low white blood cell count. The label says your blood counts should be monitored.
- Tell your provider if you have diabetes or are at risk for diabetes. Blood sugar, cholesterol, and weight are monitored during treatment.
- Tell your provider if you are at risk for low blood pressure when standing.
- Tell your provider about any plans to become pregnant or breastfeed.
- Be careful with activities that need mental alertness, such as driving or operating hazardous machinery, until you know how the medicine affects you.
- Take care to avoid overheating and dehydration, as the label advises.
🔀 Risperidone with other medicines, food and alcohol
The label says to discuss these with your doctor or pharmacist
- Carbamazepine and other enzyme inducers can lower risperidone levels in the blood. The label says the dose may need to be increased, slowly.
- Fluoxetine, paroxetine, and other CYP2D6 enzyme inhibitors can raise risperidone levels. The label says the starting dose may need to be reduced, and that the final dose should not exceed a set maximum.
- The label says no dose change is generally needed with ranitidine, cimetidine, amitriptyline, or erythromycin.
- The label says risperidone does not change the levels of lithium, so no dose adjustment is recommended for lithium.
- Avoid alcohol while taking risperidone, as the label advises.
Alcohol and food
The label advises avoiding alcohol while taking risperidone. The label does not give specific food instructions.
🤰 Risperidone in pregnancy and breastfeeding
Pregnancy
The label says a pregnancy exposure registry monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone. Neonates exposed to antipsychotic drugs in the third trimester may have extrapyramidal and/or withdrawal symptoms after birth. The label says available data have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. It also notes risks to the mother from untreated schizophrenia or bipolar I disorder. Tell your healthcare provider if you become pregnant or plan to become pregnant.
Breastfeeding
The label advises breastfeeding women who use risperidone to watch their infants for sleepiness, failure to thrive, jitteriness, and abnormal movements such as tremors, and to seek medical care if these signs appear.
🗓️ Storage, missed doses and taking too much
Storage
Store at 20°C to 25°C (68°F to 77°F), with brief excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light and moisture. Keep out of reach of children.
If a dose is missed
The label does not say.
If too much is taken
The label describes overdose reports in which the effects were an exaggeration of the drug's known effects: drowsiness and sedation, fast heart rate, low blood pressure, and extrapyramidal symptoms. The label also mentions reports of low sodium, low potassium, abnormal heart rhythm changes, and seizures in some overdose cases. If you think someone has taken too much, seek medical care right away.
🗒️ Questions to ask about Risperidone
🎯 Check what you understood
1. According to the boxed warning, which group of people has an increased risk of death with antipsychotic drugs?
2. What does the label advise about drinking alcohol while taking risperidone?
3. Which medicine can raise risperidone levels in the blood, according to the interactions section?
❓ Risperidone: frequently asked questions
What is risperidone used for?
The label says risperidone is used to treat schizophrenia, acute manic or mixed episodes of Bipolar I Disorder, and irritability associated with autistic disorder. It may be used alone or with lithium or valproate for bipolar mania.
Can risperidone be used for dementia-related psychosis?
The label says risperidone is not approved for treating dementia-related psychosis. The boxed warning describes an increased risk of death in elderly patients with this condition.
Does risperidone affect blood sugar or weight?
The label says atypical antipsychotics have been associated with metabolic changes, including high blood sugar, changes in cholesterol, and weight gain. It advises monitoring blood glucose, lipids, and weight.
Can risperidone affect driving?
The label cautions patients about activities that require mental alertness, such as operating a motor vehicle or hazardous machinery. It advises caution until you are reasonably certain the medicine does not affect you adversely.
Is risperidone safe during pregnancy?
The label says available data have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. It advises telling your healthcare provider if you become pregnant or plan to become pregnant.
🧪 Tests and reports linked to Risperidone
The label text mentions these. If you have one of these reports, get every line of it explained.
- HbA1c and glucose
a test or report linked to this medicine
- Metabolic panel (BMP, CMP)
a test or report linked to this medicine
- Lipid panel (cholesterol)
a test or report linked to this medicine
- Liver function tests
a test or report linked to this medicine
- Kidney function tests
a test or report linked to this medicine
- Culture and sensitivity
a test or report linked to this medicine
📖 Medical words used on this page
- Acute vs chronic
Acute means something started recently or suddenly. Chronic means it has lasted a long time or keeps coming back.
- Allergic reaction
An allergic reaction is when the immune system overreacts to something harmless, such as a medicine or food, causing symptoms from a rash to swelling.
- Anaphylaxis
Anaphylaxis is a severe, whole-body allergic reaction that comes on fast and is a medical emergency needing urgent help.
- Angioedema
Angioedema is swelling deep under the skin, often of the lips, face, tongue or throat. Swelling of the throat or tongue needs emergency help.
- Antipsychotic
An antipsychotic is a medicine used for psychosis, schizophrenia and bipolar disorder, and sometimes for other conditions.
- Arrhythmia
An arrhythmia is a heartbeat that is too fast, too slow or irregular, because the heart's electrical signals are not working in their usual pattern.
- Atypical
Atypical means cells look different from normal under the microscope, but not clearly enough to be called cancer.
- Atypical antipsychotic
An atypical antipsychotic is a newer type of antipsychotic medicine used for schizophrenia, bipolar disorder and sometimes depression or other conditions.
- Bilateral and unilateral
Bilateral means on both sides of the body and unilateral means on one side only, and reports usually also name the side.
- Bipolar I disorder
Bipolar I disorder is a long-term mood condition in which a person has had at least one episode of mania, often with periods of depression too.
- Boxed warning
A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.
- Congenital malformations
Congenital malformations are differences in the structure of the body that are present at birth, such as heart, spine or lip and palate defects.
- Dehydration
Dehydration means the body has lost more fluid than it has taken in, so it does not have enough water to work normally.
- Dementia-related psychosis
Dementia-related psychosis means hallucinations or false beliefs in a person with dementia. Many antipsychotic labels carry a boxed warning about it.
📖 Medical words on this page
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Explain my leafletDecode my prescription🔗 Trusted sources about Risperidone
- Full official label on DailyMed ↗
US National Library of Medicine: the complete FDA label this page is based on
- Risperidone on MedlinePlus ↗
US National Library of Medicine's patient drug information
- Risperidone on the NHS website ↗
UK National Health Service medicine guide
Report a side effect or check safety alerts
- Report a side effect in the US (FDA MedWatch) ↗
- Report a side effect in the UK (Yellow Card) ↗
- FDA recalls and safety alerts ↗
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Source: official FDA drug label (label updated 2026-06-25). Read the full label on DailyMed
MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.