Generic Risperdal ( Risperidone )

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Risperdal is an atypical antipsychotic used to treat schizophrenia and related psychotic disorders, as well as acute manic or mixed episodes in bipolar disorder. It is also sometimes prescribed for irritability associated with autism in children and adolescents. The medication works by balancing dopamine and serotonin in the brain, which helps calm hallucinations, delusions, and disorganized thinking.
The usual starting dose for schizophrenia in adults is 1 mg to 2 mg per day, given once or twice daily. Your doctor may increase the dose gradually, usually to a target of 4 mg to 6 mg per day, depending on how you respond and how well you tolerate it. For acute mania, the starting dose is often 2 mg to 3 mg per day, with adjustments based on response.
The administration form is film-coated, scored tablets in 1 mg, 2 mg, 3 mg, and 4 mg strengths. Orally disintegrating tablets (Risperdal M-Tab) are also available in 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. A 1 mg/mL oral solution is available for people who have trouble swallowing tablets. A long-acting injectable form (Risperdal Consta) is also marketed in Canada.
Risperdal does not work overnight. Some calming effects may appear within the first few days, but the full benefit for psychotic symptoms usually takes several weeks of steady dosing.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that risperidone can cause, and it can increase the risk of low blood pressure and respiratory depression.
The most common side effects are parkinsonism (tremor, stiffness, slow movement), drowsiness, and headache. Weight gain, increased appetite, and metabolic changes are also possible.
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Common Use Risperdal

Risperidone is a benzisoxazole atypical antipsychotic. It works by blocking dopamine D2 receptors and serotonin 5-HT2A receptors in the brain, which helps reduce hallucinations, delusions, and disorganized thinking. It also has affinity for alpha-1 and alpha-2 adrenergic receptors and histamine H1 receptors, which explains some of its sedative and cardiovascular effects. Health Canada has approved risperidone for the treatment of schizophrenia and related psychotic disorders in adults. It is also indicated for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder, and for the treatment of irritability associated with autistic disorder in children and adolescents aged 5 to 16 years. Risperdal is not approved for treating behavioural problems in older adults with dementia, and it carries a boxed warning about increased mortality in that population.

Basic Risperdal Information

• INN (International Nonproprietary Name): Risperidone
• Brand names available in Canada: Risperdal® (Janssen Inc., DIN 02025280 for 1 mg, DIN 02025299 for 2 mg, DIN 02025302 for 3 mg, DIN 02025310 for 4 mg). Generics include AG-Risperidone (Angita Pharma Inc., DIN 02369079 for 0.25 mg, DIN 02369087 for 0.5 mg), Apo-Risperidone (Apotex Inc., DIN 02282143, DIN 02282135, DIN 02282119), Jamp-Risperidone (Jamp Pharma Corporation, DIN 02359545, DIN 02563347), Mar-Risperidone (Marcan Pharmaceuticals Inc.), Mylan-Risperidone (Mylan Pharmaceuticals ULC), pms-Risperidone (Pharmascience Inc., DIN 02279266), PMS-Risperidone ODT (Pharmascience Inc., DIN 02370700 for 4 mg, DIN 02370697 for 3 mg, DIN 02291789), Pro-Risperidone (Pro Doc Limitée, DIN 02312727), Riva-Risperidone (Laboratoire Riva Inc., DIN 02283638), Sandoz Risperidone (Sandoz Canada Inc., DIN 02279800 for 1 mg, DIN 02279819 for 2 mg, DIN 02279827 for 3 mg, DIN 02279835 for 4 mg), Sanis Risperidone (Sanis Health Inc., DIN 02356899 for 1 mg, DIN 02356929 for 3 mg, DIN 02356937 for 4 mg), Teva-Risperidone (Teva Canada Limited, DIN 02264196, DIN 02282690 for 0.25 mg), Taro-Risperidone (Sun Pharma Canada Inc.), and Risperidone (Sivem Pharmaceuticals ULC, DIN 02533936, marketed since 2023-11-09).
• ATC Code: N05AX08
• Forms and dosages: Film-coated, scored tablets – 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Orally disintegrating tablets (Risperdal M-Tab, PMS-Risperidone ODT) – 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Oral solution – 1 mg/mL (Risperdal Oral Solution, DIN 02236950; Apo-Risperidone Oral Liquid, DIN 02280396). Long-acting injectable suspension (Risperdal Consta) – 12.5 mg, 25 mg, 37.5 mg, and 50 mg vials.
• Manufacturers in Canada: Janssen Inc. (Risperdal, Risperdal M-Tab, Risperdal Consta), Angita Pharma Inc. (AG-Risperidone), Apotex Inc. (Apo-Risperidone, Apo-Risperidone Oral Liquid), Jamp Pharma Corporation (Jamp-Risperidone), Marcan Pharmaceuticals Inc. (Mar-Risperidone), Mylan Pharmaceuticals ULC (Mylan-Risperidone), Pharmascience Inc. (pms-Risperidone, PMS-Risperidone ODT), Pro Doc Limitée (Pro-Risperidone), Laboratoire Riva Inc. (Riva-Risperidone), Sandoz Canada Inc. (Sandoz Risperidone), Sanis Health Inc. (Risperidone), Sivem Pharmaceuticals ULC (Risperidone), Sun Pharma Canada Inc. (Taro-Risperidone), and Teva Canada Limited (Teva-Risperidone).
• Registration status in Canada: Approved by Health Canada. Multiple DINs exist for the brand and generic products. Risperdal 1 mg (DIN 02025280), 2 mg (DIN 02025299), 3 mg (DIN 02025302), and 4 mg (DIN 02025310) are marketed. Generic risperidone tablets are available under numerous DINs, including 02279800 (Sandoz Risperidone 1 mg), 02279819 (Sandoz Risperidone 2 mg), 02279827 (Sandoz Risperidone 3 mg), 02279835 (Sandoz Risperidone 4 mg), 02279266 (pms-Risperidone), 02356899 (Sanis Risperidone 1 mg), 02356929 (Sanis Risperidone 3 mg), 02356937 (Sanis Risperidone 4 mg), 02533936 (Risperidone, Sivem, 1 mg, marketed since 2023-11-09), 02563347 (Jamp Risperidone Tablets, approved 2025-12-02), 02282143 (Apo-Risperidone), 02264196 (Teva-Risperidone), and 02283638 (Riva-Risperidone). Orally disintegrating tablets are available under DINs 02370697 (pms-Risperidone ODT 3 mg) and 02370700 (pms-Risperidone ODT 4 mg). The oral solution is available under DIN 02236950 (Risperdal Oral Solution) and DIN 02280396 (Apo-Risperidone Oral Liquid).
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Risperdal exactly as your doctor prescribes. The dose depends on what is being treated and how you respond. For schizophrenia in adults, the recommended starting dose is 1 mg to 2 mg per day, given once or twice daily. Your doctor may increase the dose gradually over several days to a target of 4 mg to 6 mg per day. Some patients may need higher doses, but doses above 6 mg per day have not been shown to be more effective and may cause more side effects. For acute manic episodes in bipolar disorder, the usual starting dose is 2 mg to 3 mg per day, given once daily. The dose may be adjusted by 1 mg per day every 24 hours, up to a maximum of 6 mg per day. For irritability associated with autism in children and adolescents, the dose is based on body weight. For children weighing less than 20 kg, the starting dose is 0.25 mg per day, with a target of 0.5 mg per day. For those weighing 20 kg or more, the starting dose is 0.5 mg per day, with a target of 1 mg per day. Take the tablet with or without food. Swallow it whole with water. If you are using the orally disintegrating tablet, peel back the foil and place it on your tongue; it will dissolve within seconds. Do not push it through the foil. If you are using the oral solution, measure your dose with the syringe or cup provided. Do not use a household spoon. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once. Do not stop taking Risperdal suddenly without talking to your doctor. Tapering is usually recommended to avoid withdrawal symptoms such as insomnia, agitation, and nausea.

Precautions

Risperdal carries a boxed warning about increased mortality in elderly patients with dementia-related psychosis. Antipsychotic drugs, including risperidone, increase the risk of death in this population, mostly from cardiovascular causes or infections like pneumonia. Risperdal is not approved for treating dementia-related psychosis and should not be used for that purpose. Neuroleptic malignant syndrome (NMS) is a rare but life-threatening reaction that has been reported with risperidone. It causes high fever, severe muscle rigidity, confusion, and autonomic instability. Stop the medication and seek emergency care if these symptoms occur. Tardive dyskinesia is another serious concern. It causes involuntary, repetitive movements of the tongue, lips, face, and sometimes the limbs. The risk increases with longer treatment and higher total doses, and it can be irreversible. Risperidone can cause orthostatic hypotension, a drop in blood pressure when standing up, leading to dizziness and falls. This is more common early in treatment and in elderly or debilitated patients. Move slowly when getting up from a sitting or lying position. The medication can cause drowsiness, so do not drive or operate machinery until you know how it affects you. Risperidone can cause metabolic changes, including weight gain, high blood sugar, and high cholesterol. Your doctor should check your weight, blood sugar, and lipid levels before you start and periodically during treatment. Risperidone can increase prolactin levels, which may cause breast enlargement, milk production, and menstrual irregularities. It can also cause a condition called priapism, a prolonged and painful erection that requires emergency medical attention. Risperidone can cause a serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), which involves a rash, fever, swollen lymph nodes, and organ inflammation. If you develop a rash with fever, stop the medication and seek medical attention. Risperidone may cause a condition called tardive dyskinesia, and the risk is higher in older adults, especially women. Tell your doctor if you have a history of seizures, heart disease, liver disease, kidney disease, or Parkinson's disease. Risperidone is not recommended during pregnancy unless the benefit clearly outweighs the risk. It can cause extrapyramidal and/or withdrawal symptoms in a newborn if used in the third trimester. It passes into breast milk, so breastfeeding is not recommended during treatment. Women who could become pregnant should discuss the risks with their doctor. Risperidone should not be used in children under 5 years of age for autism-related irritability. Older adults may be more sensitive to the side effects of risperidone and may need lower doses. Tell your doctor if you have liver or kidney problems, as dose adjustments may be needed.

Contraindications

Do not take Risperdal if you have had an allergic reaction to risperidone or any of the inactive ingredients in the tablet, oral solution, or orally disintegrating tablet. Risperdal is contraindicated in patients with a known hypersensitivity to paliperidone, which is the active metabolite of risperidone. The medication should not be used in elderly patients with dementia-related psychosis, because of the increased risk of death. Risperdal is not recommended during pregnancy or breastfeeding unless specifically directed by a doctor. The safety and effectiveness of risperidone in children under 5 years of age for autism-related irritability have not been established. Do not take risperidone if you have severe liver or kidney impairment without close medical supervision and dose adjustment. If you are unsure whether any of these apply to you, check with your doctor or pharmacist.

Possible Side Effects

In clinical trials, the most common side effects in adults with schizophrenia were parkinsonism (tremor, stiffness, slow movement), drowsiness, and headache. Other common side effects include insomnia, agitation, anxiety, nausea, vomiting, constipation, diarrhea, and weight gain. In children and adolescents with autism, the most common side effects were drowsiness, increased appetite, fatigue, and nasal congestion. In elderly patients with dementia, the most common side effects were falls, drowsiness, and urinary tract infection. These effects are often most noticeable when starting treatment or increasing the dose, and they may fade as your body adjusts. Serious side effects require immediate medical attention. Neuroleptic malignant syndrome presents with high fever, severe muscle rigidity, confusion, and autonomic instability. Tardive dyskinesia causes involuntary movements of the face, tongue, or limbs. Orthostatic hypotension can cause fainting. Priapism, a prolonged erection, is a medical emergency. Metabolic changes such as high blood sugar and high cholesterol can develop gradually and may not cause symptoms at first. Severe skin reactions such as DRESS syndrome can cause fever, rash, swollen lymph nodes, and organ inflammation. Increased prolactin levels can cause breast enlargement, milk production, and menstrual irregularities. If you develop any of these serious effects, stop the medication and seek medical help right away.

Drug Interaction

Risperidone is metabolized mainly by the liver enzyme CYP2D6, with a lesser contribution from CYP3A4. Drugs that inhibit CYP2D6 can increase risperidone levels and the risk of side effects. Strong CYP2D6 inhibitors include fluoxetine, paroxetine, and quinidine. If you take one of these, your doctor may need to adjust your risperidone dose. Drugs that induce CYP3A4, such as carbamazepine, rifampin, phenytoin, and phenobarbital, can decrease risperidone levels and make it less effective. If you start or stop one of these medications, your doctor may need to adjust your risperidone dose. Risperidone can add to the blood pressure-lowering effects of antihypertensive medications, potentially requiring a dose adjustment. It can also add to the sedative effects of alcohol, benzodiazepines, opioids, and other central nervous system depressants. Risperidone can counteract the effects of dopamine agonists, such as levodopa, which are used for Parkinson's disease. Fluoxetine, a strong CYP2D6 inhibitor, can increase risperidone levels and the risk of side effects. Paroxetine, another strong CYP2D6 inhibitor, can also increase risperidone levels. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of Risperdal, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Missing doses can increase the risk of symptom relapse, so try to take the medication at the same times each day.

Overdose

Overdose with Risperdal can cause severe drowsiness, fast heart rate, low blood pressure, and extrapyramidal symptoms such as muscle stiffness or tremors. In severe cases, it can cause QT prolongation, dangerous arrhythmias, and coma. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of heart rhythm and vital signs. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Risperdal tablets and orally disintegrating tablets at room temperature between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. For orally disintegrating tablets, keep them in the original blister pack until use. Peel back the foil and place the tablet on your tongue; it will dissolve within seconds. Do not push it through the foil. Store the oral solution at room temperature. Do not freeze. Keep all forms of risperidone out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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