Risperidone Depot: Uses, Side Effects and Dosage

Serious Warnings and Precautions

Increased Risk of Death in Elderly People with Dementia.

Medicines like Risperidone Depot can raise the risk of death in elderly people who have dementia. Risperidone Depot is not approved for use in patients with dementia.

What is Risperidone Depot used for?

Risperidone Depot given by your healthcare professional and is used in adults to treat the symptoms of schizophrenia and related psychotic disorders, as well as those of bipolar disorder.

Not all people with these disorders have the same symptoms.

Some of the most common symptoms of schizophrenia and related psychotic disorders may include:

• hallucinations (seeing, feeling, hearing, or smelling things that are not there)
• delusions (believing things that are not true)
• paranoia (not trusting others and feeling very suspicious)
• avoiding family and friends and wanting to be alone
• feeling depressed, anxious or tense

Some of the most common symptoms of bipolar mania may include:

• mania (being very over-active and over-excited, feeling invincible and powerful, having racing thoughts and overreaction, talking too loudly, quickly or more than usual, having poor judgment)
• depression (feeling sad, hopeless, helpless, tired, or sleeping a lot or not enough)

How does Risperidone Depot work?

Risperidone Depot belongs to a group of medicines called antipsychotic drugs. Antipsychotic medications affect dopamine and serotonin (chemicals found in the brain) that allow for the communication between your nerve cells. Exactly how this medication works is not known. However, it seems that Risperidone Depot corrects the balance of dopamine and serotonin in your body.

What are the ingredients in Risperidone Depot?

Medicinal ingredients: risperidone

Non-medicinal ingredients:

Risperidone is micro-encapsulated in polylactide-co-glycolide. The diluent contains polysorbate 20, sodium carboxymethylcellulose, disodium hydrogen phosphate dihydrate, citric acid anhydrous, sodium chloride, sodium hydroxide, and water for injection.

Risperidone Depot comes in the following dosage forms:

A combination of the prolonged-release powder and diluent: powder for injection is available in 12.5 mg, 25 mg, 37.5 mg or 50 mg risperidone per vial, and a prefilled syringe containing 2 mL of diluent.

Do not use Risperidone Depot if:

• you or the person you are caring for has had an allergic reaction to:

  • risperidone
  • paliperidone (this is a compound resulting from the breakdown of risperidone in the body) or
  • any of the other ingredients in Risperidone Depot

Signs of an allergic reaction include:

• itching
• skin rash
• swelling of the face, lips or tongue
• shortness of breath

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Risperidone Depot. Talk about any health conditions or problems you may have, including if you:

• are taking or planning to take any other medication (prescription, over-the-counter and natural health products)

  • are taking paliperidone
• have had serious allergic reactions to other medications, including oral risperidone or oral paliperidone. Even if you have not had a reaction to oral risperidone or oral paliperidone before, it can occur very rarely after receiving injections of Risperidone Depot

• have a history of:

  • stroke
  • mini-stroke
  • high cholesterol or
  • high blood pressure

Medicines like Risperidone Depot can raise the risk of stroke/mini-stroke in elderly people who have dementia.

• have or are at risk for diabetes or high blood sugar or a family history of diabetes

• are pregnant, think you may be pregnant or planning to become pregnant

• are breast-feeding or planning to breast-feed. Risperidone Depot can pass into your breast milk. You should not breast-feed while taking this medication and for at least 12 weeks after the last injection.
• have or have had prolonged and/or painful erection

• have a history of:

  • heart problems
  • any problems with the way your heart beats
  • congenital long QT syndrome
• are being treated for high blood pressure
• are taking any medications that affect how your heart beats
• are prone to hypotension (low blood pressure), have or have had heart disease treatment that makes you more likely to have low blood pressure or feeling dizzy or faint when you stand up from lying or sitting positions
• have or have ever had blackouts or seizures
• have or have had low white blood cell counts in your blood. Let your doctor know right away if you develop a fever or infection while being treated with Risperidone Depot
• have high levels of cholesterol or fats (triglycerides) in your blood

• have or have a history of, or are at risk of:

  • sleep apnea (a sleep disorder where your breathing is interrupted during sleep)
  • sleep walking
  • sleep-related eating disorder
• have Parkinson’s disease or dementia with Lewy bodies (DLB)
• have / had breast cancer
• have pituitary tumours

• drink alcoholic beverages or use drugs

• have a history of kidney problems
• have liver problems
• suffer from Alzheimer’s disease
• are feeling thirsty and unwell
• exercise strenuously. This kind of medication may interfere with your body’s ability to adjust to heat. You should avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking Risperidone Depot.

• are at risk for developing blood clots. Risk factors include:

  • a family history of blood clots
  • being over the age of 65
  • smoking
  • being overweight
  • having a recent major surgery (such as hip or knee replacement)
  • not being able to move due to air travel or other reasons
  • taking oral birth control (“The Pill”)

• are planning to have an operation on the eye(s). During surgery to treat the cloudiness of the lens in your eye(s) (known as cataract surgery):

  • the pupil (the black circle in the middle of your eye) may not increase in size as needed
  • the iris (the coloured part of the eye) may become floppy during surgery. This may lead to eye damage.

Tell your eye doctor you are taking this medicine.

Other warnings you should know about:

Elderly Patients with Dementia: Studies have shown that when risperidone is taken by itself or taken together with furosemide (a “water pill”) by elderly patients who have dementia, it is linked to a higher rate of death.

• Tell your doctor if you are taking furosemide. This drug can be used to treat:

  • swelling of parts of the body caused by the buildup of too much fluid
  • some heart problems
  • high blood pressure

In elderly patients with dementia, oral risperidone and other drugs that belong to the same group of drugs as Risperidone Depot have also been linked to side effects that include:

• a sudden change in mental state
• sudden weakness or numbness of the face, arms or legs, especially on one side of the body
• slurred speech
• vision problems

If you have any of these symptoms, get medical help right away.

Dysphagia: Tell your doctor if you have difficulty swallowing food or have esophageal dysmotility (problems with your food pipe) as there is a risk of pneumonia caused by inhaling food or liquid that gets into your lungs.

Effects on newborns: You should not take Risperidone Depot while you are pregnant or if you are planning on becoming pregnant unless you have talked to your doctor about it.

If you took Risperidone Depot at any time while you were pregnant or if you took it before you became pregnant, the following symptoms may happen in your newborn baby:

• shaking
• stiffness in their muscles and/or weakness
• sleepiness
• agitation
• breathing problems
• difficulty feeding

Get medical help right away if your newborn baby has any of these symptoms.

In some cases, babies born to a mother who took risperidone while she was pregnant have had to be hospitalized after experiencing symptoms that were severe.

Driving and using machines: Do not drive or operate machinery until you know how you respond to Risperidone Depot. Some people experience drowsiness or blurred vision while taking Risperidone Depot.

Falls: Feeling sleepy, a fall in blood pressure when you stand up from sitting or lying down, vision and speech problems have been reported with the use of antipsychotic drugs. This can lead to falls that may cause fractures or other fall-related injuries. Certain medications, diseases or conditions can make this worse.

Weight gain: Weight gain has been seen in patients who are taking antipsychotic drugs. Your doctor may monitor your body weight when you are taking Risperidone Depot.

Blood tests: Your doctor should do blood tests before you start taking Risperidone Depot. They will check your blood sugar levels, and for those with certain risk factors, the level of white blood cells in your blood. Your doctor should continue to do blood tests for as long as you are being treated with Risperidone Depot.

The following serious or life-threatening side effects have been reported with the use of risperidone:

• Neuroleptic Malignant Syndrome (NMS):

  • mental changes such as agitation, hallucinations, confusion, or other changes in mental status
  • coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes)
  • restlessness
  • racing or fast heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • stiff muscles

• Severe Skin Reactions: In very rare cases, skin reactions that can be serious or life- threatening have been reported. This includes skin conditions such as Stevens- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). The following symptoms may be related to these skin reactions:

  • Early warnings for patients:

    • fever
    • severe rash
    • swollen lymph glands
    • flu-like feeling
    • blisters and peeling skin that may start in and around the mouth, nose, eyes, and genitals and spread to other areas of the body

  • Later developments:

    • yellow skin or eyes
    • shortness of breath
    • dry cough
    • chest pain or discomfort
    • feeling thirsty
    • urinating less often, less urine

Call your doctor right away if you start to have any of the following symptoms while taking Risperidone Depot.

Tardive Dyskinesia (TD): Risperidone Depot, like other antipsychotic medications, can cause potentially irreversible muscle twitching or unusual/abnormal movement of the face or tongue or other parts of your body.

Increased levels of prolactin: Risperidone Depot can raise your levels of a hormone called “prolactin”. This is measured with a blood test. Symptoms may include:

• In men:

  • swelling in the breast
  • difficulty in getting or maintaining an erection or other sexual dysfunction

• In women:

  • discomfort in the breasts
  • leaking of milk from the breasts (even if not pregnant)
  • missing your menstrual period or other problems with your cycle

If you have high levels of prolactin and a condition called hypogonadism, you may be at an increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

Tell your healthcare professional about all the medications you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. Some medicines, when they are taken together with risperidone, may increase or decrease the level of risperidone in your blood and your doctor may need to change the dose.

The following may interact with Risperidone Depot:

• DO NOT drink alcohol and only take medications prescribed by your doctor. Since Risperidone Depot works primarily in the brain, interference with other drugs that also work in the brain could occur.
• Dopamine agonists, e.g., levodopa (a drug used to treat Parkinson’s disease), as these may decrease the effect of Risperidone Depot. Also Risperidone Depot can affect how drugs used to treat Parkinson’s disease work.
• Phenothiazines and some heart medications (e.g., medication for high blood pressure, antiarrhythmics, or beta-blockers), as these may interact with Risperidone Depot to cause your blood pressure to drop too low.
• Risperidone Depot should be used with caution when taking medications that may change the electrical activity of the heart (QT prolongation), such as but not restricted to: medicines for malaria, heart rhythm disorders, allergies, other antipsychotics, antidepressants, water tablets or other medicines affecting body salts (sodium, potassium, magnesium).
• Carbamazepine and topiramate (drugs used to treat seizures), as these may change the effect of Risperidone Depot.
• PROZAC (fluoxetine), PAXIL (paroxetine) (antidepressants) and CLOZARIL (clozapine) (antipsychotic), as these may increase the level of Risperidone Depot in your blood.
• LASIX (furosemide): Studies in elderly patients with dementia have shown that taking risperidone along with furosemide, a medicine which is sometimes used to treat high blood pressure, some heart problems, or to treat swelling of parts of the body caused by the build-up of too much fluid, is associated with an increased rate of death.
• Itraconazole and ketoconazole, medicines for treating fungal infections.
• Certain medicines used in the treatment of HIV/AIDS, such as NORVIR (ritonavir).
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.
• Rifampicin, a medicine for treating some infections.

• Risperidone Depot should be used with caution with medicines that increase the activity of

  • the central nervous system (psychostimulants such as methylphenidate).

How Risperidone Depot is given:

Risperidone Depot is a long-acting medicine. It will be given to you:

• by your healthcare professional
• as an injection into your muscle (intramuscularly) located on the uppermost part of your arm, or in the upper outer side of your buttocks

If you have never taken Risperidone Depot or risperidone before:

• your doctor will need to make sure you can tolerate the medicine. You will be given the pill form of risperidone to be taken orally (by mouth) everyday for a few days before starting Risperidone Depot. Your oral medication may continue for a few weeks after you start Risperidone Depot.

It is important not to miss your scheduled dose. If you cannot keep your appointment with the doctor, make sure you call him/her right away so another appointment can be made as soon as possible.

Usual adult dose:

Every 2 weeks: 25 mg – 50 mg (given in your upper arm or buttocks) For some patients, a lower dose of 12.5 mg may be given.

The doctor has decided on the best dosage for you. Your dose may be increased or decreased depending on:

• other health conditions you may have
• how you respond to the medication

Overdose:

Patients who have been given too much risperidone may experience the following symptoms:

• reduced consciousness
• sleepiness
• excessive trembling
• excessive muscle stiffness
• fast beating heart
• irregular heartbeat or other symptoms of an irregular heartbeat, such as lightheadedness or fainting
• dizziness or lightheadedness when standing up

Cases of abnormal electrical conduction in the heart (QT prolongation) and seizures (fits) have been reported.

Missed Dose:

It is important not to miss your scheduled dose.

If you cannot keep your appointment with the doctor, make sure you call him/her right away so another appointment can be made as soon as possible. Your doctor will decide what you should do next.

If you stop coming for your injections, your symptoms may return. You should not stop this medicine unless told to do so by your doctor.

What are possible side effects from using Risperidone Depot?

These are not all the possible side effects you may feel when taking Risperidone Depot. If you experience any side effects not listed here, contact your healthcare professional.

Side effects include:

• common cold symptoms
• trouble falling or staying asleep
• depression
• anxiety
• tremor (shaking)
• increased saliva
• drooling
• headache
• pneumonia
• urinary tract infection
• feeling like you have the flu
• fever (let your doctor know right away if you develop a fever or infection while on this medication)
• anemia
• feeling restlessness
• being over-active and over-excited, sometimes with delusions (believing things that are not true) or hallucinations (seeing, feeling, hearing or smelling things that are not there)
• weight loss
• uncontrollable movements of the face or body, rigid muscles
• slowness of movement and muscle stiffness or spasm
• blurred vision
• faster heart rate
• low blood pressure (sudden dizziness or lightheadedness may occur if you rise rapidly after having been sitting or lying for a long time)
• high blood pressure
• stomach ache
• nausea and vomiting
• constipation
• diarrhea
• indigestion
• dry mouth
• loss of urine
• swelling of the body, arms or legs
• lack of energy
• fatigue
• injection site pain, itchiness or swelling

• low blood sugar, diabetes or worsening of diabetes

  • high blood sugar has been reported; see your doctor if you experience symptoms such as excessive thirst or urination
• high levels of cholesterol or fats (triglycerides) in the blood
• concentration difficulties
• nervousness
• itching
• swelling of joints or ankles
• heartbeat irregularities
• changes in body temperature
• lack of bowel muscle movement that causes blockage (may occur very rarely)

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store Risperidone Depot:

• In the refrigerator between 2°C–8°C in its original package, protected from light.
• If refrigeration is not available, store at temperatures not exceeding 25°C and protected from light for no more than 7 days. Do not expose unrefrigerated product to temperatures above 25°C.

Keep out of reach and sight of children.

The expiry date for Risperidone Depot is printed on the package. Do not use the medicine after this date.

If you want more information about Risperidone Depot:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website (www.sterimaxinc.com), or by calling SteriMax Inc. at: 1-800-881-3550.

Last Revised: 2026-10-20