Risperidone Side Effects

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Answer the side-effect intent for risperidone without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

Part of mental health medication side effects side effects.

What is risperidone?

Risperidone contains the active ingredient Risperidone.

• Active ingredient — Risperidone
• Registration holder — Innovata Pharmaceuticals (Pty) Ltd

It is approved for:

• RISTABBS is a so-called antipsychotic
• The active ingredient in RISTABBS is risperidone
• RISTABBS is indicated for the treatment of: Acute and chronic schizophrenic psychoses (mental health problems) and related psychosis in which positive symptoms (such as seeing things that are not there, false beliefs, thought disturbances, hostility, suspiciousness) and/or the negative symptoms (such as difficulty in expressing emotions, emotional and social withdrawal, poor speech) are prominent
• RISTABBS also relieves affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia

Common side effects of risperidone

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Difficulty falling or staying asleep
• Parkinsonism: This condition may include slow or impaired movement, sensation of stiffness or tightness of the muscles (making your movements jerky), and sometimes even a sensation of movement “freezing up” and then restarting. Other signs of parkinsonism include a slow shuffling walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression on the face
• Feeling sleepy, or less alert
• Headache
• Pneumonia, infection of the chest (bronchitis), common cold symptoms, sinus infection, urinary tract infection, ear infection, feeling like you have the flu
• RISTABBS can raise your levels of a hormone called “prolactin” found on a blood test (which may or may not cause symptoms). When symptoms of high prolactin occur, they may include in men breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction. In women they may include breast discomfort, leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle
• Weight gain, increased appetite, increased or decreased appetite
• Sleep disorder, irritability, depression, anxiety, restlessness
• Dystonia: This is a condition involving slow or sustained involuntary contraction of muscles. While it can involve any part of the body (and may result in abnormal posture), dystonia often involves muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw
• Dizziness
• Dyskinesia: This is a condition involving involuntary muscle movements, and can include repetitive, spastic or writhing movements, or twitching
• Tremor (shaking)
• Blurry vision, eye infection or “pink eye”
• Rapid heart rate, high blood pressure, shortness of breath
• Sore throat, cough, nosebleeds, stuffy nose
• Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth, toothache
• Rash, skin redness
• Muscle spasms, bone or muscle ache, back pain, joint pain
• Incontinence (lack of control) of urine
• Swelling of the body, arms or legs, fever, chest discomfort, weakness, fatigue (tiredness), pain
• Fall

Less frequent side effects

• Infection of the breathing passages, bladder infection, eye infection, tonsillitis, fungal infection of the nails, infection of the skin, an infection confined to a single area of skin or part of the body, viral infection, skin inflammation caused by mites
• Decrease in the type of white blood cells that help to protect you against infection, white blood cell count decreased, decrease in platelets (blood cells that help you stop bleeding), anaemia, decrease in red blood cells, increase in eosinophils (a type of white blood cell) in your blood
• Allergic reaction
• Diabetes or worsening of diabetes, high blood sugar, excessive drinking of water
• Weight loss, loss of appetite resulting in malnutrition and low body weight
• Increased cholesterol in your blood
• Elated mood (mania), confusion, decreased sexual drive, nightmares
• Tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
• Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of RISTABBS may be needed
• Sudden loss of blood supply to brain (stroke or “mini” stroke)
• Unresponsive to stimuli, loss of consciousness, low level of consciousness
• Convulsion (fits), Fainting
• A restless urge to move parts of your body, balance disorder, abnormal coordination, dizziness upon standing, disturbance in attention, problems with speech, loss or abnormal sense of taste, reduced sensation of skin to pain and touch, a sensation of tingling, pricking, or numbness of skin
• Oversensitivity of the eyes to light, dry eye, increased tears, redness of the eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (an abnormal heart rhythm), an interruption in conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval from your heart, slow heart rate, abnormal electrical tracing of the heart (electrocardiogram or ECG), a fluttering or pounding feeling in your chest (palpitations)
• Low blood pressure, low blood pressure upon standing (consequently, some people taking RISTABBS may feel faint, dizzy, or may pass out when they stand or sit up suddenly, flushing
• Pneumonia caused by inhaling food, lung congestion, congestion of breathing passages, crackly lung sounds, wheezing, voice disorder, breathing passage disorder
• Stomach or intestinal infection, stool incontinence, very hard stool, difficulty swallowing, excessive passing of gas or wind
• Hives (or “nettle rash”), itching, hair loss, thickening of skin, eczema, dry skin, skin discolouration, acne, dandruff, skin disorder, skin lesion
• An increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes released with muscle breakdown
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent passing of urine, inability to pass urine, pain when passing urine
• Erectile dysfunction, ejaculation disorder
• Loss of menstrual periods, missed menstrual periods or other problems with your cycle (females)
• Development of breasts in men, leakage of milk from the breasts, sexual dysfunction, breast discomfort, vaginal discharge
• Swelling of the face, mouth, eyes, or lips
• Chills, an increase in body temperature
• A change in the way you walk
• Feeling thirsty, feeling unwell, feeling “out of sorts”, discomfort
• Increased liver transaminases in your blood, Increased GGT (a liver enzyme called gamma-glutamyltransferase) in your blood, Increased liver enzymes in your blood
• Procedural pain
• Infection
• Inappropriate secretion of a hormone that controls urine volume
• Sugar in the urine, Low blood sugar, High blood triglycerides (a fat)
• Lack of emotion, inability to reach orgasm
• Neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness)
• Blood vessel problems in the brain
• Coma due to uncontrolled diabetes
• Shaking of the head
• Glaucoma (increased pressure within the eyeball), problems with movement of your eyes, eye rolling, eyelid margin crusting
• Irregular heartbeat
• Blood clot in the legs, blood clot in the lungs
• Trouble breathing during sleep (sleep apnoea), fast, shallow breathing
• Inflammation of the pancreas, a blockage in the bowels
• Swollen tongue, chapped lips, rash on skin related to drug
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
• A delay in menstrual periods, enlargement of the glands in your breasts, breast enlargement, discharge from the breasts
• Decreased body temperature, coldness in arms and legs
• Symptoms of drug withdrawal
• Yellowing of the skin and the eyes (jaundice)
• Life threatening complications of uncontrolled diabetes
• Serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing
• Lack of bowel muscle movement that causes blockage
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken RISTABBS. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken RISTABBS
• Dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood
• Severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure
• Dangerously excessive intake of water
• Increased insulin (a hormone that controls blood sugar levels) in your blood
• Rapid heartbeat upon standing
• Priapism (a prolonged penile erection that may require surgical treatment)
• Hardening of the skin

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are allergic (hypersensitive) to risperidone, or any of the other ingredients of RISTABBS listed in section 6. Allergy can be recognised for instance by skin rash, itching, shortness of breath or swollen face. If any of these occur, contact your doctor right away
• Do not give RISTABBS to children under 5 years of age with conduct and other disruptive behaviours
• Do not take RISTABBS if you have Parkinson’s disease or Lewy Body Dementia

Use with care, and tell your doctor, if

• You have a heart problem. Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure. RISTABBS can cause low blood pressure. Your dose needs to be adjusted
• You know of any factors which would increase your chance of you having a stroke, such as high blood pressure, or blood vessels problems in the brain
• You have experienced uncontrolled movements of the tongue, mouth and face
• You have ever had a condition whose symptoms include high temperature, muscle stiffness, sweating or a lower level of consciousness (also known as Neuroleptic Malignant Syndrome)
• You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines). Your doctor may check your white blood cell counts
• You are diabetic
• You have epilepsy
• You are a man and you have ever had a prolonged or painful erection
• You have problems controlling your body temperature or overheating
• You have kidney problems
• You have liver problems
• You have abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour
• You or someone else in your family has a history of blood clots. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using RISTABBS. RISTABBS can cause you to gain weight. Significant weight gain can adversely affect your health. Your doctor should regularly measure your body weight. As diabetes mellitus or worsening of pre-existing diabetes mellitus has been seen in patients taking RISTABBS, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus, blood glucose should be monitored regularly. RISTABBS commonly raises levels of a hormone called “prolactin”. This may cause side effects such as menstrual disorders or fertility problems in women, breast swelling in men. If such side effects occur, evaluation of the prolactin level in blood is recommended. During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery and that may lead to eye damage. If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking RISTABBS. Elderly people with dementia In elderly patients with dementia, there is an increased risk of stroke. You should not take RISTABBS if you have dementia caused by stroke. During treatment with RISTABBS you should frequently see your doctor. Medical treatment should be sought straight away if your care-giver notices a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time. . Tell your doctor if you are taking furosemide. Furosemide is 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. Children and adolescents:
• Children and adolescents under 15 years should not be treated with RISTABBS for schizophrenia or mania
• Before treatment is started for conduct disorder, other causes of aggressive behaviour should have been ruled out
• If during treatment with RISTABBS tiredness occurs, a change in the time of administration might improve attention difficulties
• Before treatment is started your, or your child’s body weight may be measured and it may be regularly monitored during treatment
• For the treatment of conduct disorder, the doctor’s will prescribe the suitable dose and treatment duration according to the patient’s weight. Children under 5 years should not be treated with RISTABBS for conduct disorder
• A small and inconclusive study has reported an increase in height in children who took RISTABBS, but whether this is an effect of the drug or due to some other reason is not known

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine
• Your doctor will decide if you can take RISTABBS during pregnancy
• Shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding, have been observed in new-borns, if a mother used RISTABBS in the last trimester of her pregnancy
• Breastfeeding You should not breastfeed your baby whilst taking RISTABBS

Interactions and medicines to check

The approved leaflet names these interactions.

• RISTABBS can enhance the effect of alcohol and medicines that reduce the ability to react (e.g., “tranquilisers”, narcotic painkillers, certain antihistamines, certain antidepressants). So, do not drink alcohol and only take such medicines if your doctor prescribes them
• Some medicines for treating Parkinson’s disease (dopamine agonists, e.g., levodopa) may counteract RISTABBS
• If you are taking medicines for high blood pressure, consult your doctor, as taking these medicines together with RISTABBS may cause the blood pressure to drop too low
• RISTABBS should be used with caution when taking medications that may change the electrical activity of the heart, 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, a medicine mainly used for epilepsy or trigeminal neuralgia (severe pain attacks in the face), may change the effect of RISTABBS. Therefore, inform your doctor if you start or stop taking carbamazepine
• Fluoxetine and paroxetine, medicines mainly used to treat depression and various anxiety disorders, may increase the level of RISTABBS in your blood. Therefore, tell your doctor if you start and/or stop taking fluoxetine or paroxetine
• Cimetidine and ranitidine, two medicines used to reduce stomach acid, may slightly increase the level of RISTABBS in your blood, but they are unlikely to change the effect of RISTABBS
• Erythromycin, an antibiotic, does not have an effect on level of RISTABBS in the blood
• Topiramate, a medicine used to treat epilepsy, does not have a significant effect on the level of RISTABBS in the blood
• Galantamine and donepezil, medicines used to treat dementia, do not have an effect on RISTABBS
• RISTABBS does not show an effect on lithium or valproate, two medicines used to treat mania, or on digoxin, a heart medication
• Taking RISTABBS with furosemide, a medicine used to treat conditions such as heart failure and hypertension, may be associated with harmful effects. Tell your doctor if you are taking furosemide. RISTABBS with food, drink, and alcohol: You can take RISTABBS with or without food. You should avoid drinking alcohol when taking RISTABBS

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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