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The following information is not a substitute for the knowledge and judgement of a healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Always consult with your doctor, nurse, or pharmacist before taking medication.

Risperidone Side Effects

In Summary

Commonly reported side effects of risperidone include: agitation, akathisia, anxiety, constipation, dizziness, drowsiness, dystonia, extrapyramidal reaction, nausea, rhinitis, and weight gain. Other side effects include: abdominal pain, sialorrhea, skin rash, tachycardia, and xeroderma. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to risperidone: oral solution, oral tablet, oral tablet disintegrating

Other dosage forms:

As well as its needed effects, risperidone may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking risperidone, check with your doctor immediately:

More common: Less common: Rare

Minor Side Effects

Some risperidone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common: Less common:

For Healthcare Professionals

Applies to risperidone: intramuscular powder for injection extended release, oral solution, oral tablet, oral tablet disintegrating

Nervous system

Very common (10% or more): Sedation (up to 63%), parkinsonism (up to 28%), akathisia (up to 10%), dizziness, (up to 14%), tremor (up to 11%), drooling (up to 12%), headache (up to 12%)
Common (1% to 10%): Dystonia, dyskinesia, gait disturbance
Uncommon (0.1% to 1%): Syncope
Rare (less than 0.1%): Tardive dyskinesia, cerebral ischemia, unresponsive to stimuli, depressed or loss of consciousness, psychomotor hyperactivity, balance disorder, abnormal coordination, attention disturbance
Very rare (less than 0.01%): Neuroleptic malignant syndrome, cerebrovascular disorder, head titubation
Frequency not reported: Vertigo, dysarthria, movement disorder, cerebrovascular accident, speech disorder, hypoesthesia, convulsion, paresthesia
Postmarketing reports: Dysgeusia

Parkinsonism includes extrapyramidal disorder, musculoskeletal stiffness, parkinsonism, cogwheel rigidity, akinesia, bradykinesia, hypokinesia, masked facies, muscle rigidity, and Parkinson's disease. Akathisia includes akathisia and restlessness. Dystonia includes muscle spasms, involuntary muscle contractions, muscle contracture, oculogyration, tongue paralysis. Tremor includes parkinsonian rest tremor.

In randomized placebo-controlled trials in elderly patients with dementia-related psychosis, cerebrovascular adverse events occurred more frequently in patients treated with atypical antipsychotics than those receiving placebo. Pooled data from 6 trials mainly in elderly patients older than 65 years showed that cerebrovascular events occurred in 3.3% (33 of 1009) of patients treated with risperidone compared with 1.2% (8 of 712) of placebo-treated patients. The mechanism for this risk is unknown. The risk for a cerebrovascular event was significantly higher in patients with mixed or vascular type dementia compared with Alzheimer's dementia.


Common (1% to 10%): Tachycardia, palpitations, orthostatic hypotension, hypotension
hypertension, peripheral edema, chest pain
Uncommon (0.1% to 1%): ECG QT prolonged, bundle branch block right, flushing
Frequency not reported: bradycardia, atrioventricular block, bundle branch block left, abnormal ECG
Postmarketing reports: Atrial fibrillation, deep vein thrombosis, cardiopulmonary arrest

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including risperidone, for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug- treated patient than in the placebo- treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Similar results (i.e., increased risk of mortality with atypical antipsychotics) were reported in another meta-analysis involving elderly dementia patients that consisted of 15 randomized, placebo-controlled trials (n=3353) of 10 to 12 weeks in duration. Risperidone is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia. However, in contrast, the results of another meta-analysis of 6 randomized, double-blind, placebo-controlled, clinical trials (n=1721) found a nonsignificant increase in overall mortality in elderly dementia patients treated with risperidone.

The results of a large retrospective cohort study appear to indicate that atypical antipsychotic agents (i.e., risperidone, olanzapine, clozapine, quetiapine) increase the risk of venous thromboembolism in elderly patients; however, these events seem to be rare.

Based on data from four placebo controlled trials conducted in elderly patients (n=1230), cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in elderly patients with dementia- related psychosis. In placebo controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. Risperidone has not been shown to be safe or effective in the treatment of patients with dementia- related psychosis. Additional information on these and other clinical trials conducted in elderly patients can be obtained by calling 1-800- JANSSEN (800-526-7736). However, the association between the use of atypical antipsychotics (i.e., risperidone, olanzapine) and the risk of cerebrovascular events appears to be somewhat controversial. The results of a case-control study found no increased risk of cerebrovascular events in elderly patients treated with atypical antipsychotics.


Common (1% to 10%): Hyperprolactinemia
Uncommon (0.1% to 1%): Gynecomastia, galactorrhea, breast pain, breast discomfort
Rare (less than 0.1%): Inappropriate antidiuretic hormone secretion, breast enlargement, breast discharge, breast engorgement
Postmarketing reports: Precocious puberty

Risperidone is associated with higher levels of prolactin elevation than other antipsychotic drugs. Hyperprolactinemia may suppress hypothalamic gonadotropin-releasing hormone (GnRH) resulting in reduced pituitary gonadotropin secretion and in turn inhibit reproductive function by impairing gonadal steroidogenesis. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.


Risperidone is associated with higher levels of prolactin elevation than other antipsychotic drugs. Hyperprolactinemia may suppress hypothalamic gonadotropin-releasing hormone (GnRH) resulting in reduced pituitary gonadotropin secretion and in turn inhibit reproductive function by impairing gonadal steroidogenesis. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

Very common (10% or more): Enuresis (16%)
Common (1% to 10%): Urinary incontinence, urinary tract infection
Uncommon (0.1% to 1%): Amenorrhea, urinary retention, dysuria, pollakiuria, erectile dysfunction, ejaculation disorder, menstrual disorder, sexual dysfunction, vaginal discharge, cystitis
Rare (less than 0.1%): Delayed menstruation,
Frequency not reported: Retrograde ejaculation, ejaculation failure, libido decreased, anorgasmia
Postmarketing reports: Priapism, urinary retention


Very common (10% or more): Nausea (16%), vomiting (20%), constipation (17%), abdominal pain (16%)
Common (1% to 10%): Dyspepsia, dysphagia, dry mouth, salivary hypersecretion, diarrhea, stomach discomfort
Uncommon (0.1% to 1%): Toothache, gastroenteritis, flatulence
Rare (less than 0.1%): Pancreatitis, swollen tongue, cheilitis
Frequency not reported: Aptyalism, fecaloma
Postmarketing reports: Ileus


Uncommon (0.1% to 1%): Increased gamma-glutamyltransferase, hepatic enzyme increases
Rare (less than 0.1%): Jaundice
Frequency not reported: Transaminases increased


Very common (10% or more): Insomnia (32%), anxiety (16%)
Uncommon (0.1% to 1%): Nervousness
Rare (less than 0.1%): Mania, confusional state, nightmare
Very rare (less than 0.01%): Blunted affect
Frequency not reported: Agitation, sleep disorder, listlessness, depression


Common (1% to 10%): Blurred vision, conjunctivitis
Uncommon (0.1% to 1%): Photophobia, dry eye, lacrimation increased,
Rare (less than 0.1%): Glaucoma, eye movement disorder, eyelid margin crusting
Frequency not reported: Ocular hyperemia, eye discharge, eye rolling, eyelid edema, eyelid swelling, visual acuity reduced, eye infection, blepharospasm
Postmarketing reports: Floppy iris syndrome, retinal artery occlusion


Very common (10% or more): Increased appetite (up to 44%),
Common (1% to 10%): Increased weight, decreased appetite
Uncommon (0.1% to 1%): Diabetes mellitus, hyperglycemia, polydipsia, weight decreased, anorexia, increased cholesterol,
Rare (less than 0.1%): Hypoglycemia, increased triglycerides,
Very rare (less than 0.01%): Diabetic coma
Postmarketing reports: Diabetic ketoacidosis, hyperinsulinemia, water intoxication, aggravated diabetes mellitus


Very common (10% or more): Nasopharyngitis (up to 19%), cough (up to 17%), rhinorrhea (up to 12%)
Common (1% to 10%): Upper respiratory tract infection, rhinitis, sinusitis, nasal congestion, dyspnea, pharyngolaryngeal pain
Uncommon (0.1% to 1%): Epistaxis, aspiration pneumonia, pulmonary congestion, rales, wheezing dysphonia, tonsillitis
Rare (less than 0.1%): Hyperventilation
Frequency not reported: Tonsillitis, bronchitis, pharyngitis, nasal edema, pneumonia, pharyngitis, bronchitis, bronchopneumonia
Postmarketing reports: Pulmonary embolism, sleep apnea syndrome


Very common (10% or more): Fatigue (up to 31%), Pyrexia (up to 16%),
Common (1% to 10%): Asthenia, thirst,
Rare (less than 0.1%): Chills,
Very rare (less than 0.01%): Hypothermia, decreased body temperature, peripheral coldness, drug withdrawal syndrome, drug withdrawal in neonate
Frequency not reported: Ear pain, malaise, feeling abnormal, Influenza-like illness, ear infection, otitis media, tinnitus
Postmarketing reports: Sudden death, drug withdrawal syndrome,


Common (1% to 10%): Rash, erythema, dry skin, acne, dandruff
Uncommon (0.1% to 1%): Seborrheic dermatitis, hyperkeratosis, urticaria, pruritus, alopecia, eczema, skin discoloration, skin lesion, skin disorder
Rare (less than 0.1%): Drug eruption
Postmarketing reports: Angioedema


Common (1% to 10%): Back pain, arthralgia, extremity pain, muscle spasms
Uncommon (0.1% to 1%): Myalgia, neck pain, increased creatine phosphokinase, joint stiffness, joint swelling, abnormal posture, muscular weakness
Very rare (less than 0.01%): Rhabdomyolysis


There have been post marketing reports of anaphylactic reaction in patients receiving long-acting injection who had previously tolerated oral risperidone.

Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction


Uncommon (0.1% to 1%): Neutropenia, WBC decreased, thrombocytopenia, anemia, decreased hematocrit, increased eosinophil count
Frequency not reported: Granulocytopenia, decreased hemoglobin,
Postmarketing reports: Agranulocytosis, thrombotic thrombocytopenic purpura


Uncommon (0.1% to 1%): Onychomycosis, acarodermatitis


The most commonly reported adverse reactions included parkinsonism, dizziness, akathisia, anxiety, fatigue, constipation, tremor, sedation, increased appetite, nausea, vomiting, abdominal pain, drooling, insomnia, nasopharyngitis, and nasal congestion.[Ref]


Uncommon (0.1% to 1%): Redness, swelling, induration at injection site
Postmarketing reports: Serious injection site reactions, including abscess, cellulitis, cyst, hematoma, necrosis, nodule, and ulcer


Postmarketing reports: Pituitary adenoma


1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Risperdal Consta (risperidone)." Janssen Pharmaceuticals, Titusville, NJ.

It is possible that some side effects of risperidone may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

More about risperidone

Consumer resources

Other brands: Risperdal, Risperdal Consta, Risperdal M-Tab

Professional resources

Related treatment guides

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.