Risperidone Side Effects

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.

For the Consumer

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

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

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

More common
  • Aggressive behavior
  • agitation
  • anxiety
  • changes in vision, including blurred vision
  • difficulty concentrating
  • difficulty speaking or swallowing
  • inability to move the eyes
  • increase in amount of urine
  • loss of balance control
  • mask-like face
  • memory problems
  • muscle spasms of the face, neck, and back
  • problems with urination
  • restlessness or need to keep moving (severe)
  • shuffling walk
  • skin rash or itching
  • stiffness or weakness of the arms or legs
  • tic-like or twitching movements
  • trembling and shaking of the fingers and hands
  • trouble sleeping
  • twisting body movements
Less common
  • Back pain
  • chest pain
  • speech or vision problems
  • sudden weakness or numbness in the face, arms, or legs
Rare
  • Confusion
  • dizziness
  • drowsiness
  • extreme thirst
  • fast, shallow breathing
  • fast, weak heartbeat
  • headache
  • increased thirst
  • lip smacking or puckering
  • loss of appetite
  • muscle cramps
  • pale, clammy skin
  • poor coordination
  • prolonged, painful, inappropriate erection of the penis
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • shivering
  • talking, feeling, and acting with excitement and activity that cannot be controlled
  • uncontrolled chewing movements
  • uncontrolled twisting movements of neck, trunk, arms, or legs
  • unusual bleeding or bruising
  • unusual facial expressions or body positions

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
  • Constipation
  • cough
  • diarrhea
  • dry mouth
  • headache
  • heartburn
  • increased dream activity
  • increased length of sleep
  • nausea
  • sleepiness or unusual drowsiness
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
  • weight gain
Less common
  • Absent, missed, or irregular menstrual periods
  • body aches or pain
  • breast swelling or soreness
  • chills
  • dandruff
  • darkening of skin color
  • decreased interest in sexual intercourse
  • dry skin
  • ear congestion
  • fever
  • inability to have or keep an erection
  • increase in body movements
  • increased watering of the mouth
  • joint pain
  • loss in sexual ability, desire, drive, or performance
  • loss of voice
  • oily skin
  • pain or tenderness around the eyes and cheekbones
  • shortness of breath or troubled breathing
  • sneezing
  • stomach pain
  • stopping of menstrual bleeding
  • tightness of the chest or wheezing
  • toothache
  • unusual breast milk production
  • vomiting
  • weight loss

For Healthcare Professionals

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

Nervous system

Nervous system side effects have frequently included insomnia (26%), dystonia (18%), akathisia (16%), extrapyramidal symptoms (17%), headache (14%), dizziness (11%), parkinsonism (6%), asthenia (4%), somnolence (3%), and hypoesthesia (2%). Increased dream activity, nervousness, impaired concentration, increased sleep duration, dysarthria, vertigo, stupor, paraesthesia, confusion, and amnesia have also been reported. Delirium, withdrawal syndrome, yawning, aphasia, cholinergic syndrome, hypoesthesia, tongue paralysis, leg cramps, torticollis, hypotonia, coma, migraine, hyperreflexia, choreoathetosis, seizures, neuroleptic malignant syndrome, tardive dyskinesia, and sleep related eating disorder (SRED) have been reported rarely. Head titubation and dysgeusia have also been reported.

Extrapyramidal symptoms may be less frequently associated with risperidone than most other available antipsychotics. Treatment of extrapyramidal effects, in addition to general supportive measures, may include judicious use of one or more of the following: benztropine, trihexyphenidyl, biperiden, or diphenhydramine.

Sedation may occur, particularly at higher doses. Blurred vision, vertigo, impaired concentration, increased appetite and decreased appetite have also been reported.

At least three cases of tardive dyskinesia have also been reported with risperidone use with one case accompanied by risperidone induced parkinsonism. Tardive dyskinesia involves involuntary, dyskinetic, repetitive movements. Tardive dyskinesia may be irreversible and is related to both the duration of therapy and the total amount of drug consumed. Frequent discontinuation and resumption of therapy may predispose patients to the development of tardive dyskinesia.

At least fourteen cases of neuroleptic malignant syndrome have been reported with risperidone use. Fever, altered consciousness, autonomic dysfunction and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of neuroleptic therapy, consideration of dantrolene administration as well as intensive monitoring and supportive care are indicated. Nine of the 13 cases reported were between 15 and 43 years old. One of the cases had a delayed onset and another case resulted in death.

One study has reported that in patients who were given risperidone, there was a positive correlation between improvement in psychopathology and improvement in cognitive test of explicit memory and alertness.

Cardiovascular

Cardiovascular side effects have frequently included tachycardia, hypertension, and hypotension. Palpitation, AV block, and myocardial infarction have also been reported. Ventricular tachycardia, angina pectoris, premature atrial contractions, T wave inversions, ventricular extrasystoles, syncope, edema, ST depression, myocarditis, venous thromboembolism, and bradycardia have been reported rarely. Prolongation of the QT interval has been reported in some patients. One fatal cardiac event following initiation of risperidone therapy has been reported.

Cerebrovascular events (e.g., stroke and transient ischemic attack), including fatalities, have rarely been reported and then primarily in elderly patients with dementia- related psychosis.

An increased risk of mortality, possibly due to heart failure or sudden death, has been reported with the use of atypical antipsychotic agents, including risperidone, in the treatment of behavioral disorders in the elderly patient with dementia. However, it should be noted that conflicting data exist regarding an increased risk of mortality and use of risperidone in elderly dementia patients.

During postmarketing surveillance, retinal artery occlusion in the presence of abnormal arteriovenous anastomosis has been reported following injection of long-acting risperidone.

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.

Endocrine

Hyperprolactinemia in some patients may cause sexual dysfunction (i.e., decreased libido, impaired performance), gynecomastia, reduced fertility, galactorrhea, menstrual irregularities (i.e., amenorrhea, oligomenorrhea), and osteoporosis. In addition, as many as one-third of human breast cancers may be prolactin-dependent in vitro. Treatment of risperidone- induced hyperprolactinemia may include use of bromocriptine, amantadine, or cabergoline as well as discontinuation of therapy.

A study of U.S. military veterans with schizophrenia has reported that patients on risperidone had 1.49 times as many cases of diabetes when compared to patients taking decades old drugs for psychosis including haloperidol, thioridazine, and others. Additional studies have confirmed that patients receiving atypical antipsychotics (i.e., clozapine, risperidone, olanzapine, quetiapine, ziprasidone) are at an increased risk of developing hyperglycemia and/or diabetes mellitus.

Endocrine side effects have included hyperprolactinemia, diabetes, and antidiuretic hormone disorder. Compared with other antipsychotic drugs, risperidone is associated with a greater elevation in prolactin levels.

Genitourinary

A case of priapism lasting approximately 36- hours in duration was reported in a 32- year- old male approximately 8 weeks after initiation of risperidone for the treatment of schizophrenia and 2 weeks after an increase in daily dosage to 5 mg. Risperidone was discontinued immediately. The patient reported, after this event, that he had been experiencing prolonged erections since initiation of risperidone therapy, a phenomenon commonly reported with priapism. However, the patient did not report these events to his clinicians until after this event.

Approximately 18 cases of risperidone- associated priapism have been reported, including a patient who developed priapism while being switched from the oral to the intramuscular formulation. Risperidone- induced priapism is believed to be caused by alpha-adrenergic blockade.

Genitourinary side effects have frequently included urinary incontinence, polyuria, and polydipsia. Hematuria and dysuria have also been reported. Urinary retention, gynecomastia, and cystitis have been reported rarely. Menorrhagia, galactorrhea, orgastic dysfunction, dry vagina, nonpuerperal lactation, amenorrhea, breast pain, leukorrhea, mastitis, dysmenorrhea, perineal pain, intermenstrual bleeding, and vaginal hemorrhage have been reported in females. Erectile dysfunction, ejaculation failure, breast pain, and priapism have been reported in males. Hyperprolactinemia caused by risperidone may impair reproductive function in both male and female patients. Hyperprolactinemia causes a reduction in the pituitary secretion of gonadotropin which, in turn, impairs gonadal steroidogenesis.

Gastrointestinal

Gastrointestinal side effects have frequently included constipation, nausea, dyspepsia, vomiting, abdominal pain, tooth ache, tooth disorder, dry mouth, and hypersalivation. Anorexia, hyposalivation, flatulence, diarrhea, increased appetite, stomatitis, melena, dysphagia, hemorrhoids, and gastritis have also been reported. Fecal incontinence, eructation, gastroesophageal reflux, gastroenteritis, esophagitis, tongue discoloration, cholelithiasis, tongue edema, diverticulitis, gingivitis, discolored feces, gastrointestinal hemorrhage, bitter taste, and hematemesis have also been reported.

Hepatic

Hepatic side effects have included mild reversible elevations in liver function tests, including SGOT and SGPT. Hepatic failure, cholestatic hepatitis, cholecystitis, cholelithiasis, hepatitis, and hepatocellular damage have been reported rarely.

At least one case of rapid onset risperidone induced hepatotoxicity has been reported.

A 30-year-old patient experienced acute symptoms of cholestasis after 8 years of risperidone therapy. Once the drug was discontinued, the symptoms resolved completely. Eleven months later, quetiapine was introduced and the patient once again developed acute symptoms of cholestasis which later resolved after quetiapine discontinuation.

Psychiatric

Psychiatric side effects have frequently included agitation, anxiety, manic reaction, and aggressive reaction. Diminished sexual desire, depression, apathy, catatonic reaction, euphoria, and increased libido have also been reported. Emotional lability, nightmares, and obsessive-compulsive symptoms have been reported rarely.

Ocular

Ocular side effects were looked at in one study on the adverse effects of risperidone on eye movement. The study reported a prolonged latency and decreased peak velocity and accuracy of saccadic eye movements that was detectable four weeks after treatment initiation.

Ocular side effects have frequently included abnormal vision. Abnormal accommodation and xerophthalmia have also been reported. Diplopia, eye pain, blepharitis, photopsia, photophobia, and abnormal lacrimation have been reported rarely. A case of periorbital edema has also been reported.

Metabolic

The results of the large scale clinical trial noted that treatment related changes in glucose tolerance were largely explained by changes in insulin sensitivity.

Hyperglycemia has been reported in some cases to be extreme and associated with ketoacidosis or hyperosmolar coma and death.

Treatment with risperidone has been associated with moderate weight gain (mean 2.1 kg). Risperidone- associated weight gain appears to be more pronounced in the young, males, non- white race, and those with a lower body mass index.

Metabolic side effects have frequently included weight gain. Hyponatremia, creatine phosphokinase increase, thirst, weight decrease, and hyperglycemia have also been reported. Decreased serum iron, cachexia, dehydration, hypokalemia, hypoproteinemia, hyperphosphatemia, hypertriglyceridemia, hyperuricemia, and hypoglycemia have been reported rarely. A large scale clinical trial at clinically relevant doses has reported significant reductions in glucose tolerance during treatment with risperidone.

Respiratory

Respiratory side effects have frequently included rhinitis, coughing, sinusitis, pharyngitis, upper respiratory infection, and dyspnea. Hyperventilation, bronchospasm, pneumonia, and stridor have also been reported. Asthma, increased sputum, and aspiration have been reported rarely. A case of respiratory dyskinesia has also been reported.

An increased risk of mortality, possibly due to an infection such as pneumonia, has been reported with the use of atypical antipsychotic agents, including risperidone, in the treatment of behavioral disorders in the elderly patient with dementia.

Postmarketing experience has included sleep apnea syndrome.

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. Risperidone is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

A case of respiratory dyskinesia characterized by involuntary movements of the respiratory musculature, irregular respiration, grunting, and hyperventilation was reported in a patient following discontinuation of risperidone. Symptoms resolved after restarting risperidone and subsequently, were less severe with a more gradual withdrawal of risperidone.

Other

Other side effects have frequently included back pain, chest pain, fever, pain, fatigue, and injury. Edema, rigors, malaise, and influenza-like symptoms have also been reported. Pallor, enlarged abdomen, ascites, sarcoidosis, flushing, tinnitus, hyperacusis, decreased hearing, and nose bleeds have been reported rarely. Postmarketing experience has included hypothermia and pyrexia.

Dermatologic

Dermatologic side effects have frequently included rash, dry skin, seborrhea, acne, pruritus, increased pigmentation, and photosensitivity. Increased sweating, acne, decreased sweating, alopecia, hyperkeratosis, and skin exfoliation have also been reported. Bullous eruption, skin ulceration, aggravated psoriasis, furunculosis, verruca, dermatitis lichenoid, hypertrichosis, genital pruritus, and urticaria have been reported rarely.

Musculoskeletal

Musculoskeletal side effects have frequently included arthralgia, myalgia, and skeletal pain. Arthrosis, synostosis, bursitis, arthritis, and skeletal pain have been reported rarely. Decreased bone density may occur in both male and female patients as a result of risperidone- induced prolonged hyperprolactinemia. A case of Pisa syndrome has also been reported.

Renal

Renal side effects have rarely included renal insufficiency.

Hypersensitivity

Hypersensitivity side effects have rarely included allergic reaction.

Hematologic

Hematologic side effects have rarely included epistaxis, purpura, hemorrhage, superficial phlebitis, thrombophlebitis, thrombocytopenia, anemia, hypochromic anemia, normocytic anemia, leukocytosis, lymphadenopathy, leukopenia, and Pelger Hu√ęt anomaly. Neutropenia has also been reported

Immunologic

Immunologic side effects have included one case of risperidone induced erythema multiforme minor and a case of immuno allergic hepatitis.

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