Risperdal Consta Side Effects

Generic Name: risperidone

Please note - some side effects for Risperdal Consta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Risperdal Consta - for the Consumer

Risperdal Consta

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Risperdal Consta:

Anxiety; constipation; cough; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; increased appetite; increased saliva production; lightheadedness; nausea; restlessness; runny nose; stomach pain or upset; trouble sleeping; vomiting; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; confusion; decreased sexual ability; drooling; enlarged breasts; fainting; fast or irregular heartbeat; fever; inability to control urination; increased sweating; missed menstrual period; new or worsening mental or mood changes (eg, agitation, aggression, severe anxiety); nipple discharge; prolonged painful erection; seizures; severe dizziness; stiff or rigid muscles; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes.

Risperdal Consta Side Effects - for the Professional

Risperdal Consta

Adverse findings were assessed by spontaneous reports of adverse events, laboratory tests, vital signs, body weight, and ECGs. Adverse events were classified using the World Health Organization preferred terms. Treatment-emergent adverse events were defined as those events with an onset between the first dose and 49 days after the last dose.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in this clinical trial. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.

Associated with Discontinuation of Treatment

In the 12-week, placebo-controlled trial, the incidence of schizophrenic patients who discontinued treatment due to an adverse event was lower with RISPERDAL® CONSTA® (11%; 22/202 patients) than with placebo (13%; 13/98 patients).

Incidence in Controlled Trials

The incidence of adverse reactions in the placebo-controlled trial was based on 202 schizophrenic patients treated with 25 or 50 mg RISPERDAL® CONSTA® and 98 schizophrenic patients treated with placebo for up to 12 weeks.

Spontaneously reported, treatment-emergent adverse events with an incidence of 5% or greater in at least one of the RISPERDAL® CONSTA® groups (25 mg or 50 mg) and at least twice that of placebo were: somnolence, akathisia, parkinsonism, dyspepsia, constipation, dry mouth, fatigue, weight increase.

Table 1 enumerates adverse events that occurred at an incidence of 2% or more, and were at least as frequent among patients treated with 25 mg or 50 mg RISPERDAL® CONSTA™ as patients treated with placebo in the 12-week, placebo-controlled trial. This table shows the percentage of patients in each dose group who spontaneously reported at least one episode of an event at some time during double-blind treatment. All patients were titrated to a dose of 4 mg oral RISPERDAL® during a 1-week run-in period. Patients who received RISPERDAL® CONSTA® were given doses of oral RISPERDAL® (2 mg for patients in the 25-mg group, and 4 mg for patients in the 50-mg group) during the 3 weeks after the first injection to provide therapeutic levels until the main release phase of risperidone from the injection site had begun. Patients who received placebo injections were given placebo tablets.

Extrapyramidal Symptoms:

Two methods were used to measure extrapyramidal symptoms (EPS) in the 12-week, placebo-controlled trial comparing three doses of RISPERDAL® CONSTA® (25 mg, 50 mg, and 75 mg) with placebo, including: (1) the incidence of spontaneous reports of EPS symptoms; and (2) the change from baseline to endpoint on the total score (sum of the subscale scores for parkinsonism, dystonia, and dyskinesia) of the Extrapyramidal Symptom Rating Scale (ESRS).

As shown in Table 1, the overall incidence of EPS-related adverse events (akathisia, dystonia, parkinsonism, and tremor) in patients treated with 25 mg RISPERDAL® CONSTA® was comparable to that of patients treated with placebo; the incidence of EPS-related adverse events was higher in patients treated with 50 mg RISPERDAL® CONSTA®.

The median change from baseline to endpoint in total ESRS score showed no worsening in patients treated with RISPERDAL® CONSTA® compared with patients treated with placebo: 0 (placebo group); -1 (25-mg group, significantly less than the placebo group); and 0 (50-mg group).

RISPERDAL® is associated with orthostatic hypotension and tachycardia. In the placebo-controlled trial, orthostatic hypotension was observed in 2% of patients treated with 25 mg or 50 mg RISPERDAL® CONSTA®.

In the 12-week, placebo-controlled trial, 9% of patients treated with RISPERDAL® CONSTA®, compared with 6% of patients treated with placebo, experienced a weight gain of >7% of body weight at endpoint.

The percentage of patients treated with RISPERDAL® CONSTA® who experienced potentially important changes in routine serum chemistry, hematology, or urinalysis parameters was similar to or less than that of placebo patients. Additionally, no patients discontinued treatment due to changes in serum chemistry, hematology, or urinalysis parameters.

The electrocardiograms of 202 schizophrenic patients treated with 25 mg or 50 mg RISPERDAL® CONSTA® and 98 schizophrenic patients treated with placebo in a 12-week, double-blind, placebo-controlled trial were evaluated. Compared with placebo, there were no statistically significant differences in QTc intervals (using Fridericia's and linear correction factors) during treatment with RISPERDAL® CONSTA®.

Between-group comparisons for pooled placebo-controlled trials with oral RISPERDAL® revealed no statistically significant differences between risperidone and placebo in mean changes from baseline in ECG parameters, including QT, QTc, and PR intervals, and heart rate. When all oral RISPERDAL® doses were pooled from randomized controlled trials in several indications, there was a mean increase in heart rate of 1 beat per minute compared to no change for placebo patients. In short-term schizophrenia trials, higher doses of oral risperidone (8-16 mg/day) were associated with a higher mean increase in heart rate compared to placebo (4-6 beats per minute).

The mean intensity of injection pain reported by patients using a visual analog scale (0 = no pain to 100 = unbearably painful) decreased in all treatment groups from the first to the last injection (placebo: 16.7 to 12.6; 25 mg: 12.0 to 9.0; 50 mg: 18.2 to 11.8). After the sixth injection (Week 10), investigator ratings indicated that 1% of patients treated with 25 mg or 50 mg RISPERDAL® CONSTA® experienced redness, swelling, or induration at the injection site.

Other Events Observed During the Premarketing Evaluation of RISPERDAL® CONSTA™

During its premarketing assessment, RISPERDAL® CONSTA® was administered to 1499 patients in multiple-dose studies. The conditions and duration of exposure to RISPERDAL® CONSTA® varied greatly, and included (in overlapping categories) open-label and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and short-term and long-term exposure studies. In all studies, untoward events associated with this exposure were obtained by spontaneous report and were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.

In the listings that follow, spontaneously reported adverse events were classified using World Health Organization (WHO) preferred terms. The frequencies presented, therefore, represent the proportion of the 1499 patients exposed to multiple doses of RISPERDAL® CONSTA® who experienced an event of the type cited on at least one occasion while receiving RISPERDAL® CONSTA®. All reported events are included except those already listed in Table 1, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening. It is important to emphasize that, although the reported events occurred during treatment with RISPERDAL® CONSTA®, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from the placebo-controlled trial appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; and rare events are those occurring in fewer than 1/1000 patients.

Psychiatric Disorders

Frequent: anxiety, psychosis, depression, agitation, nervousness, paranoid reaction, delusion, apathy. Infrequent: anorexia, impaired concentration, impotence, emotional lability, manic reaction, decreased libido, increased appetite, amnesia, confusion, euphoria, depersonalization, paroniria, delirium, psychotic depression.

Central and Peripheral Nervous System Disorders

Frequent: hypertonia, dystonia. Infrequent: dyskinesia, vertigo, leg cramps, tardive dyskinesiaa, involuntary muscle contractions, paraesthesia, abnormal gait, bradykinesia, convulsions, hypokinesia, ataxia, fecal incontinence, oculogyric crisis, tetany, apraxia, dementia, migraine. Rare: neuroleptic malignant syndrome.

a In the integrated database of multiple-dose studies (1499 patients with schizophrenia or schizoaffective disorder), 9 patients (0.6%) treated with RISPERDAL® CONSTA® (all dosages combined) experienced an adverse event of tardive dyskinesia.

Body as a Whole/General Disorders

Frequent: back pain, chest pain, asthenia. Infrequent: malaise, choking.

Gastrointestinal Disorders

Frequent: nausea, vomiting, abdominal pain. Infrequent: gastritis, gastroesophageal reflux, flatulence, hemorrhoids, melena, dysphagia, rectal hemorrhage, stomatitis, colitis, gastric ulcer, gingivitis, irritable bowel syndrome, ulcerative stomatitis.

Respiratory System Disorders

Frequent: dyspnea. Infrequent: pneumonia, stridor, hemoptysis. Rare: pulmonary edema.

Skin and Appendage Disorders

Frequent: rash. Infrequent: eczema, pruritus, erythematous rash, dermatitis, alopecia, seborrhea, photosensitivity reaction, increased sweating.

Metabolic and Nutritional Disorders

Infrequent: hyperuricemia, hyperglycemia, hyperlipemia, hypokalemia, glycosuria, hypercholesterolemia, obesity, dehydration, diabetes mellitus, hyponatremia.

Musculo-Skeletal System Disorders

Frequent: arthralgia, skeletal pain. Infrequent: torticollis, arthrosis, muscle weakness, tendinitis, arthritis, arthropathy.

Heart Rate and Rhythm Disorders

Frequent: tachycardia. Infrequent: bradycardia, AV block, palpitation, bundle branch block. Rare: T-wave inversion.

Cardiovascular Disorders

Frequent: hypotension. Infrequent: postural hypotension.

Urinary System Disorders

Frequent: urinary incontinence. Infrequent: hematuria, micturition frequency, renal pain, urinary retention.

Vision Disorders

Infrequent: conjunctivitis, eye pain, abnormal accommodation.

Reproductive Disorders, Female

Frequent: amenorrhea. Infrequent: nonpuerperal lactation, vaginitis, dysmenorrhea, breast pain, leukorrhea.

Resistance Mechanism Disorders

Infrequent: abscess.

Liver and Biliary System Disorders

Frequent: increased hepatic enzymes. Infrequent: hepatomegaly, increased SGPT. Rare: bilirubinemia, increased GGT, hepatitis, hepatocellular damage, jaundice, fatty liver, increased SGOT.

Reproductive Disorders, Male

Infrequent: ejaculation failure.

Application Site Disorders

Frequent: injection site pain. Infrequent: injection site reaction.

Hearing and Vestibular Disorders

Infrequent: earache, deafness, hearing decreased.

Red Blood Cell Disorders

Frequent: anemia.

White Cell and Resistance Disorders

Infrequent: lymphadenopathy, leucopenia, cervical lymphadenopathy. Rare: granulocytopenia, leukocytosis, lymphopenia.

Endocrine Disorders

Infrequent: hyperprolactinemia, gynecomastia, hypothyroidism.

Platelet, Bleeding and Clotting Disorders

Infrequent: purpura, epistaxis. Rare: pulmonary embolism, hematoma, thrombocytopenia.

Myo-, Endo-, and Pericardial and Valve Disorders

Infrequent: myocardial ischemia, angina pectoris, myocardial infarction.

Vascular (Extracardiac) Disorders

Infrequent: phlebitis. Rare: intermittent claudication, flushing, thrombophlebitis.

Postintroduction Reports

Adverse events reported since market introduction which were temporally (but not necessarily causally) related to oral RISPERDAL® therapy include the following: anaphylactic reaction, angioedema, apnea, atrial fibrillation, cerebrovascular disorder, including cerebrovascular accident, diabetes mellitus aggravated, including diabetic ketoacidosis, hyperglycemia, intestinal obstruction, jaundice, mania, pancreatitis, Parkinson's disease aggravated, pituitary adenomas, pulmonary embolism, and QT prolongation. There have been rare reports of sudden death and/or cardiopulmonary arrest in patients receiving oral RISPERDAL®. A causal relationship with oral RISPERDAL® has not been established. It is important to note that sudden and unexpected death may occur in psychotic patients whether they remain untreated or whether they are treated with other antipsychotic drugs.

Retinal artery occlusion after injection of RISPERDAL® CONSTA® has been reported during postmarketing surveillance. This has been reported in the presence of abnormal arteriovenous anastomosis.

Side Effects by Body System

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.

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

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.

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.

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.

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-Huet anomaly.

Immunologic

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

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