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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.

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; appetite changes; constipation; cough; dizziness; drowsiness; dry mouth; fatigue; headache; increased saliva production; indigestion; light-headedness; nausea; pain, swelling, or redness at the injection site; restlessness; runny or stuffy nose; stomach pain or upset; trouble sleeping; vomiting; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Risperdal Consta:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; confusion; drooling; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; inability to control urination; increased sweating; new or worsening mental or mood changes (eg, agitation, aggression, depression, severe anxiety); 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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Risperdal Consta Side Effects - for the Professional

Risperdal Consta

The following are discussed in more detail in other sections of the labeling:

The most common adverse reactions in clinical trials in patients with schizophrenia (≥5%) were: headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increased, pain in extremity, and dry mouth. The most common adverse reactions in the double-blind, placebo-controlled periods of the bipolar disorder trials were weight increased (5% in the monotherapy trial) and tremor and parkinsonism (≥10% in the adjunctive treatment trial).

The most common adverse reactions that were associated with discontinuation from the 12-week double-blind, placebo-controlled trial in patients with schizophrenia (causing discontinuation in ≥ 1% of patients) were agitation, depression, anxiety, and akathisia. Adverse reactions that were associated with discontinuation from the double-blind, placebo-controlled periods of the bipolar disorder trials were hyperglycemia (one patient in the monotherapy trial) and hypokinesia and tardive dyskinesia (one patient each in the adjunctive treatment trial).

The data described in this section are derived from a clinical trial database consisting of 2392 patients exposed to one or more doses of RISPERDAL® CONSTA® for the treatment of schizophrenia. Of these 2392 patients, 332 were patients who received RISPERDAL® CONSTA® while participating in a 12-week double-blind, placebo-controlled trial. Two hundred two (202) of the 332 were schizophrenia patients who received 25 mg or 50 mg RISPERDAL® CONSTA®. The conditions and duration of treatment with RISPERDAL® CONSTA® in the other clinical trials varied greatly and included (in overlapping categories) double-blind, fixed- and flexible-dose, placebo- or active-controlled studies and open-label phases of studies, inpatients and outpatients, and short-term (up to 12 weeks) and longer-term (up to 4 years) exposures. Safety was assessed by collecting adverse events and performing physical examinations, vital signs, body weights, laboratory analyses, and ECGs.

In addition to the studies in patients with schizophrenia, safety data are presented from a trial assessing the efficacy and safety of RISPERDAL® CONSTA® when administered as monotherapy for maintenance treatment in patients with bipolar I disorder. The subjects in this multi-center, double-blind, placebo-controlled study were adult patients who met DSM-IV criteria for Bipolar Disorder Type I and who were stable on risperidone (oral or long-acting injection), were stable on other antipsychotics or mood stabilizers, or were experiencing an acute episode. After a 3-week period of treatment with open-label oral risperidone (n=440), subjects who demonstrated an initial response to oral risperidone in this period and those who were stable on risperidone (oral or long-acting injection) at study entry entered into a 26-week stabilization period of open-label RISPERDAL® CONSTA® (n=501). Subjects who demonstrated a maintained response during this period were then randomized into a 24-month double-blind, placebo-controlled period in which they received RISPERDAL® CONSTA® (n=154) or placebo (n=149) as monotherapy. Subjects who relapsed or who completed the double-blind period could choose to enter an 8-week open-label RISPERDAL® CONSTA® extension period (n=160).

Safety data are also presented from a trial assessing the efficacy and safety of RISPERDAL® CONSTA® when administered as adjunctive maintenance treatment in patients with bipolar disorder. The subjects in this multi-center, double-blind, placebo-controlled study were adult patients who met DSM-IV criteria for Bipolar Disorder Type I or Type II and who experienced at least 4 episodes of mood disorder requiring psychiatric/clinical intervention in the previous 12 months, including at least 2 episodes in the 6 months prior to the start of the study. At the start of this study, all patients (n=275) entered into a 16-week open-label treatment phase in which they received RISPERDAL® CONSTA® in addition to continuing their treatment as usual, which consisted of various mood stabilizers (primarily lithium and valproate), antidepressants, and/or anxiolytics. Patients who reached remission at the end of this 16-week open-label treatment phase (n=139) were then randomized into a 52-week double-blind, placebo-controlled phase in which they received RISPERDAL® CONSTA® (n=72) or placebo (n = 67) as adjunctive treatment in addition to continuing their treatment as usual. Patients who did not reach remission at the end of the 16-week open-label treatment phase could choose to continue to receive RISPERDAL® CONSTA® as adjunctive therapy in an open-label manner, in addition to continuing their treatment as usual, for up to an additional 36 weeks as clinically indicated for a total period of up to 52 weeks; these patients (n=70) were also included in the evaluation of safety.

Adverse events during exposure to study treatment were obtained by general inquiry and recorded by clinical investigators using their own terminology. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of RISPERDAL® CONSTA® (adverse drug reactions) based on the comprehensive assessment of the available adverse event information. A causal association for RISPERDAL® CONSTA® often cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The majority of all adverse reactions were mild to moderate in severity.

Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Schizophrenia

Table 4 lists the adverse reactions reported in 2% or more of RISPERDAL® CONSTA®-treated patients with schizophrenia in one 12-week double-blind, placebo-controlled trial.

Table 4. Adverse Reactions in ≥ 2% of RISPERDAL® CONSTA®-Treated Patients with Schizophrenia in a 12-Week Double-Blind, Placebo-Controlled Trial
Percentage of Patients Reporting Event
RISPERDAL® CONSTA® Placebo
System Organ Class 25 mg 50 mg
  Adverse Reaction (N=99) (N=103) (N=98)
*
Fatigue includes fatigue and asthenia. Parkinsonism includes extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia. Akathisia includes akathisia and restlessness. Sedation includes sedation and somnolence.
Eye disorders
  Vision blurred 2 3 0
Gastrointestinal disorders
  Constipation 5 7 1
  Dry mouth 0 7 1
  Dyspepsia 6 6 0
  Nausea 3 4 5
  Toothache 1 3 0
  Salivary hypersecretion 4 1 0
General disorders and administration site conditions
  Fatigue* 3 9 0
  Edema peripheral 2 3 1
  Pain 4 1 0
  Pyrexia 2 1 0
Infections and infestations
  Upper respiratory tract infection 2 0 1
Investigations
  Weight increased 5 4 2
  Weight decreased 4 1 1
Musculoskeletal and connective tissue disorders
  Pain in extremity 6 2 1
Nervous system disorders
  Headache 15 21 12
  Parkinsonism* 8 15 9
  Dizziness 7 11 6
  Akathisia* 4 11 6
  Sedation* 5 6 3
  Tremor 0 3 0
  Syncope 2 1 0
  Hypoesthesia 2 0 0
Respiratory, thoracic and mediastinal disorders
  Cough 4 2 3
  Sinus congestion 2 0 0
Skin and subcutaneous tissue disorders
  Acne 2 2 0
  Dry skin 2 0 0

Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials – Bipolar Disorder

Table 5 lists the treatment-emergent adverse reactions reported in 2% or more of RISPERDAL® CONSTA®-treated patients in the 24-month double-blind, placebo-controlled treatment period of the trial assessing the efficacy and safety of RISPERDAL® CONSTA® when administered as monotherapy for maintenance treatment in patients with Bipolar I Disorder.

Table 5. Adverse Reactions in ≥ 2% of Patients with Bipolar I Disorder Treated with RISPERDAL® CONSTA® as Monotherapy in a 24-Month Double-Blind, Placebo-Controlled Trial
Percentage of Patients Reporting Event
System/Organ Class
  Adverse Reaction		 RISPERDAL® CONSTA®
(N=154)		 Placebo
(N=149)
Investigations
  Weight increased 5 1
Nervous system disorders
  Dizziness 3 1
Vascular disorders
  Hypertension 3 1

Table 6 lists the treatment-emergent adverse reactions reported in 4% or more of patients in the 52-week double-blind, placebo-controlled treatment phase of a trial assessing the efficacy and safety of RISPERDAL® CONSTA® when administered as adjunctive maintenance treatment in patients with bipolar disorder.

Table 6. Adverse Reactions in ≥ 4% of Patients with Bipolar Disorder Treated with RISPERDAL® CONSTA® as Adjunctive Therapy in a 52-Week Double-Blind, Placebo-Controlled Trial
Percentage of Patients Reporting Event
System/Organ Class
  Adverse Reaction		 RISPERDAL® CONSTA® + Treatment as Usual*
(N=72)		 Placebo + Treatment as Usual*
(N=67)
*
Patients received double-blind RISPERDAL® CONSTA® or placebo in addition to continuing their treatment as usual, which included mood stabilizers, antidepressants, and/or anxiolytics.
†
Parkinsonism includes muscle rigidity, hypokinesia, cogwheel rigidity, and bradykinesia. Dyskinesia includes muscle twitching and dyskinesia.
‡
Sedation includes sedation and somnolence.
General disorders and administration site conditions
  Gait abnormal 4 0
Infections and infestations
  Upper respiratory tract infection 6 3
Investigations
  Weight increased 7 1
Metabolism and nutrition disorders
  Decreased appetite 6 1
  Increased appetite 4 0
Musculoskeletal and connective tissue disorders
  Arthralgia 4 3
Nervous system disorders
  Tremor 24 16
  Parkinsonism† 15 6
  Dyskinesia† 6 3
  Sedation‡ 7 1
  Disturbance in attention 4 0
Reproductive system and breast disorders
  Amenorrhea 4 1
Respiratory, thoracic and mediastinal disorders
  Cough 4 1

Other Adverse Reactions Observed During the Clinical Trial Evaluation of Risperidone

The following additional adverse reactions occurred in <2% of the RISPERDAL® CONSTA®-treated patients in the above schizophrenia double-blind, placebo-controlled trial dataset, in <2% of the RISPERDAL® CONSTA®-treated patients in the above double-blind, placebo-controlled period of the monotherapy bipolar disorder trial dataset, or in <4% of the RISPERDAL® CONSTA®-treated patients in the above double-blind, placebo-controlled period of the adjunctive treatment bipolar disorder trial dataset. The following also includes additional adverse reactions reported at any frequency in RISPERDAL® CONSTA®-treated patients who participated in the open-label phases of the above bipolar disorder studies and in other studies, including double-blind, active controlled and open-label studies in schizophrenia and bipolar disorder.

Blood and lymphatic system disorders: anemia, neutropenia

Cardiac disorders: tachycardia, atrioventricular block first degree, palpitations, sinus bradycardia, bundle branch block left, bradycardia, sinus tachycardia, bundle branch block right

Ear and labyrinth disorders: ear pain, vertigo

Endocrine disorders: hyperprolactinemia

Eye disorders: conjunctivitis, visual acuity reduced

Gastrointestinal disorders: diarrhea, vomiting, abdominal pain upper, abdominal pain, stomach discomfort, gastritis

General disorders and administration site conditions: injection site pain, chest discomfort, chest pain, influenza like illness, sluggishness, malaise, induration, injection site induration, injection site swelling, injection site reaction, face edema

Immune system disorders: hypersensitivity

Infections and infestations: nasopharyngitis, influenza, bronchitis, urinary tract infection, rhinitis, respiratory tract infection, ear infection, pneumonia, lower respiratory tract infection, pharyngitis, sinusitis, viral infection, infection, localized infection, cystitis, gastroenteritis, subcutaneous abscess

Injury and poisoning: fall, procedural pain

Investigations: blood prolactin increased, alanine aminotransferase increased, electrocardiogram abnormal, gamma-glutamyl transferase increased, blood glucose increased, hepatic enzyme increased, aspartate aminotransferase increased, electrocardiogram QT prolonged, glucose urine present

Metabolism and nutritional disorders: anorexia, hyperglycemia

Musculoskeletal, connective tissue and bone disorders: posture abnormal, myalgia, back pain, buttock pain, muscular weakness, neck pain, musculoskeletal chest pain

Nervous system disorders: coordination abnormal, dystonia, tardive dyskinesia, drooling, paresthesia, dizziness postural, convulsion, akinesia, hypokinesia, dysarthria

Psychiatric disorders: insomnia, agitation, anxiety, sleep disorder, depression, initial insomnia, libido decreased, nervousness

Renal and urinary disorders: urinary incontinence

Reproductive system and breast disorders: galactorrhea, oligomenorrhea, erectile dysfunction, sexual dysfunction, ejaculation disorder, gynecomastia, breast discomfort, menstruation irregular, menstruation delayed, menstrual disorder, ejaculation delayed

Respiratory, thoracic and mediastinal disorders: nasal congestion, pharyngolaryngeal pain, dyspnea, rhinorrhea

Skin and subcutaneous tissue disorders: rash, eczema, pruritus generalized, pruritus

Vascular disorders: hypotension, orthostatic hypotension

Additional Adverse Reactions Reported with Oral RISPERDAL®

The following is a list of additional adverse reactions that have been reported during the clinical trial evaluation of oral RISPERDAL®, regardless of frequency of occurrence:

Blood and Lymphatic Disorders: granulocytopenia

Cardiac Disorders: atrioventricular block

Ear and Labyrinth Disorders: tinnitus

Eye Disorders: ocular hyperemia, eye discharge, eye rolling, eyelid edema, eye swelling, eyelid margin crusting, dry eye, lacrimation increased, photophobia, glaucoma

Gastrointestinal Disorders: abdominal pain upper, dysphagia, fecaloma, abdominal discomfort, fecal incontinence, lip swelling, cheilitis, aptyalism

General Disorders: thirst, feeling abnormal, gait disturbance, pitting edema, edema, chills, discomfort, generalized edema, drug withdrawal syndrome, peripheral coldness

Immune System Disorders: drug hypersensitivity

Infections and Infestations: tonsillitis, eye infection, cellulitis, otitis media, onychomycosis, acarodermatitis, bronchopneumonia, respiratory tract infection, tracheobronchitis, otitis media chronic

Investigations: body temperature increased, heart rate increased, eosinophil count increased, white blood cell count decreased, hemoglobin decreased, blood creatine phosphokinase increased, hematocrit decreased, body temperature decreased, blood pressure decreased, transaminases increased

Metabolism and Nutrition Disorders: polydipsia

Musculoskeletal, Connective Tissue, and Bone Disorders: joint swelling, joint stiffness, rhabdomyolysis, torticollis

Nervous System Disorders: hypertonia, balance disorder, dysarthria, unresponsive to stimuli, depressed level of consciousness, movement disorder, hypokinesia, parkinsonian rest tremor, transient ischemic attack, cerebrovascular accident, masked facies, speech disorder, loss of consciousness, muscle contractions involuntary, akinesia, cerebral ischemia, cerebrovascular disorder, neuroleptic malignant syndrome, diabetic coma, head titubation

Psychiatric Disorders: blunted affect, confusional state, middle insomnia, listlessness, anorgasmia

Renal and Urinary Disorders: enuresis, dysuria, pollakiuria

Reproductive System and Breast Disorders: vaginal discharge, retrograde ejaculation, ejaculation disorder, ejaculation failure, breast enlargement

Respiratory, Thoracic, and Mediastinal Disorders: epistaxis, wheezing, pneumonia aspiration, dysphonia, productive cough, pulmonary congestion, respiratory tract congestion, rales, respiratory disorder, hyperventilation, nasal edema

Skin and Subcutaneous Tissue Disorders: erythema, skin discoloration, skin lesion, skin disorder, rash erythematous, rash papular, hyperkeratosis, dandruff, seborrheic dermatitis, rash generalised, rash maculopapular

Vascular Disorders: flushing

Discontinuations Due to Adverse Reactions

Schizophrenia

Approximately 11% (22/202) of RISPERDAL® CONSTA®-treated patients in the 12-week double-blind, placebo-controlled schizophrenia trial discontinued treatment due to an adverse event, compared with 13% (13/98) who received placebo. The adverse reactions associated with discontinuation in two or more RISPERDAL® CONSTA®-treated patients were: agitation (3%), depression (2%), anxiety (1%), and akathisia (1%).

Bipolar Disorder

In the 24-month double-blind, placebo-controlled treatment period of the trial assessing the efficacy and safety of RISPERDAL® CONSTA® when administered as monotherapy for maintenance treatment in patients with bipolar I disorder, 1 (0.6%) of 154 RISPERDAL® CONSTA®-treated patients discontinued due to an adverse reaction (hyperglycemia).

In the 52-week double-blind phase of the placebo-controlled trial in which RISPERDAL® CONSTA® was administered as adjunctive therapy to patients with bipolar disorder in addition to continuing with their treatment as usual, approximately 4% (3/72) of RISPERDAL® CONSTA®-treated patients discontinued treatment due to an adverse event, compared with 1.5% (1/67) of placebo-treated patients. Adverse reactions associated with discontinuation in RISPERDAL® CONSTA®-treated patients were: hypokinesia (one patient) and tardive dyskinesia (one patient).

Dose Dependency of Adverse Reactions in Clinical Trials

Extrapyramidal Symptoms:

Two methods were used to measure extrapyramidal symptoms (EPS) in the 12-week double-blind, placebo-controlled trial comparing three doses of RISPERDAL® CONSTA® (25 mg, 50 mg, and 75 mg) with placebo in patients with schizophrenia, 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 reactions (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 reactions 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).

Dystonia

Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Changes in ECG

The electrocardiograms of 202 schizophrenic patients treated with 25 mg or 50 mg RISPERDAL® CONSTA® and 98 schizophrenic patients treated with placebo in the 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®.

The electrocardiograms of 227 patients with Bipolar I Disorder were evaluated in the 24-month double-blind, placebo-controlled period. There were no clinically relevant differences in QTc intervals (using Fridericia's and linear correction factors) during treatment with RISPERDAL® CONSTA® compared to placebo.

The electrocardiograms of 85 patients with bipolar disorder were evaluated in the 52-week double-blind, placebo-controlled trial. There were no statistically significant differences in QTc intervals (using Fridericia's and linear correction factors) during treatment with RISPERDAL® CONSTA® 25 mg, 37.5 mg, or 50 mg when administered as adjunctive treatment in addition to continuing treatment as usual compared to placebo.

Pain Assessment and Local Injection Site Reactions

The mean intensity of injection pain reported by patients with schizophrenia 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.

In a separate study to observe local-site tolerability in which RISPERDAL® CONSTA® was administered into the deltoid muscle every 2 weeks over a period of 8 weeks, no patient discontinued treatment due to local injection site pain or reaction. Clinician ratings indicated that only mild redness, swelling, or induration at the injection site was observed in subjects treated with 37.5 mg or 50 mg RISPERDAL® CONSTA® at 2 hours after deltoid injection. All ratings returned to baseline at the predose assessment of the next injection 2 weeks later. No moderate or severe reactions were observed in any subject.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of risperidone; because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency: agranulocytosis, alopecia, anaphylactic reaction, angioedema, atrial fibrillation, blood cholesterol increased, blood triglycerides increased, diabetes mellitus, diabetic ketoacidosis in patients with impaired glucose metabolism, drug withdrawal syndrome neonatal, dysgeusia, hypoglycemia, hypothermia, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, priapism, QT prolongation, sleep apnea syndrome, thrombocytopenia, urinary retention, and water intoxication. In addition, the following adverse reactions have been observed during postapproval use of RISPERDAL® CONSTA®: cerebrovascular disorders, including cerebrovascular accidents, and diabetes mellitus aggravated.

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.

Serious injection site reactions including abscess, cellulitis, cyst, hematoma, necrosis, nodule, and ulcer have been reported with RISPERDAL® CONSTA® during postmarketing surveillance. Isolated cases required surgical intervention.

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Side Effects by Body System - for Healthcare Professionals

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 Huët 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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