Risperidone

DEA Class;  Rx

Common Brand Names; Risperdal, Risperdal Consta, Risperdal M-Tab, Perseris

Documented hypersensitivity

• Somnolence (40-45%)
• Insomnia (26-30%)
• Agitation (20-25%)
• Anxiety (10-15%)
• Headache (10-15%)
• Rhinitis (10-15%)
• Fatigue (18-31%)
• Parkinsonism (28-62%)
• Akathisia (5-11%)
• Increased appetite (4-44%)
• Vomiting (10-20%)
• Drooling (<12%)
• Urinary incontinence (5-22%)
• Tremor (11-24%)
• Nasopharyngitis (4-19%)
• Rhinorrhea (4-12%)
• Enuresis (1-16%)
• Increased weight (12.8-13%)
• Constipation (5-10%)
• Dyspepsia (5-10%)
• Nausea (5-10%)
• Abdominal pain (1-5%)
• Aggressive reaction (1-5%)
• Facial edema (<4%)
• QT prolongation (<4%)
• Dizziness (1-5%)
• Extrapyramidal symptoms (EPS; 1-5%)
• Gynecomastia in children (1-5%)
• Rash (1-5%)
• Tachycardia (1-5%)
• Syncope (1-2%)
• Bradycardia (<4%)
• Palpitation (<4%)
• Chest pain (<4%)
• Agitation (<4%)
• Postural dizziness (<4%)
• Pruritus (<4%)
• Acne (1-2%)
• Hyperprolactinemia (<4%)
• Sexual dysfunction (<4%)
• Xerostomia (7-10%)

Increased incidence of cerebrovascular disease reported; may alter cardiac conduction; life threatening arrhythmias reported with therapeutic doses of antipsychotics

May cause anticholinergic effects including blurred vision, urinary retention, agitation, confusion, blurred vision, and xerostomia

Use with caution in patients with history of seizures, Parkinson disease, Lewy body dementia, cardiovascular disease, hypovolemia, dehydration

Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia

If patient has history of clinically significant low WBC count or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/μL in absence of other causative factors, and continue monitoring WBC count until recovery

May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy

Use caution in patients at risk of pneumonia; esophageal dysmotility and aspiration reported with antipsychotic use

May cause extrapyramidal symptoms including acute dystonic reactions, akathisia, pseudoparkinsonism, and tardive dyskinesia

Intraoperative floppy iris syndrome reported in patients receiving risperidone therapy

Monitor for fever, mental status changes, muscle rigidity and or autonomic instability; neuroleptic malignant syndrome (NMS) associated with risperidone use; if NMS suspected, discontinue therapy immediately and provide symptomatic treatment and monitoring

Use with caution in children <15 kg

Cases of priapism reported with therapy

Prolactin elevations occur and persist during chronic administration; risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents

Use caution when operating heavy machinery

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, during pregnancy

Limited data from published literature reports the presence of risperidone and its metabolite, 9- hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3 and 4.7% of the maternal weight-adjusted dosage