Risperidone

What Are the Most Common and Serious Side Effects of Risperidone?

Common side effects of risperidone (Risperdal) include:

• Sleepiness
• Dizziness
• Nausea or vomiting
• Diarrhea
• Constipation
• Heartburn
• Dry mouth
• Increased saliva
• Increased appetite
• Weight gain
• Stomach pain
• Anxiety
• Agitation
• Restlessness
• More frequent dreaming
• Trouble sleeping
• Low sex drive or sexual problems
• Unusual breast milk production
• Vision problems
• Muscle or joint pain
• Dry or discolored skin
• Trouble urinating

Serious side effects can also occur while taking risperidone. If you have any of these side effects, call your doctor immediately:

• Fever
• Muscle stiffness
• Confusion
• Fast or irregular pulse
• Sweating
• Abnormal movements of your face or body that you cannot control
• Lightheadedness
• Seizures
• Slow movements or shuffling walk
• Rash
• Hives
• Itching
• Trouble breathing or swallowing
• Painful erection that lasts for hours

RISPERDAL® contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:

Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.

RISPERDAL® Tablets are for oral administration and available in 0.25 mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. RISPERDAL® tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch (corn). The 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg tablets also contain talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.

RISPERDAL® is also available as a 1 mg/mL oral solution. RISPERDAL® Oral Solution contains the following inactive ingredients: tartaric acid, benzoic acid, sodium hydroxide, and purified water.

RISPERDAL® M-TAB® Orally Disintegrating Tablets are available in 0.5 mg (light coral), 1 mg (light coral), 2 mg (coral), 3 mg (coral), and 4 mg (coral) strengths. RISPERDAL® M-TAB® Orally Disintegrating Tablets contain the following inactive ingredients: Amberlite® resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame, red ferric oxide, and peppermint oil. In addition, the 2 mg, 3 mg, and 4 mg RISPERDAL® M-TAB® Orally Disintegrating Tablets contain xanthan gum.

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

• Increased mortality in elderly patients with dementia-related psychosis [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS]
• Neuroleptic malignant syndrome [see WARNINGS AND PRECAUTIONS]
• Tardive dyskinesia [see WARNINGS AND PRECAUTIONS]
• Metabolic Changes (Hyperglycemia and diabetes mellitus, Dyslipidemia, and Weight Gain) [see WARNINGS AND PRECAUTIONS]
• Hyperprolactinemia [see WARNINGS AND PRECAUTIONS]
• Orthostatic hypotension [see WARNINGS AND PRECAUTIONS]
• Leukopenia, neutropenia, and agranulocytosis [see WARNINGS AND PRECAUTIONS]
• Potential for cognitive and motor impairment [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]
• Dysphagia [see WARNINGS AND PRECAUTIONS]
• Priapism [see WARNINGS AND PRECAUTIONS]
• Disruption of body temperature regulation [see WARNINGS AND PRECAUTIONS]
• Patients with Phenylketonuria [see WARNINGS AND PRECAUTIONS].

The most common adverse reactions in clinical trials ( > 5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.

The most common adverse reactions that were associated with discontinuation from clinical trials (causing discontinuation in > 1% of adults and/or > 2% of pediatrics) were nausea, somnolence, sedation, vomiting, dizziness, and akathisia [see Discontinuations Due to Adverse Reactions].

The data described in this section are derived from a clinical trial database consisting of 9803 adult and pediatric patients exposed to one or more doses of RISPERDAL® for the treatment of schizophrenia, bipolar mania, autistic disorder, and other psychiatric disorders in pediatrics and elderly patients with dementia. Of these 9803 patients, 2687 were patients who received RISPERDAL® while participating in double-blind, placebo-controlled trials. The conditions and duration of treatment with RISPERDAL® 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 3 years) exposures. Safety was assessed by collecting adverse events and performing physical examinations, vital signs, body weights, laboratory analyses, and ECGs.

Clinical Trials Experience

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.

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

Table 8 lists the adverse reactions reported in 2% or more of RISPERDAL®-treated adult patients with schizophrenia in three 4- to 8-week, double-blind, placebo-controlled trials.

Table 8: Adverse Reactions in ≥ 2% of RISPERDAL®-Treated Adult Patients (and greater than placebo) with Schizophrenia in Double-Blind, Placebo-Controlled Trials

Table 9 lists the adverse reactions reported in 5% or more of RISPERDAL®-treated pediatric patients with schizophrenia in a 6-week double-blind, placebo-controlled trial.

Table 9: Adverse Reactions in ≥ 5% of RISPERDAL®-Treated Pediatric Patients (and greater than placebo) with Schizophrenia in a Double-Blind Trial

Commonly-Observed Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials - Bipolar Mania

Table 10 lists the adverse reactions reported in 2% or more of RISPERDAL®-treated adult patients with bipolar mania in four 3-week, double-blind, placebo-controlled monotherapy trials.

Table 10: Adverse Reactions in ≥ 2% of RISPERDAL®-Treated Adult Patients (and greater than placebo) with Bipolar Mania in Double-Blind, Placebo-Controlled Monotherapy Trials

Table 11 lists the adverse reactions reported in 2% or more of RISPERDAL®-treated adult patients with bipolar mania in two 3-week, double-blind, placebo-controlled adjuvant therapy trials.

Table 11: Adverse Reactions in ≥ 2% of RISPERDAL®-Treated Adult Patients (and greater than placebo) with Bipolar Mania in Double-Blind, Placebo-Controlled Adjunctive Therapy Trials

Table 12 lists the adverse reactions reported in 5% or more of RISPERDAL®-treated pediatric patients with bipolar mania in a 3-week double-blind, placebo-controlled trial.

Table 12: Adverse Reactions in ≥ 5% of RISPERDAL®-Treated Pediatric Patients (and greater than placebo) with Bipolar Mania in Double-Blind, Placebo-Controlled Trials

Commonly-Observed Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials - Autistic Disorder

Table 13 lists the adverse reactions reported in 5% or more of RISPERDAL®-treated pediatric patients treated for irritability associated with autistic disorder in two 8-week, double-blind, placebo-controlled trials and one 6-week double-blind, placebo-controlled study.

Table 13: Adverse Reactions in ≥ 5% of RISPERDAL®-Treated Pediatric Patients (and greater than placebo) Treated for Irritability Associated with Autistic Disorder in Double-Blind, Placebo-Controlled Trials

Other Adverse Reactions Observed During The Clinical Trial Evaluation Of Risperidone

The following additional adverse reactions occurred across all placebo-controlled, active-controlled, and open-label studies of RISPERDAL® in adults and pediatric patients.

Blood and Lymphatic System Disorders: anemia, granulocytopenia, neutropenia

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

Ear and Labyrinth Disorders: ear pain, tinnitus

Endocrine Disorders: hyperprolactinemia

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

Gastrointestinal Disorders: dysphagia, fecaloma, fecal incontinence, gastritis, lip swelling, cheilitis, aptyalism

General Disorders: edema peripheral, thirst, gait disturbance, influenza-like illness, pitting edema, edema, chills, sluggishness, malaise, chest discomfort, face edema, discomfort, generalized edema, drug withdrawal syndrome, peripheral coldness, feeling abnormal

Immune System Disorders: drug hypersensitivity

Infections and Infestations: pneumonia, influenza, ear infection, viral infection, pharyngitis, tonsillitis, bronchitis, eye infection, localized infection, cystitis, cellulitis, otitis media, onychomycosis, acarodermatitis, bronchopneumonia, respiratory tract infection, tracheobronchitis, otitis media chronic

Investigations: body temperature increased, blood prolactin increased, alanine aminotransferase increased, electrocardiogram abnormal, eosinophil count increased, white blood cell count decreased, blood glucose increased, hemoglobin decreased, hematocrit decreased, body temperature decreased, blood pressure decreased, transaminases increased

Metabolism and Nutrition Disorders: decreased appetite, polydipsia, anorexia

Musculoskeletal and Connective Tissue Disorders: joint stiffness, joint swelling, musculoskeletal chest pain, posture abnormal, myalgia, neck pain, muscular weakness, rhabdomyolysis

Nervous System Disorders: balance disorder, disturbance in attention, dysarthria, unresponsive to stimuli, depressed level of consciousness, movement disorder, transient ischemic attack, coordination abnormal, cerebrovascular accident, speech disorder, syncope, loss of consciousness, hypoesthesia, tardive dyskinesia, dyskinesia, cerebral ischemia, cerebrovascular disorder, neuroleptic malignant syndrome, diabetic coma, head titubation

Psychiatric Disorders: agitation, blunted affect, confusional state, middle insomnia, nervousness, sleep disorder, listlessness, libido decreased, and anorgasmia

Renal and Urinary Disorders: enuresis, dysuria, pollakiuria, urinary incontinence

Reproductive System and Breast Disorders: menstruation irregular, amenorrhea, gynecomastia, galactorrhea, vaginal discharge, menstrual disorder, erectile dysfunction, retrograde ejaculation, ejaculation disorder, sexual dysfunction, breast enlargement

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

Skin and Subcutaneous Tissue Disorders: erythema, skin discoloration, skin lesion, pruritus, skin disorder, rash erythematous, rash papular, rash generalized, rash maculopapular, acne, hyperkeratosis, seborrheic dermatitis

Vascular Disorders: hypotension, flushing

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

Cardiac Disorders: bradycardia

Ear and Labyrinth Disorders: vertigo

Eye Disorders: blepharospasm

Gastrointestinal Disorders: toothache, tongue spasm

General Disorders and Administration Site Conditions: pain

Infections and Infestations: lower respiratory tract infection, infection, gastroenteritis, subcutaneous abscess

Injury and Poisoning: fall

Investigations: weight decreased, gamma-glutamyltransferase increased, hepatic enzyme increased

Musculoskeletal, Connective Tissue, and Bone Disorders: buttock pain

Nervous System Disorders: convulsion, paresthesia

Psychiatric Disorders: depression

Skin and Subcutaneous Tissue Disorders: eczema

Vascular Disorders: hypertension

Discontinuations Due To Adverse Reactions

Approximately 7% (39/564) of RISPERDAL®-treated patients in double-blind, placebo-controlled trials discontinued treatment due to an adverse reaction, compared with 4% (10/225) who were receiving placebo. The adverse reactions associated with discontinuation in 2 or more RISPERDAL®-treated patients were:

Table 14: Adverse Reactions Associated With Discontinuation in 2 or More RISPERDAL®Treated Adult Patients in Schizophrenia Trials

Discontinuation for extrapyramidal symptoms (including Parkinsonism, akathisia, dystonia, and tardive dyskinesia) was 1% in placebo-treated patients, and 3.4% in active control-treated patients in a double-blind, placebo- and active-controlled trial.

Approximately 7% (7/106), of RISPERDAL®-treated patients discontinued treatment due to an adverse reaction in a double-blind, placebo-controlled trial, compared with 4% (2/54) placebo-treated patients. The adverse reactions associated with discontinuation for at least one RISPERDAL®-treated patient were dizziness (2%), somnolence (1%), sedation (1%), lethargy (1%), anxiety (1%), balance disorder (1%), hypotension (1%), and palpitation (1%).

In double-blind, placebo-controlled trials with RISPERDAL® as monotherapy, approximately 6% (25/448) of RISPERDAL®-treated patients discontinued treatment due to an adverse event, compared with approximately 5% (19/424) of placebo-treated patients. The adverse reactions associated with discontinuation in RISPERDAL®-treated patients were:

Table 15: Adverse Reactions Associated With Discontinuation in 2 or More RISPERDAL®Treated Adult Patients in Bipolar Mania Clinical Trials

In a double-blind, placebo-controlled trial 12% (13/111) of RISPERDAL®-treated patients discontinued due to an adverse reaction, compared with 7% (4/58) of placebo-treated patients. The adverse reactions associated with discontinuation in more than one RISPERDAL®-treated pediatric patient were nausea (3%), somnolence (2%), sedation (2%), and vomiting (2%).

In the two 8-week, placebo-controlled trials in pediatric patients treated for irritability associated with autistic disorder (n = 156), one RISPERDAL®-treated patient discontinued due to an adverse reaction (Parkinsonism), and one placebo-treated patient discontinued due to an adverse event.

Dose Dependency Of Adverse Reactions In Clinical Trials

Data from two fixed-dose trials in adults with schizophrenia provided evidence of dose-relatedness for extrapyramidal symptoms associated with RISPERDAL® treatment.

Two methods were used to measure extrapyramidal symptoms (EPS) in an 8-week trial comparing 4 fixed doses of RISPERDAL® (2, 6, 10, and 16 mg/day), including (1) a Parkinsonism score (mean change from baseline) from the Extrapyramidal Symptom Rating Scale, and (2) incidence of spontaneous complaints of EPS:

Table 16

Similar methods were used to measure extrapyramidal symptoms (EPS) in an 8-week trial comparing 5 fixed doses of RISPERDAL® (1, 4, 8, 12, and 16 mg/day):

Table 17

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.

Other Adverse Reactions

Adverse event data elicited by a checklist for side effects from a large study comparing 5 fixed doses of RISPERDAL® (1, 4, 8, 12, and 16 mg/day) were explored for dose-relatedness of adverse events. A Cochran-Armitage Test for trend in these data revealed a positive trend (p < 0.05) for the following adverse reactions: somnolence, vision abnormal, dizziness, palpitations, weight increase, erectile dysfunction, ejaculation disorder, sexual function abnormal, fatigue, and skin discoloration.

Weight gain was observed in short-term, controlled trials and longer-term uncontrolled studies in adult and pediatric patients [see WARNINGS AND PRECAUTIONS, and Use In Specific Populations].

Between-group comparisons for pooled placebo-controlled trials in adults 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 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 risperidone (8-16 mg/day) were associated with a higher mean increase in heart rate compared to placebo (4-6 beats per minute). In pooled placebo-controlled acute mania trials in adults, there were small decreases in mean heart rate, similar among all treatment groups.

In the two placebo-controlled trials in children and adolescents with autistic disorder (aged 5 - 16 years) mean changes in heart rate were an increase of 8.4 beats per minute in the RISPERDAL® groups and 6.5 beats per minute in the placebo group. There were no other notable ECG changes.

In a placebo-controlled acute mania trial in children and adolescents (aged 10 - 17 years), there were no significant changes in ECG parameters, other than the effect of RISPERDAL® to transiently increase pulse rate ( < 6 beats per minute). In two controlled schizophrenia trials in adolescents (aged 13 - 17 years), there were no clinically meaningful changes in ECG parameters including corrected QT intervals between treatment groups or within treatment groups over time.

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 always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions include: alopecia, anaphylactic reaction, angioedema, atrial fibrillation, cardiopulmonary arrest, diabetic ketoacidosis in patients with impaired glucose metabolism, dysgeusia, hypoglycemia, hypothermia, ileus, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, pituitary adenoma, precocious puberty, pulmonary embolism, QT prolongation, sleep apnea syndrome, sudden death, thrombocytopenia, thrombotic thrombocytopenic purpura, urinary retention, and water intoxication.

Read the entire FDA prescribing information for Risperdal (Risperidone)

• Bipolar Disorder
• Prescription Anxiety Medications
• Schizophrenia

CYP2D6 is a protein in your body that is involved in the elimination of risperidone and other drugs from your body. Some patients have less of this protein in their bodies, affecting how much of the drug gets eliminated. Levels of CYP2D6 can vary greatly between individuals, and those having less of this protein are known as "poor metabolizers." 

CYP2D6 testing is done to determine whether you are a poor metabolizer. If you are a poor metabolizer, the levels of risperidone in your blood can become too high. As a result you may be at an increased risk of having more side effects from risperidone. 

Your doctor may adjust your dose of risperidone if you are a poor metabolizer.

Tell your doctor if you are breastfeeding or plan to breastfeed. Risperidone can cross into human breast milk. It may harm your baby.

If your doctor has decided that risperidone is right for you, and you have never taken risperidone, he or she may give you a test dose of an oral version to ensure that you can tolerate the medicine.

Oral:

• Risperidone comes as a tablet, a solution (liquid), and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth.
• It is usually taken once or twice a day with or without food. Take risperidone at around the same time(s) every day.
• Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
• Take risperidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Injectable:

• If you have taken risperidone before, and you can tolerate it, you may get your first injection right away. After the first injection, you will keep taking the oral medicine you're already on for 3 weeks to give risperidone a chance to start working. After that, you will come back to your healthcare professional every 2 weeks for your next dose.
• Once your doctor has prescribed risperidone, he or she may offer you a choice of where you want to get the medicine. Risperidone can be given as an injection in the upper arm or the upper buttock.
• Risperidone is given by a doctor or nurse every 2 weeks. In most cases, you may only have to expose a small area of skin.

Metabolized by CYP2D6 to 9-hydroxyrisperidone, which has similar pharmacologic activity.1 103 May weakly inhibit CYP2D6.1

Drugs Affecting Hepatic Microsomal Enzymes

CYP2D6 inhibitors: Potential pharmacokinetic interaction (altered risperidone metabolism and plasma concentrations of the active moiety [risperidone plus 9-hydroxyrisperidone]; increased plasma concentrations of risperidone likely).1 Adjust oral risperidone dosage during concurrent use.1 (See Specific Drugs under Interactions and see Metabolism under Pharmacokinetics.)

Inducers of CYP enzymes: Potential pharmacokinetic interaction (decreased plasma concentrations of risperidone).1 103 Increase oral risperidone dosage up to twice original dosage when administered concurrently with enzyme inducers (e.g., CYP3A inducers); a reduction in oral risperidone dosage may be necessary when the enzyme inducer is discontinued.1 Patients receiving IM risperidone may need dosage increase or supplemental oral risperidone when therapy with an enzyme inducer is initiated; consider reducing IM risperidone dosage 2–4 weeks before discontinuance of the enzyme inducer.103 (See Specific Drugs under Interactions.)

Drugs Metabolized by Hepatic Microsomal Enzymes

Drugs metabolized by CYP2D6: Substantial pharmacokinetic interaction unlikely.1

In vitro, drugs metabolized by CYP1A1, CYP1A2, CYP2C9, CYP2C19, and CYP3A4 only weakly inhibit risperidone metabolism.1

Specific Drugs1 103

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For risperidone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to risperidone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of risperidone in children younger than 13 years with schizophrenia, in children younger than 10 years with bipolar disorder, or in children younger than 5 years with autistic disorder. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of risperidone have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of risperidone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving risperidone.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking risperidone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using risperidone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Levomethadyl
• Mesoridazine
• Metoclopramide
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using risperidone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Ajmaline
• Amiodarone
• Amitriptyline
• Anagrelide
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azimilide
• Bretylium
• Bupropion
• Buserelin
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Citalopram
• Clarithromycin
• Clozapine
• Crizotinib
• Dabrafenib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Efavirenz
• Encainide
• Enflurane
• Erythromycin
• Escitalopram
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Gemifloxacin
• Ginkgo Biloba
• Gonadorelin
• Goserelin
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Imipramine
• Itraconazole
• Ivabradine
• Ketoconazole
• Leuprolide
• Levofloxacin
• Linezolid
• Lithium
• Lorcainide
• Mefloquine
• Methadone
• Metronidazole
• Milnacipran
• Moxifloxacin
• Nafarelin
• Nortriptyline
• Octreotide
• Ondansetron
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pimavanserin
• Pitolisant
• Posaconazole
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Protriptyline
• Quetiapine
• Remifentanil
• Ribociclib
• Sematilide
• Sertindole
• Sertraline
• Sevoflurane
• Simvastatin
• Sotalol
• Spiramycin
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Tacrolimus
• Tedisamil
• Telithromycin
• Tetrabenazine
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Vandetanib
• Vemurafenib
• Vinflunine
• Zotepine
• Zuclopenthixol

Using risperidone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Cimetidine
• Fosphenytoin
• Lamotrigine
• Levorphanol
• Midodrine
• Phenobarbital
• Phenytoin
• Ranitidine
• Ritonavir
• Valproic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of risperidone. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergic reaction to paliperidone (Invega®), history of—Should not be used in patients with this condition.

• Alzheimer disease or
• Dehydration or
• Heart attack, recent or history of or
• Heart or blood vessel disease or
• Heart failure, history of or
• Heart rhythm problem, or a history of or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood) or
• Stroke, history of or
• Trouble with swallowing—May cause side effects to become worse.

• Blood or bone marrow problems or
• Breast cancer, prolactin-dependent or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Hyperprolactinemia (high prolactin in the blood) or
• Neuroleptic malignant syndrome (NMS), history of or
• Parkinson disease or
• Priapism (painful or prolonged erection of the penis) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make this condition worse.

Human Experience

Premarketing experience included eight reports of acute Risperidone overdosage with estimated doses ranging from 20 to 300 mg and no fatalities. In general, reported signs and symptoms were those resulting from an exaggeration of the drug's known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms. One case, involving an estimated overdose of 240 mg, was associated with hyponatremia, hypokalemia, prolonged QT, and widened QRS. Another case, involving an estimated overdose of 36 mg, was associated with a seizure.

Postmarketing experience includes reports of acute Risperidone overdosage, with estimated doses of up to 360 mg. In general, the most frequently reported signs and symptoms are those resulting from an exaggeration of the drug's known pharmacological effects, i.e., drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms. Other adverse reactions reported since market introduction related to Risperidone overdose include prolonged QT interval and convulsions. Torsade de pointes has been reported in association with combined overdose of Risperidone and paroxetine.

Management of Overdosage

For the most up to date information on the management of Risperidone overdosage, contact a certified poison control center (1-800-222-1222 or www.poison.org). Provide supportive care including close medical supervision and monitoring. Treatment should consist of general measures employed in the management of overdosage with any drug. Consider the possibility of multiple drug overdosage. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Use supportive and symptomatic measures. There is no specific antidote to Risperidone.

Physicians are advised to discuss the following issues with patients for whom they prescribe Risperidone and their caregivers:

Orthostatic Hypotension

Advise patients and caregivers about the risk of orthostatic hypotension, especially during the period of initial dose titration [see Warnings and Precautions (5.7)].

Interference with Cognitive and Motor Performance

Inform patients and caregivers that Risperidone has the potential to impair judgment, thinking, or motor skills. Advise caution about operating hazardous machinery, including automobiles, until patients are reasonably certain that Risperidone therapy does not affect them adversely [see Warnings and Precautions (5.10)].

Pregnancy

Advise patients and caregivers to notify their physician if the patient becomes pregnant or intends to become pregnant during therapy [see Use in Specific Populations (8.1)].

Nursing

Inform patients and caregivers that Risperidone and its active metabolite are present in human breast milk; there is a potential for serious adverse reactions from Risperidone in nursing infants. Advise patients that the decision whether to discontinue nursing or to discontinue the Risperidone should take into account the importance of the drug to the patient [see Use in Specific Populations (8.3)].

Concomitant Medication

Advise patients and caregivers to inform their physicians if the patient is taking, or plans to take, any prescription or over-the-counter drugs, because there is a potential for interactions [see Drug Interactions (7)].

Alcohol

Advise patients to avoid alcohol while taking Risperidone

[see Drug Interactions (7.2)].

Metabolic Changes

Inform patients and caregivers that treatment with Risperidone can be associated with hyperglycemia and diabetes mellitus, dyslipidemia, and weight gain [see Warnings and Precautions (5.5)].

Tardive Dyskinesia

Inform patients and caregivers about the risk of tardive dyskinesia [see Warnings and Precautions (5.4)].

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India

Revised: 03/2017

NDC 65862-119-60
Risperidone
Tablets, USP
0.25 mg
Rx only                   60 Tablets
AUROBINDO

NDC 65862-120-10
Risperidone 
Tablets, USP
0.5 mg
Rx only                   100 Tablets (10 x 10 Unit-dose)
AUROBINDO

NDC 65862-121-60
Risperidone
Tablets, USP
1 mg
Rx only                   60 Tablets
AUROBINDO

NDC 65862-124-60
Risperidone
Tablets, USP
4 mg
Rx only                   60 Tablets
AUROBINDO

NDC 65862-124-10
Risperidone
Tablets, USP
4 mg
Rx only                   100 Tablets (10 x 10 Unit-dose)
AUROBINDO

• RisperDAL
• RisperDAL Consta
• RisperDAL M-TAB
• RisperiDONE M-TAB

Cl of parent drug and active metabolite decreased 60%.

Injection:

Bipolar disorder: As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.

Schizophrenia: Treatment of schizophrenia.

Oral:

Bipolar mania:

Monotherapy: For the treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and in children and adolescents 10 to 17 years of age.

Adjunctive therapy: As adjunctive therapy with lithium or valproate for the treatment of adults with acute manic or mixed episodes associated with bipolar I disorder.

Irritability associated with autistic disorder: For the treatment of irritability associated with autistic disorder in children and adolescents 5 to 17 years of age, including symptoms of aggression toward others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

Schizophrenia: For the treatment of schizophrenia in adults and adolescents 13 to 17 years of age.

Injection: Risperdal Consta: Store at 2°C to 8°C (36°F to 46°F) and protect from light. May be stored at 25°C (77°F) for up to 7 days prior to administration; do not expose unrefrigerated product to temperatures above 77°F (25°C). Following reconstitution, administer immediately (do not store for future use).

Oral solution, tablet: Store at 15°C to 25°C (59°F to 77°F). Protect from light and moisture. Keep orally-disintegrating tablets sealed in foil pouch until ready to use. Do not freeze solution.

Taking risperidone with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• blood pressure medication;

• carbamazepine;

• clozapine;

• fluoxetine (Prozac) or paroxetine (Paxil); or

• levodopa.

This list is not complete. Other drugs may interact with risperidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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

General

IM Injection: The most commonly reported side effects include tremor, headache, parkinsonism, akathisia, and dizziness.

Oral: The most commonly reported side effects included sedation, increased appetite, extrapyramidal symptoms, and parkinsonism.[Ref]

Nervous system

IM Injection:
Very common (10% or more): Tremor (up to 24%), headache (up to 21%), parkinsonism (up to 15%), akathisia (up to 11%), dizziness (up to 11%)
Common (1% to 10%): Abnormal gait, bradykinesia, cogwheel rigidity, disturbance in attention, drooling, dyskinesia, dystonia, hypoesthesia, hypokinesia, sedation, somnolence, syncope, tardive dyskinesia
Uncommon (0.1% to 1%): Abnormal coordination, balance disorder, cerebral ischemia, convulsion, dysarthria, dysgeusia, loss of consciousness, paresthesia, postural dizziness, psychomotor hyperactivity, vertigo
Rare (0.01% to 0.1%): Cerebrovascular disorder, depressed level of consciousness, diabetic coma, head titubation, neuroleptic malignant syndrome, unresponsive to stimuli
Frequency not reported: Abnormal glabellar reflex, akinesia, athetosis, cerebrovascular accident, choreoathetosis, emprosthotonus, extrapyramidal disorder, facial spasm, gait disturbance, grand mal convulsion, head titubation, hyperkinesia, hypertonia, masked facies, movement disorder, myoclonus, myotonia, opisthotonos, parkinsonian gait, parkinsonian rest tremor, pleurothotonus, restless legs syndrome, risus sardonicus, speech disorder, tongue paralysis, transient ischemic attack

Oral:
Very common (10% or more): Sedation (up to 63%), extrapyramidal symptoms (up to 35%), parkinsonism (up to 28%), somnolence (up to 26.5%), headache (up to 22.4%), dizziness (up to 16%), drooling (up to 12%), tremor (up to 11%), akathisia (up to 10.1%)
Common (1% to 10%): Balance disorder, cerebrovascular accident, depressed level of consciousness, disturbance in attention, dysarthria, dyskinesia, dystonia, gait disturbance, hypersomnia, lethargy, postural dizziness, syncope, transient ischemic attack
Uncommon (0.1% to 1%): Abnormal coordination, abnormal gait, cerebral ischemia, convulsion, dysgeusia, hypoesthesia, loss of consciousness, paresthesia, psychomotor hyperactivity, speech disorder, tardive dyskinesia, unresponsive to stimuli, vertigo
Rare (0.01% to 0.1%): Cerebrovascular disorder, diabetic coma, head titubation, neuroleptic malignant syndrome
Frequency not reported: Abnormal glabellar reflex, akinesia, athetosis, bradykinesia, chorea, choreoathetosis, cogwheel rigidity, emprosthotonus, facial spasm, grand mal convulsion, hyperkinesia, hypertonia, hypokinesia, masked facies, movement disorder, myoclonus, myotonia, opisthotonos, parkinsonian rest tremor, Parkinson's disease, pleurothotonus, restless legs syndrome, risus sardonicus, tongue paralysis
Postmarketing reports: Seizure[Ref]

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

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

Metabolic

IM Injection:
Common (1% to 10%): Anorexia, decreased appetite, decreased weight, hyperglycemia, increased appetite, increased weight
Uncommon (0.1% to 1%): Blood cholesterol increased, blood triglycerides increased, diabetes mellitus
Rare (0.01% to 0.1%): Hyperinsulinemia, hypoglycemia, polydipsia, water intoxication
Very rare (less than 0.01%): Diabetic ketoacidosis
Frequency not reported: Blood glucose increased, tetany, thirst
Postmarketing reports: Aggravated diabetes mellitus

Oral:
Very common (10% or more): Increased appetite (up to 44%)
Common (1% to 10%): Decreased appetite, increased weight, thirst
Uncommon (0.1% to 1%): Anorexia, blood cholesterol increased, blood triglycerides increased, decreased weight, diabetes mellitus, hyperglycemia, polydipsia
Rare (0.01% to 0.1%): Hyperinsulinemia, hypoglycemia, water intoxication
Very rare (less than 0.01%): Diabetic ketoacidosis
Frequency not reported: Blood glucose increased, tetany[Ref]

Psychiatric

IM Injection:
Common (1% to 10%): Agitation, anxiety, decreased libido, depression, insomnia, sleep disorder
Uncommon (0.1% to 1%): Anorgasmia, confusional state, mania, nervousness, nightmare
Rare (0.01% to 0.1%): Blunted affect, drug withdrawal syndrome, neonatal drug withdrawal syndrome
Frequency not reported: Initial insomnia, listlessness, middle insomnia, restlessness

Oral:
Very common (10% or more): Insomnia (up to 32%), anxiety (up to 16%)
Common (1% to 10%): Agitation, confusional state, depression, listlessness, mild insomnia, nervousness, sleep disorder
Uncommon (0.1% to 1%): Decreased libido, mania, nightmare
Rare (0.01% to 0.1%): Anorgasmia, blunted affect, drug withdrawal syndrome, neonatal drug withdrawal syndrome
Frequency not reported: Initial insomnia, middle insomnia[Ref]

Other

IM Injection:
Common (1% to 10%): Asthenia, extremity pain, fall, fatigue, pain, pyrexia
Uncommon (0.1% to 1%): Body temperature increased, chills, ear infection, ear pain, feeling abnormal, malaise, procedural pain, tinnitus
Rare (0.01% to 0.1%): Body temperature decreased, discomfort, hypothermia, peripheral coldness
Frequency not reported: Chronic otitis media, otitis media, sluggishness, sudden death

Oral:
Very common (10% or more): Fatigue (up to 31%), pyrexia (up to 16%)
Common (1% to 10%): Asthenia, ear infection, ear pain, fall, feeling abnormal, increased body temperature, pain, sluggishness
Uncommon (0.1% to 1%): Chills, discomfort, malaise, procedural pain, tinnitus
Rare (0.01% to 0.1%): Decreased body temperature, hypothermia, peripheral coldness
Frequency not reported: Adverse reaction, chronic otitis media, otitis media
Postmarketing reports: Body temperature dysregulation, sudden death[Ref]

Gastrointestinal

IM Injection:
Common (1% to 10%): Abdominal discomfort, abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, gastroenteritis, nausea, salivary hypersecretion, toothache, vomiting
Uncommon (0.1% to 1%): Dysphagia, fecal incontinence, flatulence
Rare (0.01% to 0.1%): Cheilitis, fecaloma, intestinal obstruction, pancreatitis, swollen tongue
Very rare (less than 0.01%): Ileus
Frequency not reported: Aptyalism, gastritis, lip swelling, stomach discomfort, tongue spasm, upper abdominal pain

Oral:
Very common (10% or more): Vomiting (up to 20%), constipation (up to 17%), nausea (up to 16%), upper abdominal pain (up to 16%), dry mouth (up to 10%), dyspepsia (up to 10%), salivary hypersecretion (up to 10%)
Common (1% to 10%): Abdominal discomfort/pain, diarrhea, dysphagia, fecaloma, stomach discomfort, toothache
Uncommon (0.1% to 1%): Fecal incontinence, flatulence, gastroenteritis
Rare (0.01% to 0.1%): Cheilitis, intestinal obstruction, lip swelling, pancreatitis, swollen tongue
Very rare (less than 0.01%): Ileus
Frequency not reported: Aptyalism, gastritis, tongue protrusion, tongue spasm[Ref]

Respiratory

IM Injection:
Common (1% to 10%): Bronchitis, cough, dyspnea, nasal congestion, pharyngolaryngeal pain, pneumonia, sinus congestion, sinusitis, upper respiratory tract infection
Uncommon (0.1% to 1%): Epistaxis, hyperventilation, respiratory tract congestion/infection, tonsillitis, wheezing
Rare (0.01% to 0.1%): Aspiration pneumonia, dysphonia, laryngospasm, oropharyngeal spasm, pulmonary congestion, pulmonary embolism, rales, respiratory disorder, sleep apnea syndrome
Frequency not reported: Bronchopneumonia, lower respiratory tract infection, nasal edema, nasopharyngitis, pharyngitis, productive cough, rhinitis, rhinorrhea, tracheobronchitis

Oral:
Very common (10% or more): Nasopharyngitis (up to 19%), cough (up to 17%), rhinorrhea (up to 12%), nasal congestion (up to 10%), pharyngolaryngeal pain (up to 10%)
Common (1% to 10%): Bronchitis, dyspnea, epistaxis, pneumonia, pulmonary congestion, rhinitis, sinus congestion, sinusitis, upper respiratory tract infection
Uncommon (0.1% to 1%): Aspiration pneumonia, dysphonia, rales, respiratory disorder, respiratory tract congestion/infection, tonsillitis, wheezing
Rare (0.01% to 0.1%): Hyperventilation, pulmonary embolism, sleep apnea syndrome
Frequency not reported: Bronchopneumonia, laryngospasm, lower respiratory tract infection, nasal edema, oropharyngeal spasm, pharyngitis, productive cough, tracheobronchitis[Ref]

Genitourinary

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

IM Injection:
Common (1% to 10%): Amenorrhea, erectile dysfunction, galactorrhea, menstrual disorder, sexual dysfunction, urinary incontinence, urinary tract infection
Uncommon (0.1% to 1%): Breast discomfort/pain/discharge, delayed menstruation, dysuria, ejaculation disorder, pollakiuria, urinary retention
Rare (0.01% to 0.1%): Breast discharge/engorgement/enlargement
Frequency not reported: Anovulation, delayed ejaculation, ejaculation failure, enuresis, fertility disorder, irregular menstruation, menstrual disturbances, oligomenorrhea, retrograde ejaculation, vaginal discharge
Postmarketing reports: Priapism

Oral:
Very common (10% or more): Enuresis (up to 16%), urinary tract infection (up to 12.9%)
Common (1% to 10%): Ejaculation failure, galactorrhea, pollakiuria, urinary incontinence
Uncommon (0.1% to 1%): Amenorrhea, breast discomfort, breast pain, dysuria, ejaculation disorder, erectile dysfunction, menstrual disorder, sexual dysfunction, urinary retention, vaginal discharge
Rare (0.01% to 0.1%): Breast discharge/engorgement/enlargement, delayed menstruation, priapism
Frequency not reported: Abnormal sexual dysfunction, anovulation, fertility disorder, irregular menstruation, oligomenorrhea, retrograde ejaculation[Ref]

Musculoskeletal

IM Injection:
Very common (10% or more): Muscle rigidity (up to 11%)
Common (1% to 10%): Abnormal posture, arthralgia, back pain, muscle spasms, muscle twitching, musculoskeletal pain
Uncommon (0.1% to 1%): Blood creatine phosphokinase increased, joint stiffness, joint swelling, muscular weakness, neck pain
Rare (0.01% to 0.1%): Rhabdomyolysis
Frequency not reported: Buttock pain, involuntary muscle contractions, muscle contracture, muscle rigidity, musculoskeletal chest pain, musculoskeletal stiffness, myalgia, nuchal rigidity, torticollis, trismus

Oral:
Common (1% to 10%): Abnormal posture, arthralgia, back pain, blood creatine phosphokinase increased, extremity pain, joint swelling, muscle spasms, musculoskeletal pain, myalgia, neck pain
Uncommon (0.1% to 1%): Joint stiffness, muscular weakness
Rare (0.01% to 0.1%): Rhabdomyolysis
Frequency not reported: Buttock pain, cervical spasm, involuntary muscle contractions, muscle contracture, muscle rigidity, muscle tightness, muscle twitching, musculoskeletal chest pain, musculoskeletal stiffness, nuchal rigidity, torticollis, trismus[Ref]

Cardiovascular

IM Injection:
Common (1% to 10%): Chest pain, edema, electrocardiogram QT prolonged, hypertension, hypotension, orthostatic hypotension, peripheral edema, right bundle branch block, tachycardia
Uncommon (0.1% to 1%): Abnormal electrocardiogram, atrial fibrillation, atrioventricular block, bradycardia, chest discomfort, conduction disorder, palpitations
Rare (0.01% to 0.1%): Flushing, sinus arrhythmias, venous thrombosis/thromboembolism
Frequency not reported: Cardiac arrest, decreased blood pressure, deep vein thrombosis, first degree atrioventricular block, generalized edema, increased heart rate, left bundle branch block, pitting edema, postural orthostatic tachycardia syndrome, sinus bradycardia, sinus tachycardia, Torsade de pointes, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia

Oral:
Common (1% to 10%): Chest discomfort/pain, edema, hypertension, hypotension, increased heart rate, orthostatic hypotension, palpitations, peripheral edema, pitting edema, tachycardia
Uncommon (0.1% to 1%): Abnormal electrocardiogram, atrial fibrillation, atrioventricular block/first degree atrioventricular block, bradycardia, bundle branch block/left bundle branch block/right bundle branch block, conduction disorder, electrocardiogram QT prolonged, flushing, palpitations
Rare (0.01% to 0.1%): Sinus arrhythmia, venous thrombosis/thromboembolism
Frequency not reported: Decreased blood pressure, generalized edema, postural orthostatic tachycardia syndrome, sinus bradycardia, sinus tachycardia, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, Torsade de pointes
Postmarketing reports: Cardiac/cardiopulmonary arrest, deep vein thrombosis[Ref]

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.[Ref]

Dermatologic

IM Injection:
Common (1% to 10%): Acne, dry skin, rash
Uncommon (0.1% to 1%): Acarodermatitis, alopecia, cellulitis, eczema, erythema, facial edema, induration, onychomycosis, pruritus, seborrheic dermatitis, skin discoloration, subcutaneous abscess
Rare (0.01% to 0.1%): Dandruff, drug eruption, hyperkeratosis, skin disorder, skin lesion, urticaria
Frequency not reported: Erythematous rash, generalized pruritus, generalized rash, maculopapular rash, papular rash

Oral:
Common (1% to 10%): Acne, cellulitis, dandruff, dry skin, erythema, hyperkeratosis, pruritus, rash, seborrheic dermatitis
Uncommon (0.1% to 1%): Acarodermatitis, alopecia, eczema, facial edema, onychomycosis, skin discoloration, skin disorder, skin lesion, urticaria
Rare (0.01% to 0.1%): Drug eruption, induration
Frequency not reported: Erythematous rash, generalized rash, maculopapular rash, papular rash, subcutaneous abscess[Ref]

Ocular

IM Injection:
Common (1% to 10%): Blurred vision, reduced visual acuity
Uncommon (0.1% to 1%): Conjunctivitis, dry eye, eye infection, lacrimation disorder, ocular hyperemia
Rare (0.01% to 0.1%): Eye movement disorder, eye rolling, eyelid margin crusting, glaucoma, intraoperative floppy iris syndrome, photophobia, retinal artery occlusion
Frequency not reported: Eye discharge, eye swelling, eyelid edema, increased lacrimation

Oral:
Common (1% to 10%): Blurred vision, conjunctivitis
Uncommon (0.1% to 1%): Dry eye, eye discharge, eye infection, eye swelling, increased lacrimation, ocular hyperemia, photophobia
Rare (0.01% to 0.1%): Eye movement disorder, eye rolling, eyelid margin crusting, glaucoma, intraoperative floppy iris syndrome, reduced visual acuity
Frequency not reported: Blepharospasm, eyelid edema, oculogyration[Ref]

Immunologic

IM Injection:
Common (1% to 10%): Infection, influenza, viral infection
Frequency not reported: Influenza-like illness

Oral:
Common (1% to 10%): Influenza/influenza-like illness
Uncommon (0.1% to 1%): Viral infection
Frequency not reported: Infection[Ref]

Endocrine

IM Injection:
Common (1% to 10%): Hyperprolactinemia
Uncommon (0.1% to 1%): Gynecomastia
Rare (0.01% to 0.1%): Inappropriate antidiuretic hormone secretion
Frequency not reported: Blood prolactin increased

Oral:
Common (1% to 10%): Blood prolactin increased, hyperprolactinemia
Uncommon (0.1% to 1%): Gynecomastia
Rare (0.01% to 0.1%): Inappropriate antidiuretic hormone secretion
Postmarketing reports: Pituitary adenoma, precocious puberty[Ref]

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

Renal

IM Injection:
Uncommon (0.1% to 1%): Cystitis, glucose urine present

Oral:
Uncommon (0.1% to 1%): Cystitis
Rare (0.01% to 0.1%): Glucose urine present[Ref]

Hematologic

IM Injection:
Common (1% to 10%): Anemia
Uncommon (0.1% to 1%): Decreased hematocrit, decreased white blood cell count, thrombocytopenia
Rare (0.01% to 0.1%): Agranulocytosis, increased eosinophil count, neutropenia
Frequency not reported: Decreased hemoglobin, granulocytopenia, thrombocytopenia

Oral:
Common (1% to 10%): Anemia
Uncommon (0.1% to 1%): Decreased hematocrit, decreased white blood cell count, increased eosinophil count, neutropenia, thrombocytopenia
Rare (0.01% to 0.1%): Agranulocytosis
Frequency not reported: Decreased hemoglobin, granulocytopenia
Postmarketing reports: Thrombotic thrombocytopenic purpura[Ref]

Hepatic

IM Injection:
Common (1% to 10%): Gamma-glutamyltransferase increased, increased transaminases
Uncommon (0.1% to 1%): Hepatic enzymes increased
Rare (0.01% to 0.1%): Jaundice
Frequency not reported: ALT increased, AST increased

Oral:
Uncommon (0.1% to 1%): Hepatic enzymes increased, increased ALT, increased AST, increased transaminases, gamma glutamyltransferase increased
Rare (0.01% to 0.1%): Jaundice[Ref]

Local

IM Injection:
Common (1% to 10%): Injection site reaction
Uncommon (0.1% to 1%): Localized infection
Frequency not reported: Injection site induration, injection site pain, injection site swelling
Postmarketing reports: Injection site abscess, injection site cellulitis, injection site cyst, injection site hematoma, injection site necrosis, injection site nodule, injection site ulcer

Oral:
Uncommon (0.1% to 1%): Localized infection[Ref]

Hypersensitivity

There have been post marketing reports of anaphylactic reaction in patients who had previously tolerated oral risperidone.[Ref]

IM Injection:
Uncommon (0.1% to 1%): Hypersensitivity
Rare (0.01% to 0.1%): Anaphylactic reaction
Very rare (less than 0.01%): Angioedema
Frequency not reported: Drug hypersensitivity

Oral:
Common (1% to 10%): Angioedema, hypersensitivity
Rare (0.01% to 0.1%): Anaphylactic reaction
Frequency not reported: Drug hypersensitivity[Ref]

Some side effects of risperidone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

• Some effects may be noticed within a few days but it may take up to three to four weeks for the full effects of risperidone to be seen.
• Risperidone is metabolized to an active metabolite, 9-hydroxy-risperidone.
• Risperidone orally disintegrating tablets, risperidone oral solution, and risperidone tablets are all bioequivalent (this means that there is no difference in the extent to which they are absorbed and reach the site of effect).

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