Note: This document contains side effect information about risperidone. Some dosage forms listed on this page may not apply to the brand name Uzedy.

Applies to risperidone: oral solution, oral tablet, oral tablet disintegrating. Other dosage forms:

• powder for suspension extended release, suspension extended release

Serious side effects of Uzedy

Along with its needed effects, risperidone (the active ingredient contained in Uzedy) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking risperidone:

More common

• Aggressive behavior
• agitation
• anxiety
• changes in vision, including blurred vision
• difficulty concentrating
• difficulty speaking or swallowing
• inability to move the eyes
• increase in amount of urine
• loss of balance control
• mask-like face
• memory problems
• muscle spasms of the face, neck, and back
• problems with urination
• restlessness or need to keep moving (severe)
• shuffling walk
• skin rash or itching
• stiffness or weakness of the arms or legs
• tic-like or twitching movements
• trembling and shaking of the fingers and hands
• trouble sleeping
• twisting body movements

Less common

• Back pain
• chest pain
• speech or vision problems
• sudden weakness or numbness in the face, arms, or legs

Rare

• Confusion
• dizziness
• drowsiness
• extreme thirst
• fast, shallow breathing
• fast, weak heartbeat
• headache
• increased thirst
• lip smacking or puckering
• loss of appetite
• muscle cramps
• pale, clammy skin
• poor coordination
• prolonged, painful, inappropriate erection of the penis
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• shivering
• talking, feeling, and acting with excitement and activity that cannot be controlled
• uncontrolled chewing movements
• uncontrolled twisting movements of neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions or body positions

Incidence not known

• Actions that are out of control
• bleeding gums
• bloating
• blood in the urine or stools
• bluish lips or skin
• change in mental status
• chills
• clay-colored stools
• clumsiness
• cold sweats
• constipation
• cool, pale skin
• cough
• dark or bloody urine
• decrease in the frequency of urination
• decrease in urine volume
• decreased awareness or responsiveness
• depression
• difficulty in passing urine (dribbling)
• dry mouth
• fainting
• fast or irregular heartbeat
• fever
• flushed, dry skin
• fruit-like breath odor
• hives
• hostility
• increased hunger
• increased urination
• indigestion
• irregular heartbeat, recurrent
• irritability
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of consciousness
• low body temperature muscle ache, twitching, or weakness
• nausea
• nervousness
• nightmares
• painful urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seizures
• severe constipation
• severe sleepiness
• shakiness
• slurred speech
• stomach pain
• swelling of the face, ankles, or hands
• tightness in the chest
• troubled breathing
• unexplained weight loss
• unpleasant breath odor
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting
• vomiting of blood
• weak or feeble pulse
• yellow eyes or skin

Other side effects of Uzedy

Some side effects of risperidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• heartburn
• increased dream activity
• increased length of sleep
• sore throat
• stuffy or runny nose

Less common

• Absent, missed, or irregular menstrual periods
• body aches or pain
• breast swelling or soreness
• dandruff
• darkening of skin color
• decreased interest in sexual intercourse
• dry skin
• ear congestion
• inability to have or keep an erection
• increase in body movements
• increased watering of the mouth
• joint pain
• loss in sexual ability, desire, drive, or performance
• loss of voice
• oily skin
• pain or tenderness around the eyes and cheekbones
• sneezing
• stopping of menstrual bleeding
• toothache
• unusual breast milk production
• weight loss

Incidence not known

• Acne
• change in taste
• enlargement of the penis or testes
• growth of pubic hair
• loss of taste
• rapid increase in height
• sleepwalking
• thinning or loss of hair

For Healthcare Professionals

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

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

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]

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]

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

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including risperidone (the active ingredient contained in Uzedy) 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]

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]

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

Risperidone (the active ingredient contained in Uzedy) 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%): 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]

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

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]

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