Risperidone Side Effects
Medically reviewed by Drugs.com. Last updated on May 24, 2024.
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
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
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%): 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]
Frequently asked questions
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- Risperidone monograph
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Related treatment guides
References
1. (2001) "Product Information. Risperdal (risperidone)." Janssen Pharmaceuticals
2. (2005) "Product Information. Risperdal Consta (risperidone)." Janssen Pharmaceuticals
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.