Risperdal Side Effects

Generic name: risperidone

Medically reviewed by Drugs.com. Last updated on Dec 12, 2023.

Note: This document provides detailed information about Risperdal.

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 Side Effects associated with risperidone. Some dosage forms listed on this page may not apply specifically to the brand name Risperdal.

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

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 (the active ingredient contained in Risperdal) 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

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

• What is the difference between Perseris and Risperdal Consta?

Further information

Risperdal side effects can vary depending on the individual. 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.

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