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Risperdal Consta Side Effects

Generic Name: risperidone

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

For the Consumer

Applies to risperidone: oral solution, oral tablet, oral tablet disintegrating

Along with its needed effects, risperidone (the active ingredient contained in Risperdal Consta) 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

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
  • Constipation
  • cough
  • diarrhea
  • dry mouth
  • headache
  • heartburn
  • increased dream activity
  • increased length of sleep
  • nausea
  • sleepiness or unusual drowsiness
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
  • weight gain
Less common
  • Absent, missed, or irregular menstrual periods
  • body aches or pain
  • breast swelling or soreness
  • chills
  • dandruff
  • darkening of skin color
  • decreased interest in sexual intercourse
  • dry skin
  • ear congestion
  • fever
  • 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
  • shortness of breath or troubled breathing
  • sneezing
  • stomach pain
  • stopping of menstrual bleeding
  • tightness in the chest
  • toothache
  • unusual breast milk production
  • vomiting
  • weight loss

For Healthcare Professionals

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 (the active ingredient contained in Risperdal Consta) 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 (the active ingredient contained in Risperdal Consta) [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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Risperdal (risperidone)." Janssen Pharmaceutica, Titusville, NJ.

4. "Product Information. Risperdal Consta (risperidone)." Janssen Pharmaceuticals, Titusville, NJ.

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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