Risperdal Consta Side Effects

Generic Name: risperidone

Note: This page contains side effects data for the generic drug risperidone. It is possible that some of the dosage forms included below may not apply to the brand name Risperdal Consta.

It is possible that some side effects of Risperdal Consta may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

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

As well as its needed effects, risperidone (the active ingredient contained in Risperdal Consta) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking risperidone, check with your doctor immediately:

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 risperidone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 of the chest or wheezing
  • 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

Nervous system

Very common (10% or more): Sedation (up to 63%), parkinsonism (up to 28%), akathisia (up to 10%), dizziness, (up to 14%), tremor (up to 11%), drooling (up to 12%), headache (up to 12%)
Common (1% to 10%): Dystonia, dyskinesia, gait disturbance
Uncommon (0.1% to 1%): Syncope
Rare (less than 0.1%): Tardive dyskinesia, cerebral ischemia, unresponsive to stimuli, depressed or loss of consciousness, psychomotor hyperactivity, balance disorder, abnormal coordination, attention disturbance
Very rare (less than 0.01%): Neuroleptic malignant syndrome, cerebrovascular disorder, head titubation
Frequency not reported: Vertigo, dysarthria, movement disorder, cerebrovascular accident, speech disorder, hypoesthesia, convulsion, paresthesia
Postmarketing reports: Dysgeusia

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.

Cardiovascular

Common (1% to 10%): Tachycardia, palpitations, orthostatic hypotension, hypotension
hypertension, peripheral edema, chest pain
Uncommon (0.1% to 1%): ECG QT prolonged, bundle branch block right, flushing
Frequency not reported: bradycardia, atrioventricular block, bundle branch block left, abnormal ECG
Postmarketing reports: Atrial fibrillation, deep vein thrombosis, cardiopulmonary arrest

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.

Endocrine

Common (1% to 10%): Hyperprolactinemia
Uncommon (0.1% to 1%): Gynecomastia, galactorrhea, breast pain, breast discomfort
Rare (less than 0.1%): Inappropriate antidiuretic hormone secretion, breast enlargement, breast discharge, breast engorgement
Postmarketing reports: Precocious puberty

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.

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.

Very common (10% or more): Enuresis (16%)
Common (1% to 10%): Urinary incontinence, urinary tract infection
Uncommon (0.1% to 1%): Amenorrhea, urinary retention, dysuria, pollakiuria, erectile dysfunction, ejaculation disorder, menstrual disorder, sexual dysfunction, vaginal discharge, cystitis
Rare (less than 0.1%): Delayed menstruation,
Frequency not reported: Retrograde ejaculation, ejaculation failure, libido decreased, anorgasmia
Postmarketing reports: Priapism, urinary retention

Gastrointestinal

Very common (10% or more): Nausea (16%), vomiting (20%), constipation (17%), abdominal pain (16%)
Common (1% to 10%): Dyspepsia, dysphagia, dry mouth, salivary hypersecretion, diarrhea, stomach discomfort
Uncommon (0.1% to 1%): Toothache, gastroenteritis, flatulence
Rare (less than 0.1%): Pancreatitis, swollen tongue, cheilitis
Frequency not reported: Aptyalism, fecaloma
Postmarketing reports: Ileus

Hepatic

Uncommon (0.1% to 1%): Increased gamma-glutamyltransferase, hepatic enzyme increases
Rare (less than 0.1%): Jaundice
Frequency not reported: Transaminases increased

Psychiatric

Very common (10% or more): Insomnia (32%), anxiety (16%)
Uncommon (0.1% to 1%): Nervousness
Rare (less than 0.1%): Mania, confusional state, nightmare
Very rare (less than 0.01%): Blunted affect
Frequency not reported: Agitation, sleep disorder, listlessness, depression

Ocular

Common (1% to 10%): Blurred vision, conjunctivitis
Uncommon (0.1% to 1%): Photophobia, dry eye, lacrimation increased,
Rare (less than 0.1%): Glaucoma, eye movement disorder, eyelid margin crusting
Frequency not reported: Ocular hyperemia, eye discharge, eye rolling, eyelid edema, eyelid swelling, visual acuity reduced, eye infection, blepharospasm
Postmarketing reports: Floppy iris syndrome, retinal artery occlusion

Metabolic

Very common (10% or more): Increased appetite (up to 44%),
Common (1% to 10%): Increased weight, decreased appetite
Uncommon (0.1% to 1%): Diabetes mellitus, hyperglycemia, polydipsia, weight decreased, anorexia, increased cholesterol,
Rare (less than 0.1%): Hypoglycemia, increased triglycerides,
Very rare (less than 0.01%): Diabetic coma
Postmarketing reports: Diabetic ketoacidosis, hyperinsulinemia, water intoxication, aggravated diabetes mellitus

Respiratory

Very common (10% or more): Nasopharyngitis (up to 19%), cough (up to 17%), rhinorrhea (up to 12%)
Common (1% to 10%): Upper respiratory tract infection, rhinitis, sinusitis, nasal congestion, dyspnea, pharyngolaryngeal pain
Uncommon (0.1% to 1%): Epistaxis, aspiration pneumonia, pulmonary congestion, rales, wheezing dysphonia, tonsillitis
Rare (less than 0.1%): Hyperventilation
Frequency not reported: Tonsillitis, bronchitis, pharyngitis, nasal edema, pneumonia, pharyngitis, bronchitis, bronchopneumonia
Postmarketing reports: Pulmonary embolism, sleep apnea syndrome

Other

Very common (10% or more): Fatigue (up to 31%), Pyrexia (up to 16%),
Common (1% to 10%): Asthenia, thirst,
Rare (less than 0.1%): Chills,
Very rare (less than 0.01%): Hypothermia, decreased body temperature, peripheral coldness, drug withdrawal syndrome, drug withdrawal in neonate
Frequency not reported: Ear pain, malaise, feeling abnormal, Influenza-like illness, ear infection, otitis media, tinnitus
Postmarketing reports: Sudden death, drug withdrawal syndrome,

Dermatologic

Common (1% to 10%): Rash, erythema, dry skin, acne, dandruff
Uncommon (0.1% to 1%): Seborrheic dermatitis, hyperkeratosis, urticaria, pruritus, alopecia, eczema, skin discoloration, skin lesion, skin disorder
Rare (less than 0.1%): Drug eruption
Postmarketing reports: Angioedema

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, extremity pain, muscle spasms
Uncommon (0.1% to 1%): Myalgia, neck pain, increased creatine phosphokinase, joint stiffness, joint swelling, abnormal posture, muscular weakness
Very rare (less than 0.01%): Rhabdomyolysis

Hypersensitivity

There have been post marketing reports of anaphylactic reaction in patients receiving long-acting injection who had previously tolerated oral risperidone (the active ingredient contained in Risperdal Consta)

Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction

Hematologic

Uncommon (0.1% to 1%): Neutropenia, WBC decreased, thrombocytopenia, anemia, decreased hematocrit, increased eosinophil count
Frequency not reported: Granulocytopenia, decreased hemoglobin,
Postmarketing reports: Agranulocytosis, thrombotic thrombocytopenic purpura

Immunologic

Uncommon (0.1% to 1%): Onychomycosis, acarodermatitis

General

The most commonly reported adverse reactions included parkinsonism, dizziness, akathisia, anxiety, fatigue, constipation, tremor, sedation, increased appetite, nausea, vomiting, abdominal pain, drooling, insomnia, nasopharyngitis, and nasal congestion.[Ref]

Local

Uncommon (0.1% to 1%): Redness, swelling, induration at injection site
Postmarketing reports: Serious injection site reactions, including abscess, cellulitis, cyst, hematoma, necrosis, nodule, and ulcer

Oncologic

Postmarketing reports: Pituitary adenoma

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 Consta (risperidone)." Janssen Pharmaceuticals, Titusville, NJ.

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