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Risperdal M-Tab Side Effects

Generic name: risperidone

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

Note: This document provides detailed information about Risperdal M-Tab Side Effects associated with risperidone. Some dosage forms listed on this page may not apply specifically to the brand name Risperdal M-Tab.

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

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Oral route (tablet; tablet, disintegrating; solution)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

RisperiDONE is not approved for the treatment of patients with dementia-related psychosis.

Serious side effects of Risperdal M-Tab

Along with its needed effects, risperidone (the active ingredient contained in Risperdal M-Tab) 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 Risperdal M-Tab

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:

Oral:

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:

Oral:

Psychiatric

IM Injection:

Oral:

Other

IM Injection:

Oral:

Gastrointestinal

IM Injection:

Oral:

Respiratory

IM Injection:

Oral:

Genitourinary

IM Injection:

Oral:

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:

Oral:

Cardiovascular

IM Injection:

Oral:

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:

Oral:

Ocular

IM Injection:

Oral:

Immunologic

IM Injection:

Oral:

Endocrine

IM Injection:

Oral:

Risperidone (the active ingredient contained in Risperdal M-Tab) 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:

Oral:

Hematologic

IM Injection:

Oral:

Hepatic

IM Injection:

Oral:

Local

IM Injection:

Oral:

Hypersensitivity

IM Injection:

Oral:

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

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."

Frequently asked questions

Further information

Risperdal M-Tab 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.