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Risperidone, sold under the trade name Risperdal among others, is an antipsychotic medication.
Common side effects include movement problems, sleepiness, dizziness, trouble seeing, constipation, and increased weight.
Study of risperidone began in the late 1980s and it was approved for sale in the United States in 1993.
1 Medical uses
1.2 Bipolar disorder
1.4 Other uses
2 Adverse effects
2.1 Drug interactions
4 Society and culture
4.1 Regulatory status
6 External links
Risperidone is mainly used for the treatment of schizophrenia, bipolar disorder, and irritability associated with autism.
Risperidone is effective in treating the acute exacerbations of schizophrenia.
Studies evaluating the utility of risperidone by mouth for maintenance therapy have reached varying conclusions. A 2012 systematic review concluded that there is strong evidence that risperidone is more effective than all first generation antipsychotics other than haloperidol, but that evidence directly supporting its superiority to placebo is equivocal.
Risperidone seems to produce somewhat more extrapyramidal side effects and clearly more prolactin increase than most other atypical antipsychotics. It may also differ from other compounds in the occurrence of other adverse effects such as weight gain, metabolic problems, cardiac effects, sedation and seizures. Nevertheless, the large proportion of participants leaving studies early and incomplete reporting of outcomes makes it difficult to draw firm conclusions.
Findings in words
Findings in numbers
Quality of evidence
No clinically significant response
Risperidone is not clearly different when compared to olanzapine. Data supporting this finding are based on moderate quality evidence.
RR 1.06 (0.99 to 1.13)
Leaving the study early due to any reason
Risperidone probably slightly increases the chance of leaving the study early, when compared with olanzapine. Data are based on moderate quality evidence.
RR 1.14 (1.07 to 1.21)
Number of patients re-hospitalized Follow-up: up to 12 weeks
There is no clear difference between risperidone and olanzapine for the outcome of how much hospital/community care is used. These findings are based on data of low quality.
RR 1.35 (0.41 to 4.40)
Average PANSS score (high = poor) Follow-up: up to 12 weeks
On average, people receiving risperidone scored slightly higher (worse) than people treated with olanzapine but there was no clear difference between the groups. The meaning of this in day-to-day care is unclear. This finding is based on data of low quality.
MD 0.97 higher (1.1 lower to 3.05 higher)
At least one adverse effect
There was no clear difference between risperidone and olanzapine for this very general adverse effect outcome. These findings are based on data of low quality.
RR 0.96 (0.88 to 1.03)
Quality of life
Average QLS scale score (high = poor) Follow-up: over 26 weeks
On average, people receiving risperidone scored higher than people treated with olanzapine. There was no clear difference between the groups. The meaning of this in day-to-day care is unclear. This finding is based on data of moderate quality.
MD 0.97 higher (1.1 lower to 3.05 higher)
Long-acting injectable formulations of antipsychotic drugs provide improved compliance with therapy and reduce relapse rates relative to oral formulations.
Second generation antipsychotics, including risperidone, are effective in the treatment of manic symptoms in acute manic or mixed exacerbations of bipolar disorder.
Compared to placebo, risperidone treatment reduces certain problematic behaviors in autistic children, including aggression toward others, self-injury, temper tantrums, and rapid mood changes. The evidence for its efficacy appears to be greater than that for alternative pharmacological treatments.
Risperidone has shown promise in treating therapy resistant obsessive–compulsive disorder, when serotonin reuptake inhibitors are not sufficient.
Risperidone has not demonstrated a benefit in the treatment of eating disorders or personality disorders.
While antipsychotic medications such as risperidone have a slight benefit in people with dementia, they have been linked to higher incidences of death and stroke.
See also: List of adverse effects of risperidone
Common side effects include movement problems, sleepiness, dizziness, trouble seeing, constipation, and increased weight.
While atypical antipsychotics appear to have a lower rate of movement problems as compared to typical antipsychotics, risperidone has a high risk of movement problems among the atypicals.
Carbamazepine and other enzyme inducers may reduce plasma levels of risperidone.
CYP2D6 inhibitors, such as SSRI medications, may increase plasma levels of risperidone.
Since risperidone can cause hypotension, its use should be monitored closely when a patient is also taking anti-hypertensive medicines to avoid severe low blood pressure.
The British National Formulary recommends a gradual withdrawal when discontinuing antipsychotic treatment to avoid acute withdrawal syndrome or rapid relapse.
Older people with dementia-related psychosis are at a higher risk of death if they take risperidone compared to those who do not. Most deaths are related to heart problems or infections.
See also: Atypical antipsychotic § Pharmacodynamics, and Antipsychotic § Comparison of medications
K i (nM)
Risperidone pharmacodynamics excluding D -amino acid oxidase inhibition
Risperidone has been classified as a “qualitatively atypical” antipsychotic agent with a relatively low incidence of extrapyramidal side effects (when given at low doses) that has more pronounced serotonin antagonism than dopamine antagonism. Risperidone contains the functional groups of benzisoxazole and piperidine as part of its molecular structure. Although not a butyrophenone, it was developed with the structures of benperidol and ketanserin as a basis. It has actions at several 5-HT ( serotonin ) receptor subtypes. These are 5-HT 2C, linked to weight gain, 5-HT 2A, linked to its antipsychotic action and relief of some of the extrapyramidal side effects experienced with the typical neuroleptics.
It was recently found that D -amino acid oxidase, the enzyme that catalyses the breakdown of D -amino acids (e.g. D -alanine and D -serine — the neurotransmitters) is inhibited by risperidone.
Risperidone acts on the following receptors:
Dopamine receptors : This drug is an antagonist of the D 1 (D 1, and D 5 ) as well as the D 2 family (D 2, D 3 and D 4 ) receptors, with 70-fold selectivity for the D 2 family. This drug has “tight binding” properties, which means it has a long half-life and like other antipsychotics, risperidone blocks the mesolimbic pathway, the prefrontal cortex limbic pathway, and the tuberoinfundibular pathway in the central nervous system. Risperidone may induce extrapyramidal side effects, akathisia and tremors, associated with diminished dopaminergic activity in the striatum. It can also cause sexual side effects, galactorrhoea, infertility, gynecomastia and, with chronic use reduced bone mineral density leading to breaks, all of which are associated with increased prolactin secretion.
Serotonin receptors : Its action at these receptors may be responsible for its lower extrapyramidal side effect liability (via the 5-HT 2A/2C receptors) and improved negative symptom control compared to typical antipsychotics such as haloperidol for instance. Its antagonistic actions at the 5-HT 2C receptor may account, in part, for its weight gain liability.
Alpha α 1 adrenergic receptors : This action accounts for its orthostatic hypotensive effects and perhaps some of the sedating effects of risperidone.
Alpha α 2 adrenergic receptors : Perhaps greater positive, negative, affective and cognitive symptom control.
Histamine H 1 receptors : effects on these receptors account for its sedation and reduction in vigilance. This may also lead to drowsiness and weight gain.
Though this medication possesses similar effects to other typical and atypical antipsychotics, it does not possess an affinity for the muscarinic acetylcholine receptors. In many respects, this medication can be useful as an ” acetylcholine release-promoter” similar to gastrointestinal drugs such as metoclopramide and cisapride.
Risperidone undergoes hepatic metabolism and renal excretion. Lower doses are recommended for patients with severe liver and kidney disease.
Society and culture
Risperdal (risperidone) 4 mg tablets ( UK )
Risperidone was approved by the United States Food and Drug Administration (FDA) in 1993 for the treatment of schizophrenia.
Janssen’s patent on risperidone expired on December 29, 2003, opening the market for cheaper generic versions from other companies, and Janssen’s exclusive marketing rights expired on June 29, 2004 (the result of a pediatric extension). It is available under many brand names worldwide.
Risperidone is available as a tablet, an oral solution, and an ampule, which is a depot injection.
On 11 April 2012, Johnson & Johnson (J&J) and its subsidiary Janssen Pharmaceuticals Inc. were fined $1.2 billion by Judge Timothy Davis Fox of the Sixth Division of the Sixth Judicial Circuit of the U.S. state of Arkansas.
In August 2012, Johnson & Johnson agreed to pay $181 million to 36 U.S. states in order to settle claims that it had promoted risperidone and paliperidone for off-label uses including for dementia, anger management, and anxiety.
In November 2013, J&J was fined $2.2 billion for illegally marketing risperidone for use in people with dementia.
J&J has faced numerous civil lawsuits on behalf of children who were prescribed risperidone who grew breasts (a condition called gynecomastia ); as of July 2016 there were about 1,500 cases in Pennsylvania state court in Philadelphia, and there had been a February 2015 verdict against J&J with $2.5 million awarded to a man from Alabama, a $1.75M verdict against J&J that November, and in 2016 a $70 million verdict against J&J.
In 2015, Steven Brill posted a 15-part investigative journalism piece on J&J in Huffington Post, called “America’s most admired lawbreaker”, which was focused on J&J’s marketing of risperidone.
Brand names include Risperdal, Risperdal Consta, Risperdal M-Tab, Risperdal Quicklets, and Risperlet.
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