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Risperdal (Risperidone) - Summary



Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL® (risperidone) is not approved for the treatment of patients with dementia-related psychosis. [See Warnings and Precautions ]




RISPERDAL® contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.

RISPERDAL® is an atypical antipsychotic indicated for:

  • Treatment of schizophrenia (1.1)
  • As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2)
  • Treatment of irritability associated with autistic disorder (1.3)

RISPERDAL® (risperidone) is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1) ].



RISPERDAL® is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2) ].


Adjunctive Therapy

RISPERDAL® adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3) ].


RISPERDAL® is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4) ].


See all Risperdal indications & dosage >>


Published Studies Related to Risperdal (Risperidone)

Risperidone versus risperidone plus sodium valproate for treatment of bipolar disorders: a randomized, double-blind clinical-trial. [2014]
CONCLUSIONS: Risperidone can be effective and well tolerated in both acute manic

A head-to-head comparison of aripiprazole and risperidone for safety and treating autistic disorders, a randomized double blind clinical trial. [2014]
Aripiprazole and risperidone are the only FDA approved medications for treating irritability in autistic disorder, however there are no head-to-head data comparing these agents. This is the first prospective randomized clinical trial comparing the safety and efficacy of these two medications in patients with autism spectrum disorders...

Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. [2014]
antipsychotics in markedly-to-severely ill schizophrenia subjects... CONCLUSIONS: Using the recommended dosing regimens for PP and RLAI, both PP and

Double-blind, placebo-controlled trial of risperidone plus amantadine in children with autism: a 10-week randomized study. [2013]
risperidone for treatment of autism... CONCLUSIONS: The present study suggests that amantadine may be a potential

Memantine add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: randomized, double-blind, placebo-controlled study. [2013]
We aimed to evaluate the efficacy of memantine add-on in the treatment of primary negative symptoms of patients with stable schizophrenia. In a double-blind placebo-controlled clinical trial, 40 patients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) who were stabilized on risperidone for a minimum of 8 weeks were randomized to either memantine (20 mg) or placebo in addition to risperidone, 6 mg/d, for eight weeks...

more studies >>

Clinical Trials Related to Risperdal (Risperidone)

Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection (RISPERDAL CONSTA) [Completed]
The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.

Bioequivalence Test for Risperdal 2mg of Janssen Korea [Completed]
The purpose of this study was to conduct the bioequivalence (biological equivalence of two preparations of a drug) test in healthy adults with "Risperdal OD Tab. 2mg" of Janssen Korea as the investigational drug and "Risperdal Quicklet Tab. 2mg" as the control drug.

A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers [Completed]
This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline.

A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa [Active, not recruiting]
The aim of this pilot study is to determine the safety and efficacy of risperidone for the treatment of anorexia nervosa. Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image

distortion and Eating Disorder Inventory - 2 scores than subjects on placebo.

Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body weight sooner than controls.

Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia [Completed]
This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

more trials >>

Reports of Suspected Risperdal (Risperidone) Side Effects

Weight Increased (126)Self Injurious Behaviour (111)Somnolence (89)Suicide Attempt (85)Drug Ineffective (62)Aggression (55)Multiple Drug Overdose Intentional (53)Pneumonia (53)Type 2 Diabetes Mellitus (53)Insomnia (52)more >>


Based on a total of 8 ratings/reviews, Risperdal has an overall score of 3. The effectiveness score is 4.75 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Risperdal review by 30 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   Anxiety
Dosage & duration:   1 mg a day and as needed taken every day for the period of for 3+ years-currently, various doses
Other conditions:   bipolar disorder, add, hypothyroid
Other drugs taken:   Lamictal, Neurontin, Strattera, Levothyroid, Klonopin
Reported Results
Benefits:   In the case of a panic attack, this would soothe the anxiety and calm me down-a numbing sensation--a highly effective anti-psychotic in several situations--kept a low-level feeling of calmness and barrier to anxiety/stress
Side effects:   Unfortunately, weight gain was a marked side effect, and led me to take a lower dose--also in high doses, I almost felt like a zombie--totally numb and emotionless--a disturbing concept.
Comments:   Prescribed by my psychiatrist to use in various doses over several years of use to use for anxiety and panic, and in conjunction with Klonopin as an effective measure to reduce a mixed/manic episode of bipolar disorder in an acute situation, and also at a low-level dose every day to reduce the chance of episodes from occuring. Good tool in anger management as well.


Risperdal review by 28 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   phycotic episode
Dosage & duration:   I was to druged to remember (dosage frequency: daily) for the period of 10 months
Other conditions:   Bi-polar
Other drugs taken:   anti-depressent
Reported Results
Benefits:   The benefit to the drug was that yes it did work i was crazy (locked up in mental ward) and then after usage became normal (not crazy) again.However my treatment plan was not good. plan
Side effects:   The side affects were realy they inclued; Leg jerking/kicking in bed at night sudden stiffning of legs ( unable to walk) Eyes unable to close eyes rolling back into head unable to make it to the toilet on time sleeping a lot gained 12kg unable to think , no thoughts in head unable to concentrate
Comments:   The treatment plan was realy bad. Although i had gone from crazy back to normal again over an 8 day period i was then made to take the drug for another 9 and a half months there after. This drug should be used as needed e.g taken to stop being crazy, and then stopped once patient has returned to normal state NOT any longer! I was basicly druged up to the eye balls an lost almost a year of my life.


Risperdal review by 25 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   schizophrenia
Dosage & duration:   3.5 (dosage frequency: twice) for the period of enough to ruin me
Other conditions:   Depression
Other drugs taken:   Lexapro 10 mg
Reported Results
Benefits:   There were no known benefits. I truly believed that the doctor that prescribed me this stupid medication should rot in hell. There are too many side effects, especially long term ones. The worst part is, they did not even tell me how and why their diagnosis was accurate. they just prescribe drugs left and right as if they had no conscience or they are evil people just out for the money.
Side effects:   memory loss, heart diseasse, increased panick attacks, curbed thinking, loss of sex drive, increased paranoia, increased suicidal thoughts, increase in depression, anxiety. Decreased mental capacities.
Comments:   I was put on 3.5 mg of this damned drug.

See all Risperdal reviews / ratings >>

Page last updated: 2015-08-10

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