Side effects for risperidone

Contents

Risperdal

SIDE EFFECTS

The following are discussed in more detail in other sections of the labeling:

  • Increased mortality in elderly patients with dementia-related psychosis
  • Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis
  • Neuroleptic malignant syndrome
  • Tardive dyskinesia
  • Metabolic Changes (Hyperglycemia and diabetes mellitus, Dyslipidemia, and Weight Gain)
  • Hyperprolactinemia
  • Orthostatic hypotension
  • Leukopenia, neutropenia, and agranulocytosis
  • Potential for cognitive and motor impairment
  • Seizures
  • Dysphagia
  • Priapism
  • Disruption of body temperature regulation
  • Patients with Phenylketonuria .

The most common adverse reactions in clinical trials ( > 5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.

The most common adverse reactions that were associated with discontinuation from clinical trials (causing discontinuation in > 1% of adults and/or > 2% of pediatrics) were nausea, somnolence, sedation, vomiting, dizziness, and akathisia .

The data described in this section are derived from a clinical trial database consisting of 9803 adult and pediatric patients exposed to one or more doses of RISPERDAL® for the treatment of schizophrenia, bipolar mania, autistic disorder, and other psychiatric disorders in pediatrics and elderly patients with dementia. Of these 9803 patients, 2687 were patients who received RISPERDAL® while participating in double-blind, placebo-controlled trials. The conditions and duration of treatment with RISPERDAL® varied greatly and included (in overlapping categories) double-blind, fixed- and flexible-dose, placebo- or active-controlled studies and open-label phases of studies, inpatients and outpatients, and short-term (up to 12 weeks) and longer-term (up to 3 years) exposures. Safety was assessed by collecting adverse events and performing physical examinations, vital signs, body weights, laboratory analyses, and ECGs.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Commonly-Observed Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials – Schizophrenia

Adult Patients with Schizophrenia

Table 8 lists the adverse reactions reported in 2% or more of RISPERDAL®-treated adult patients with schizophrenia in three 4- to 8-week, double-blind, placebo-controlled trials.

Table 8: Adverse Reactions in ≥ 2% of RISPERDAL®-Treated Adult Patients (and greater than placebo) with Schizophrenia in Double-Blind, Placebo-Controlled Trials

System/Organ Class Adverse Reaction Percentage of Patients Reporting Reaction RISPERDAL® Placebo (N=225)
2-8 mg per day
(N=366)
> 8-16 mg per
day (N=198)
Cardiac Disorders
Tachycardia 1 3 0
Eye Disorders
Vision blurred 3 1 1
Gastrointestinal Disorders
Nausea 9 4 4
Constipation 8 9 6
Dyspepsia 8 6 5
Dry mouth 4 0 1
Abdominal discomfort 3 1 1
Salivary hypersecretion 2 1 < 1
Diarrhea 2 1 1
General Disorders
Fatigue 3 1 0
Chest pain 2 2 1
Asthenia 2 1 < 1
Infections and Infestations
Nasopharyngitis 3 4 3
Upper respiratory tract infection 2 3 1
Sinusitis 1 2 1
Urinary tract infection 1 3 0
Investigations
Blood creatine phosphokinase increased 1 2 < 1
Heart rate increased < 1 2 0
Musculoskeletal and Connective Tissue Disorders
Back pain 4 1 1
Arthralgia 2 3 < 1
Pain in extremity 2 1 1
Nervous System Disorders
Parkinsonism* 14 17 8
Akathisia* 10 10 3
Sedation 10 5 2
Dizziness 7 4 2
Dystonia* 3 4 2
Tremor* 2 3 1
Dizziness postural 2 0 0
Psychiatric Disorders
Insomnia 32 25 27
Anxiety 16 11 11
Respiratory, Thoracic and Mediastinal Disorders
Nasal congestion 4 6 2
Dyspnea 1 2 0
Epistaxis < 1 2 0
Skin and Subcutaneous Tissue Disorders
Rash 1 4 1
Dry skin 1 3 0
Vascular Disorders
Orthostatic hypotension 2 1 0
* 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 dystonia, muscle spasms, muscle contractions involuntary, muscle contracture, oculogyration, tongue paralysis. Tremor includes tremor and parkinsonian rest tremor.

Pediatric Patients with Schizophrenia

Table 9 lists the adverse reactions reported in 5% or more of RISPERDAL®-treated pediatric patients with schizophrenia in a 6-week double-blind, placebo-controlled trial.

Table 9: Adverse Reactions in ≥ 5% of RISPERDAL®-Treated Pediatric Patients (and greater than placebo) with Schizophrenia in a Double-Blind Trial

System/Organ Class Adverse Reaction Percentage of Patients Reporting Reaction RISPERDAL® Placebo
(N=54)
1-3 mg per day
(N=55)
4-6 mg per day
(N=51)
Gastrointestinal Disorders
Salivary hypersecretion 0 10 2
Nervous System Disorders
Sedation 24 12 4
Parkinsonism* 16 28 11
Tremor 11 10 6
Akathisia* 9 10 4
Dizziness 7 14 2
Dystonia* 2 6 0
Psychiatric Disorders
Anxiety 7 6 0
* Parkinsonism includes extrapyramidal disorder, muscle rigidity, musculoskeletal stiffness, and hypokinesia. Akathisia includes akathisia and restlessness. Dystonia includes dystonia and oculogyration.

Commonly-Observed Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials – Bipolar Mania

Adult Patients with Bipolar Mania

Table 10 lists the adverse reactions reported in 2% or more of RISPERDAL®-treated adult patients with bipolar mania in four 3-week, double-blind, placebo-controlled monotherapy trials.

Table 10: Adverse Reactions in ≥ 2% of RISPERDAL®-Treated Adult Patients (and greater than placebo) with Bipolar Mania in Double-Blind, Placebo-Controlled Monotherapy Trials

System/Organ Class
Adverse Reaction
Percentage of Patients Reporting Reaction Placebo
(N=424)
RISPERDAL® 1-6 mg per day
(N=448)
Eye Disorders
Vision blurred 2 1
Gastrointestinal Disorders
Nausea 5 2
Diarrhea 3 2
Salivary hypersecretion 3 1
Stomach discomfort 2 < 1
General Disorders
Fatigue 2 1
Nervous System Disorders
Parkinsonism* 25 9
Sedation 11 4
Akathisia* 9 3
Tremor* 6 3
Dizziness 6 5
Dystonia* 5 1
Lethargy 2 1
* Parkinsonism includes extrapyramidal disorder, parkinsonism, musculoskeletal stiffness, hypokinesia, muscle rigidity, muscle tightness, bradykinesia, cogwheel rigidity. Akathisia includes akathisia and restlessness. Tremor includes tremor and parkinsonian rest tremor. Dystonia includes dystonia, muscle spasms, oculogyration, torticollis.

Table 11 lists the adverse reactions reported in 2% or more of RISPERDAL®-treated adult patients with bipolar mania in two 3-week, double-blind, placebo-controlled adjuvant therapy trials.

Table 11: Adverse Reactions in ≥ 2% of RISPERDAL®-Treated Adult Patients (and greater than placebo) with Bipolar Mania in Double-Blind, Placebo-Controlled Adjunctive Therapy Trials

System/Organ Class
Adverse Reaction
Percentage of Patients Reporting Reaction
RISPERDAL® + Mood Stabilizer
(N=127)
Placebo +Mood Stabilizer
(N=126)
Cardiac Disorders
Palpitations 2 0
Gastrointestinal Disorders
Dyspepsia 9 8
Nausea 6 4
Diarrhea 6 4
Salivary hypersecretion 2 0
General Disorders
Chest pain 2 1
Infections and Infestations
Urinary tract infection 2 1
Nervous System Disorders
Parkinsonism* 14 4
Sedation 9 4
Akathisia* 8 0
Dizziness 7 2
Tremor 6 2
Lethargy 2 1
Psychiatric Disorders
Anxiety 3 2
Respiratory, Thoracic and Mediastinal Disorders
Pharyngolaryngeal pain 5 2
Cough 2 0
* Parkinsonism includes extrapyramidal disorder, hypokinesia and bradykinesia. Akathisia includes hyperkinesia and akathisia.

Pediatric Patients with Bipolar Mania

Table 12 lists the adverse reactions reported in 5% or more of RISPERDAL®-treated pediatric patients with bipolar mania in a 3-week double-blind, placebo-controlled trial.

Table 12: Adverse Reactions in ≥ 5% of RISPERDAL®-Treated Pediatric Patients (and greater than placebo) with Bipolar Mania in Double-Blind, Placebo-Controlled Trials

System/Organ Class Adverse Reaction Percentage of Patients Reporting Reaction
RISPERDAL ® Placebo
(N=58)
0.5-2.5 mg per day
(N=50)
3-6 mg per day
(N=61)
Eye Disorders
Vision blurred 4 7 0
Gastrointestinal Disorders
Abdominal pain upper 16 13 5
Nausea 16 13 7
Vomiting 10 10 5
Diarrhea 8 7 2
Dyspepsia 10 3 2
Stomach discomfort 6 0 2
General Disorders
Fatigue 18 30 3
Metabolism and Nutrition Disorders
Increased appetite 4 7 2
Nervous System Disorders
Sedation 42 56 19
Dizziness 16 13 5
Parkinsonism* 6 12 3
Dystonia* 6 5 0
Akathisia* 0 8 2
Psychiatric Disorders
Anxiety 0 8 3
Respiratory, Thoracic and Mediastinal Disorders
Pharyngolaryngeal pain 10 3 5
Skin and Subcutaneous Tissue Disorders
Rash 0 7 2
* Parkinsonism includes musculoskeletal stiffness, extrapyramidal disorder, bradykinesia, and nuchal rigidity. Dystonia includes dystonia, laryngospasm, and muscle spasms. Akathisia includes restlessness and akathisia.

Commonly-Observed Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials – Autistic Disorder

Table 13 lists the adverse reactions reported in 5% or more of RISPERDAL®-treated pediatric patients treated for irritability associated with autistic disorder in two 8-week, double-blind, placebo-controlled trials and one 6-week double-blind, placebo-controlled study.

Table 13: Adverse Reactions in ≥ 5% of RISPERDAL®-Treated Pediatric Patients (and greater than placebo) Treated for Irritability Associated with Autistic Disorder in Double-Blind, Placebo-Controlled Trials

System/Organ Class
Adverse Reaction
Percentage of Patients Reporting Reaction
RISPERDAL® 0.5-4.0 mg/day
(N=107)
Placebo
(N=115)
Gastrointestinal Disorders
Vomiting 20 17
Constipation 17 6
Dry mouth 10 4
Nausea 8 5
Salivary hypersecretion 7 1
General Disorders and Administration Site Conditions
Fatigue 31 9
Pyrexia 16 13
Thirst 7 4
Infections and Infestations
Nasopharyngitis 19 9
Rhinitis 9 7
Upper respiratory tract infection 8 3
Investigations
Weight increased 8 2
Metabolism and Nutrition Disorders
Increased appetite 44 15
Nervous System Disorders
Sedation 63 15
Drooling 12 4
Headache 12 10
Tremor 8 1
Dizziness 8 2
Parkinsonism* 8 1
Renal and Urinary Disorders
Enuresis 16 10
Respiratory, Thoracic and Mediastinal Disorders
Cough 17 12
Rhinorrhea 12 10
Nasal congestion 10 4
Skin and Subcutaneous Tissue Disorders
Rash 8 5
*Parkinsonism includes musculoskeletal stiffness, extrapyramidal disorder, muscle rigidity, cogwheel rigidity, and muscle tightness.

Other Adverse Reactions Observed During The Clinical Trial Evaluation Of Risperidone

The following additional adverse reactions occurred across all placebo-controlled, active-controlled, and open-label studies of RISPERDAL® in adults and pediatric patients.

Blood and Lymphatic System Disorders: anemia, granulocytopenia, neutropenia

Cardiac Disorders: sinus bradycardia, sinus tachycardia, atrioventricular block first degree, bundle branch block left, bundle branch block right, atrioventricular block

Ear and Labyrinth Disorders: ear pain, tinnitus

Endocrine Disorders: hyperprolactinemia

Eye Disorders: ocular hyperemia, eye discharge, conjunctivitis, eye rolling, eyelid edema, eye swelling, eyelid margin crusting, dry eye, lacrimation increased, photophobia, glaucoma, visual acuity reduced

Gastrointestinal Disorders: dysphagia, fecaloma, fecal incontinence, gastritis, lip swelling, cheilitis, aptyalism

General Disorders: edema peripheral, thirst, gait disturbance, influenza-like illness, pitting edema, edema, chills, sluggishness, malaise, chest discomfort, face edema, discomfort, generalized edema, drug withdrawal syndrome, peripheral coldness, feeling abnormal

Immune System Disorders: drug hypersensitivity

Infections and Infestations: pneumonia, influenza, ear infection, viral infection, pharyngitis, tonsillitis, bronchitis, eye infection, localized infection, cystitis, cellulitis, otitis media, onychomycosis, acarodermatitis, bronchopneumonia, respiratory tract infection, tracheobronchitis, otitis media chronic

Investigations: body temperature increased, blood prolactin increased, alanine aminotransferase increased, electrocardiogram abnormal, eosinophil count increased, white blood cell count decreased, blood glucose increased, hemoglobin decreased, hematocrit decreased, body temperature decreased, blood pressure decreased, transaminases increased

Metabolism and Nutrition Disorders: decreased appetite, polydipsia, anorexia

Musculoskeletal and Connective Tissue Disorders: joint stiffness, joint swelling, musculoskeletal chest pain, posture abnormal, myalgia, neck pain, muscular weakness, rhabdomyolysis

Nervous System Disorders: balance disorder, disturbance in attention, dysarthria, unresponsive to stimuli, depressed level of consciousness, movement disorder, transient ischemic attack, coordination abnormal, cerebrovascular accident, speech disorder, syncope, loss of consciousness, hypoesthesia, tardive dyskinesia, dyskinesia, cerebral ischemia, cerebrovascular disorder, neuroleptic malignant syndrome, diabetic coma, head titubation

Psychiatric Disorders: agitation, blunted affect, confusional state, middle insomnia, nervousness, sleep disorder, listlessness, libido decreased, and anorgasmia

Renal and Urinary Disorders: enuresis, dysuria, pollakiuria, urinary incontinence

Reproductive System and Breast Disorders: menstruation irregular, amenorrhea, gynecomastia, galactorrhea, vaginal discharge, menstrual disorder, erectile dysfunction, retrograde ejaculation, ejaculation disorder, sexual dysfunction, breast enlargement

Respiratory, Thoracic, and Mediastinal Disorders: wheezing, pneumonia aspiration, sinus congestion, dysphonia, productive cough, pulmonary congestion, respiratory tract congestion, rales, respiratory disorder, hyperventilation, nasal edema

Skin and Subcutaneous Tissue Disorders: erythema, skin discoloration, skin lesion, pruritus, skin disorder, rash erythematous, rash papular, rash generalized, rash maculopapular, acne, hyperkeratosis, seborrheic dermatitis

Vascular Disorders: hypotension, flushing

Additional Adverse Reactions Reported With RISPERDAL® CONSTA®

The following is a list of additional adverse reactions that have been reported during the premarketing evaluation of RISPERDAL® CONSTA®, regardless of frequency of occurrence:

Cardiac Disorders: bradycardia

Ear and Labyrinth Disorders: vertigo

Eye Disorders: blepharospasm

Gastrointestinal Disorders: toothache, tongue spasm

General Disorders and Administration Site Conditions: pain

Infections and Infestations: lower respiratory tract infection, infection, gastroenteritis, subcutaneous abscess

Injury and Poisoning: fall

Investigations: weight decreased, gamma-glutamyltransferase increased, hepatic enzyme increased

Musculoskeletal, Connective Tissue, and Bone Disorders: buttock pain

Nervous System Disorders: convulsion, paresthesia

Psychiatric Disorders: depression

Skin and Subcutaneous Tissue Disorders: eczema

Vascular Disorders: hypertension

Discontinuations Due To Adverse Reactions

Schizophrenia – Adults

Approximately 7% (39/564) of RISPERDAL®-treated patients in double-blind, placebo-controlled trials discontinued treatment due to an adverse reaction, compared with 4% (10/225) who were receiving placebo. The adverse reactions associated with discontinuation in 2 or more RISPERDAL®-treated patients were:

Table 14: Adverse Reactions Associated With Discontinuation in 2 or More RISPERDAL®Treated Adult Patients in Schizophrenia Trials

Discontinuation for extrapyramidal symptoms (including Parkinsonism, akathisia, dystonia, and tardive dyskinesia) was 1% in placebo-treated patients, and 3.4% in active control-treated patients in a double-blind, placebo- and active-controlled trial.

Schizophrenia – Pediatrics
Bipolar Mania – Adults

In double-blind, placebo-controlled trials with RISPERDAL® as monotherapy, approximately 6% (25/448) of RISPERDAL®-treated patients discontinued treatment due to an adverse event, compared with approximately 5% (19/424) of placebo-treated patients. The adverse reactions associated with discontinuation in RISPERDAL®-treated patients were:

Table 15: Adverse Reactions Associated With Discontinuation in 2 or More RISPERDAL®Treated Adult Patients in Bipolar Mania Clinical Trials

Bipolar Mania – Pediatrics
Autistic Disorder – Pediatrics

In the two 8-week, placebo-controlled trials in pediatric patients treated for irritability associated with autistic disorder (n = 156), one RISPERDAL®-treated patient discontinued due to an adverse reaction (Parkinsonism), and one placebo-treated patient discontinued due to an adverse event.

Dose Dependency Of Adverse Reactions In Clinical Trials

Extrapyramidal Symptoms

Data from two fixed-dose trials in adults with schizophrenia provided evidence of dose-relatedness for extrapyramidal symptoms associated with RISPERDAL® treatment.

Two methods were used to measure extrapyramidal symptoms (EPS) in an 8-week trial comparing 4 fixed doses of RISPERDAL® (2, 6, 10, and 16 mg/day), including (1) a Parkinsonism score (mean change from baseline) from the Extrapyramidal Symptom Rating Scale, and (2) incidence of spontaneous complaints of EPS:

Table 16

Dose Groups Placebo RISPERDAL® 2 mg RISPERDAL® 6 mg RISPERDAL® 10 mg RISPERDAL® 16 mg
Parkinsonism 1.2 0.9 1.8 2.4 2.6
EPS Incidence 13% 17% 21% 21% 35%

Similar methods were used to measure extrapyramidal symptoms (EPS) in an 8-week trial comparing 5 fixed doses of RISPERDAL® (1, 4, 8, 12, and 16 mg/day):

Table 17

Dose Groups RISPERDAL® 1 mg RISPERDAL® 4 mg RISPERDAL® 8 mg RISPERDAL® 12 mg RISPERDAL® 16 mg
Parkinsonism 0.6 1.7 2.4 2.9 4.1
EPS Incidence 7% 12% 17% 18% 20%

Dystonia

Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Other Adverse Reactions

Adverse event data elicited by a checklist for side effects from a large study comparing 5 fixed doses of RISPERDAL® (1, 4, 8, 12, and 16 mg/day) were explored for dose-relatedness of adverse events. A Cochran-Armitage Test for trend in these data revealed a positive trend (p < 0.05) for the following adverse reactions: somnolence, vision abnormal, dizziness, palpitations, weight increase, erectile dysfunction, ejaculation disorder, sexual function abnormal, fatigue, and skin discoloration.

Changes In Body Weight

Weight gain was observed in short-term, controlled trials and longer-term uncontrolled studies in adult and pediatric patients .

Changes In ECG Parameters

Between-group comparisons for pooled placebo-controlled trials in adults revealed no statistically significant differences between risperidone and placebo in mean changes from baseline in ECG parameters, including QT, QTc, and PR intervals, and heart rate. When all RISPERDAL® doses were pooled from randomized controlled trials in several indications, there was a mean increase in heart rate of 1 beat per minute compared to no change for placebo patients. In short-term schizophrenia trials, higher doses of risperidone (8-16 mg/day) were associated with a higher mean increase in heart rate compared to placebo (4-6 beats per minute). In pooled placebo-controlled acute mania trials in adults, there were small decreases in mean heart rate, similar among all treatment groups.

In the two placebo-controlled trials in children and adolescents with autistic disorder (aged 5 – 16 years) mean changes in heart rate were an increase of 8.4 beats per minute in the RISPERDAL® groups and 6.5 beats per minute in the placebo group. There were no other notable ECG changes.

In a placebo-controlled acute mania trial in children and adolescents (aged 10 – 17 years), there were no significant changes in ECG parameters, other than the effect of RISPERDAL® to transiently increase pulse rate ( < 6 beats per minute). In two controlled schizophrenia trials in adolescents (aged 13 – 17 years), there were no clinically meaningful changes in ECG parameters including corrected QT intervals between treatment groups or within treatment groups over time.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of risperidone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions include: alopecia, anaphylactic reaction, angioedema, atrial fibrillation, cardiopulmonary arrest, diabetic ketoacidosis in patients with impaired glucose metabolism, dysgeusia, hypoglycemia, hypothermia, ileus, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, pituitary adenoma, precocious puberty, pulmonary embolism, QT prolongation, sleep apnea syndrome, sudden death, thrombocytopenia, thrombotic thrombocytopenic purpura, urinary retention, and water intoxication.

Read the entire FDA prescribing information for Risperdal (Risperidone)

Risperidone

Before taking risperidone,

  • tell your doctor and pharmacist if you are allergic to risperidone or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; carbamazepine (Tegretol); cimetidine (Tagamet); clozapine (Clozaril); dopamine agonists such as bromocriptine (Parlodel), cabergoline (Dostinex), levodopa (Dopar, Larodopa), pergolide (Permax), and ropinirole (Requip); medications for anxiety, high blood pressure, or seizures; other medications for mental illness; paroxetine (Paxil); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); quinidine (Quinaglute, Quinidex); ranitidine (Zantac); rifampin (Rifadin, Rimactane); sedatives; sleeping pills; tranquilizers; and valproic acid (Depakote, Depakene). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you use or have ever used street drugs or large amounts of alcohol; if you have ever overused prescription medications; if you have or have ever had Parkinson’s disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); dyslipidemia (high cholesterol levels); a low level of white blood cells in your blood or a decrease in white blood cells; difficulty swallowing; trouble keeping your balance; breast cancer; angina (chest pain); irregular heartbeat; high or low blood pressure; heart failure; a heart attack; a stroke; seizures; heart, kidney or liver disease; or if you or anyone in your family has or has ever had diabetes. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects. Tell your doctor if you have severe vomiting or diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment.
  • tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking risperidone, call your doctor. Risperidone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking risperidone.
  • you should know that risperidone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking risperidone.
  • you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking risperidone or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking risperidone: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, upset stomach and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
  • you should know that risperidone may make it harder for your body to cool down when it gets very hot or warm up when it gets very cold. Tell your doctor if you plan to do vigorous exercise or be exposed to extremely high or low temperatures.
  • you should know that risperidone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking risperidone. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the orally disintegrating tablets contain phenylalanine.

Risperidone, the generic form of the brand name drug Risperdal, is in a class of medications called atypical antipsychotics. It works by changing the activity of dopamine and other naturally occurring chemicals in the brain.

Janssen Pharmaceuticals makes risperidone, and the Food and Drug Administration (FDA) first approved Risperdal in 2002 to treat schizophrenia in adults and youths at least 13 years old. Schizophrenia is a mental illness that can cause people to lose interest in life and develop abnormal thoughts and emotions.

In 2003, the FDA also approved Risperdal for the short-term treatment of adults and children 10 and older with bipolar disorder who experience mania, or episodes of unusually excited moods. Doctors can also prescribe the drug to treat mixed episodes that cause people to experience symptoms of both mania and depression. The FDA approved the first generic forms of Risperdal, risperidone tablets, in 2008.

Doctors can also prescribe risperidone for children 5 to 16 years old with autism, a condition that causes repetitive behavior and difficulty communicating and interacting with others. The drug can alleviate symptoms that include aggression, self-injury, and sudden mood changes.

Medical evidence does not indicate whether the drug is safe and effective in younger children.

Janssen, however, also marketed Risperdal as a treatment for older people with agitation from dementia, which is not an FDA-approved use of the medication. In fact, it can be dangerous for older adults with dementia to take antipsychotics, including Risperdal, and Janssen had to pay a fine for misbranding the drug. The combined criminal plea agreement with the Justice Department and a civil settlement totaled more than $1.67 billion.

In This Section:

What Are the Key Things I Need to Know About Risperidone (Risperdal)?

Before taking risperidone, you should be aware of several important warnings:

  • Anyone with dementia should not take risperidone. Older adults with dementia who take risperidone or other medications for mental illness are at greater risk for death during treatment. They also face an increased risk for stroke or mini-stroke.
  • Risperidone can cause hyperglycemia (high blood sugar levels). This can happen even if you do not have diabetes before treatment begins. High blood sugar that is not treated can lead to a potentially life-threatening condition called ketoacidosis.
  • If you have schizophrenia, you are at greater risk for developing diabetes. Taking risperidone can increase this risk even more.
  • Risperidone could make it harder for your body to regulate temperature. If you become very hot, for instance, it could be harder for you to cool down. You may also have a hard time warming up if you are cold.
  • Risperidone may cause you to feel dizzy or lightheaded so don’t get up too quickly after lying down.
  • If you have phenylketonuria, it’s important to realize that orally disintegrating risperidone tablets contain phenylalanine.

Read the complete FDA warning on Risperidone

Is There Anything Special I Should Discuss With My Doctor Before Taking Risperidone (Risperdal)?

Risperidone could cause certain side effects and can interfere with many medications. If you have certain medical conditions, take risperidone with caution. Always tell your doctor if you have allergies to any medications and discuss the risks and benefits of risperidone.

Tell your doctor if you use or have ever used illegal or “street” drugs, or if you are a heavy drinker. Also let your doctor know if you have ever abused prescription drugs.

Because it may be more difficult for your body to warm up or cool down while taking risperidone, let your doctor know if you plan to engage in vigorous exercise or if you will be in a place where temperatures are very hot or very cold.

Your doctor should also know if you ever developed severe side effects from a medication to treat mental illness.

Tell your doctor if you are pregnant, particularly if you are in your third trimester. Risperidone may be harmful for newborns right after delivery. This is particularly true if women take the drug during the final few months of pregnancy.

Your doctor should also know if you might become pregnant or if you are breastfeeding. Women who are nursing shouldn’t take risperidone or should stop breastfeeding.

Also tell your doctor if you have ever had:

  • Parkinson’s disease
  • Trouble swallowing
  • Breast cancer
  • Chest pain
  • Irregular heartbeat
  • High or low blood pressure
  • Heart failure
  • A heart attack
  • Kidney or liver disease
  • Diabetes

Older people with liver disease or low blood pressure should receive a lower initial dose of risperidone.

Risperidone, the first drug approved for children with autism and the most widely used, improves some children’s behavior but can have severe sideeffects, suggests an informal analysis of the drug’s use.

The drug effectively treats the explosive and aggressive behavior that can accompany autism. “It has pretty big effects on tantrums, aggression and self-injury,” says Lawrence Scahill, professor of pediatrics at the Marcus Autism Center at Emory University in Atlanta, who has conducted clinical trials of risperidone. The change can be dramatic, he says, taking effect in a matter of weeks.

It has also been shown to reduce hyperactivity and repetitive behaviors, though the Food and Drug Administration has not approved it for those purposes.

Through these effects, risperidone allows children with autism to benefit from social services, educational programs and behavioral interventions, experts say.

“If you can’t sit still during speech therapy, you’re attacking the teachers, you’re not going to be able to take advantage of it,” says Christopher McDougle, director of the Lurie Center for Autism at MassGeneral Hospital for Children in Boston, who has studied risperidone use in children and adolescents.

But risperidone also has significant drawbacks and limitations. Not all people respond to it, symptoms often return when the drug is discontinued, and it doesn’t improve many of the core behaviors associated with autism.

In other words, risperidone is “not a cure for autism,” says Benedetto Vitiello, chief of the Child and Adolescent Treatment and Preventive Intervention Research Branch at the National Institute of Mental Health. “It doesn’t really go to the core symptoms of autism.”

More worrisome, however, are the side effects, the most significant of which is weight gain from an increased appetite. Children taking risperidone gain an average of 6 pounds within eight weeks of taking the drug. The drug can also cause drowsiness, hormonal changes and, in rare cases, involuntary movements.

If he were prescribing risperidone for a child with autism, says Scahill, “I would use as low a dosage as I possibly could and I would periodically see if I could take him off.”

Reducing irritability
Although numerous studies have documented risperidone’s risks, efforts to find safer alternatives have so far come up short.
Aripiprazole, the only other drug approved to treat irritability in autism, has similar side effects. (The FDA approved it for children with autism in 2009.) And a clinical trial designed to evaluate the safety and efficacy of an extremely low dose of risperidone yielded disappointing results last year.

Risperidone is an antipsychotic that blocks the brain’s receptors for dopamine and serotonin. It was initially developed to treat schizophrenia. The U.S. Food and Drug Administration (FDA) approved risperidone for schizophrenia in 1993.

Older antipsychotics, most notably haloperidol, also work by dampening dopamine activity. Before risperidone came on the market, these drugs had often been prescribed to treat severe behaviors in some people with autism, such as temper tantrums and self-injury, symptoms often lumped together as ‘irritability.’

After risperidone’s approval for schizophrenia, researchers began to investigate its usefulness for autism. “The idea is that maybe we would be turning down the child’s tendency to overreact, to be able to give them another second or two before they erupt or become aggressive or self-injurious,” Scahill says.

In 2002, a randomized clinical trial of children with autism between 5 and 17 years of age showed a 57 percent reduction in tantrums, aggression and self-injury after taking risperidone, compared with a 14 percent reduction in children taking a placebo. Among the children who responded positively to the drug, nearly 70 percent still showed improvements after six months of taking it.

In October 2006, the FDA approved risperidone to treat irritability in children with autism between 5 and 16 years of age.

This January, researchers published a new analysis of the 2002 data, in which they classified the participants by the type of aggressive behavior they showed — hotheaded aggression in response to provocation versus unprovoked aggression, for example. Risperidone significantly improved symptoms in all these subgroups, the researchers found.

The challenge is to figure out how to maintain these benefits while minimizing the risks.

Last year, scientists at Janssen Research and Development — a sister company of Janssen Pharmaceuticals, Inc., which manufactures risperidone under the brand name Risperdal — published the results of a study designed to determine whether a low dose of risperidone reduces irritability in children with autism.

Researchers randomly assigned children with autism to one of three groups. Each day for six weeks, one-third of the children received a standard dose of risperidone, one-third got a dose lower than the FDA’s recommended minimum, and the final third received a placebo.

The lower dosage did decrease several side effects, including sleepiness and increased appetite, the researchers reported in a 2013 paper. Unfortunately, the dose was no more effective than a placebo in alleviating irritability.

“It’s a tradeoff between what benefits you’re expecting the risks for the specific patient,” says Gahan Pandina, senior director at Janssen Research and Development.

Weighty decision
The researchers also found that after six weeks of taking a standard dose of risperidone, children had greater increases in insulin levels and insulin resistance than children taking a placebo. Weight gain and the resulting metabolic problems are side effects of nearly all antipsychotic drugs, but rapid weight gain can be especially worrisome in children.

“It’s the cumulative impact,” says Jeremy Veenstra-VanderWeele, medical director of the Treatment and Research Institute for Autism Spectrum Disorders at Vanderbilt University in Nashville, Tennessee. “You may change the body shape or body fat distribution in a child for the rest of their life.”

Risperidone can also cause fatigue and drowsiness. In a 2011 paper, Shafali Jeste and her colleagues reviewed the medical records of 70 children with autism treated with risperidone. They found that these records mentioned sleepiness less frequently than weight gain, but the former is often the reason that families take children off the drug.

“Unless it’s severe, most parents are willing to put up with some weight gain as long as their child’s behavior is better,” says Jeste, assistant professor of psychiatry and neurology at the Center for Autism Research and Treatment at the University of California, Los Angeles. Sleepiness, which can interfere with school and therapies, is “a pretty quick deal-breaker.”

Risperidone can also cause a less common side effect called tardive dyskinesia, or involuntary repetitive movements.

Like many antipsychotic drugs, it also increases levels of prolactin, a hormone secreted by the pituitary gland. High levels of the hormone can have a feminizing effect, causing breast development in boys and lactation in girls, as well as problems with menstruation and sexual dysfunction.

“When prolactin goes up, your body essentially thinks it’s pregnant,” McDougle says.

However, researchers caution, high prolactin levels don’t always cause clinical symptoms, and it’s not clear that elevated prolactin alone presents a health risk. There needs to be much more research on the effects of chronically elevated prolactin levels, especially in children and teens, they say.

Risperidone’s side effects have been the focus of several lawsuits. By the end of 2013, 500 plaintiffs had filed lawsuits alleging that the drug had caused personal injuries, according to Johnson & Johnson’s annual report. Johnson & Johnson is the parent company of Janssen Pharmaceuticals.

“Janssen intends to defend the company against the allegations made in these lawsuits,” says Greg Panico, spokesman for Janssen Research and Development. The company has “acted responsibly regarding informing physicians and the public about the risks and benefits of Risperdal.”

Last fall, Johnson & Johnson agreed to pay more than $2.2 billion to resolve claims that it had improperly marketed Risperdal and two other drugs.

In the final analysis, researchers say risperidone should be given with caution, only for children with the most serious symptoms and only after other treatments have failed.

“Is someone going to get hurt if we don’t intervene? And if I think the answer is yes, then I’ll be thinking about risperidone,” Veenstra-VanderWeele says. “If I think the answer is no, I’ll be thinking about doing other things.”
Reprinted with permission from SFARI.org, an editorially independent division of the Simons Foundation. (Find original story here)

What is Risperdal?

Risperdal is a medication known as an atypical antipsychotic that is used to treat symptoms of schizophrenia in teenagers and adults. The medication is also sometimes used to treat symptoms of bipolar disorder.

When did the U.S. Food and Drug Administration (FDA) approve the medication?

Risperdal was first approved by the FDA in 1993.

Is there a generic version of Risperdal?

Yes, risperidone is the generic version of Risperdal and is available in the United States.

Are there any major differences between Risperdal and other antipsychotics used to treat Risperdal?

Risperdal belongs to the class of medications known as atypical antipsychotics or second generation psychotics. The drug is also used to treat symptoms of bipolar disorder and irritability associated with autistic disorder in children. The medication comes in tablet, oral solution, and orally disintegrating tablet forms. Talk to your doctor about what might work best for you and the costs and benefits of taking the medication. Some people may need to try several different antipsychotics before they find the most effective with the fewest side effects.

Can children take Risperdal?

Risperdal has been approved for treatment of schizophrenia for children ages 13-17 years, for Bipolar I disorder in children ages 10-17 years, and for irritability associated with autistic disorder for children ages 5-16 years.

Are there potential interaction issues for people taking Risperdal and any other drugs?

There are hundreds of other drugs which are known to interact with Risperdal in major, moderate, or mild ways. Some of these include antidepressants, carbamazepine, cimetidine, clozapine, dopamine agonists, anxiety medication, high blood pressure medication, seizure medication, paroxetine, phenobarbital, phenytoin, quinidine, ranitidine, rifampin, sedatives, sleep medications, tranquilizers, and valproic acid. Let your doctor know what other prescription and nonprescription medications you are taking before you begin taking the medication.

Are there any other medical conditions that would make someone ineligible for Risperdal therapy?

Talk to your doctor about other medical conditions before you take Risperdal, such as diabetes, dementia, seizures, low white blood cell count, Parkinson’s disease, high cholesterol, high or low blood pressure, a history of heart attack or stroke, breast cancer, heart disease, kidney, disease, or liver disease. Also, talk to your doctor if you have a history of substance abuse or any other mental health issues.

What is the typical starting dose that would be prescribed to someone taking Risperdal?

The FDA recommends a starting dosage of 2mg a day for the treatment of schizophrenia in adults. Safety and efficacy have not been established beyond a dosage of 16mg a day. Dosage may differ when treating other conditions.

What do I do if I miss a dose?

Take the dose of Risperdal when you remember, but skip the missed dose if it’s almost time for your next dose. You should never take extra doses of the medication to make up for missed doses.

Can Risperdal cause side effects?

Common side effects of Risperdal can include:

  • Weight gain
  • Restlessness
  • Agitation
  • Dry mouth
  • Increased saliva
  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Trouble urinating
  • Stomach pain
  • Vision problems
  • Muscle or joint paint
  • Heartburn
  • Increased appetite
  • Anxiety
  • Trouble sleeping
  • Breast enlargement
  • Late or missed menstrual periods
  • Decreased sexual ability
  • Dry or discolored skin.

Doctors recommend that you not drink alcohol while on the medication. It also is recommended that you wait to drive or operate machinery until you know how the medication affects you. Report major side effects to your doctor immediately, which can include faintness, unusual body movements, sweating, fever, stiff muscles, fever, seizures, hives, itching, shuffling walk, difficulty breathing or swallowing, and long-lasting and pain erection. You can also report side effects to the FDA at 1-800-FDA-1088 or online.

What are the potential long-term effects of taking Risperdal?

Your doctor should monitor for progression of potential long-term side effects of Risperdal, which can include changes in heart rhythm, weight gain, high blood sugar, and tardive dyskinesia.

Is it safe for a woman who is pregnant, about to become pregnant, or nursing to take Risperdal?

There have been no controlled human pregnancy studies on the effects of Risperdal. The drug can be transferred via human breast milk, and patients are advised not to breastfeed while taking the medication. Before you take Risperdal, talk to your doctor if you are pregnant, planning to become pregnant, or are nursing.

Can symptoms occur if Risperdal is discontinued?

It’s important not to discontinue use of the drug if you feel better. Withdrawal symptoms may include dizziness, nausea, sleepiness, and the return of symptoms of schizophrenia. Maintain contact with your doctor and seek medical attention if necessary when discontinuing the drug, and talk to your doctor about how to mitigate potential withdrawal symptoms.

What should I do if I overdose on Risperdal?

Seek immediate help or call the Poison Help Line at 1-800-222-1222 if you overdose, as it can be fatal. Symptoms may include fainting, blurred vision, drowsiness, fast or irregular heartbeat, dizziness, and seizures.

Is Risperdal habit-forming?
Risperdal has no habit-forming potential, but it is not recommended that you discontinue use of the drug before talking with your doctor, as withdrawal symptoms can occur.

How much does Risperdal cost?

According to goodrx.com, 30 tablets of 1mg Risperdal cost approximately $300. 30 tablets of 1mg generic risperidone cost approximately $14.

Are there any disadvantages to Risperdal?

The biggest disadvantages of Risperdal are the potential long-term side effects, which can include tardive dyskinesia, increased blood sugar, high triglycerides, and weight gain.

DISCLAIMER: The information contained herein should NOT be used as a substitute for the advice of an appropriately qualified and licensed physician or other health care provider. This article mentions drugs that were FDA-approved and available at the time of publication and may not include all possible drug interactions or all FDA warnings or alerts. The author of this page explicitly does not endorse this drug or any specific treatment method. If you have health questions or concerns about interactions, please check with your physician or go to the FDA site for a comprehensive list of warnings.

Article Sources Last Updated: Feb 21, 2018

Generic Name: risperidone (oral)

  • What is risperidone?
  • What are the possible side effects of risperidone?
  • What is the most important information I should know about risperidone?
  • What should I discuss with my healthcare provider before taking risperidone?
  • How should I take risperidone?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking risperidone?
  • What other drugs will affect risperidone?
  • Where can I get more information?

Risperidone is a antipsychotic medicine that works by changing the effects of chemicals in the brain.

Risperidone is used to treat schizophrenia in adults and children who are at least 13 years old.

Risperidone is also used to treat symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Risperidone is also used to treat symptoms of irritability in autistic children who are 5 to 16 years old.

Risperidone may also be used for purposes not listed in this medication guide.

What are the possible side effects of risperidone?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • breast swelling or tenderness (in men or women), nipple discharge, impotence, lack of interest in sex, missed menstrual periods;
  • severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • low white blood cells–sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
  • low levels of platelets in your blood–easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor; or
  • penis erection that is painful or lasts 4 hours or longer.

Common side effects may include:

  • headache;
  • dizziness, drowsiness, feeling tired;
  • tremors, twitching or uncontrollable muscle movements;
  • agitation, anxiety, restless feeling;
  • depressed mood;
  • dry mouth, upset stomach, diarrhea, constipation;
  • weight gain; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about risperidone?

Risperidone may increase the risk of death in older adults with dementia-related conditions and is not approved for this use.

Generic Name: risperidone (oral) (ris PER i done)
Brand Names: Risperdal

Medically reviewed by Sanjai Sinha, MD Last updated on Jul 1, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
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What is risperidone?

Risperidone is an antipsychotic medicine that works by changing the effects of chemicals in the brain.

Risperidone is used to treat schizophrenia in adults and children who are at least 13 years old.

Risperidone is also used to treat symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Risperidone is also used to treat symptoms of irritability in autistic children who are 5 to 16 years old.

Important Information

Risperidone may increase the risk of death in older adults with dementia-related conditions and is not approved for this use.

Do not give risperidone to a child without a doctor’s advice.

While you are taking this medicine, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medication.

Risperidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of this medicine.

Stop using this medicine and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

Before taking this medicine

You should not use risperidone if you are allergic to it.

Risperidone may increase the risk of death in older adults with dementia-related conditions and is not approved for this use.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • heart disease, high blood pressure, heart rhythm problems, stroke or heart attack;

  • diabetes (or risk factors such as obesity or family history of diabetes);

  • low white blood cell (WBC) counts;

  • liver or kidney disease;

  • seizures;

  • breast cancer;

  • low bone mineral density;

  • trouble swallowing;

  • Parkinson’s disease; or

  • if you are dehydrated.

The risperidone orally disintegrating tablet may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking risperidone, do not stop taking it without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risperidone on the baby.

This medicine may temporarily affect fertility (ability to have children) in women.

Risperidone can pass into breast milk and may cause side effects in the baby. If you breast-feed while using this medicine, tell your doctor if the baby has symptoms such as drowsiness, tremors, or involuntary muscle movements.

Do not give this medicine to a child without a doctor’s advice.

How should I take risperidone?

Take risperidone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Risperidone can be taken with or without food.

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not mix the liquid medicine with cola or tea.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture, heat, and light. Do not liquid medicine to freeze.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness, fast heart rate, feeling light-headed, fainting, and restless muscle movements in your eyes, tongue, jaw, or neck.

What should I avoid while taking risperidone?

Avoid driving or hazardous activity until you know how risperidone will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

While you are taking risperidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

What other drugs will affect risperidone?

Taking risperidone with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

  • blood pressure medication;

  • carbamazepine;

  • clozapine;

  • fluoxetine (Prozac) or paroxetine (Paxil); or

  • levodopa.

This list is not complete. Other drugs may interact with risperidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use risperidone only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 21.02.

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Other brands: Risperdal, Perseris, Risperdal Consta, Risperdal M-Tab

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