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Risperdal

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Risperdal

Risperdal Side Effects Center

Pharmacy Editor: Eni Williams, PharmD, PhD

Risperdal (risperidone) is a medication belonging to the drug class, atypical antipsychotics. Risperdal is available as a generic drug. Risperdal is prescribed to treat schizophrenia, bipolar mania, and autism. Common side effects of Risperdal include extrapyramidal effects (sudden, often jerky, involuntary motions of the head, neck, arms, body, or eyes), dizziness, tiredness, fatigue, fever, and nausea.

Risperdal dose ranges from 0.5 mg to 8mg/day. Drug interactions include clozapine (Clozaril), serotonin reuptake inhibitors (for example, paroxetine [Paxil]) and antifungal drugs (for example, fluconazole [Diflucan]). There are no adequate studies of risperidone in pregnant women so it should not be used unless the benefits outweigh the potential unknown risks. Risperidone is excreted in human breast milk and women receiving risperidone should not breastfeed.

Our Risperdal Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. articles.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Risperdal in Detail - Patient Information: Side Effects

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

Stop taking risperidone and call your doctor at once if you have a serious side effect such as:

  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • drooling, tremor (uncontrolled shaking);
  • seizure (convulsions);
  • fever, chills, body aches, flu symptoms;
  • nosebleeds;
  • white patches or sores inside your mouth or on your lips;
  • trouble swallowing;
  • feeling like you might pass out; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • weight gain;
  • feeling hot or cold;
  • headache, dizziness;
  • drowsiness, tired feeling;
  • dry mouth, increased appetite;
  • feeling restless or anxious;
  • sleep problems (insomnia);
  • nausea, vomiting, stomach pain, constipation;
  • cough, sore throat, runny or stuffy nose; or
  • mild skin rash.

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.

Read the entire detailed patient monograph for Risperdal (Risperidone) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Risperdal Overview - Patient Information: Side Effects

SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, drooling, nausea, weight gain, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: difficulty swallowing, muscle spasms, shaking (tremor), mental/mood changes (such as anxiety, restlessness), signs of infection (such as fever, persistent sore throat).

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

Risperidone may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face, lips, mouth, tongue, arms or legs).

This medication may increase a certain natural substance (prolactin) made by your body. For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, seizures.

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Risperdal (Risperidone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Risperdal FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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 [see ADVERSE REACTIONS, Discontinuations Due to Adverse Reactions].

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®  
2-8 mg per day
(N=366)
> 8-16 mg per day
(N=198)
Placebo
(N=225)
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 1-3 mg per day
(N=55)
4-6 mg per day
(N=51)
Placebo
(N=54)
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 Patints Reporting Reaction
RISPERDAL® 1-6 mg per day
(N=448)
Placebo
(N=424)
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

Adverse Reaction RISPERDAL® Placebo
(N=225)
2-8 mg/day
(N=366)
> 8-16 mg/day
(N=198)
Dizziness 1.4% 1.0% 0%
Nausea 1.4% 0% 0%
Vomiting 0.8% 0% 0%
Parkinsonism 0.8% 0% 0%
Somnolence 0.8% 0% 0%
Dystonia 0.5% 0% 0%
Agitation 0.5% 0% 0%
Abdominal pain 0.5% 0% 0%
Orthostatic hypotension 0.3% 0.5% 0%
Akathisia 0.3% 2.0% 0%

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

Approximately 7% (7/106), of RISPERDAL®-treated patients discontinued treatment due to an adverse reaction in a double-blind, placebo-controlled trial, compared with 4% (2/54) placebo-treated patients. The adverse reactions associated with discontinuation for at least one RISPERDAL®-treated patient were dizziness (2%), somnolence (1%), sedation (1%), lethargy (1%), anxiety (1%), balance disorder (1%), hypotension (1%), and palpitation (1%).

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

Adverse Reaction RISPERDAL® 1-6 mg/day
(N=448)
Placebo
(N=424)
Parkinsonism 0.4% 0%
Lethargy 0.2% 0%
Dizziness 0.2% 0%
Alanine aminotransferase increased 0.2% 0.2%
Aspartate aminotransferase increased 0.2% 0.2%

Bipolar Mania - Pediatrics

In a double-blind, placebo-controlled trial 12% (13/111) of RISPERDAL®-treated patients discontinued due to an adverse reaction, compared with 7% (4/58) of placebo-treated patients. The adverse reactions associated with discontinuation in more than one RISPERDAL®-treated pediatric patient were nausea (3%), somnolence (2%), sedation (2%), and vomiting (2%).

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 EPS Incidence 0.6 7% 1.7 12% 2.4 17% 2.9 18% 4.1 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 [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

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) »

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