Risperdal Side Effects
Generic Name: risperidone
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Risperdal:
Anxiety; constipation; cough; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; increased appetite; increased saliva production; indigestion; lightheadedness; nausea; restlessness; runny nose; stomach pain or upset; trouble sleeping; vomiting; weight gain.
Seek medical attention right away if any of these SEVERE side effects occur when using Risperdal:
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; confusion; drooling; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to control urination; increased sweating; new or worsening mental or mood changes (eg, aggression, agitation, depression, severe anxiety); seizures; severe dizziness; stiff or rigid muscles; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes.
Risperdal Consta
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Risperdal Consta:
Anxiety; constipation; cough; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; increased appetite; increased saliva production; lightheadedness; nausea; restlessness; runny nose; stomach pain or upset; trouble sleeping; vomiting; weight gain.
Seek medical attention right away if any of these SEVERE side effects occur when using Risperdal Consta:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; confusion; decreased sexual ability; drooling; enlarged breasts; fainting; fast or irregular heartbeat; fever; inability to control urination; increased sweating; missed menstrual period; new or worsening mental or mood changes (eg, agitation, aggression, severe anxiety); nipple discharge; prolonged painful erection; seizures; severe dizziness; stiff or rigid muscles; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes.
Risperdal M-Tab Orally Disintegrating Tablets
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Risperdal M-Tab Orally Disintegrating Tablets:
Anxiety; constipation; cough; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; increased appetite; increased saliva production; indigestion; lightheadedness; nausea; restlessness; runny nose; stomach pain or upset; trouble sleeping; vomiting; weight gain.
Seek medical attention right away if any of these SEVERE side effects occur when using Risperdal M-Tab Orally Disintegrating Tablets:
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; confusion; drooling; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to control urination; increased sweating; new or worsening mental or mood changes (eg, aggression, agitation, depression, severe anxiety); seizures; severe dizziness; stiff or rigid muscles; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes.
Risperdal Solution
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Risperdal Solution:
Anxiety; constipation; cough; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; increased appetite; increased saliva production; indigestion; lightheadedness; nausea; restlessness; runny nose; stomach pain or upset; trouble sleeping; vomiting; weight gain.
Seek medical attention right away if any of these SEVERE side effects occur when using Risperdal Solution:
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); abnormal thoughts; confusion; drooling; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to control urination; increased sweating; new or worsening mental or mood changes (eg, aggression, agitation, depression, severe anxiety); seizures; severe dizziness; stiff or rigid muscles; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes.
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Risperdal Side Effects - for the Professional
Risperdal
The following are discussed in more detail in other sections of the labeling:
* Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1)]
* Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.2)]
* Neuroleptic malignant syndrome [see Warnings and Precautions (5.3)]
* Tardive dyskinesia [see Warnings and Precautions (5.4)]
* Hyperglycemia and diabetes mellitus [see Warnings and Precautions (5.5)]
* Hyperprolactinemia [see Warnings and Precautions (5.6)]
* Orthostatic hypotension [see Warnings and Precautions (5.7)]
* Leukopenia, neutropenia, and agranulocytosis [see Warnings and Precautions (5.8)]
* Potential for cognitive and motor impairment [see Warnings and Precautions (5.9)]
* Seizures [see Warnings and Precautions (5.10)]
* Dysphagia [see Warnings and Precautions (5.11)]
* Priapism [see Warnings and Precautions (5.12)]
* Thrombotic Thrombocytopenic Purpura (TTP) [see Warnings and Precautions (5.13)]
* Disruption of body temperature regulation [see Warnings and Precautions (5.14)]
* Antiemetic effect [see Warnings and Precautions (5.15)]
* Suicide [see Warnings and Precautions (5.16)]
* Increased sensitivity in patients with Parkinson's disease or those with dementia with Lewy bodies [see Warnings and Precautions (5.17)]
* Diseases or conditions that could affect metabolism or hemodynamic responses [see Warnings and Precautions (5.17)]
The most common adverse reactions in clinical trials (≥ 10%) were somnolence, appetite increased, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, saliva increased, constipation, fever, Parkinsonism, dystonia, abdominal pain, anxiety, nausea, dizziness, dry mouth, tremor, rash, akathisia, and dyspepsia.
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 somnolence, nausea, abdominal pain, dizziness, vomiting, agitation, and akathisia [see Adverse Reactions (6.5)].
The data described in this section are derived from a clinical trial database consisting of 9712 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 9712 patients, 2626 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.
Adverse events during exposure to study treatment were obtained by general inquiry and recorded by clinical investigators using their own terminology. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using WHOART terminology.
Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Risperdal® (adverse drug reactions) based on the comprehensive assessment of the available adverse event information. A causal association for Risperdal® often cannot be reliably established in individual cases. Further, 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.
The majority of all adverse reactions were mild to moderate in severity.
Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Schizophrenia
Adult Patients with Schizophrenia
Table 1 lists the adverse reactions reported in 1% or more of Risperdal®-treated adult patients with schizophrenia in three 4- to 8-week, double-blind, placebo-controlled trials.
Table 1. Adverse Reactions in ≥1% of Risperdal®-Treated Adult Patients with Schizophrenia in Double-Blind, Placebo-Controlled Trials Percentage of Patients Reporting Event
Risperdal®
Body System
Adverse Reaction 2–8 mg per day
(N=366) >8–16 mg per day
(N=198) Placebo
(N=225)
*
Parkinsonism includes extrapyramidal disorder, hypokinesia, and bradycardia. Dystonia includes dystonia, hypertonia, oculogyric crisis, muscle contractions involuntary, tetany, laryngismus, tongue paralysis, and torticollis. Akathisia includes hyperkinesia and akathisia.
Body as a whole - general disorders
Back pain 3 2 <1
Fatigue 3 1 0
Chest pain 3 1 2
Fever 2 1 1
Asthenia 1 1 <1
Syncope <1 1 <1
Edema <1 1 0
Cardiovascular disorders, general
Hypotension postural 2 <1 0
Hypotension <1 1 0
Central and peripheral nervous system disorders
Parkinsonism* 12 17 6
Dizziness 10 4 2
Dystonia* 5 5 2
Akathisia* 5 5 2
Dyskinesia 1 1 <1
Gastrointestinal system disorders
Dyspepsia 10 7 6
Nausea 9 4 4
Constipation 8 9 7
Abdominal pain 4 3 0
Mouth dry 4 <1 <1
Saliva increased 3 1 <1
Diarrhea 2 <1 1
Hearing and vestibular disorders
Earache 1 1 0
Heart rate and rhythm disorders
Tachycardia 2 5 0
Arrhythmia 0 1 0
Metabolic and nutritional disorders
Weight increase 1 <1 0
Creatine phosphokinase increased <1 2 <1
Musculoskeletal system disorders
Arthralgia 2 3 <1
Myalgia 1 0 0
Platelet, bleeding and clotting disorders
Epistaxis <1 2 0
Psychiatric disorders
Anxiety 16 12 11
Somnolence 14 5 4
Anorexia 2 0 <1
Red blood cell disorders
Anemia <1 1 0
Reproductive disorders, male
Ejaculation failure <1 1 0
Respiratory system disorders
Rhinitis 7 11 6
Coughing 3 3 3
Upper respiratory tract infection 2 3 <1
Dyspnea 2 2 0
Skin and appendages disorders
Rash 2 4 2
Seborrhea <1 2 0
Urinary system disorders
Urinary tract infection <1 3 0
Vision disorders
Vision abnormal 3 1 <1
Pediatric Patients with Schizophrenia
Table 2 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 2. Adverse Reactions in ≥5% of Risperdal®-Treated Pediatric Patients with Schizophrenia in a Double-Blind Trial Percentage of Patients Reporting Event
Risperdal®
Body System
Adverse Reaction 1–3 mg per day
(N=55) 4–6 mg per day
(N=51) Placebo
(N=54)
*
Parkinsonism includes extrapyramidal disorder, hypokinesia, and bradykinesia. Dystonia includes dystonia, hypertonia, oculogyric crisis, muscle contractions involuntary, tetany, laryngismus, tongue paralysis, and torticollis. Akathisia includes hyperkinesia and akathisia.
Central and peripheral nervous system disorders
Parkinsonism* 13 16 6
Tremor 11 10 6
Dystonia* 9 18 7
Dizziness 7 14 2
Akathisia* 7 10 6
Gastrointestinal system disorders
Saliva increased 0 10 2
Psychiatric disorders
Somnolence 24 12 4
Anxiety 7 6 0
Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials – Bipolar Mania
Adult Patients with Bipolar Mania
Table 3 lists the adverse reactions reported in 1% or more of Risperdal®-treated adult patients with bipolar mania in four 3-week, double-blind, placebo-controlled monotherapy trials.
Table 3. Adverse Reactions in ≥1% of Risperdal®-Treated Adult Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Monotherapy Trials Percentage of Patients Reporting Event
Body System
Adverse Reaction Risperdal®
1–6 mg per day
(N=448) Placebo
(N=424)
*
Parkinsonism includes extrapyramidal disorder, hypokinesia, and bradycardia. Dystonia includes dystonia, hypertonia, oculogyric crisis, muscle contractions involuntary, tetany, laryngismus, tongue paralysis, and torticollis. Akathisia includes hyperkinesia and akathisia.
Body as a whole - general disorders
Fatigue 2 <1
Fever 1 <1
Asthenia 1 <1
Edema 1 <1
Central and peripheral nervous system disorders
Parkinsonism* 20 6
Dystonia* 11 3
Akathisia* 9 3
Tremor 6 4
Dizziness 5 5
Gastrointestinal system disorders
Nausea 5 2
Dyspepsia 4 2
Saliva increased 3 <1
Diarrhea 3 2
Mouth dry 1 1
Heart rate and rhythm disorders
Tachycardia 1 <1
Liver and biliary system disorders
SGOT increased 1 <1
Musculoskeletal disorders
Myalgia 2 2
Psychiatric disorders
Somnolence 12 4
Anxiety 2 2
Reproductive disorders, female
Lactation nonpuerperal 1 0
Respiratory disorders
Rhinitis 2 2
Skin and appendages disorders
Acne 1 0
Vision disorders
Vision abnormal 2 <1
Table 4 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 4. Adverse Reactions in ≥2% of Risperdal®-Treated Adult Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Adjuvant Therapy Trials Percentage of Patients Reporting Event
Body System
Adverse Reaction Risperdal® + Mood Stabilizer
(N=127) Placebo + Mood Stabilizer
(N=126)
*
Parkinsonism includes extrapyramidal disorder, hypokinesia and bradykinesia. Dystonia includes dystonia, hypertonia, oculogyric crisis, muscle contractions involuntary, tetany, laryngismus, tongue paralysis, and torticollis. Akathisia includes hyperkinesia and akathisia.
Body as a whole – general disorders
Chest pain 2 2
Fatigue 2 2
Central and peripheral nervous system disorders
Parkinsonism* 9 4
Dizziness 8 2
Dystonia* 6 3
Akathisia* 6 0
Tremor 5 2
Gastrointestinal system disorders
Nausea 6 5
Diarrhea 6 4
Saliva increased 4 0
Abdominal pain 2 0
Heart rate and rhythm disorders
Palpitation 2 0
Metabolic and nutritional disorders
Weight increase 2 2
Psychiatric disorders
Somnolence 12 5
Anxiety 4 2
Respiratory disorders
Pharyngitis 5 2
Coughing 3 1
Skin and appendages disorders
Rash 2 2
Urinary system disorders
Urinary incontinence 2 1
Urinary tract infection 2 1
Pediatric Patients with Bipolar Mania
Table 5 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 5. Adverse Reactions in ≥5% of Risperdal®-Treated Pediatric Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Trials Percentage of Patients Reporting Event
Risperdal ®
Body System
Adverse Reaction 0.5–2.5 mg per day
(N=50) 3–6 mg per day
(N=61) Placebo
(N=58)
*
Dystonia includes dystonia, hypertonia, oculogyric crisis, muscle contractions involuntary, tetany, laryngismus, tongue paralysis, and torticollis. Parkinsonism includes extrapyramidal disorder, hypokinesia, and bradykinesia. Akathisia includes hyperkinesia and akathisia.
Body as a whole - general disorders
Fatigue 18 30 3
Central and peripheral nervous system disorders
Dizziness 16 13 5
Dystonia* 8 13 2
Parkinsonism* 2 7 2
Akathisia* 0 7 2
Gastrointestinal system disorders
Abdominal pain 18 15 5
Dyspepsia 16 5 3
Nausea 16 13 7
Vomiting 12 10 7
Diarrhea 8 7 2
Heart rate and rhythm disorders
Tachycardia 0 5 2
Psychiatric disorders
Somnolence 42 56 19
Appetite increased 4 7 2
Anxiety 0 8 3
Reproductive disorders, female
Lactation nonpuerperal 2 5 0
Respiratory system disorders
Rhinitis 14 13 10
Dyspnea 2 5 0
Skin and appendages disorders
Rash 0 7 2
Urinary system disorders
Urinary incontinence 0 5 0
Vision disorders
Vision abnormal 4 7 0
Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Autistic Disorder
Table 6 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.
Table 6. Adverse Reactions in ≥5% of Risperdal®-Treated Pediatric Patients Treated for Irritability Associated with Autistic Disorder in Double-Blind, Placebo-Controlled Trials Percentage of Patients Reporting Event
Body System
Adverse Reaction Risperdal®
0.5–4.0 mg per day
(N=76) Placebo
(N=80)
*
Dystonia includes dystonia, hypertonia, oculogyric crisis, muscle contractions involuntary, tetany, laryngismus, tongue paralysis, and torticollis. Parkinsonism includes extrapyramidal disorder, hypokinesia, and bradycardia.
Body as a whole - general disorders
Fatigue 42 13
Fever 20 19
Central and peripheral nervous system disorders
Dystonia* 12 6
Tremor 12 1
Dizziness 9 3
Parkinsonism* 8 0
Automatism 7 1
Dyskinesia 7 0
Gastrointestinal system disorders
Vomiting 25 21
Saliva increased 22 6
Constipation 21 8
Mouth dry 13 6
Nausea 8 8
Heart rate and rhythm disorders
Tachycardia 7 0
Metabolic and nutritional disorders
Weight increase 5 0
Psychiatric disorders
Somnolence 67 23
Appetite increased 49 19
Anxiety 16 15
Anorexia 8 8
Confusion 5 0
Respiratory system disorders
Rhinitis 36 23
Upper respiratory tract infection 34 15
Coughing 24 18
Skin and appendages disorders
Rash 11 8
Urinary system disorders
Urinary incontinence 22 20
Other Adverse Reactions Observed During the Premarketing Evaluation of Risperdal®
The following adverse reactions occurred in < 1% of the adult patients and in < 5% of the pediatric patients treated with Risperdal® in the above double-blind, placebo-controlled clinical trial data sets. In addition, the following also includes adverse reactions reported in Risperdal®-treated patients who participated in other studies, including double-blind, active-controlled and open-label studies in schizophrenia and bipolar mania studies in pediatric patients with psychiatric disorders other than schizophrenia, bipolar mania, or autistic disorder, and studies in elderly patients with dementia.
Body as a Whole, General Disorders: edema peripheral, pain, influenza-like symptoms, leg pain, malaise, allergy, crying abnormal, allergic reaction, rigors, allergy aggravated, anaphylactoid reaction, hypothermia
Central Nervous System Disorders: gait abnormal, speech disorder, coma, ataxia, dysphonia, stupor, cramps legs, vertigo, hypoesthesia, tardive dyskinesia, neuroleptic malignant syndrome
Endocrine Disorders: hyperprolactinemia, gynecomastia
Gastrointestinal System Disorders: dysphagia, flatulence
Heart Rate and Rhythm Disorders: AV block, bundle branch block
Liver and Biliary Disorders: SGPT increased, hepatic enzymes increased
Metabolic and Nutritional Disorders: thirst, hyperglycemia, xerophthalmia, generalized edema, diabetes mellitus aggravated, diabetic coma
Musculoskeletal Disorders: muscle weakness, rhabdomyolysis
Platelet, Bleeding, and Clotting Disorders: purpura
Psychiatric Disorders: insomnia, agitation, emotional lability, apathy, nervousness, concentration impaired, impotence, decreased libido
Reproductive Disorders, Female: amenorrhea, menstrual disorder, leukorrhea
Reproductive Disorders, Male: ejaculation disorder, abnormal sexual function, priapism
Resistance Mechanism Disorders: otitis media, viral infection
Respiratory Disorders: respiratory disorder
Skin and Appendages Disorders: skin ulceration, skin discoloration, rash erythematous, skin exfoliation, rash maculopapular, erythema multiforme
Urinary Disorders: micturition frequency
Vascular Disorders: cerebrovascular disorder
Vision Disorders: conjunctivitis
White Cell Disorders: leucopenia, granulocytopenia
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 event, compared with 4% (10/225) who were receiving placebo. The adverse reactions associated with discontinuation in 2 or more Risperdal®-treated patients were:
Table 7. Adverse Reactions Associated With Discontinuation in 2 or More Risperdal®-Treated Adult Patients in Schizophrenia Trials Risperdal®
Adverse Reaction 2–8 mg/day
(N=366) >8–16 mg/day
(N=198) Placebo
(N=225)
Dizziness 1.4% 1.0% 0%
Nausea 1.4% 0% 0%
Agitation 1.1% 1.0% 0%
Parkinsonism 0.8% 0% 0%
Somnolence 0.8% 0.5% 0%
Dystonia 0.5% 0% 0%
Abdominal pain 0.5% 0% 0%
Hypotension postural 0.3% 0.5% 0%
Tachycardia 0.3% 0.5% 0%
Akathisia 0% 1.0% 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 event 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 somnolence (2%), dizziness (2%), anorexia (1%), anxiety (1%), ataxia (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 8. 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%
Somnolence 0.2% 0%
Dizziness 0.2% 0%
Dystonia 0.2% 0%
SGOT increased 0.2% 0.2%
SGPT 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 event, compared with 7% (4/58) of placebo-treated patients. The adverse reactions associated with discontinuation in more than one Risperdal®-treated pediatric patient were somnolence (5%), nausea (3%), abdominal pain (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:
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 11% 15% 16% 20% 31%
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):
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% 11% 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
The proportions of Risperdal® and placebo-treated adult patients with schizophrenia meeting a weight gain criterion of ≥ 7% of body weight were compared in a pool of 6- to 8-week, placebo-controlled trials, revealing a statistically significantly greater incidence of weight gain for Risperdal® (18%) compared to placebo (9%). In a pool of placebo-controlled 3-week studies in adult patients with acute mania, the incidence of weight increase of ≥ 7% at endpoint was comparable in the Risperdal® (2.5%) and placebo (2.4%) groups, and was slightly higher in the active-control group (3.5%).
Changes in body weight were also evaluated in pediatric patients [see Use in Specific Populations (8.4)]
Changes in ECG
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 possible to reliably estimate their frequency: agranulocytosis, alopecia, anaphylactic reaction, angioedema, atrial fibrillation, diabetes mellitus, diabetic ketoacidosis in patients with impaired glucose metabolism, hypoglycemia, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, QT prolongation, sleep apnea, thrombocytopenia, urinary retention, and water intoxication.
Other adverse events reported since market introduction, which were temporally related to risperidone but not necessarily causally related, include the following: pituitary adenoma, pulmonary embolism, precocious puberty, cardiopulmonary arrest, and sudden death.
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Side Effects by Body System
Nervous system
Nervous system side effects have frequently included insomnia (26%), dystonia (18%), akathisia (16%), extrapyramidal symptoms (17%), headache (14%), dizziness (11%), parkinsonism (6%), asthenia (4%), somnolence (3%), and hypoesthesia (2%). Increased dream activity, nervousness, impaired concentration, increased sleep duration, dysarthria, vertigo, stupor, paraesthesia, confusion, and amnesia have also been reported. Delirium, withdrawal syndrome, yawning, aphasia, cholinergic syndrome, hypoesthesia, tongue paralysis, leg cramps, torticollis, hypotonia, coma, migraine, hyperreflexia, choreoathetosis, seizures, neuroleptic malignant syndrome, tardive dyskinesia, and sleep- related eating disorder (SRED) have been reported rarely.
Extrapyramidal symptoms may be less frequently associated with risperidone than most other available antipsychotics....