Risperidone Orally Disintegrating Side Effects
Please note - some side effects for Risperidone Orally Disintegrating may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Risperidone Orally Disintegrating Side Effects - for the Professional
Risperidone Orally Disintegrating
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, increased appetite, fatigue, insomnia, sedation, parkinsonism, akathisia, vomiting, cough, constipation, nasopharyngitis, drooling, rhinorrhea, dry mouth, abdominal pain upper, dizziness, nausea, anxiety, headache, nasal congestion, rhinitis, tremor, and rash.
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 (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 risperidone 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 risperidone while participating in double-blind, placebo-controlled trials. The conditions and duration of treatment with risperidone 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 MedDRA terminology.
Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of risperidone (adverse drug reactions) based on the comprehensive assessment of the available adverse event information. A causal association for risperidone 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 SchizophreniaTable 1 lists the adverse reactions reported in 1% or more of risperidone-treated adult patients with schizophrenia in three 4 to 8 week, double-blind, placebo-controlled trials.
Pediatric Patients with SchizophreniaTable 2 lists the adverse reactions reported in 5% or more of risperidone-treated pediatric patients with schizophrenia in a 6 week double-blind, placebo-controlled trial.
Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials – Bipolar Mania
Adult Patients with Bipolar ManiaTable 3 lists the adverse reactions reported in 1% or more of risperidone-treated adult patients with bipolar mania in four 3 week, double-blind, placebo-controlled monotherapy trials.
Table 4 lists the adverse reactions reported in 2% or more of risperidone-treated adult patients with bipolar mania in two 3 week, double-blind, placebo-controlled adjuvant therapy trials.
Pediatric Patients with Bipolar ManiaTable 5 lists the adverse reactions reported in 5% or more of risperidone-treated pediatric patients with bipolar mania in a 3 week double-blind, placebo-controlled trial.
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 risperidone-treated pediatric patients treated for irritability associated with autistic disorder in two 8 week, double-blind, placebo-controlled trials.
In another study with patients treated for irritability associated with autistic disorder, headache (6%), epistaxis (6%), and pyrexia (6%) were also observed in risperidone-treated pediatric subjects.
Other Adverse Reactions Observed During the Premarketing Evaluation of Risperidone
The following adverse reactions occurred in < 1% of the adult patients and in < 5% of the pediatric patients treated with risperidone in the above double-blind, placebo-controlled clinical trial data sets. In addition, the following also includes adverse reactions reported in risperidone-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.
Blood and Lymphatic System Disorders: 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: 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
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: polydipsia, anorexia
Musculoskeletal and Connective Tissue Disorders: 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, hypersomnia, transient ischemic attack, coordination abnormal, cerebrovascular accident, speech disorder, loss of consciousness, hypoesthesia, tardive dyskinesia, cerebral ischemia, cerebrovascular disorder, neuroleptic malignant syndrome, diabetic coma, head titubation
Psychiatric Disorders: agitation, blunted affect, confusional state, middle insomnia, sleep disorder, listless, libido decreased, anorgasmia
Renal and Urinary Disorders: enuresis, dysuria, pollakiuria
Reproductive System and Breast Disorders: menstruation irregular, amenorrhea, gynecomastia, 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, pruritis, skin disorder, rash erythematous, rash papular, rash generalized, rash maculopapular
Additional Adverse Reactions Reported with Risperidone
The following is a list of additional adverse reactions that have been reported during the premarketing evaluation of risperidone, regardless of frequency of occurrence:
Cardiac Disorders: bradycardia
Ear and Labyrinth Disorders: vertigo
Gastrointestinal Disorders: toothache, tongue spasm
General Disorders and Administration Site Conditions: pain
Infections and Infestations: lower respiratory tract infection, infection, gastroenteritis, subcutaneous abscess
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 - AdultsApproximately 7% (39/564) of risperidone-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 risperidone-treated patients were:
| Risperidone | |||
| Adverse Reaction | 2 to 8 mg/day (N=366) | >8 to 16 mg/day (N=198) | Placebo (N=225) |
| 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 - PediatricsApproximately 7% (7/106), of risperidone-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 risperidone-treated patient were dizziness (2%), somnolence (1%), sedation (1%), lethargy (1%), anxiety (1%) balance disorder (1%), hypotension (1%), and palpitation (1%).
Bipolar Mania – AdultsIn double-blind, placebo-controlled trials with risperidone as monotherapy, approximately 6% (25/448) of risperidone-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 risperidone-treated patients were:
| Risperidone 1to 6 mg/day (N=448) | Placebo (N=424) | |
| Adverse Reaction | ||
| 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% |
In a double-blind, placebo-controlled trial 12% (13/111) of risperidone-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 risperidone-treated pediatric patient were nausea (3%), somnolence (2%), sedation (2%), and vomiting (2%).
Autistic Disorder - PediatricsIn the two 8-week, placebo-controlled trials in pediatric patients treated for irritability associated with autistic disorder (n = 156), one risperidone -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 SymptomsData from two fixed-dose trials in adults with schizophrenia provided evidence of dose-relatedness for extrapyramidal symptoms associated with risperidone treatment.
Two methods were used to measure extrapyramidal symptoms (EPS) in an 8 week trial comparing 4 fixed doses of risperidone (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 | Risperidone 2 mg | Risperidone 6 mg | Risperidone 10 mg | Risperidone 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 risperidone (1, 4, 8, 12, and 16 mg/day):
| Dose Groups | Risperidone 1 mg | Risperidone | Risperidone 8 mg | Risperidone 12 mg | Risperidone 16 mg |
| Parkinsonism | 0.6 | 1.7 | 2.4 | 2.9 | 4.1 |
| EPS Incidence | 7% | 12% | 17% | 18% | 20% |
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 ReactionsAdverse event data elicited by a checklist for side effects from a large study comparing 5 fixed doses of risperidone (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 risperidone 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 risperidone (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 risperidone (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 risperidone 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 to 16 mg/day) were associated with a higher mean increase in heart rate compared to placebo (4 to 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 to 16 years) mean changes in heart rate were an increase of 8.4 beats per minute in the risperidone 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 to 17 years), there were no significant changes in ECG parameters,other than the effect of risperidone to transiently increase pulse rate (< 6 beats per minute). In two controlled schizophrenia trials in adolescents (aged 13 to 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, blood cholesterol increased, blood triglycerides increased, diabetes mellitus, diabetic ketoacidosis in patients with impaired glucose metabolism, drug withdrawal syndrome neonatal, dysgeusia, hypoglycemia, hypothermia, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, priapism, QT prolongation, sleep apnea syndrome, 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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