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adverse reactions
6 ADVERSE REACTIONS 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. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088, or www.fda.gov/medwatch 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 )] Metabolic Changes (Hyperglycemia and diabetes mellitus, Dyslipidemia, and Weight Gain) [see Warnings and Precautions ( 5.5 )] Hyperprolactinemia [see Warnings and Precautions ( 5.6 )] Orthostatic hypotension [see Warnings and Precautions ( 5.7 )] Falls [see Warnings and Precautions ( 5.8 )] Leukopenia, neutropenia, and agranulocytosis [see Warnings and Precautions ( 5.9 )] Potential for cognitive and motor impairment [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Dysphagia [see Warnings and Precautions ( 5.12 )] Priapism [see Warnings and Precautions ( 5.13 )] Disruption of body temperature regulation [see Warnings and Precautions ( 5.14 )] 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...
adverse reactions table
Table 8. Adverse Reactions in ≥2% of Risperidone -Treated Adult Patients (and greater than placebo) with Schizophrenia in Double-Blind, Placebo-Controlled Trials* 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.Percentage of Patients Reporting Reaction RisperidoneSystem/Organ Class Adverse Reaction2 to 8 mg per day (N=366)>8 to 16 mg per day (N=198)Placebo (N=225)Cardiac DisordersTachycardia130Eye DisordersVision blurred311Gastrointestinal DisordersNausea944Constipation896Dyspepsia865Dry mouth401Abdominal discomfort311Salivary hypersecretion21<1Diarrhea211General DisordersFatigue310Chest pain221Asthenia21<1Infections and InfestationsNasopharyngitis343Upper respiratory tract infection231Sinusitis121Urinary tract infection130InvestigationsBlood creatine phosphokinase increased12<1Heart rate increased<120Musculoskeletal and Connective Tissue DisordersBack pain411Arthralgia23<1Pain in extremity211Nervous System DisordersParkinsonism*14178Akathisia*10103Sedation1052Dizziness742Dystonia*342Tremor*231Dizziness postural200Psychiatric DisordersInsomnia322527Anxiety161111Respiratory, Thoracic and Mediastinal DisordersNasal congestion462Dyspnea120Epistaxis<120Skin and Subcutaneous Tissue DisordersRash141Dry skin130Vascular DisordersOrthostatic hypotension210