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adverse reactions
ADVERSE REACTIONS The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials. These participants were treated with oxybutynin chloride 5 mg/day to 20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients. Table 3 Incidence (%) of Adverse Events Reported by ≥5% of Patients Using Oxybutynin Chloride (5 to 20 mg/day) Body System Adverse Event Oxybutynin Chloride (5 to 20 mg/day) (n=199) Infections and Infestations Urinary tract infection 6.5% Psychiatric Disorders Insomnia 5.5% Nervousness 6.5% Nervous System Disorders Dizziness 16.6% Somnolence 14.0% Headache 7.5% Eye Disorders Blurred vision 9.6% Gastrointestinal Disorders Dry mouth 71.4% Constipation 15.1% Nausea 11.6% Dyspepsia 6.0% Renal and Urinary Disorders Urinary Hesitation 8.5% Urinary Retention 6.0% The most common adverse events reported by patients receiving oxybutynin chloride 5 to 20 mg/day were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related. In addition, the following adverse events were reported by 1% to <5% of patients using oxybutynin chloride (5 to 20 mg/day) in all studies. Infections and Infestations: nasopharyngitis, upper respiratory tract infection, bronchitis, cystitis, fungal infection Metabolism and Nutrition Disorders: fluid retention Psychiatric Disorders: confusional state Nervous System Disorders: dysgeusia, sinus headache Eye Disorders: keratoconjunctivitis sicca, eye irritation Cardiac Disorders: palpitations, sinus arrhythmia Vascular Disorders: flushing Respiratory, Thoracic and Mediastinal Disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat, sinus congestion, hoarseness, asthma, nasal congestion Gastrointestinal Disorders: diarrhea, abdominal pain, loose stools, flatulence, vomiting, abdominal pain upper, dysphagia, aptyalism, eructation, tongue coated Skin and Subcutaneous Tissue Disorders: dry skin, pruritis Musculoskeletal and Connective Tissue Disorders: back pain, arthralgia, pain in extremity, flank pain Renal and Urinary Disorders: dysuria, pollakiuria General Disorders and Administration Site Conditions: fatigue, edema peripheral, asthenia, pain, thirst, edema Investigations: blood pressure increased, blood glucose increased, blood pressure decreased Injury, Poisoning, and Procedural Complications : fall Postmarketing Surveillance Because postmarketing adverse events 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. The following additional adverse events have been reported from worldwide postmarketing experience with oxybutynin chloride: Psychiatric Disorders: psychotic disorder, agitation, hallucination, memory impairment Nervous System Disorders: convulsions Eye Disorders: cycloplegia, mydriasis, glaucoma Cardiac Disorders: tachycardia, QT interval prolongation, chest discomfort Gastrointestinal Disorders: decreased gastrointestinal motility, frequent bowel movement Skin and Subcutaneous Tissue Disorders: rash, decreased sweating Renal and Urinary Disorders: impotence Reproductive System and Breast Disorders: suppression of lactation General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment Metabolism and Nutrition Disorders: anorexia Respiratory, Thoracic and Mediastinal Disorders: dysphonia