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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 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 greater than or equal to 5% of Patients Using Oxybutynin Chloride (5 to 20 mg/day) Body System Adverse Events Oxybutynin Chloride (5 - 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 less than 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 oral 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 movements; 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. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.