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warnings
WARNINGS Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.
ADVERSE REACTIONS Adverse Events with Oxybutynin chloride extended-release tablets The safety and efficacy of Oxybutynin chloride extended-release tablets were evaluated in a total of 580 participants who received Oxybutynin chloride extended-release tablets in 4 clinical trials (429 patients) and four pharmacokinetic studies (151 healthy volunteers). The 429 patients were treated with 5-30 mg/day for up to 4.5 months. Three of the 4 clinical trials allowed dose adjustments based on efficacy and adverse events and one was a fixed dose escalation design. Safety information is provided for 429 patients from these three controlled clinical studies and one open label study in the first column of Table 3 below. Adverse events from two additional fixed dose, active controlled, 12 week treatment duration, postmarketing studies, in which 576 patients were treated with Oxybutynin chloride extended-release tablets 10 mg/day, are also listed in Table 3 (second column). The adverse events are reported regardless of causality. Table 3 Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using Oxybutynin chloride extended-release tablets (5-30 mg/day) and % of Corresponding Adverse Events in Two Fixed Dose (10 mg/day) Studies Body System Adverse Event Oxybutynin chloride extended-release tablets 5-30 mg/day (n=429) Oxybutynin chloride extended-release tablets 10 mg/day (n=576) General headache 10 6 asthenia 7 3 pain 7 4 Digestive dry mouth 61 29 constipation 13 7 diarrhea 9 7 nausea 9 2 dyspepsia 7 5 Nervous somnolence 12 2 dizziness 6 4 Respiratory rhinitis 6 2 Special Senses blurred vision 8 1 dry eyes 6 3 Urogenital urinary tract infection 5 5 The most common adverse events reported by the 429 patients receiving 5-30 mg/day Oxybutynin chloride extended-release tablets were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related. The discontinuation rate for all adverse events was 6.8% in the 429 patients from the 4 studies of efficacy and safety who received 5-30 mg/day. The most frequent adverse event causing early discontinuation of study medication was nausea (1.9%), while discontinuation due to dry mouth was 1.2%. In addition, the following adverse events were reported by ≥1 to < 5% of all patients who received Oxybutynin chloride extended-release tablets in the 6 adjustable and fixed dose efficacy and safety studies. Infections and infestations : nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, cystitis; Psychiatric disorders : insomnia, depression, nervousness, confusional state; Nervous System Disorders : dysgeusia; Cardiac disorders : palpitations; Vascular disorders : hypertension; Respiratory, thoracic and mediastinal disorders : nasal dryness, cough, pharyngolaryngeal pain, dry throat; Gastrointestinal Disorders : gastroesophageal reflux disease, abdominal pain, loose stools, flatulence, vomiting; Skin and subcutaneous tissue disorders : dry skin, pruritis; Musculoskeletal and connective tissue disorders : back pain, arthralgia, pain in extremity; Renal and urinary disorders : urinary retention, urinary hesitation, dysuria; General disorders and administration site conditions : fatigue, edema peripheral, asthenia, chest pain; Investigations : blood pressure increased. Postmarketing Surveillance Because postmarketing reactions 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 drug reactions have been reported from worldwide postmarketing experience with Oxybutynin chloride extended-release tablets: Psychiatric Disorders : psychotic disorder, agitation, hallucinations; Nervous System Disorders : convulsions; Cardiac Disorders : arrhythmia; tachycardia; QT interval prolongation, Vascular Disorders : flushing; Skin and Subcutaneous Tissue Disorders : rash; Renal and Urinary Disorders : impotence; 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; Injury, poisoning and procedural complications : fall. Additional adverse events reported with some other oxybutynin chloride formulations include: cycloplegia, mydriasis, and suppression of lactation.