FDA label 49b10531-f2c8-434c-b8ba-78f9fd9d095b

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 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 5-20 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 (5-20 mg/day) Body System Adverse Event OXYBUTYNIN CHLORIDE 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 5-20 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 (5-20 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, hallucinations, 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.

<table cellpadding="3"> <caption>Table 3 Incidence (%) of Adverse events Reported by &#x2265; 5% of Patients Using OXYBUTYNIN CHLORIDE (5-20 mg/day)</caption> <tbody> <tr> <th styleCode="Botrule">Body System</th> <th styleCode="Botrule">Adverse Event</th> <th styleCode="Botrule">OXYBUTYNIN CHLORIDE</th> </tr> <tr> <td>Infections and Infestations</td> <td>Urinary tract infection</td> <td>6.5%</td> </tr> <tr> <td>Psychiatric Disorders</td> <td>Insomnia</td> <td>5.5%</td> </tr> <tr> <td/> <td>Nervousness</td> <td>6.5%</td> </tr> <tr> <td>Nervous System Disorders</td> <td>Dizziness</td> <td>16.6%</td> </tr> <tr> <td/> <td>Somnolence</td> <td>14.0%</td> </tr> <tr> <td/> <td>Headache</td> <td>7.5%</td> </tr> <tr> <td>Eye Disorders</td> <td>Blurred vision</td> <td>9.6%</td> </tr> <tr> <td>Gastrointestinal Disorders</td> <td>Dry mouth</td> <td>71.4%</td> </tr> <tr> <td/> <td>Constipation</td> <td>15.1%</td> </tr> <tr> <td/> <td>Nausea</td> <td>11.6%</td> </tr> <tr> <td/> <td>Dyspepsia</td> <td>6.0%</td> </tr> <tr> <td>Renal and Urinary Disorders</td> <td>Urinary Hesitation</td> <td>8.5%</td> </tr> <tr> <td/> <td>Urinary Retention</td> <td>6.0%</td> </tr> </tbody> </table>