Oxybutyninside effects

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. 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. table3 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. To report SUSPECTED ADVERSE REACTIONS, contact TruPharma LLC at 1-877-541-5504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.