ADVERSE REACTIONS Adverse Events with DITROPAN XL The safety and efficacy of DITROPAN XL ® (oxybutynin chloride) was evaluated in a total of 580 participants who received DITROPAN XL in clinical trials (429 patients, 151 healthy volunteers). These participants were treated with 5-30 mg/ day for up to 4.5 months. Safety information is provided for 429 patients from three controlled clinical studies and one open label study (Table 3). The adverse events are reported regardless of causality.  The most common adverse events reported by patients receiving 5-30 mg/ day DITROPAN XL 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%. 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 2 to <5% of patients using DITROPAN XL (5-30 mg/ day) in all studies. General: abdominal pain, dry nasal and sinus mucous membranes, accidental injury, back pain, flu syndrome; Cardiovascular: hypertension, palpitation, vasodilatation; Digestive: flatulence, gastroesophageal reflux; Musculoskeletal: arthritis; Nervous: insomnia, nervousness, confusion; Respiratory: upper respiratory tract infection, cough, sinusitis, bron-chitis, pharyngitis; Skin: dry skin, rash; Urogenital: impaired urination (hesitancy), increased post void residual volume, urinary retention, cystitis. Additional rare adverse events reported from worldwide post-marketing experience with DITROPAN XL include: peripheral edema, cardiac arrhythmia, tachycardia, hallucinations, convulsions, and impotence. Additional adverse events reported with some other oxybutynin chloride formulations include: cycloplegia, mydriasis, and suppression of lactation. | ||||
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