Oxybutynin Chloride Side Effects

Brand Names: Ditropan, Gelnique, Oxytrol, Ditropan XL

Please note - some side effects for Oxybutynin Chloride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Oxybutynin Chloride Side Effects - for the Professional

Oxybutynin Chloride

Adverse Events with Oxybutynin Chloride Extended-release Tablets

The safety and efficacy of Oxybutynin Chloride was evaluated in a total of 580 participants who received Oxybutynin Chloride extended-release tablets in four clinical trials (429 patients) and four pharmacokinetic studies (151 healthy volunteers). The 429 patients were treated with 5 to 30 mg/day for up to 4.5 months. Three of the four 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 2 below.

Adverse events from two additional fixed dose, active controlled, 12 week treatment duration, post-marketing studies, in which 576 patients were treated with Oxybutynin Chloride extended-release tablets 10 mg/day, are also listed in Table 2 (second column). The adverse events are reported regardless of causality.

The most common adverse events reported by the 429 patients receiving 5 to 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 four studies of efficacy and safety who received 5 to 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 six 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.

Post-Marketing Surveillance

Because post-marketing 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 post-marketing experience with Oxybutynin Chloride extended-release tablets: Psychiatric Disorders: psychotic disorder, agitation, hallucinations; Nervous System Disorders: convulsions; Cardiac Disorders: arrhythmia; tachycardia; Vascular Disorders: flushing; Skin and Subcutaneous Tissue Disorders: rash; Renal and Urinary Disorders: impotence; Injury, Poisoning and Procedural Complications: fall.

Additional adverse events reported with some other Oxybutynin Chloride formulations include: cycloplegia, mydriasis, and suppression of lactation.

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