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U.S. Department of Health and Human Services

Safety

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Ditropan XL (oxybutynin chloride) Extended Release Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

PRECAUTIONS

  • Central Nervous System Effects
    • Oxybutynin is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence.
    • Ditropan XL should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.

ADVERSE REACTIONS (see highlighted section)

  • ...The following adverse events were reported by >1 to < 5% of all patients who received Ditropan XL in the 6 adjustable and fixed dose efficacy and safety studies...
    • Infections and Infestations
    • Psychiatric Disorders
    • Nervous System Disorders
    • Eye Disorders
    • Cardiac Disorders
    • Vascular Disorders
    • Respiratory, Thoracic and Mediastinal Disorders
    • Gastrointestinal Disorders
    • Skin and Subcutaneous Tissue Disorders
    • Musculoskeletal and Connective Tissue Disorders
    • Renal and Urinary Disorders
    • General Disorders and Administration Site Conditions
    • Investigations
  • Postmarketing Surveillance
    • Psychiatric Disorders
    • Nervous System Disorders
    • Cardiac Disorders
    • Vascular Disorders
    • Skin and Subcutaneous Tissue Disorders
    • Renal and Urinary Disorders
    • Injury, Poisoning, and Procedural Complications