Label Changes for:

Ditropan (oxybutynin chloride) Tablets

March 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

March 2012

ADVERSE REACTIONS

Postmarketing Experience
  • glaucoma 

 

 

August 2011

 

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.

 

PRECAUTIONS

Information for Patients
  • Patients should be informed that oxybutynin may produce angioedema that could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.

 

ADVERSE REACTIONS

Postmarketing Experience
  • ...hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment.

 

July 2009

 

ADVERSE REACTIONS

Postmarketing Surveillance
  • memory impairment
  • Cardiac Disorders: QT interval prolongation

 

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