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U.S. Department of Health and Human Services

Safety

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Detrol (tolterodine tartrate) tablets and Detrol LA (tolterodine tartrate) extended release tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2011

 

Summary View

CONTRAINDICATIONS

  • contraindicated in patients with known hypersen to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, are metabolized to 5-hydroxymethyl tolterodine.

WARNING

  • Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of DETROL. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, DETROL should be discontinued and appropriate therapy promptly provided.

ADVERSE REACTIONS

Post-Marketing Surveillance
  • General: anaphylaxis and angioedema;

PATIENT PACKAGE INSERT

Who should not take DETROL?
  • Are allergic to Toviaz which contains fesoterodine.
What are possible side effects of Detrol?
  • Symptoms of a serious allergic reaction may include swelling of the face, lips, throat or tongue.
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