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U.S. Department of Health and Human Services

Safety

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Detrol (tolterodine tartrate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

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. Read about the new physician labeling format.


Summary View

 

Brand (Generic) Name

Sections Modified

Detrol (tolterodine tartrate) tablets, 1 and 2 mg

PATIENT PACKAGE INSERT

  • Changes in text and formatting throughout document
  • Addition in "What should I avoid while taking Detrol?" section
    • Medicines like Detrol can cause blurred vision or drowsiness. Use caution while driving or doing other dangerous activities until you know how Detrol affects you.
  • Addition in "What are possible side effects" section
    • Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
    • Tell your doctor if you have any side effects that bother your or that do not go away.