Safety

Gelnique (oxybutynin chloride) 10% gel

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

July 2015

Summary View

WARNINGS

Central Nervous System Effects
  • *Addition of the terms “hallucinations” and “confusion”

ADVERSE REACTIONS

Postmarketing Experience
  • *Addition of “hallucinations” and “confusion”

 

October 2012

Summary View 

WARNINGS and PRECAUTIONS

Central Nervous System Effects
  • A variety of CNS anticholinergic effects have been reported, including headache, dizziness, and somnolence.

 

Page Last Updated: 08/14/2015
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