Safety

Gelnique (oxybutynin chloride), 3 percent 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”

 

January 2013

Summary View

5 WARNINGS and PRECAUTIONS

5.5 Central Nervous System Effects
  • Drugs containing oxybutynin are associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6.1)]. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly .....

 

Page Last Updated: 08/14/2015
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