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U.S. Department of Health and Human Services

Safety

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Vesicare (solifenacin succinate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2012

 

Summary View

 

WARNINGS AND PRECAUTIONS

Central Nervous System Effects
  • Vesicare is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how VESIcare affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.