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U.S. Department of Health and Human Services

Safety

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Toviaz (Fesoterodine Fumarate) Extended-Release Tablets

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

Summary View

 

WARNINGS AND PRECAUTIONS

  • Central Nervous System Effects: Toviaz is associated with anticholinergic central nervous sytem (CNS) effects…
  • Concomitant Administration with CYP3A4 Inhibitors: Doses of Toviaz greater than 4 mg are not recommended in patients taking a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin)…
 

ADVERSE REACTIONS

Post-marketing Experiences:
  • Central nervous system disorders: Dizziness, headache, somnolence…