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U.S. Department of Health and Human Services

Safety

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Vesicare (solifenacin succinate) tablet

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

 

October 2013

Summary View

ADVERSE REACTIONS

  • Cardiovascular: atrial fibrillation, tachycardia and palpitations 

 

March 2013

Summary View

ADVERSE REACTIONS

Post-Marketing Experience
  • muscular weakness

 

July 2012

ADVERSE REACTIONS

Post-Marketing Experiences
  • Central Nervous: delirium
  • Hepatic: liver disorders mostly characterized by abnormal liver function tests (AST,ALT, GGT) Renal: renal impairment
  • Metabolism and nutrition disorders: decreased appetite, hyperkalemia

 

 

January 2012

Summary View

ADVERSE REACTIONS

Postmarketing Experience 
  • Dermatologic: exfoliative dermatitis and erythema multiforme  

 

 

July 2010

Summary View

 

WARNINGS

  • Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin. In some cases angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, solifenacin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

PRECAUTIONS

Information for Patients
  • Patients should be informed that solifenacin may produce angioedema, which could result in lifethreatening airway obstruction. Patients should be advised to promptly discontinue solifenacin therapy and seek immediate attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing.

ADVERSE REACTIONS

Post-Marketing Surveillance
  • with airway obstruction