Label Changes for:
VESIcare (solifenacin succinate) Tablets
March 2013
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2013
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
ADVERSE REACTIONS
Postmarketing Experience
- Dermatologic: exfoliative dermatitis and erythema multiforme
July 2010
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
