Label Changes for:
VESIcare (solifenacin succinate) Tablets
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)
- muscular weakness
- 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
- Dermatologic: exfoliative dermatitis and erythema multiforme
- 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.
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.
with airway obstruction