Label Changes for:
Zonegran (zonisamide) Capsules
January 2012
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)
January 2012
ADVERSE REACTIONS
Postmarketing Experience
- Acute pancreatitis, rhabdomyolysis, creatine phosphokinase increased
April 2010
WARNINGS
Metabolic Acidosis
- added safety-related language regarding metabolic acidosis
PRECAUTIONS
Kidney Stones
- Although the clinical significance of the sonographic findings may not be certain, the development of nephrolithiasis may be related to metabolic acidosis.
Information for patients
- Patients should contact their physician immediately if they develop fast breathing, fatigue/tiredness loss of appetite, or irregular heart beat or palpitations (possible manifestations of metabolic acidosis).
