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U.S. Department of Health and Human Services


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Zonegran (zonisamide) capsules

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


January 2012

Summary View


Postmarketing Experience
  • Acute pancreatitis, rhabdomyolysis, creatine phosphokinase increased



April 2010 

Summary View



Metabolic Acidosis
  • added safety-related language regarding metabolic acidosis


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).