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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


Postmarketing Experience
  • Acute pancreatitis, rhabdomyolysis, creatine phosphokinase increased



April 2010 



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).