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Zonegran (zonisamide) capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Acute pancreatitis, rhabdomyolysis, creatine phosphokinase increased
- added safety-related language regarding metabolic acidosis
- 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).