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ZONISAMIDE


DIR Classification


Classification:Less-DIR concern
Severity Score:1

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • ADVERSE REACTIONS
  • Post-Marketing Experience
  • The following serious adverse events have been reported since approval and use of zonisamide worldwide. These reactions are reported voluntarily from a population of uncertain size; therefore, it is not possible to estimate their frequency or establish a causal relationship to drug exposure.
  • Acute pancreatitis, rhabdomyolysis, creatine phosphokinase increased.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
34
42878
Other ADRs
3523
14113756

Odds Ratio = 3.177

Drug Property Information



ATC Code(s):
  • N03AX15 - zonisamide
    • N03AX - Other antiepileptics
    • N03A - ANTIEPILEPTICS
    • N03 - ANTIEPILEPTICS
    • N - NERVOUS SYSTEM
Active Ingredient:zonisamide
Active Ingredient UNII:459384H98V
Drugbank ID:DB00909
PubChem Compound:5734
CAS Number:68291-97-4
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
  • 200.0 mg/day N03AX15
Chemical Structure:
SMILE Code:
C1=CC=C2C(=C1)C(=NO2)CS(=O)(=O)N

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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