Zonisamide has been administered to over 1,200 patients in clinical studies, more than 400 of whom received Zonisamide for at least 1 year. The most common adverse reactions in controlled adjunctive therapy studies were somnolence, dizziness and anorexia. Adverse reactions associated with Zonisamide obtained from clinical studies and post-marketing surveillance are tabulated below*.
| System Organ Class | Very Common (>10%) |
Common (1-10%) |
Uncommon (0.1 – 1%) |
Very Rare (<0.001 %) |
| Blood and lymphatic system | Ecchymosis | Agranulocytosis Aplastic anemia Thrombocytopenia |
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| Immune system disorders | Hypersensitivity | |||
| Metabolism & Nutrition disorders | Anorexia | |||
| Psychiatric disorders | Affect lability, agitation, anxiety, depression, insomnia, irritability, psychotic disorder |
Suicide attempt | ||
| Nervous system disorders | Dizziness, somnolence | Ataxia, bradyphrenia, confusion, convulsion, disturbance in attention, memory impairment, nystagmus, paresthesia, speech disorder, tremor |
Status epilepticus | |
| Eye disorders | Diplopia | |||
| Gastrointestinal disorders | Abdominal pain, constipation, diarrhea, dyspepsia, nausea | Pancreatitis | ||
| Skin & subcutaneous tissue disorders | Rash | Anhidrosis, erythema multiforme, Stevens- Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS) |
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| Renal and urinary disorders | Nephrolithiasis | Renal failure | ||
| General disorders and administration site conditions | Fatigue, influenza like illness |
Hyperthermia, sudden unexplained death in epilepsy | ||
| Investigations | Decreased bicarbonate | Weight decreased | Increase in alanine aminotransferase, aspartate aminotransferase, blood creatine phosphokinase, blood creatinine, blood urea |
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| * The basic rule used in creating the table was to include in the tabulation for the very common & common adverse reactions those adverse reactions experienced by >2% and more by Zonisamide treated patients than the placebo in the double blind studies. The one exception is Nephrolithiasis which is based on the reported incidence in the open label studies because it appears to increase in frequency with increased duration of therapy. The other events are based on post marketing reports. |
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| Reporting of suspected adverse drug reactions |
| Please contact: |
| HI-Eisai Pharmaceutical, Inc. |
| +63 2 88875837 / +63 2 88875160 / +63 9088672236 |
| Or Report to FDA Philippines: www.fda.gov.ph |
