Zonegran Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

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 as follows^*. (See Table 4.)

Click on icon to see table/diagram/image

* 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.

View ADR Reporting Link

zonisamide

Manufacturer:

Sumitomo Pharma

Distributor:

Zuellig

HI-Eisai

Marketer:

Eisai