abstract_textpZonisamide safety was evaluated based on a postmarketing surveillance study of patients treated for 1-3 years. Nine hundred twenty-eight children and 584 adults (ages 1 month to 79 years), including 372 newly-diagnosed patients, received zonisamide for partial and generalized epilepsies. Of the intractable patients, 1088 received zonisamide in combination with other antiepileptic drugs (AED), and 52 successfully transitioned to zonisamide monotherapy. A total of 1089 adverse events occurred in 476 (31.5) of 1512 patients. Incidence of adverse effects was significantly tower among patients receiving zonisamide monotherapy than in those receiving polytherapy: 21 (18.9 of children, 29.4 of adults) versus 35.6 (30.4 of children, 41.7 of adults), respectively. The total incidence of adverse effects was tower for children (26.2) than for adults (39.9). Most common adverse events included mental/psychiatric symptoms (19.4), gastrointestinal symptoms (8.7), and neurological symptoms (6.5). Effects that seemed unique to zonisamide were impairment of mental function, motivation or volition, and hypohidrosis. Urinary calculi were detected in only two patients (0.13). Teratogenicity was evaluated in six patients. Two patients on zonisamide monotherapy and three on polytherapy delivered normal children. One of four patients on polytherapy conceived a fetus with a skull defect with cerebral and cerebellar dysgenesis, namely anencephaly. (c) 2004 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved./p/abstract_text
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