Zonisamide (All indications) updated on 06-15-2026

Table   Graphic     exposition period:

Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
All congenital malformations (majors, minors, majors and minors, or unspecified)1.69 [0.75, 3.79]0%7 studies49,667325not evaluable ROB-
Major congenital malformations1.69 [0.75, 3.79]0%7 studies49,667325not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low birth weight (< 2500g)2.17 [0.91, 5.14]-1 study2698not evaluable ROB-
Preterm (< 37 weeks)0.76 [0.49, 1.18]-1 study215228not evaluable ROB-
Small for gestational age (weight)1.90 [1.20, 3.00]-1 study125not evaluable ROB3.21 [1.69; .]

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)1.16 [0.02, 62.85]-1 study13not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Language disorders/delay0.66 [0.22, 2.01]67%2 studies469257not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis0.93 [0.48, 1.80]-1 study246not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk0.93 [0.48, 1.80]-1 study246not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis0.92 [0.28, 3.00]-1 study246not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk0.92 [0.28, 3.00]-1 study246not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)3.62 [0.81, 16.21]-1 study246not evaluable ROB-
Learning disorders 0.53 [0.03, 9.00]-1 study12246not evaluable ROB-
Psychomotor developmental disorders/delay0.74 [0.18, 3.10]-1 study246not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)3.62 [0.81, 16.21]-1 study246not evaluable ROB-

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