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Zonisamide (All indications)
Overall results
Study description
Excluded studies
Table
Graphic
auto
during pregnancy (anytime or not specified)
1st trimester
2nd trimester
3rd trimester
2nd and/or 3rd trimester
throughout pregnancy
early pregnancy
days before delivery
late pregnancy
preconception-only
periconceptional
preconceptional for kinetic reason
at least 1st trimester
3 months (or more) before pregnancy or during pregnancy
1st and 2nd trimester
3 months or more before pregnancy or1st trimester
Paternal exp. genotoxic window only (0–3 months preconception)
Paternal exposure: epigenetic window only (3–xxx months preconception)
Paternal exposure: genotoxic/epigenetic window (0–xxx months preconception)
Paternal exposure: other window
Whatever the period exposition
individual studies
Outcome
TE
95% CI
n cases
n exposed
k
Pub. bias
Congenital malformations
All congenital malformations (majors, minors, majors and minors, or unspecified)
Källén (Zonisamide) (Controls unexposed, NOS) (Indications NOS), 2013 Meador (Zonisamide) (Controls unexposed, sick), 2020 The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024 Battino (Zonisamide) (Epilepsy), 2024 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 The NAAED (Zonisamide) (Controls unexposed, disease free) (Indications NOS), 2025
7
1.69
[
0.75
; 3.79]
49,667
325
not evaluable
Major congenital malformations
Källén (Zonisamide) (Controls unexposed, NOS) (Indications NOS), 2013 Meador (Zonisamide) (Controls unexposed, sick), 2020 The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024 Battino (Zonisamide) (Epilepsy), 2024 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 The NAAED (Zonisamide) (Controls unexposed, disease free) (Indications NOS), 2025
7
1.69
[
0.75
; 3.79]
49,667
325
not evaluable
Growth parameters and prematurity
Low birth weight (< 2500g)
Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2014
1
2.17
[
0.91
; 5.14]
26
98
not evaluable
Preterm (< 37 weeks)
The NAAED (Zonisamide) (Controls unexposed, disease free) (Indications NOS), 2025
1
0.76
[
0.49
; 1.18]
215
228
not evaluable
Small for gestational age (weight)
Hernández-Díaz (Zonisamide), 2017
1
1.90
[
1.20
; 3.00]
-
125
not evaluable
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Meador (Zonisamide) (Controls unexposed, sick), 2020
1
1.16
[
0.02
; 62.85]
-
13
not evaluable
Neuro-developmental disorders
Language disorders/delay
Meador (Zonisamide) (Controls unexposed, disease free), 2021 Straub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026
2
0.66
[
0.22
; 2.01]
469
257
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Straub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026
1
0.93
[
0.48
; 1.80]
357
246
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Straub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026
1
0.93
[
0.48
; 1.80]
357
246
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Straub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026
1
0.92
[
0.28
; 3.00]
97
246
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Straub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026
1
0.92
[
0.28
; 3.00]
97
246
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Straub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026
1
3.62
[
0.81
; 16.21]
17
246
not evaluable
Learning disorders
Straub (Controls exposed to LTG) (Zonisamide) (Epilepsy), 2026
1
0.53
[
0.03
; 9.00]
12
246
not evaluable
Psychomotor developmental disorders/delay
Straub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026
1
0.74
[
0.18
; 3.10]
82
246
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Straub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026
1
3.62
[
0.81
; 16.21]
17
246
not evaluable
0.0
100.0
1.0