Zonisamide (Epilepsy) updated on 04-22-2025

Major congenital malformations

id	Study   Auto Battino, 2024The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2020Meador (Zonisamide) (Controls unexposed, disease free), 2020Meador (Zonisamide) (Controls unexposed, sick), 2020Hernández-Díaz (Zonisamide) (Controls exposed to Lamotrigine, sick), 2012Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012	Lib. in paper	Exposition period  Auto during pregnancy (anytime or not specified)1st trimester2nd trimester3rd trimester2nd and/or 3rd trimesterthroughout pregnancyearly pregnancydays before deliverylate pregnancypreconception-onlypericonceptionalpreconceptional for kinetic reasonat least 1st trimester3 months (or more) before pregnancy or during pregnancy1st and 2nd trimester3 months or more before pregnancy or1st trimester	Study type  All studies Case control excluded Only case control	Control type    Auto unexposed (general population or NOS)unexposed, sickunexposed, disease freeexposed to other treatment, sicknot specifiedsiblingwhatever (meta-analysis)	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S16719 R70315	Battino, 2024	Major congenital malformations (MCMs)	early pregnancy	prospective cohort	exposed to other treatment, sick	Adjustment: No	1.13 [0.15;8.37] C	1/29   110/3,584	111	29		ref
S17204 R72086	The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	6.47 [0.21;202.45] C excluded (control group)	0/3   1/50	1	3		ref
S17205 R72088	The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024	Major congenital malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	3.92 [0.18;85.02] C	0/3   16/340	16	3		ref
S17184 R72030	The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024	Major malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.84 [0.05;14.09] C excluded (control group)	0/25   49/2,098	49	25		ref
S17185 R72032	The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024	Major malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	0.80 [0.05;13.81] C	0/25   13/541	13	25		ref
S7506 R22455	Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2020	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	1.75 [0.19;16.25] C excluded (control group)	1/13   5/110	6	13		ref
S7497 R22428	Meador (Zonisamide) (Controls unexposed, disease free), 2020	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No	4.33 [0.37;51.42] C excluded (control group)	1/13   2/106	3	13		ref
S7502 R22443	Meador (Zonisamide) (Controls unexposed, sick), 2020	Major congenital malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	1.17 [0.07;20.72] C	1/13   1/15	2	13		ref
S8122 R24945	Hernández-Díaz (Zonisamide) (Controls exposed to Lamotrigine, sick), 2012	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No Controls: mixed indications	0.27 [0.02;4.47] C excluded (control group)	0/90   31/1,562	31	90		ref
S7939 R24015	Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free	Adjustment: No	0.44 [0.02;8.09] C	0/90   5/442	5	90		ref
					Total	5 studies	1.10 [0.34;3.58]		147	160
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

Sensitivity analysis

Publication bias and p-hacking diagnosis

Sub-groups analysis using all included studies

excluded 8122, 7506, 7497, 17204, 17184