Gabapentin (All indications) updated on 04-22-2025

Major congenital malformations

id	Study   Auto Kim (Controls exposed to LTG) (Gabapentin) (Indications NOS), 2026Kim (Controls unexposed, NOS) (Gabapentin) (Indications NOS), 2026Moore (Controls exposed to LTG) (Indication NOS), 2025Moore (Controls unexposed, general pop) (Indication NOS), 2025The NAAED (Controls exposed to LTG) (Indications NOS), 2025The NAAED (Controls unexposed, disease free) (Indications NOS), 2025Battino (Gabapentin) (Epilepsy), 2024Arkilo, 2015Källén (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013Källén (Controls unexposed, NOS) (Indications NOS), 2013Vajda (Controls exposed to Lamotrigine, sick), 2013Vajda (Controls unexposed, sick), 2013Mawer (Controls exposed to Lamotrigine, sick), 2010Mawer (Controls unexposed, disease free), 2010Mawer (Controls unexposed, sick), 2010Morrow (Controls exposed to Lamotrigine, sick), 2006Morrow (Controls unexposed, sick), 2006Dean, 2002	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 trimesterPaternal 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	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.
S19321 R81878	Kim (Controls exposed to LTG) (Gabapentin) (Indications NOS), 2026	Congenital anomalies (ICD-10 codes related to major malformations)	1st trimester	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No	0.98 [0.71;1.33] C excluded (control group)	111/1,131   72/718	183	1,131		ref
S19313 R81774	Kim (Controls unexposed, NOS) (Gabapentin) (Indications NOS), 2026	Congenital anomalies (ICD-10 codes related to major malformations)	1st trimester	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes	1.12 [0.91;1.38]	111/1,131   173,861/2,489,078	173,972	1,131		ref
S19340 R81982	Moore (Controls exposed to LTG) (Indication NOS), 2025	Congenital conditions (any major structural congenital condition in a baby with no known associated/underlying genetic condition)	during pregnancy (anytime or not specified)	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No	0.78 [0.51;1.21] C excluded (control group)	44/2,103   39/1,470	83	2,103		ref
S19334 R81958	Moore (Controls unexposed, general pop) (Indication NOS), 2025	Congenital conditions (any major structural congenital condition in a baby with no known associated/underlying genetic condition)	during pregnancy (anytime or not specified) excluded	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes Matched	0.93 [0.67;1.29] excluded (exposition period)	44/2,103   400/20,608	444	2,103		ref
S16190 R67083	The NAAED (Controls exposed to LTG) (Indications NOS), 2025	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.67 [0.24;1.86] C excluded (control group)	4/296   52/2,587	56	296		ref
S16180 R67072	The NAAED (Controls unexposed, disease free) (Indications NOS), 2025	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free	Adjustment: No	1.22 [0.40;3.69] C	4/296   15/1,346	19	296		ref
S16582 R69645	Battino (Gabapentin) (Epilepsy), 2024	Major congenital malformations (MCMs)	early pregnancy	prospective cohort	exposed to other treatment, sick	Adjustment: No	0.88 [0.12;6.46] C	1/37   110/3,584	111	37		ref
S8485 R27851	Arkilo, 2015	Major malformations	during pregnancy (anytime or not specified) excluded	retrospective cohort	exposed to other treatment, sick	Adjustment: No	47.00 [0.38;5814.69] C excluded (exposition period)	0/1   0/24	0	1		ref
S8507 R27984	Källén (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013	Relatively severe malformations	early pregnancy	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No	0.48 [0.12;2.03] C excluded (control group)	2/119   37/1,084	39	119		ref
S8508 R27986	Källén (Controls unexposed, NOS) (Indications NOS), 2013	Relatively severe malformations	early pregnancy	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: No	0.53 [0.13;2.13] C	2/119   49,499/1,575,847	49,501	119		ref
S8496 R27909	Vajda (Controls exposed to Lamotrigine, sick), 2013	Fetal malformations	at least 1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.83 [0.05;14.66] C excluded (control group)	0/14   13/315	13	14		ref
S8497 R27910	Vajda (Controls unexposed, sick), 2013	Fetal malformations	at least 1st trimester	prospective cohort	unexposed, sick	Adjustment: No	0.95 [0.05;18.18] C	0/14   5/147	5	14		ref
S8487 R27874	Mawer (Controls exposed to Lamotrigine, sick), 2010	Major malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	4.60 [0.15;144.69] C excluded (control group)	0/2   2/37	2	2		ref
S8488 R27876	Mawer (Controls unexposed, disease free), 2010	Major malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No Matched	14.28 [0.53;384.83] C excluded (control group)	0/2   6/285	6	2		ref
S8489 R27878	Mawer (Controls unexposed, sick), 2010	Major malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	8.78 [0.24;318.70] C	0/2   1/41	1	2		ref
S8493 R27897	Morrow (Controls exposed to Lamotrigine, sick), 2006	Major congenital malformation	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.99 [0.13;7.64] C excluded (control group)	1/31   21/647	22	31		ref
S8494 R27905	Morrow (Controls unexposed, sick), 2006	Major congenital malformation	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	0.91 [0.11;7.55] C	1/31   8/227	9	31		ref
S8486 R27858	Dean, 2002	Major congenital malformations	at least 1st trimester	retrospective cohort	unexposed, sick	Adjustment: No	14.20 [0.23;878.06] C	0/1   2/38	2	1		ref
					Total	8 studies	1.11 [0.91;1.36]		223,620	1,631
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 8493, 8487, 8488, 8507, 8496, 19340, 16190, 19321

Umbrella review (other published meta-analyses)