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

All congenital malformations (majors, minors, majors and minors, or unspecified)

id	Study   Auto Moore (Gabapentin) (Mixed indications) (Controls exposed to LTG), 2025Moore (Gabapentin) (Mixed indications) (Controls unexposed, general pop), 2025The NAAED (Controls exposed to LTG) (Indications NOS), 2025The NAAED (Controls unexposed, disease free) (Indications NOS), 2025Battino (Gabapentin) (Epilepsy), 2024Miškov (Controls unexposed, disease free), 2016Miškov (Controls unexposed, sick), 2016Arkilo, 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.
S18752 R79757	Moore (Gabapentin) (Mixed indications) (Controls exposed to LTG), 2025	Congenital conditions (any major structural congenital condition with no known associated/underlying genetic condition, as defined by EUROCAT)	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
S18753 R79761	Moore (Gabapentin) (Mixed indications) (Controls unexposed, general pop), 2025	Congenital conditions (any major structural congenital condition with no known associated/underlying genetic condition, as defined by EUROCAT)	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 R67104	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 R67105	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 R69646	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
S8491 R27888	Miškov (Controls unexposed, disease free), 2016	Congenital anomalies	during pregnancy (anytime or not specified)	prospective cohort	unexposed, disease free excluded	Adjustment: No	765.00 [11.05;52971.87] C excluded (control group)	1/2   0/128	1	2		ref
S8492 R27894	Miškov (Controls unexposed, sick), 2016	Congenital anomalies	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	21.00 [0.27;1646.32] C excluded (exposition period)	1/2   0/4	1	2		ref
S8485 R27857	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 R27985	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 R27987	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 R35195	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 R35196	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 R27875	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 R27877	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 R27879	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 R27904	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 R27906	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 R27873	Dean, 2002	Congenital malformations (major and minor)	at least 1st trimester	retrospective cohort	unexposed, sick	Adjustment: No	4.07 [0.07;222.16] C	0/1   7/38	7	1		ref
					Total	7 studies	1.01 [0.50;2.04]		49,653	500
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, 8491, 18752, 16190