Topiramate (All indications) - Medication and Pregnancy KB

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

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

R analysis

id	Study	Lib. in paper	Exposition period	Study type All studies Case control excluded Only case control	Control type	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S18034 R75986	Hao (Topiramate) (Epilepsy) (Controls exposed to LTG), 2025	Major congenital malformation (MCM)	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.56 [0.03;11.30] ^C excluded (control group)	0/21 3/84	3	21		ref
S18033 R75987	Hao (Topiramate) (Epilepsy) (Controls unexposed, sick), 2025	Major congenital malformation (MCM)	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	0.58 [0.03;10.29] ^C	0/21 10/261	10	21		ref
S16105 R67089	Battino (Topiramate) (Epilepsy), 2024	Major congenital malformations (MCMs)	early pregnancy	prospective cohort	exposed to other treatment, sick	Adjustment: No	1.63 [0.84;3.16] ^C	10/204 110/3,584	120	204		ref
S18053 R76028	Vajda b (Topiramate) (Epilepsy) (Controls exposed to Lamotrigine, sick), 2024	Fetal malformations	early pregnancy	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	1.49 [0.49;4.49] ^C excluded (control group)	4/65 20/473	24	65		ref
S18055 R76032	Vajda b (Topiramate) (Epilepsy) (Controls unexposed, sick), 2024	Fetal malformations	at least 1st trimester	prospective cohort	unexposed, sick	Adjustment: No	1.77 [0.53;5.84]	4/65 7/201	11	65		ref
S15206 R62381	Cohen (Topiramate) (Mixed indications) (Controls exposed to LTG), 2023	Major congenital malformations (excluding genetic/chromosomal)	1st trimester	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: Yes Partial overlapping	1.81 [1.26;2.60] excluded (control group)	32/509 314/8,339	346	509		ref
S15207 R62382	Cohen (Topiramate) (Mixed indications) (Controls unexposed, NOS), 2023	Major congenital malformations (excluding genetic/chromosomal)	1st trimester	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: No Partial overlapping	2.14 [1.50;3.06] ^C	32/509 147,928/4,866,362	147,960	509		ref
S15268 R62768	Li (Topiramate) (Controls exposed to LTG), 2023	Major congenital malformation	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	20.45 [0.74;567.72] ^C excluded (control group)	1/7 0/38	1	7		ref
S15269 R62769	Li (Topiramate) (Controls unexposed, sick), 2023	Major congenital malformation	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	5.86 [0.62;55.37] ^C excluded (exposition period)	1/7 7/253	8	7		ref
S16187 R67120	The NAAED (Topiramate) (Controls exposed to LTG) (Indications NOS), 2023	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	2.49 [1.54;4.03] ^C excluded (control group)	26/510 52/2,461	78	510		ref
S16177 R67119	The NAAED (Topiramate) (Controls unexposed, disease free) (Indications NOS), 2023	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free	Adjustment: No	4.64 [2.44;8.84] ^C	26/510 15/1,311	41	510		ref
S12693 R48033	Alsfouk (Topiramate) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformation	during pregnancy (anytime or not specified)	retrospective cohort	exposed to other treatment, sick excluded	Adjustment: No	1.67 [0.05;53.93] ^C excluded (control group)	0/2 2/15	2	2		ref
S12695 R48032	Alsfouk (Topiramate) (Controls unexposed, sick), 2021	Major congenital malformation	during pregnancy (anytime or not specified) excluded	retrospective cohort	unexposed, sick	Adjustment: No	6.33 [0.17;231.15] ^C excluded (exposition period)	0/2 1/30	1	2		ref
S12873 R48622	Thomas (Topiramate) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	1.90 [0.07;50.68] ^C excluded (control group)	0/9 1/50	1	9		ref
S12874 R48630	Thomas (Topiramate) (Controls unexposed, disease free), 2021	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No	2.43 [0.13;46.65] ^C excluded (control group)	0/6 11/319	11	6		ref
S12875 R48634	Thomas (Topiramate) (Controls unexposed, sick), 2021	Major congenital malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	1.15 [0.06;20.85] ^C	0/9 16/340	16	9		ref
S8552 R28454	AlSheikh (Topiramate) (Controls exposed to Lamotrigine, sick), 2020	Fetal/neonatal malformation	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	39.00 [0.31;4841.77] ^C excluded (control group)	0/1 0/20	0	1		ref
S8553 R28457	AlSheikh (Topiramate) (Controls unexposed, sick), 2020	Fetal/neonatal malformation	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	4.33 [0.06;320.42] ^C excluded (exposition period)	0/1 1/8	1	1		ref
S8564 R28487	Meador (Topiramate) (Controls exposed to Lamotrigine, sick), 2020	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	4.20 [0.41;43.04] ^C excluded (control group)	1/6 5/110	6	6		ref
S8565 R28491	Meador (Topiramate) (Controls unexposed, disease free), 2020	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No	10.40 [0.80;134.90] ^C excluded (control group)	1/6 2/106	3	6		ref
S8566 R28495	Meador (Topiramate) (Controls unexposed, sick), 2020	Major congenital malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	2.80 [0.15;53.71] ^C	1/6 1/15	2	6		ref
S8602 R28640	Bank (Topiramate) (Mixed indications) , 2017	Major Malformation	during pregnancy (anytime or not specified) excluded	prospective cohort	exposed to other treatment, sick	Adjustment: No	23.67 [0.34;1653.93] ^C excluded (exposition period)	0/2 0/36	0	2		ref
S8554 R28464	Arkilo (Topiramate), 2015	Major malformations	during pregnancy (anytime or not specified) excluded	retrospective cohort	exposed to other treatment, sick	Adjustment: No	15.67 [0.22;1102.00] ^C excluded (exposition period)	0/2 0/24	0	2		ref
S8555 R28467	Babic (Topiramate), 2014	Major congential malformations	during pregnancy (anytime or not specified) excluded	prospective cohort	exposed to other treatment, sick	Adjustment: No	15.00 [0.12;1923.88] ^C excluded (exposition period)	0/1 0/8	0	1		ref
S8594 R28610	Veiby (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014	Major congenital malformation	throughout pregnancy	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No Partial overlapping	1.25 [0.29;5.41] ^C excluded (control group)	2/48 28/833	30	48		ref
S8595 R28614	Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014	Major malformations	throughout pregnancy	population based cohort retrospective	unexposed, disease free excluded	Adjustment: Yes Partial overlapping	1.66 [0.40;6.85] excluded (control group)	2/48 22,371/771,412	22,373	48		ref
S8596 R28618	Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014	Major malformations	throughout pregnancy	population based cohort retrospective	unexposed, sick	Adjustment: No Controls: epilepsy indication Partial overlapping	1.50 [0.36;6.28] ^C	2/48 106/3,773	108	48		ref
S8559 R28475	Källén (Topiramate) (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 Partial overlapping	3.95 [1.58;9.86] ^C excluded (control group)	6/49 37/1,084	43	49		ref
S8560 R28477	Källén (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2013	Relatively severe malformations	early pregnancy	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes Partial overlapping	3.73 [1.97;8.11]	6/49 49,499/1,575,847	49,505	49		ref
S8568 R28506	Margulis (Topiramate) (Mixed indication), 2012	Major congenital malformations	1st trimester	case control	unexposed (general population or NOS)	Adjustment: No Matched	1.01 [0.37;3.22]	15/21 33,605/48,972	33,620	21		ref
S8561 R28479	Mawer (Topiramate) (Controls exposed to Lamotrigine, sick), 2010	Major malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	2.76 [0.10;74.58] ^C excluded (control group)	0/3 2/37	2	3		ref
S8562 R28481	Mawer (Topiramate) (Controls unexposed, disease free), 2010	Major malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No Matched	8.57 [0.37;196.88] ^C excluded (control group)	0/3 6/285	6	3		ref
S8563 R28483	Mawer (Topiramate) (Controls unexposed, sick), 2010	Major malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	5.27 [0.17;165.32] ^C	0/3 1/41	1	3		ref
S8571 R28518	Ornoy (Topiramate), 2008	Non-genetic anomalies	at least 1st trimester	prospective cohort	unexposed (general population or NOS)		1.44 [0.16;12.74] ^C	1/29 5/206	6	29		ref
S8569 R28514	Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006	Major congenital malformation	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	2.29 [0.51;10.30] ^C excluded (control group)	2/28 21/647	23	28		ref
S8570 R28516	Morrow (Topiramate) (Controls unexposed, sick), 2006	Major congenital malformation	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	2.11 [0.42;10.45] ^C	2/28 8/227	10	28		ref
					Total	13 studies	2.29 [1.80;2.91]		231,410	1,502
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

1: Topiramate) (Epilepsy) (Controls unexposed, sick; 2: Topiramate) (Epilepsy; 3: Topiramate) (Epilepsy) (Controls unexposed, sick; 4: Topiramate) (Mixed indications) (Controls unexposed, NOS; 5: Topiramate) (Controls unexposed, disease free) (Indications NOS; 6: Topiramate) (Controls unexposed, sick; 7: Topiramate) (Controls unexposed, sick; 8: Topiramate) (Controls unexposed, sick) (Mixed indications; 9: Topiramate) (Controls unexposed, NOS) (Indications NOS; 10: Topiramate) (Mixed indication; 11: Topiramate) (Controls unexposed, sick; 12: Topiramate; 13: Topiramate) (Controls unexposed, sick;

Sensitivity analysis

Publication bias and p-hacking diagnosis

funnel plot

Asymetry test p-value = 0.4563 (by Egger's regression)

slope=0.9566 (0.2062); intercept=-0.3628 (0.4698); t=0.7722; p=0.4563

p values plot

Sub-groups analysis using all included studies

excluded 8569, 8561, 8562, 8559, 8594, 8595, 8552, 8564, 8565, 12693, 12873, 12874, 15206, 15268, 16187, 18053, 18034

S18034 R75986	Hao (Topiramate) (Epilepsy) (Controls exposed to LTG), 2025	Major congenital malformation (MCM) (67)	1st trimester	exposed to other treatment, sick	0.56 [0.03;11.30]	0/21 3/84
S18033 R75987	Hao (Topiramate) (Epilepsy) (Controls unexposed, sick), 2025	Major congenital malformation (MCM) (67)	1st trimester	unexposed, sick	0.58 [0.03;10.29]	0/21 10/261
S16105 R67089	Battino (Topiramate) (Epilepsy), 2024	Major congenital malformations (MCMs) (67)	early pregnancy	exposed to other treatment, sick	1.63 [0.84;3.16]	10/204 110/3584
S18053 R76028	Vajda b (Topiramate) (Epilepsy) (Controls exposed to Lamotrigine, sick), 2024	Fetal malformations (67)	early pregnancy	exposed to other treatment, sick	1.49 [0.49;4.49]	4/65 20/473
S18055 R76032	Vajda b (Topiramate) (Epilepsy) (Controls unexposed, sick), 2024	Fetal malformations (67)	at least 1st trimester	unexposed, sick	1.77 [0.53;5.84]	4/65 7/201
S15206 R62381	Cohen (Topiramate) (Mixed indications) (Controls exposed to LTG), 2023	Major congenital malformations (excluding genetic/chromosomal) (67)	1st trimester	exposed to other treatment, sick	1.81 [1.26;2.60]	32/509 314/8339
S15207 R62382	Cohen (Topiramate) (Mixed indications) (Controls unexposed, NOS), 2023	Major congenital malformations (excluding genetic/chromosomal) (67)	1st trimester	unexposed (general population or NOS)	2.14 [1.50;3.06]	32/509 147928/4866362
S15268 R62768	Li (Topiramate) (Controls exposed to LTG), 2023	Major congenital malformation (67)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	20.45 [0.74;567.72]	1/7 0/38
S15269 R62769	Li (Topiramate) (Controls unexposed, sick), 2023	Major congenital malformation (67)	during pregnancy (anytime or not specified)	unexposed, sick	5.86 [0.62;55.37]	1/7 7/253
S16187 R67120	The NAAED (Topiramate) (Controls exposed to LTG) (Indications NOS), 2023	Major congenital malformations (67)	1st trimester	exposed to other treatment, sick	2.49 [1.54;4.03]	26/510 52/2461
S16177 R67119	The NAAED (Topiramate) (Controls unexposed, disease free) (Indications NOS), 2023	Major congenital malformations (67)	1st trimester	unexposed, disease free	4.64 [2.44;8.84]	26/510 15/1311
S12693 R48033	Alsfouk (Topiramate) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformation (67)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	1.67 [0.05;53.93]	0/2 2/15
S12695 R48032	Alsfouk (Topiramate) (Controls unexposed, sick), 2021	Major congenital malformation (67)	during pregnancy (anytime or not specified)	unexposed, sick	6.33 [0.17;231.15]	0/2 1/30
S12873 R48622	Thomas (Topiramate) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformations (67)	1st trimester	exposed to other treatment, sick	1.90 [0.07;50.68]	0/9 1/50
S12874 R48630	Thomas (Topiramate) (Controls unexposed, disease free), 2021	Major congenital malformations (67)	1st trimester	unexposed, disease free	2.43 [0.13;46.65]	0/6 11/319
S12875 R48634	Thomas (Topiramate) (Controls unexposed, sick), 2021	Major congenital malformations (67)	1st trimester	unexposed, sick	1.15 [0.06;20.85]	0/9 16/340
S8552 R28454	AlSheikh (Topiramate) (Controls exposed to Lamotrigine, sick), 2020	Fetal/neonatal malformation (67)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	39.00 [0.31;4841.77]	0/1 0/20
S8553 R28457	AlSheikh (Topiramate) (Controls unexposed, sick), 2020	Fetal/neonatal malformation (67)	during pregnancy (anytime or not specified)	unexposed, sick	4.33 [0.06;320.42]	0/1 1/8
S8564 R28487	Meador (Topiramate) (Controls exposed to Lamotrigine, sick), 2020	Major congenital malformations (67)	1st trimester	exposed to other treatment, sick	4.20 [0.41;43.04]	1/6 5/110
S8565 R28491	Meador (Topiramate) (Controls unexposed, disease free), 2020	Major congenital malformations (67)	1st trimester	unexposed, disease free	10.40 [0.80;134.90]	1/6 2/106
S8566 R28495	Meador (Topiramate) (Controls unexposed, sick), 2020	Major congenital malformations (67)	1st trimester	unexposed, sick	2.80 [0.15;53.71]	1/6 1/15
S8602 R28640	Bank (Topiramate) (Mixed indications) , 2017	Major Malformation (67)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	23.67 [0.34;1653.93]	0/2 0/36
S8554 R28464	Arkilo (Topiramate), 2015	Major malformations (67)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	15.67 [0.22;1102.00]	0/2 0/24
S8555 R28467	Babic (Topiramate), 2014	Major congential malformations (67)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	15.00 [0.12;1923.88]	0/1 0/8
S8594 R28610	Veiby (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014	Major congenital malformation (67)	throughout pregnancy	exposed to other treatment, sick	1.25 [0.29;5.41]	2/48 28/833
S8595 R28614	Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014	Major malformations (67)	throughout pregnancy	unexposed, disease free	1.66 [0.40;6.85]	2/48 22371/771412
S8596 R28618	Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014	Major malformations (67)	throughout pregnancy	unexposed, sick	1.50 [0.36;6.28]	2/48 106/3773
S8559 R28475	Källén (Topiramate) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013	Relatively severe malformations (67)	early pregnancy	exposed to other treatment, sick	3.95 [1.58;9.86]	6/49 37/1084
S8560 R28477	Källén (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2013	Relatively severe malformations (67)	early pregnancy	unexposed (general population or NOS)	3.73 [1.97;8.11]	6/49 49499/1575847
S8568 R28506	Margulis (Topiramate) (Mixed indication), 2012	Major congenital malformations (67)	1st trimester	unexposed (general population or NOS)	1.01 [0.37;3.22]	15/21 33605/48972
S8561 R28479	Mawer (Topiramate) (Controls exposed to Lamotrigine, sick), 2010	Major malformations (67)	1st trimester	exposed to other treatment, sick	2.76 [0.10;74.58]	0/3 2/37
S8562 R28481	Mawer (Topiramate) (Controls unexposed, disease free), 2010	Major malformations (67)	1st trimester	unexposed, disease free	8.57 [0.37;196.88]	0/3 6/285
S8563 R28483	Mawer (Topiramate) (Controls unexposed, sick), 2010	Major malformations (67)	1st trimester	unexposed, sick	5.27 [0.17;165.32]	0/3 1/41
S8571 R28518	Ornoy (Topiramate), 2008	Non-genetic anomalies (67)	at least 1st trimester	unexposed (general population or NOS)	1.44 [0.16;12.74]	1/29 5/206
S8569 R28514	Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006	Major congenital malformation (67)	1st trimester	exposed to other treatment, sick	2.29 [0.51;10.30]	2/28 21/647
S8570 R28516	Morrow (Topiramate) (Controls unexposed, sick), 2006	Major congenital malformation (67)	1st trimester	unexposed, sick	2.11 [0.42;10.45]	2/28 8/227