Oxcarbazepine (All indications) - Medication and Pregnancy KB

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

Major congenital malformations

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.
S18037 R75978	Hao (Oxcarbazepine) (Epilepsy) (Controls exposed to LTG), 2025	Major congenital malformation (MCM)	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.61 [0.10;3.77] ^C excluded (control group)	2/90 3/84	5	90		ref
S18036 R75977	Hao (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2025	Major congenital malformation (MCM)	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	0.49 [0.12;1.97]	2/90 10/261	12	90		ref
S16100 R66791	Battino (Oxcarbazepine) (Epilepsy), 2024	Major congenital malformations (MCMs)	early pregnancy	prospective cohort	exposed to other treatment, sick	Adjustment: No	0.95 [0.53;1.71] ^C	13/443 110/3,584	123	443		ref
S18062 R76045	Vajda b (Oxcarbazepine) (Epilepsy) (Controls exposed to Lamotrigine, sick), 2024	Fetal malformations	early pregnancy	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	2.16 [0.47;9.84] ^C excluded (control group)	2/23 20/473	22	23		ref
S18063 R76047	Vajda b (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2024	Fetal malformations	at least 1st trimester	prospective cohort	unexposed, sick	Adjustment: No	2.50 [0.55;11.32]	2/23 7/201	9	23		ref
S15202 R62356	Cohen (Oxcarbazepine) (Epilepsy) (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	1.09 [0.83;1.44] excluded (control group)	58/1,313 314/8,339	372	1,313		ref
S15203 R62357	Cohen (Oxcarbazepine) (Epilepsy) (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	1.47 [1.13;1.92] ^C	58/1,313 147,928/4,866,362	147,986	1,313		ref
S15261 R62746	Li (Oxcarbazepine) (Controls exposed to LTG), 2023	Major congenital malformation	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	4.52 [0.21;97.17] ^C excluded (control group)	2/44 0/38	2	44		ref
S15262 R62747	Li (Oxcarbazepine) (Controls unexposed, sick), 2023	Major congenital malformation	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	1.67 [0.34;8.33] ^C excluded (exposition period)	2/44 7/253	9	44		ref
S16189 R67082	The NAAED (Oxcarbazepine) (Controls exposed to LTG) (Indications NOS), 2023	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.72 [0.29;1.81] ^C excluded (control group)	5/327 52/2,461	57	327		ref
S16179 R67071	The NAAED (Oxcarbazepine) (Controls unexposed, disease free) (Indications NOS), 2023	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free	Adjustment: No	1.34 [0.48;3.72] ^C	5/327 15/1,311	20	327		ref
S12890 R48707	Hosny (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2021	Major birth defects	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.20 [0.00;28.47] ^C excluded (control group)	0/3 0/1	0	3		ref
S12891 R48710	Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021	Major birth defects	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	2.60 [0.08;82.80] ^C	0/3 1/21	1	3		ref
S12831 R48319	Thomas (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	3.71 [0.42;32.79] ^C excluded (control group)	5/71 1/50	6	71		ref
S12832 R48327	Thomas (Oxcarbazepine) (Controls unexposed, disease free), 2021	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No	2.12 [0.62;7.29] excluded (control group)	3/41 11/319	14	41		ref
S12833 R48331	Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021	Major congenital malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: Yes	1.61 [0.60;4.20]	5/71 16/340	21	71		ref
S9034 R30796	AlSheikh (Oxcarbazepine) (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	7.80 [0.12;487.53] ^C excluded (control group)	0/3 0/20	0	3		ref
S9035 R30799	AlSheikh (Oxcarbazepine) (Controls unexposed, sick), 2020	Fetal/neonatal malformation	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	0.87 [0.03;29.20] ^C excluded (exposition period)	0/3 1/8	1	3		ref
S9042 R30870	Bank (Oxcarbazepine) (Mixed indications), 2017	Major Malformation	during pregnancy (anytime or not specified) excluded	prospective cohort	exposed to other treatment, sick	Adjustment: No	10.14 [0.17;594.47] ^C excluded (exposition period)	0/4 0/36	0	4		ref
S16165 R67056	Guveli (Oxcarbazepine) (Epilepsy), 2017	Major malformations	during pregnancy (anytime or not specified) excluded	retrospective cohort	unexposed, sick	Adjustment: No	1.09 [0.04;29.63] ^C excluded (exposition period)	0/8 1/26	1	8		ref
S9052 R30897	Veiby (Oxcarbazepine) (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	0.51 [0.07;3.84] ^C excluded (control group)	1/57 28/833	29	57		ref
S9053 R30899	Veiby (Oxcarbazepine) (Controls unexposed, disease free) (Mixed indications), 2014	Major malformations	throughout pregnancy	population based cohort retrospective	unexposed, disease free excluded	Adjustment: Yes Partial overlapping	0.64 [0.10;4.61] excluded (control group)	1/57 22,371/771,412	22,372	57		ref
S9054 R30901	Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014	Major malformations	throughout pregnancy	population based cohort retrospective	unexposed, sick	Adjustment: No Controls: epilepsy indication Partial overlapping	0.62 [0.08;4.50] ^C	1/57 106/3,773	107	57		ref
S9050 R30891	Källén (Oxcarbazepine) (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	3.14 [1.06;9.29] ^C excluded (control group)	4/40 37/1,084	41	40		ref
S9051 R30893	Källén (Oxcarbazepine) (Controls unexposed, NOS) (Indications NOS), 2013	Relatively severe malformations	early pregnancy	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes Partial overlapping	2.27 [0.62;5.82]	4/40 49,499/1,575,847	49,503	40		ref
S9059 R30927	Kini (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2007	Major malformations	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	29.00 [0.23;3625.72] ^C excluded (control group)	0/1 0/15	0	1		ref
S9060 R30929	Kini (Oxcarbazepine) (Controls unexposed, disease free), 2007	Major malformations	during pregnancy (anytime or not specified)	prospective cohort	unexposed, disease free excluded	Adjustment: No Matched	41.91 [0.76;2311.57] ^C excluded (control group)	0/1 5/236	5	1		ref
S9061 R30931	Kini (Oxcarbazepine) (Controls unexposed, sick), 2007	Major malformations	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	67.00 [0.54;8247.13] ^C excluded (exposition period)	0/1 0/34	0	1		ref
S9062 R30933	Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006	Major congenital malformation	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	2.24 [0.12;41.02] ^C excluded (control group)	0/7 21/647	21	7		ref
S9063 R30941	Morrow (Oxcarbazepine) (Controls unexposed, sick), 2006	Major congenital malformation	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	1.98 [0.10;38.04] ^C	0/7 8/227	8	7		ref
S9065 R30944	Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006	Major malformations	throughout pregnancy	prospective cohort	unexposed, sick	Adjustment: No	34.33 [0.49;2389.88] ^C	0/2 0/52	0	2		ref
S9058 R30925	Kaaja (Oxcarbazepine), 2003	Major malformation	1st trimester	prospective cohort	unexposed, sick	Adjustment: Yes	10.80 [1.10;106.20]	1/9 2/239	3	9		ref
S9048 R30887	Hvas (Oxcarbazepine) (Controls unexposed, disease free), 2000	Major congenital malformations	1st trimester	retrospective cohort	unexposed, disease free excluded	Adjustment: No	6.46 [0.36;114.91] ^C excluded (control group)	0/7 280/23,827	280	7		ref
S9049 R30889	Hvas (Oxcarbazepine) (Controls unexposed, sick), 2000	Major congenital malformations	1st trimester	retrospective cohort	unexposed, sick	Adjustment: No	16.23 [0.30;885.49] ^C	0/7 0/106	0	7		ref
S9070 R31052	Samrén (Oxcarbazepine), 1999	Major congential abnormalities	at least 1st trimester	retrospective cohort	unexposed, disease free	Adjustment: No Matched	22.27 [0.89;557.96] ^C	0/2 29/2,000	29	2		ref
					Total	14 studies	1.48 [1.07;2.05]		197,822	2,394
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: Oxcarbazepine) (Epilepsy) (Controls unexposed, sick; 2: Oxcarbazepine) (Epilepsy; 3: Oxcarbazepine) (Epilepsy) (Controls unexposed, sick; 4: Oxcarbazepine) (Epilepsy) (Controls unexposed, NOS; 5: Oxcarbazepine) (Controls unexposed, disease free) (Indications NOS; 6: Oxcarbazepine) (Controls unexposed, sick; 7: Oxcarbazepine) (Controls unexposed, sick; 8: Oxcarbazepine) (Controls unexposed, sick) (Mixed indications; 9: Oxcarbazepine) (Controls unexposed, NOS) (Indications NOS; 10: Oxcarbazepine) (Controls unexposed, sick; 11: Oxcarbazepine) (Controls unexposed, sick) ; 12: Oxcarbazepine; 13: Oxcarbazepine) (Controls unexposed, sick; 14: Oxcarbazepine;

Sensitivity analysis

Publication bias and p-hacking diagnosis

funnel plot

Asymetry test p-value = 0.1278 (by Egger's regression)

slope=0.1921 (0.1556); intercept=0.6251 (0.3821); t=1.6359; p=0.1278

p values plot

Sub-groups analysis using all included studies

excluded 9048, 9062, 9059, 9060, 9050, 9052, 9053, 9034, 12890, 12831, 12832, 15202, 15261, 16189, 18062, 18037

S18037 R75978	Hao (Oxcarbazepine) (Epilepsy) (Controls exposed to LTG), 2025	Major congenital malformation (MCM) (68)	1st trimester	exposed to other treatment, sick	0.61 [0.10;3.77]	2/90 3/84
S18036 R75977	Hao (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2025	Major congenital malformation (MCM) (68)	1st trimester	unexposed, sick	0.49 [0.12;1.97]	2/90 10/261
S16100 R66791	Battino (Oxcarbazepine) (Epilepsy), 2024	Major congenital malformations (MCMs) (68)	early pregnancy	exposed to other treatment, sick	0.95 [0.53;1.71]	13/443 110/3584
S18062 R76045	Vajda b (Oxcarbazepine) (Epilepsy) (Controls exposed to Lamotrigine, sick), 2024	Fetal malformations (68)	early pregnancy	exposed to other treatment, sick	2.16 [0.47;9.84]	2/23 20/473
S18063 R76047	Vajda b (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2024	Fetal malformations (68)	at least 1st trimester	unexposed, sick	2.50 [0.55;11.32]	2/23 7/201
S15202 R62356	Cohen (Oxcarbazepine) (Epilepsy) (Controls exposed to LTG), 2023	Major congenital malformations (excluding genetic/chromosomal) (68)	1st trimester	exposed to other treatment, sick	1.09 [0.83;1.44]	58/1313 314/8339
S15203 R62357	Cohen (Oxcarbazepine) (Epilepsy) (Controls unexposed, NOS), 2023	Major congenital malformations (excluding genetic/chromosomal) (68)	1st trimester	unexposed (general population or NOS)	1.47 [1.13;1.92]	58/1313 147928/4866362
S15261 R62746	Li (Oxcarbazepine) (Controls exposed to LTG), 2023	Major congenital malformation (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	4.52 [0.21;97.17]	2/44 0/38
S15262 R62747	Li (Oxcarbazepine) (Controls unexposed, sick), 2023	Major congenital malformation (68)	during pregnancy (anytime or not specified)	unexposed, sick	1.67 [0.34;8.33]	2/44 7/253
S16189 R67082	The NAAED (Oxcarbazepine) (Controls exposed to LTG) (Indications NOS), 2023	Major congenital malformations (68)	1st trimester	exposed to other treatment, sick	0.72 [0.29;1.81]	5/327 52/2461
S16179 R67071	The NAAED (Oxcarbazepine) (Controls unexposed, disease free) (Indications NOS), 2023	Major congenital malformations (68)	1st trimester	unexposed, disease free	1.34 [0.48;3.72]	5/327 15/1311
S12890 R48707	Hosny (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2021	Major birth defects (68)	1st trimester	exposed to other treatment, sick	0.20 [0.00;28.47]	0/3 0/1
S12891 R48710	Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021	Major birth defects (68)	1st trimester	unexposed, sick	2.60 [0.08;82.80]	0/3 1/21
S12831 R48319	Thomas (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformations (68)	1st trimester	exposed to other treatment, sick	3.71 [0.42;32.79]	5/71 1/50
S12832 R48327	Thomas (Oxcarbazepine) (Controls unexposed, disease free), 2021	Major congenital malformations (68)	1st trimester	unexposed, disease free	2.12 [0.62;7.29]	3/41 11/319
S12833 R48331	Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021	Major congenital malformations (68)	1st trimester	unexposed, sick	1.61 [0.60;4.20]	5/71 16/340
S9034 R30796	AlSheikh (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020	Fetal/neonatal malformation (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	7.80 [0.12;487.53]	0/3 0/20
S9035 R30799	AlSheikh (Oxcarbazepine) (Controls unexposed, sick), 2020	Fetal/neonatal malformation (68)	during pregnancy (anytime or not specified)	unexposed, sick	0.87 [0.03;29.20]	0/3 1/8
S9042 R30870	Bank (Oxcarbazepine) (Mixed indications), 2017	Major Malformation (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	10.14 [0.17;594.47]	0/4 0/36
S16165 R67056	Guveli (Oxcarbazepine) (Epilepsy), 2017	Major malformations (68)	during pregnancy (anytime or not specified)	unexposed, sick	1.09 [0.04;29.63]	0/8 1/26
S9052 R30897	Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014	Major congenital malformation (68)	throughout pregnancy	exposed to other treatment, sick	0.51 [0.07;3.84]	1/57 28/833
S9053 R30899	Veiby (Oxcarbazepine) (Controls unexposed, disease free) (Mixed indications), 2014	Major malformations (68)	throughout pregnancy	unexposed, disease free	0.64 [0.10;4.61]	1/57 22371/771412
S9054 R30901	Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014	Major malformations (68)	throughout pregnancy	unexposed, sick	0.62 [0.08;4.50]	1/57 106/3773
S9050 R30891	Källén (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013	Relatively severe malformations (68)	early pregnancy	exposed to other treatment, sick	3.14 [1.06;9.29]	4/40 37/1084
S9051 R30893	Källén (Oxcarbazepine) (Controls unexposed, NOS) (Indications NOS), 2013	Relatively severe malformations (68)	early pregnancy	unexposed (general population or NOS)	2.27 [0.62;5.82]	4/40 49499/1575847
S9059 R30927	Kini (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2007	Major malformations (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	29.00 [0.23;3625.72]	0/1 0/15
S9060 R30929	Kini (Oxcarbazepine) (Controls unexposed, disease free), 2007	Major malformations (68)	during pregnancy (anytime or not specified)	unexposed, disease free	41.91 [0.76;2311.57]	0/1 5/236
S9061 R30931	Kini (Oxcarbazepine) (Controls unexposed, sick), 2007	Major malformations (68)	during pregnancy (anytime or not specified)	unexposed, sick	67.00 [0.54;8247.13]	0/1 0/34
S9062 R30933	Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006	Major congenital malformation (68)	1st trimester	exposed to other treatment, sick	2.24 [0.12;41.02]	0/7 21/647
S9063 R30941	Morrow (Oxcarbazepine) (Controls unexposed, sick), 2006	Major congenital malformation (68)	1st trimester	unexposed, sick	1.98 [0.10;38.04]	0/7 8/227
S9065 R30944	Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006	Major malformations (68)	throughout pregnancy	unexposed, sick	34.33 [0.49;2389.88]	0/2 0/52
S9058 R30925	Kaaja (Oxcarbazepine), 2003	Major malformation (68)	1st trimester	unexposed, sick	10.80 [1.10;106.20]	1/9 2/239
S9048 R30887	Hvas (Oxcarbazepine) (Controls unexposed, disease free), 2000	Major congenital malformations (68)	1st trimester	unexposed, disease free	6.46 [0.36;114.91]	0/7 280/23827
S9049 R30889	Hvas (Oxcarbazepine) (Controls unexposed, sick), 2000	Major congenital malformations (68)	1st trimester	unexposed, sick	16.23 [0.30;885.49]	0/7 0/106
S9070 R31052	Samrén (Oxcarbazepine), 1999	Major congential abnormalities (68)	at least 1st trimester	unexposed, disease free	22.27 [0.89;557.96]	0/2 29/2000