Lamotrigine (All indications)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Mawer (Lamotrigine) (Controls unexposed, sick), 2010 Charlton (Lamotrigine), 2011 Cassina (Lamotrigine) (Mixed indications), 2013 Rihtman (Lamotrigine), 2013 Campbell (Lamotrigine), 2014 Veiby (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 Vanya (Lamotrigine) (Controls unexposed, sick), 2015 Petersen (Lamotrigine) (Controls unexposed, sick), 2017 Meador (Lamotrigine) (Controls unexposed, sick), 2020 Alsaadi (Lamotrigine) (Epilepsy) (Controls unexposed sick), 2020 Aydin (Lamotrigine), 2020 Hosny, 2021 Thomas (Lamotrigine) (Controls unexposed, sick), 2021 The NAAED (Indications NOS), 2023 Cohen (Lamotrigine) (Mixed indications), 2023 Wiggs (Epilepsy) (Lamotrigine), 2024 Hao (Lamotrigine) (Epilepsy), 2025 Vajda (Epilepsy), 2025 181.00[0.91; 1.10]148,72316,472probable Major congenital malformations Mawer (Lamotrigine) (Controls unexposed, sick), 2010 Charlton (Lamotrigine), 2011 Cassina (Lamotrigine) (Mixed indications), 2013 Campbell (Lamotrigine), 2014 Veiby (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 Vanya (Lamotrigine) (Controls unexposed, sick), 2015 Petersen (Lamotrigine) (Controls unexposed, sick), 2017 Diav-Citrin (Lamotrigine), 2017 Meador (Lamotrigine) (Controls unexposed, sick), 2020 Alsaadi (Lamotrigine) (Epilepsy) (Controls unexposed sick), 2020 Hosny, 2021 Thomas (Lamotrigine) (Controls unexposed, sick), 2021 Cohen (Lamotrigine) (Mixed indications), 2023 The NAAED (Indications NOS), 2023 Wiggs (Epilepsy) (Lamotrigine), 2024 Hao (Lamotrigine) (Epilepsy), 2025 Vajda (Epilepsy), 2025 171.01[0.92; 1.11]148,74816,537low Congenital heart defects Mawer (Lamotrigine) (Controls unexposed, sick), 2010 Vajda (Lamotrigine), 2013 Ban (Lamotrigine) (Mixed indications), 2015 Diav-Citrin (Lamotrigine), 2017 Thomas (Lamotrigine) (Controls unexposed, sick), 2021 Cohen (Lamotrigine) (Mixed indications), 2023 Wiggs (Epilepsy) (Lamotrigine), 2024 71.10[0.82; 1.48]2,07410,540not evaluable Limb defects Mawer (Lamotrigine) (Controls unexposed, sick), 2010 Vajda (Lamotrigine), 2013 Ban (Lamotrigine) (Mixed indications), 2015 Thomas (Lamotrigine) (Controls unexposed, sick), 2021 Wiggs (Epilepsy) (Lamotrigine), 2024 51.07[0.75; 1.52]1,2692,087not evaluable Oro-facial clefts Holmes (Lamotrigine), 2008 Dolk (Lamotrigine) (Mixed indications), 2016 Blotière (Lamotrigine) (Mixed indications), 2019 Cohen (Lamotrigine) (Mixed indications), 2023 Wiggs (Epilepsy) (Lamotrigine), 2024 51.78[0.74; 4.25]2,96913,432not evaluable Club foot / Talipes equinovarus Källén (Lamotrigine) (Indications NOS), 2013 Dolk (Lamotrigine) (Mixed indications), 2016 Blotière (Lamotrigine) (Mixed indications), 2019 Cohen (Lamotrigine) (Mixed indications), 2023 41.12[0.80; 1.57]3,80712,420not evaluable Hypospadias Källén (Lamotrigine) (Indications NOS), 2013 Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 Blotière (Lamotrigine) (Mixed indications), 2019 Cohen (Lamotrigine) (Mixed indications), 2023 41.14[0.82; 1.59]9,48013,253not evaluable Nervous system anomalies Ban (Lamotrigine) (Mixed indications), 2015 Thomas (Lamotrigine) (Controls unexposed, sick), 2021 Cohen (Lamotrigine) (Mixed indications), 2023 Wiggs (Epilepsy) (Lamotrigine), 2024 41.38[0.88; 2.15]36710,074not evaluable Cleft palate Holmes (Lamotrigine), 2008 Dolk (Lamotrigine) (Mixed indications), 2016 Blotière (Lamotrigine) (Mixed indications), 2019 33.22[0.42; 25.01]1,2263,681not evaluable Neural Tube Defects Mawer (Lamotrigine) (Controls unexposed, sick), 2010 Vajda (Lamotrigine), 2013 20.72[0.04; 11.59]-352not evaluable Spina bifida Charlton (Lamotrigine), 2011 Veiby (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Lamotrigine) (Mixed indications), 2019 31.04[0.25; 4.41]6223,928not evaluable Cardiac septal defects Källén (Lamotrigine) (Indications NOS), 2013 Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 21.46[0.94; 2.26]16,5771,917not evaluable Cleft lip with or without cleft palate Holmes (Lamotrigine), 2008 Blotière (Lamotrigine) (Mixed indications), 2019 22.30[0.32; 16.29]1,7433,681not evaluable Digestive system anomalies Thomas (Lamotrigine) (Controls unexposed, sick), 2021 Wiggs (Epilepsy) (Lamotrigine), 2024 20.56[0.27; 1.18]11,462not evaluable Genital anomalies Ban (Lamotrigine) (Mixed indications), 2015 Wiggs (Epilepsy) (Lamotrigine), 2024 20.77[0.45; 1.31]1,0241,685not evaluable Microcephaly / Small head circumference for gestational age Blotière (Lamotrigine) (Mixed indications), 2019 Christensen (Lamotrigine) (All indications), 2024 20.94[0.83; 1.07]134,73611,753not evaluable Minor congenital malformations Alsaadi (Lamotrigine) (Epilepsy) (Controls unexposed sick), 2020 110.14[0.38; 267.91]112not evaluable Urinary malformations Thomas (Lamotrigine) (Controls unexposed, sick), 2021 Wiggs (Epilepsy) (Lamotrigine), 2024 21.16[0.51; 2.65]71,462not evaluable Ano-rectal atresia and stenosis Blotière (Lamotrigine) (Mixed indications), 2019 11.15[0.16; 8.19]5452,997not evaluable Atrial septal defect Blotière (Lamotrigine) (Mixed indications), 2019 11.50[0.77; 2.90]3,2762,997not evaluable Atrioventricular septal defect Blotière (Lamotrigine) (Mixed indications), 2019 10.59[0.04; 9.46]5292,997not evaluable Bilateral renal agenesis including Potter syndrome Blotière (Lamotrigine) (Mixed indications), 2019 14.15[0.26; 66.90]752,997not evaluable Bladder exstrophy and/or epispadia Blotière (Lamotrigine) (Mixed indications), 2019 17.70[0.52; 114.86]832,997not evaluable Chromosomal abnormalities Wiggs (Epilepsy) (Lamotrigine), 2024 12.09[0.79; 5.53]-1,412not evaluable Coarctation of aorta Blotière (Lamotrigine) (Mixed indications), 2019 12.40[0.64; 9.04]7822,997not evaluable Craniosynostosis Blotière (Lamotrigine) (Mixed indications), 2019 10.41[0.03; 6.53]7662,997not evaluable Diaphragmatic hernia Blotière (Lamotrigine) (Mixed indications), 2019 11.66[0.23; 11.79]3792,997not evaluable Ebstein's anomaly Blotière (Lamotrigine) (Mixed indications), 2019 16.20[0.38; 100.48]502,997not evaluable Eye, ear, face and neck malformations Wiggs (Epilepsy) (Lamotrigine), 2024 10.78[0.32; 1.89]-1,412not evaluable Gastroschisis Blotière (Lamotrigine) (Mixed indications), 2019 15.20[0.93; 29.18]2452,997not evaluable Hypoplastic left heart (HLH/HLHS) Blotière (Lamotrigine) (Mixed indications), 2019 11.45[0.09; 23.19]2162,997not evaluable Hypoplastic right heart (HRH/HRHS) Blotière (Lamotrigine) (Mixed indications), 2019 14.71[0.29; 76.05]662,997not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Blotière (Lamotrigine) (Mixed indications), 2019 13.20[0.59; 17.31]3942,997not evaluable Omphalocele Blotière (Lamotrigine) (Mixed indications), 2019 12.40[0.21; 27.68]2672,997not evaluable Polydactyly Källén (Lamotrigine) (Indications NOS), 2013 11.33[0.35; 5.05]3,0871,084not evaluable Pulmonary valve atresia Blotière (Lamotrigine) (Mixed indications), 2019 12.05[0.13; 32.97]1522,997not evaluable Respiratory system anomalies Wiggs (Epilepsy) (Lamotrigine), 2024 10.85[0.35; 2.07]-1,412not evaluable Tetralogy of Fallot Blotière (Lamotrigine) (Mixed indications), 2019 10.54[0.03; 8.57]5842,997not evaluable Ventricular septal defect Blotière (Lamotrigine) (Mixed indications), 2019 11.30[0.69; 2.46]4,6532,997not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Cummings (Lamotrigine), 2011 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Artama (Lamotrigine) (Controls unexposed, sick), 2013 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Kilic (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 Miškov (Lamotrigine) (Controls unexposed, sick), 2016 Cohen (Lamotrigine) (Mixed indications), 2019 Kernizan, 2019 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Aydin (Lamotrigine), 2020 Van Marter (Lamotrigine) (Controls unexposed, sick), 2021 Bromley (Lamotrigine) (Epilepsy), 2023 Kernizan (Lamotrigine) (Bipolar disorder), 2024 Leite (Lamotrigine) (Epilepsy), 2024 141.10[0.96; 1.26]253,1268,547low Small for gestational age (weight) Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Cohen (Lamotrigine) (Mixed indications), 2019 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Aydin (Lamotrigine), 2020 Van Marter (Lamotrigine) (Controls unexposed, sick), 2021 Bromley (Lamotrigine) (Epilepsy), 2023 Christensen (Lamotrigine) (All indications), 2024 80.95[0.87; 1.03]656,43916,154not evaluable Low birth weight (< 2500g) Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Christensen (Lamotrigine) (All indications), 2024 41.05[0.90; 1.23]233,29513,253not evaluable Extremely preterm (< 28 weeks) Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Van Marter (Lamotrigine) (Controls unexposed, sick), 2021 20.51[0.14; 1.87]2,0382,923not evaluable Very preterm (28 to 32 weeks) Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Van Marter (Lamotrigine) (Controls unexposed, sick), 2021 20.53[0.19; 1.45]8,5672,923not evaluable Large for gestational age (weight) Artama (Lamotrigine) (Controls unexposed, sick), 2013 Aydin (Lamotrigine), 2020 21.47[0.05; 41.93]74180not evaluable Macrosomia (> 4000g) Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 10.89[0.82; 0.97]577,1802,813not evaluable Maternal consequences Caesarean Borthen (Lamotrigine) (Controls unexposed, sick), 2010 Artama (Lamotrigine) (Controls unexposed, sick), 2013 Kernizan (Lamotrigine) (Bipolar disorder), 2024 31.00[0.77; 1.29]795419not evaluable Preeclampsia Borthen (Lamotrigine) (Controls unexposed, sick), 2011 Cohen (Lamotrigine) (Mixed indications), 2019 Aydin (Lamotrigine), 2020 31.09[0.90; 1.31]53,7802,719not evaluable Assisted deliveries (forceps, vacuum, ...) Borthen (Lamotrigine) (Controls unexposed, sick), 2010 11.63[1.07; 2.47]185233not evaluable Gestational diabetes Aydin (Lamotrigine), 2020 Galbally, 2020 21.17[0.33; 4.20]1926not evaluable Postpartum hemorrhage Borthen (Lamotrigine) (Controls unexposed, sick), 2010 11.49[1.06; 2.10]324233not evaluable Abruptio placentae (retroplacental hematoma) Cohen (Lamotrigine) (Mixed indications), 2019 11.15[0.85; 1.56]20,3192,682not evaluable Amniotic fluid problems (polyhydramnios and/or oligohydramnios) Aydin (Lamotrigine), 2020 13.31[0.06; 183.69]-7not evaluable Maternal consequences (as a whole) Razaz (Epilepsy), 2024 10.99[0.83; 1.18]8305,080not evaluable Neonatal disorders Low Apgar score (< 7) (at 5 min) Borthen (Lamotrigine) (Controls unexposed, sick), 2010 Artama (Lamotrigine) (Controls unexposed, sick), 2013 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Christensen (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2015 41.22[0.76; 1.94]1311,343not evaluable Neonatal medical care Artama (Lamotrigine) (Controls unexposed, sick), 2013 Aydin (Lamotrigine), 2020 Bromley (Lamotrigine) (Epilepsy), 2023 Kernizan (Lamotrigine) (Bipolar disorder), 2024 41.85[1.05; 3.25]248280not evaluable Neonatal disorders (as a whole) Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Bromley (Lamotrigine) (Epilepsy), 2023 20.95[0.85; 1.07]222,1572,919not evaluable Low Apgar score (< 7) (at 1 min) Artama (Lamotrigine) (Controls unexposed, sick), 2013 11.69[0.35; 8.14]78154not evaluable Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation Kernizan, 2019 10.65[0.08; 5.30]1713not evaluable Fetal distress 0----- Neonatal death (< 28 days of life) Holmes (Lamotrigine) (Mixed indications), 2011 10.60[0.06; 5.80]4948not evaluable Long term consequences Child/Infant death (> 28 days of life) Artama (Lamotrigine) (Controls unexposed, sick), 2013 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 21.22[0.65; 2.30]4,7102,986not evaluable Intrauterine deaths Intrauterine deaths (as a whole or unspecified) Holmes (Lamotrigine) (Mixed indications), 2011 Miškov (Lamotrigine) (Controls unexposed, sick), 2016 Trivedi (Lamotrigine), 2018 Kernizan, 2019 Meador (Lamotrigine) (Controls unexposed, sick), 2020 Vajda (Lamotrigine) (Epilepsy), 2024 62.92[1.01; 8.49]401,485not evaluable Elective/induced termination of pregnancy Holmes (Lamotrigine) (Mixed indications), 2011 Miškov (Lamotrigine) (Controls unexposed, sick), 2016 Hosny, 2021 31.39[0.20; 9.76]5988not evaluable Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Miškov (Lamotrigine) (Controls unexposed, sick), 2016 Alsaadi (Lamotrigine) (Epilepsy) (Controls unexposed sick), 2020 21.14[0.16; 8.05]650not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths Holmes (Lamotrigine) (Mixed indications), 2011 AlSheikh (Lamotrigine), 2020 Aydin (Lamotrigine), 2020 31.07[0.13; 8.49]2975not evaluable Perinatal death Artama (Lamotrigine) (Controls unexposed, sick), 2013 10.49[0.03; 8.47]10173not evaluable Therapeutic terminations of pregnancy Miškov (Lamotrigine) (Controls unexposed, sick), 2016 10.10[0.00; 5.62]-37not evaluable Neuro-developmental disorders ASD (Autism spectrum disorder): Diagnosis/Risk Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Bjørk (Lamotrigine) (Controls unexposed, sick), 2018 Cohen-Israel (Lamotrigine), 2018 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Bjørk (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2022 Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 Hernandez-Diaz (Lamotrigine) (Epilepsy), 2024 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 90.98[0.84; 1.14]119,90728,010not evaluable Language disorders/delay Rihtman (Lamotrigine), 2013 Baker (Lamotrigine) (Controls unexposed, sick), 2015 Videman (Lamotrigine), 2016 Kasradze (Lamotrigine), 2017 Cohen-Israel (Lamotrigine), 2018 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Husebye (Lamotrigine) (Controls unexposed, sick), 2020 Bromley (Lamotrigine) (Epilepsy), 2023 Meador (Lamotrigine), 2023 91.12[0.79; 1.58]72,0533,181not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Rihtman (Lamotrigine), 2013 Richards (Lamotrigine) (Indications NOS), 2019 Dreier (Lamotrigine) (Epilepsy), 2023 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 71.14[0.86; 1.53]165,14311,524not evaluable ASD (Autism spectrum disorder): Diagnosis Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 Hernandez-Diaz (Lamotrigine) (Epilepsy), 2024 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 60.88[0.77; 1.00]81,34719,901serious Cognitive developmental disorders/delay (> 6 years old) Baker (Lamotrigine) (Controls unexposed, sick), 2015 Gopinath (Lamotrigine), 2015 Cohen-Israel (Lamotrigine), 2018 Dreier (Lamotrigine) (Epilepsy), 2023 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 60.99[0.80; 1.21]25,75311,375not evaluable Neuro-developmental disorders (as a whole) Dean (Lamotrigine), 2007 Rihtman (Lamotrigine), 2013 Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Charlton (Lamotrigine) (Controls unexposed, sick), 2017 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 61.08[0.66; 1.76]10,56810,961not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Dreier (Lamotrigine) (Epilepsy), 2023 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 40.91[0.74; 1.11]153,28211,292not evaluable Cognitive developmental disorders/delay (3-6 years old) Cummings (Lamotrigine), 2011 Rihtman (Lamotrigine), 2013 Kasradze (Lamotrigine), 2017 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 51.81[0.66; 4.98]3,56910,842not evaluable Psychomotor developmental disorders/delay Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Rihtman (Lamotrigine), 2013 Videman (Lamotrigine), 2016 Cohen-Israel (Lamotrigine), 2018 Thomas (Lamotrigine) (Epilepsy), 2022 Bromley (Lamotrigine) (Epilepsy), 2023 61.30[0.47; 3.59]14262not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Dreier (Lamotrigine) (Epilepsy), 2023 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 31.02[0.82; 1.27]25,71111,262not evaluable Cognitive developmental disorders/delay (< 3 years old) Bromley (Lamotrigine) (Controls unexposed, sick), 2010 Videman (Lamotrigine), 2016 Thomas (Lamotrigine) (Epilepsy), 2022 Bromley (Lamotrigine) (Epilepsy), 2023 41.55[0.68; 3.52]11141not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Cummings (Lamotrigine), 2011 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 30.98[0.26; 3.76]3,56710,798not evaluable ADHD (Attention deficit hyperactivity disorder): Risk Rihtman (Lamotrigine), 2013 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Richards (Lamotrigine) (Indications NOS), 2019 31.81[1.17; 2.79]11,861232not evaluable ASD (Autism spectrum disorder): Risk Cohen-Israel (Lamotrigine), 2018 Bjørk (Lamotrigine) (Controls unexposed, sick), 2018 21.64[0.66; 4.06]41159not evaluable Learning disorders Cohen-Israel (Lamotrigine), 2018 Ren (Lamotrigine) (Mixed indications), 2023 20.92[0.74; 1.13]9275not evaluable Childhood autism (F84.0) Christensen (Lamotrigine) (Indications NOS), 2013 11.70[0.53; 5.48]2,066647not evaluable0.0100.01.0

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