Carbamazepine (All indications)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Robert (Carbamazepine), 1986 D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Nulman (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 1997 Samrén (Carbamazepine), 1999 Canger (Carbamazepine), 1999 Kaneko (Carbamazepine), 1999 Hvas (Carbamazepine) (Controls unexposed, sick), 2000 Diav-Citrin (Carbamazepine), 2001 Dean (Carbamazepine), 2002 Kaaja (Carbamazepine), 2003 Endo (Carbamazepine) (Controls unexposed, sick), 2004 Artama (Carbamazepine), 2005 Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Mawer (Carbamazepine) (Controls unexposed, sick), 2010 Bànhidy (Carbamazepine), 2011 Charlton (Carbamazepine) (Controls unexposed, sick), 2011 Arteaga-Vázquez (Carbamazepine), 2012 Cassina (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2013 Campbell (Carbamazepine) (Controls unexposed, sick), 2014 Veiby (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 Vanya (Carbamazepine) (Controls unexposed, sick), 2015 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Alsaadi (Carbamazepine) (Epilepsy) (Controls unexposed sick), 2020 Meador (Carbamazepine) (Controls unexposed, sick), 2020 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 Hosny (Carbamazepine) (Controls unexposed, sick), 2021 Mari (Carbamazepine), 2022 The NAAED (Carbamazepine) (Controls unexposed, disease free) (Indications NOS), 2023 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023 Battino (Carbamazepine) (Epilepsy), 2024 Ertürk Çetin (Epilepsy) (Carbamazepine), 2024 Wiggs (Epilepsy) (Carbamazepine), 2024 Vajda b (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2024 Hao (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2025 351.47[1.22; 1.77]155,82514,006critical Major congenital malformations Robert (Carbamazepine), 1986 Nulman (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 1997 Samrén (Carbamazepine), 1999 Canger (Carbamazepine), 1999 Hvas (Carbamazepine) (Controls unexposed, sick), 2000 Diav-Citrin (Carbamazepine), 2001 Dean (Carbamazepine), 2002 Kaaja (Carbamazepine), 2003 Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Mawer (Carbamazepine) (Controls unexposed, sick), 2010 Charlton (Carbamazepine) (Controls unexposed, sick), 2011 Bànhidy (Carbamazepine), 2011 Cassina (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2013 Veiby (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 Campbell (Carbamazepine) (Controls unexposed, sick), 2014 Vanya (Carbamazepine) (Controls unexposed, sick), 2015 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Alsaadi (Carbamazepine) (Epilepsy) (Controls unexposed sick), 2020 Meador (Carbamazepine) (Controls unexposed, sick), 2020 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 Hosny (Carbamazepine) (Controls unexposed, sick), 2021 Mari (Carbamazepine), 2022 The NAAED (Carbamazepine) (Controls unexposed, disease free) (Indications NOS), 2023 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023 Ertürk Çetin (Epilepsy) (Carbamazepine), 2024 Wiggs (Epilepsy) (Carbamazepine), 2024 Vajda b (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2024 Battino (Carbamazepine) (Epilepsy), 2024 Hao (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2025 291.42[1.18; 1.72]155,69012,985critical Congenital heart defects D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Canger (Carbamazepine), 1999 Artama (Carbamazepine), 2005 Mawer (Carbamazepine) (Controls unexposed, sick), 2010 Bànhidy (Carbamazepine), 2011 Hernández-Díaz (Carbamazepine) (Epilepsy), 2012 Vajda (Carbamazepine) (Controls unexposed, sick), 2013 Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Tomson (Carbamazepine), 2018 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023 Wiggs (Epilepsy) (Carbamazepine), 2024 151.01[0.69; 1.48]2,18311,668low Hypospadias D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Jentink (Carbamazepine), 2010 Bànhidy (Carbamazepine), 2011 Hernández-Díaz (Carbamazepine) (Epilepsy), 2012 Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2014 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2018 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023 111.20[0.84; 1.71]9,51110,054low Minor congenital malformations Robert (Carbamazepine), 1986 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Battino (Carbamazepine), 1992 Nulman (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 1997 Wide (Carbamazepine), 2000 Dean (Carbamazepine), 2002 Alsaadi (Carbamazepine) (Epilepsy) (Controls unexposed sick), 2020 Mari (Carbamazepine), 2022 Ertürk Çetin (Epilepsy) (Carbamazepine), 2024 92.97[1.57; 5.62]127271not evaluable Limb defects Artama (Carbamazepine), 2005 Mawer (Carbamazepine) (Controls unexposed, sick), 2010 Vajda (Carbamazepine) (Controls unexposed, sick), 2013 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 Wiggs (Epilepsy) (Carbamazepine), 2024 81.11[0.81; 1.51]1,3265,863not evaluable Spina bifida Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Czeizel (Carbamazepine) (Mixed indications), 1992 Artama (Carbamazepine), 2005 Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Jentink (Carbamazepine), 2010 Charlton (Carbamazepine) (Controls unexposed, sick), 2011 Veiby (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 82.11[1.12; 3.95]6262,403not evaluable Microcephaly / Small head circumference for gestational age Nulman (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 1997 Battino (Carbamazepine), 1999 Díaz-Romero (Carbamazepine), 1999 Holmes (Carbamazepine) (Controls unexposed, sick), 2001 Kini (Carbamazepine) (Controls unexposed, sick), 2006 Pennell (Carbamazepine), 2012 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Margulis (Carbamazepine) (Mixed indications), 2019 Christensen (Carbamazepine) (All indications) (Controls unexposed, general population), 2024 91.39[1.16; 1.67]134,6406,071not evaluable Neural Tube Defects Canger (Carbamazepine), 1999 Mawer (Carbamazepine) (Controls unexposed, sick), 2010 Bànhidy (Carbamazepine), 2011 Hernández-Díaz (Carbamazepine) (Epilepsy), 2012 Vajda (Carbamazepine) (Controls unexposed, sick), 2013 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2018 72.40[1.00; 5.77]245,199not evaluable Club foot / Talipes equinovarus Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Bànhidy (Carbamazepine), 2011 Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023 51.21[0.48; 3.01]3,8114,720not evaluable Oro-facial clefts Hernández-Díaz (Carbamazepine) (Epilepsy), 2012 Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2018 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023 Wiggs (Epilepsy) (Carbamazepine), 2024 71.29[0.75; 2.21]2,8429,974not evaluable Nervous system anomalies Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023 Wiggs (Epilepsy) (Carbamazepine), 2024 50.97[0.50; 1.88]3755,648not evaluable Polydactyly D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Bànhidy (Carbamazepine), 2011 Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Tomson (Carbamazepine), 2018 51.65[0.71; 3.83]3,0953,553not evaluable Cleft lip with or without cleft palate Artama (Carbamazepine), 2005 Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Jentink (Carbamazepine), 2010 Vajda (Carbamazepine) (Controls unexposed, sick), 2013 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 50.73[0.15; 3.55]1,6401,750not evaluable Urinary malformations Artama (Carbamazepine), 2005 Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Tomson (Carbamazepine), 2018 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 Wiggs (Epilepsy) (Carbamazepine), 2024 51.23[0.72; 2.09]385,393not evaluable Digestive system anomalies Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 Wiggs (Epilepsy) (Carbamazepine), 2024 40.67[0.38; 1.19]214,288not evaluable Genital anomalies Artama (Carbamazepine), 2005 Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Wiggs (Epilepsy) (Carbamazepine), 2024 41.48[0.97; 2.26]1,0443,289not evaluable Ano-rectal atresia and stenosis Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 21.70[0.20; 14.15]545523not evaluable Cardiac septal defects Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2014 20.88[0.54; 1.43]16,5712,196not evaluable Craniosynostosis D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 22.56[0.25; 25.83]766515not evaluable Hip dislocation and/or dysplasia D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 22.46[0.14; 43.93]-14not evaluable Cleft palate Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 25.03[1.14; 22.26]1,181584not evaluable Diaphragmatic hernia Jentink (Carbamazepine), 2010 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 21.66[0.31; 8.82]378512not evaluable Atrial septal defect Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 10.56[0.03; 8.97]3,268512not evaluable Atrioventricular septal defect Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 13.46[0.22; 55.50]529512not evaluable Bilateral renal agenesis including Potter syndrome Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 124.28[1.50; 392.37]75512not evaluable Bladder exstrophy and/or epispadia Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 122.22[1.38; 358.80]82512not evaluable Chromosomal abnormalities Artama (Carbamazepine), 2005 Wiggs (Epilepsy) (Carbamazepine), 2024 21.74[0.20; 15.47]32,261not evaluable Coarctation of aorta Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 12.35[0.15; 37.68]779512not evaluable Congenital cataract Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 10.65[0.02; 17.40]111not evaluable Down syndrom / Trisomy 21 D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 13.00[0.05; 194.76]-3not evaluable Ebstein's anomaly Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 136.31[2.24; 589.29]50512not evaluable Eye defects Dean (Carbamazepine), 2002 Artama (Carbamazepine), 2005 20.49[0.16; 1.52]13874not evaluable Eye, ear, face and neck malformations Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Wiggs (Epilepsy) (Carbamazepine), 2024 20.54[0.21; 1.35]12,141not evaluable Gastroschisis Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 17.53[0.47; 120.88]243512not evaluable Hypoplastic left heart (HLH/HLHS) Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 18.47[0.53; 136.01]216512not evaluable Hypoplastic right heart (HRH/HRHS) Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 127.57[1.70; 446.03]66512not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 14.67[0.29; 74.91]392512not evaluable Omphalocele Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 16.88[0.43; 110.42]266512not evaluable Pulmonary valve atresia Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 112.02[0.75; 193.35]152512not evaluable Respiratory system anomalies Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Wiggs (Epilepsy) (Carbamazepine), 2024 21.90[0.92; 3.96]52,141not evaluable Tetralogy of Fallot Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 13.14[0.20; 50.27]584512not evaluable Ventricular septal defect Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 10.39[0.02; 6.31]4,643512not evaluable Ear, face and neck anomalies Artama (Carbamazepine), 2005 10.23[0.01; 4.86]2805not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Diav-Citrin (Carbamazepine), 2001 Endo (Carbamazepine) (Controls unexposed, sick), 2004 McVearry (Carbamazepine), 2009 Cummings (Carbamazepine) (Controls unexposed, disease free), 2011 Nadebaum (Carbamazepine), 2011 Pennell (Carbamazepine), 2012 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Kilic (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 Arkilo (Carbamazepine), 2015 Bank (Carbamazepine) (Mixed indications), 2017 Cohen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Margulis (Carbamazepine) (Mixed indications), 2019 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 Leite (Carbamazepine) (Epilepsy), 2024 181.07[0.93; 1.24]252,5535,393critical Small for gestational age (weight) Wide (Carbamazepine), 2000 Endo (Carbamazepine) (Controls unexposed, sick), 2004 Burja (Carbamazepine) (Controls unexposed, sick), 2006 Pennell (Carbamazepine), 2012 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Bank (Carbamazepine) (Mixed indications), 2017 Margulis (Carbamazepine) (Mixed indications), 2019 Cohen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 Christensen (Carbamazepine) (All indications) (Controls unexposed, general population), 2024 121.20[1.03; 1.40]655,5487,221low Low birth weight (< 2500g) Kini (Carbamazepine) (Controls unexposed, sick), 2006 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Christensen (Carbamazepine) (All indications) (Controls unexposed, general population), 2024 Leite (Carbamazepine) (Epilepsy), 2024 51.35[0.96; 1.90]232,9804,082not evaluable Large for gestational age (weight) Artama (Carbamazepine) (Controls unexposed, sick), 2013 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 20.88[0.59; 1.32]1101,092not evaluable Macrosomia (> 4000g) Endo (Carbamazepine) (Controls unexposed, sick), 2004 Kini (Carbamazepine) (Controls unexposed, sick), 2006 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 30.99[0.82; 1.20]576,481570not evaluable Very preterm (28 to 32 weeks) Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 11.28[0.41; 3.99]8,559468not evaluable Extremely preterm (< 28 weeks) Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 10.90[0.06; 14.35]2,036468not evaluable Large head circumference for gestational age Díaz-Romero (Carbamazepine), 1999 10.29[0.01; 16.12]-26not evaluable Maternal consequences Caesarean Endo (Carbamazepine) (Controls unexposed, sick), 2004 Borthen (Carbamazepine) (Controls unexposed, sick), 2010 Artama (Carbamazepine) (Controls unexposed, sick), 2013 31.03[0.88; 1.21]9441,480not evaluable Preeclampsia Borthen (Carbamazepine) (Controls unexposed, sick), 2011 Cohen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 31.25[0.92; 1.70]53,7251,275not evaluable Assisted deliveries (forceps, vacuum, ...) Endo (Carbamazepine) (Controls unexposed, sick), 2004 Borthen (Carbamazepine) (Controls unexposed, sick), 2010 20.82[0.11; 5.98]194396not evaluable Amniotic fluid problems (polyhydramnios and/or oligohydramnios) Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Mari (Carbamazepine), 2022 21.77[0.15; 20.65]244not evaluable Gestational diabetes Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Mari (Carbamazepine), 2022 20.47[0.04; 5.89]344not evaluable Postpartum hemorrhage Borthen (Carbamazepine) (Controls unexposed, sick), 2010 11.18[0.88; 1.58]342388not evaluable Abruptio placentae (retroplacental hematoma) Cohen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 10.92[0.52; 1.63]20,2881,232not evaluable Maternal consequences (as a whole) Alsfouk (Carbamazepine), 2022 Razaz (Carbamazepine), 2024 21.48[1.16; 1.89]7742,659not evaluable Polyhydramnios Endo (Carbamazepine) (Controls unexposed, sick), 2004 10.23[0.00; 17.06]18not evaluable Maternal death Mari (Carbamazepine), 2022 10.37[0.01; 19.78]-29not evaluable Maternal liver disorder / failure during pregnancy Mari (Carbamazepine), 2022 11.15[0.04; 30.40]129not evaluable Neonatal disorders Low Apgar score (< 7) (at 5 min) Borthen (Carbamazepine) (Controls unexposed, sick), 2010 Pennell (Carbamazepine), 2012 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Christensen (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2015 Bank (Carbamazepine) (Mixed indications), 2017 61.79[1.13; 2.84]1321,146not evaluable Neonatal medical care D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Viinikainen (Carbamazepine) (Controls unexposed, disease free) a, 2006 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Bank (Carbamazepine) (Mixed indications), 2017 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 61.20[0.92; 1.55]2,0901,029serious Low Apgar score (< 7) (at 1 min) Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Endo (Carbamazepine) (Controls unexposed, sick), 2004 Pennell (Carbamazepine), 2012 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Bank (Carbamazepine) (Mixed indications), 2017 51.18[0.80; 1.73]1241,022not evaluable Neonatal disorders (as a whole) D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 30.97[0.75; 1.26]221,852498not evaluable Feeding difficulty D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Yerby (Carbamazepine), 1992 Burja (Carbamazepine) (Controls unexposed, sick), 2006 31.49[0.22; 9.94]341not evaluable Neonatal intracranial hemorrhage D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Burja (Carbamazepine) (Controls unexposed, sick), 2006 23.82[0.73; 20.07]622not evaluable Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation Burja (Carbamazepine) (Controls unexposed, sick), 2006 11.70[0.03; 89.48]-19not evaluable Cerebral palsy Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 16.79[0.25; 182.34]111not evaluable Jaundice / Icterus D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 13.50[0.14; 84.70]23not evaluable Neonatal death (< 28 days of life) Holmes (Carbamazepine) (Controls unexposed, disease free), 2011 11.66[0.19; 14.33]6573not evaluable Neonatal hypotonia D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 13.00[0.05; 194.76]-3not evaluable Neonatal infections D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 13.00[0.05; 194.76]-3not evaluable Neonatal tachypnea D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 13.00[0.05; 194.76]-3not evaluable Fetal distress McVearry (Carbamazepine), 2009 10.75[0.14; 4.04]716not evaluable Long term consequences Child/Infant death (> 28 days of life) Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 31.65[0.59; 4.67]4,7081,557not evaluable Child/Infant growth abnormalities (> 1 year) Pennell (Carbamazepine), 2012 10.52[0.12; 2.16]963not evaluable Child/Infant head circumference abnormalities (> 1 year) Pennell (Carbamazepine), 2012 15.81[0.27; 123.89]252not evaluable Child/Infant lenght abnormalities (> 1 year) Kini (Carbamazepine) (Controls unexposed, sick), 2006 11.65[0.45; 6.05]1094not evaluable Child/Infant weight abnormalities (> 1 year) Kini (Carbamazepine) (Controls unexposed, sick), 2006 11.25[0.43; 3.59]1594not evaluable Intrauterine deaths Intrauterine deaths (as a whole or unspecified) Diav-Citrin (Carbamazepine), 2001 Meador (Carbamazepine), 2006 Holmes (Carbamazepine) (Controls unexposed, disease free), 2011 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2015 Arkilo (Carbamazepine), 2015 Miškov (Carbamazepine) (Controls unexposed, sick), 2016 Trivedi (Carbamazepine) (Controls unexposed, sick), 2018 Meador (Carbamazepine) (Controls unexposed, sick), 2020 Vajda a (Carbamazepine) (Controls unexposed sick) (Epilepsy), 2024 101.21[0.88; 1.67]5725,011critical Late intrauterine deaths (> 22 weeks) / Stillbirths Diav-Citrin (Carbamazepine), 2001 Holmes (Carbamazepine) (Controls unexposed, disease free), 2011 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2015 Arkilo (Carbamazepine), 2015 AlSheikh (Carbamazepine) (Controls unexposed, sick), 2020 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Mari (Carbamazepine), 2022 81.53[0.71; 3.30]494,177not evaluable Elective/induced termination of pregnancy Diav-Citrin (Carbamazepine), 2001 Holmes (Carbamazepine) (Controls unexposed, disease free), 2011 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Miškov (Carbamazepine) (Controls unexposed, sick), 2016 Hosny (Carbamazepine) (Controls unexposed, sick), 2021 Mari (Carbamazepine), 2022 61.82[1.01; 3.28]432,472serious Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Diav-Citrin (Carbamazepine), 2001 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2015 Arkilo (Carbamazepine), 2015 Miškov (Carbamazepine) (Controls unexposed, sick), 2016 Alsaadi (Carbamazepine) (Epilepsy) (Controls unexposed sick), 2020 60.91[0.69; 1.21]4393,598not evaluable Perinatal death Canger (Carbamazepine), 1999 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Tomson (Carbamazepine), 2015 31.42[0.62; 3.25]262,767not evaluable Therapeutic terminations of pregnancy Miškov (Carbamazepine) (Controls unexposed, sick), 2016 10.28[0.00; 16.82]-13not evaluable Ectopic pregnancy Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 13.84[0.16; 94.34]11,718not evaluable Neuro-developmental disorders Language disorders/delay Gaily (Carbamazepine) (Controls unexposed, sick), 2004 Adab (Carbamazepine), 2004 Eriksson (Carbamazepine), 2005 Nadebaum (Carbamazepine), 2011 Meador (Carbamazepine), 2013 Baker (Carbamazepine) (Controls unexposed, sick), 2015 Deshmukh (Carbamazepine), 2016 Videman (Carbamazepine) (Controls unexposed, disease free), 2016 Kasradze (Carbamazepine) (Controls unexposed, disease free), 2017 Husebye (Carbamazepine) (Controls unexposed, sick), 2020 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Meador (Carbamazepine) (Controls unexposed, disease free), 2021 Adams (Carbamazepine), 2022 Thomas a (Carbamazepine), 2022 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 Stjerna (Carbamazepine) (Epilepsy), 2024 161.57[1.13; 2.19]71,9921,057probable Cognitive developmental disorders/delay (> 6 years old) Adab (Carbamazepine), 2004 Gaily (Carbamazepine) (Controls unexposed, sick), 2004 Vinten (Carbamazepine), 2005 Viinikainen (Carbamazepine) b, 2006 Titze (Carbamazepine) (Controls unexposed, sick), 2008 Nadebaum (Carbamazepine), 2011 Meador (Carbamazepine), 2013 Baker (Carbamazepine) (Controls unexposed, sick), 2015 Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022 Adams (Carbamazepine), 2022 Thomas a (Carbamazepine), 2022 Stjerna (Carbamazepine) (Epilepsy), 2024 Madley-Dowd_UK (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 141.30[1.03; 1.64]25,6926,753low ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Viinikainen (Carbamazepine) b, 2006 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Cohen (Carbamazepine), 2013 Richards (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2019 Huber-Mollema (Carbamazepine), 2019 Dreier (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 91.11[0.98; 1.27]165,1716,058not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Wood (Carbamazepine), 2015 Bjørk (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2018 Bjørk (Carbamazepine) (Controls unexposed, sick), 2018 Huber-Mollema (Carbamazepine), 2019 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022 Bjørk (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2022 Madley-Dowd_UK (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 101.23[1.08; 1.40]119,70410,213low Neuro-developmental disorders (as a whole) Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Katz (Carbamazepine), 2001 Adab (Carbamazepine), 2004 Viinikainen (Carbamazepine) b, 2006 Dean (Carbamazepine) (Controls unexposed, sick), 2007 Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Arkilo (Carbamazepine), 2015 Charlton (Carbamazepine) (Controls unexposed, sick), 2017 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022 101.46[1.05; 2.03]10,5944,118low ASD (Autism spectrum disorder): Diagnosis Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Wood (Carbamazepine), 2015 Huber-Mollema (Carbamazepine), 2019 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022 Madley-Dowd_UK (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 71.20[1.03; 1.39]81,1746,875not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Gaily (Carbamazepine) (Controls unexposed, sick), 2004 Vinten (Carbamazepine), 2005 Viinikainen (Carbamazepine) b, 2006 Titze (Carbamazepine) (Controls unexposed, sick), 2008 Meador (Carbamazepine), 2013 Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022 Madley-Dowd_UK (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 81.40[1.14; 1.73]25,6876,502not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Cohen (Carbamazepine), 2013 Huber-Mollema (Carbamazepine), 2019 Dreier (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Carbamazepine) (Controls unexposed, general pop) (Mixed indications), 2024 61.07[0.95; 1.19]153,3055,814not evaluable Psychomotor developmental disorders/delay Ornoy (Carbamazepine), 1996 Adab (Carbamazepine), 2004 Viinikainen (Carbamazepine) b, 2006 Cohen (Carbamazepine), 2011 Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Deshmukh (Carbamazepine), 2016 Videman (Carbamazepine) (Controls unexposed, disease free), 2016 Thomas b (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2022 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 91.04[0.78; 1.39]25641not evaluable Cognitive developmental disorders/delay (< 3 years old) Ornoy (Carbamazepine), 1996 Wide (Carbamazepine), 2000 Bromley (Carbamazepine) (Controls unexposed, sick), 2010 Meador (Carbamazepine), 2013 Videman (Carbamazepine) (Controls unexposed, disease free), 2016 Thomas b (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2022 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 Ertürk Çetin (Epilepsy) (Carbamazepine), 2024 81.90[0.90; 3.98]47523not evaluable Cognitive developmental disorders/delay (3-6 years old) Cummings (Carbamazepine) (Controls unexposed, disease free), 2011 Meador (Carbamazepine), 2013 Deshmukh (Carbamazepine), 2016 Kasradze (Carbamazepine) (Controls unexposed, disease free), 2017 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 52.75[1.33; 5.68]3,419684not evaluable ADHD (Attention deficit hyperactivity disorder): Risk Viinikainen (Carbamazepine) b, 2006 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Cohen (Carbamazepine), 2013 Huber-Mollema (Carbamazepine), 2019 Richards (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2019 51.66[1.08; 2.54]11,888332not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Cummings (Carbamazepine) (Controls unexposed, disease free), 2011 Meador (Carbamazepine), 2013 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 32.02[0.65; 6.23]3,392571not evaluable ASD (Autism spectrum disorder): Risk Wood (Carbamazepine), 2015 Bjørk (Carbamazepine) (Controls unexposed, sick), 2018 Huber-Mollema (Carbamazepine), 2019 31.27[0.53; 3.03]38111not evaluable Learning disorders Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Forsberg (Carbamazepine) (Controls unexposed, sick), 2011 Ren (Carbamazepine) (Mixed indications), 2023 31.24[0.94; 1.65]51455not evaluable Childhood autism (F84.0) Christensen (Carbamazepine) (Controls unexposed NOS) (Indications NOS), 2013 11.40[0.37; 5.33]2,067386not evaluable Severe cognitive developmental delay (Mental retardation) (< 3 years old) Meador (Carbamazepine), 2013 11.48[0.45; 4.89]1248not evaluable0.0100.01.0

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