Topiramate (All indications)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Morrow (Topiramate) (Controls unexposed, sick), 2006 Ornoy (Topiramate), 2008 Mawer (Topiramate) (Controls unexposed, sick), 2010 Margulis (Topiramate) (Mixed indication), 2012 Källén (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Meador (Topiramate) (Controls unexposed, sick), 2020 Thomas (Topiramate) (Controls unexposed, sick), 2021 Cohen (Topiramate) (Mixed indications) (Controls unexposed, NOS), 2023 The NAAED (Topiramate) (Controls unexposed, disease free) (Indications NOS), 2023 Battino (Topiramate) (Epilepsy), 2024 Vajda b (Topiramate) (Epilepsy) (Controls unexposed, sick), 2024 Hao (Topiramate) (Epilepsy) (Controls unexposed, sick), 2025 132.29[1.80; 2.91]231,4101,502low Major congenital malformations Morrow (Topiramate) (Controls unexposed, sick), 2006 Ornoy (Topiramate), 2008 Mawer (Topiramate) (Controls unexposed, sick), 2010 Margulis (Topiramate) (Mixed indication), 2012 Källén (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Meador (Topiramate) (Controls unexposed, sick), 2020 Thomas (Topiramate) (Controls unexposed, sick), 2021 Cohen (Topiramate) (Mixed indications) (Controls unexposed, NOS), 2023 The NAAED (Topiramate) (Controls unexposed, disease free) (Indications NOS), 2023 Battino (Topiramate) (Epilepsy), 2024 Vajda b (Topiramate) (Epilepsy) (Controls unexposed, sick), 2024 Hao (Topiramate) (Epilepsy) (Controls unexposed, sick), 2025 132.29[1.80; 2.91]231,4101,502low Oro-facial clefts Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Topiramate) (Mixed indications), 2012 Mines (Topiramate) (Other indications), 2014 Veiby (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Hernandez-Diaz (Topiramate) (Mixed indications), 2018 Tomson (Topiramate), 2018 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Lyons (Topiramate) (Indications NOS), 2023 83.15[2.12; 4.69]5,6584,639not evaluable Congenital heart defects Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Topiramate) (Mixed indications), 2012 Vajda (Topiramate) (Controls unexposed, sick), 2013 Tomson (Topiramate), 2018 Thomas (Topiramate) (Controls unexposed, sick), 2021 52.47[0.98; 6.24]36592not evaluable Cleft lip with or without cleft palate Margulis (Topiramate) (Mixed indication), 2012 Vajda (Topiramate) (Controls unexposed, sick), 2013 Mines (Topiramate) (Other indications), 2014 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 44.24[2.15; 8.38]4,7002,319not evaluable Hypospadias Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Topiramate) (Mixed indications), 2012 Tomson (Topiramate), 2018 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 44.03[1.56; 10.45]3,3901,056not evaluable Limb defects Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Vajda (Topiramate) (Controls unexposed, sick), 2013 Thomas (Topiramate) (Controls unexposed, sick), 2021 33.56[0.59; 21.68]581not evaluable Microcephaly / Small head circumference for gestational age Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Christensen (Topiramate) (All indications) (Controls unexposed, general population), 2024 33.61[0.85; 15.40]153,0111,203not evaluable Neural Tube Defects Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Topiramate) (Mixed indications), 2012 Vajda (Topiramate) (Controls unexposed, sick), 2013 Tomson (Topiramate), 2018 43.21[0.62; 16.76]4583not evaluable Spina bifida Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 25.51[0.72; 41.94]619565not evaluable Cleft palate Mines (Topiramate) (Other indications), 2014 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 20.97[0.13; 7.18]1,1842,262not evaluable Digestive system anomalies Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Topiramate) (Controls unexposed, sick), 2021 26.26[0.69; 56.84]437not evaluable Urinary malformations Tomson (Topiramate), 2018 Thomas (Topiramate) (Controls unexposed, sick), 2021 21.68[0.22; 13.11]14161not evaluable Ano-rectal atresia and stenosis Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 13.33[0.21; 53.44]544517not evaluable Atrial septal defect Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 12.30[0.44; 12.02]3,270517not evaluable Atrioventricular septal defect Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 13.43[0.21; 54.96]529517not evaluable Bilateral renal agenesis including Potter syndrome Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 124.05[1.49; 388.57]75517not evaluable Bladder exstrophy and/or epispadia Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 122.01[1.36; 355.32]82517not evaluable Club foot / Talipes equinovarus Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 12.20[0.20; 24.50]1,678517not evaluable Coarctation of aorta Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 12.33[0.15; 37.31]779517not evaluable Craniosynostosis Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 12.37[0.15; 37.95]766517not evaluable Diaphragmatic hernia Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 19.80[0.59; 162.81]379517not evaluable Ebstein's anomaly Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 135.96[2.22; 583.57]50517not evaluable Gastroschisis Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 17.46[0.46; 119.71]243517not evaluable Hypoplastic left heart (HLH/HLHS) Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 18.39[0.52; 134.69]216517not evaluable Hypoplastic right heart (HRH/HRHS) Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 127.30[1.69; 441.71]66517not evaluable Nervous system anomalies Thomas (Topiramate) (Controls unexposed, sick), 2021 139.94[0.75; 2134.65]-9not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 19.40[0.58; 153.31]393517not evaluable Omphalocele Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 16.81[0.42; 109.35]266517not evaluable Pulmonary valve atresia Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 111.91[0.74; 191.48]152517not evaluable Tetralogy of Fallot Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 13.11[0.19; 49.78]584517not evaluable Ventricular septal defect Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 11.60[0.30; 8.62]4,645517not evaluable Polydactyly Tomson (Topiramate), 2018 116.59[0.33; 839.05]-152not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Kilic (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Hernández-Díaz (Topiramate) (Mixed indications) (Controls unexposed, disease free), 2014 Arkilo (Topiramate), 2015 Bank (Topiramate) (Mixed indications) , 2017 Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 61.34[0.87; 2.05]252,6563,167not evaluable Small for gestational age (weight) Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Bank (Topiramate) (Mixed indications) , 2017 Hernández-Díaz (Topiramate), 2017 Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Christensen (Topiramate) (All indications) (Controls unexposed, general population), 2024 61.60[1.11; 2.32]655,9403,839not evaluable Low birth weight (< 2500g) Hernández-Díaz (Topiramate) (Mixed indications) (Controls unexposed, disease free), 2014 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Christensen (Topiramate) (All indications) (Controls unexposed, general population), 2024 31.50[1.17; 1.94]233,0161,462not evaluable Macrosomia (> 4000g) Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 10.92[0.76; 1.11]577,249477not evaluable Very preterm (28 to 32 weeks) Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 12.53[1.13; 5.65]8,590477not evaluable Extremely preterm (< 28 weeks) Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 11.76[0.25; 12.52]2,042477not evaluable Maternal consequences Abruptio placentae (retroplacental hematoma) Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 11.27[0.96; 1.68]20,3232,280not evaluable Preeclampsia Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 11.06[0.89; 1.26]53,7652,280not evaluable Maternal consequences (as a whole) Razaz (Topiramate) (Epilepsy), 2024 11.21[0.64; 2.30]666249not evaluable Neonatal disorders Neonatal disorders (as a whole) Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 11.23[0.96; 1.58]222,275477not evaluable Low Apgar score (< 7) (at 1 min) Bank (Topiramate) (Mixed indications) , 2017 14.47[0.14; 140.56]22not evaluable Low Apgar score (< 7) (at 5 min) Bank (Topiramate) (Mixed indications) , 2017 123.67[0.34; 1653.93]-2not evaluable Neonatal medical care Bank (Topiramate) (Mixed indications) , 2017 15.00[0.27; 91.52]72not evaluable Long term consequences Child/Infant death (> 28 days of life) Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 10.76[0.11; 5.43]4,696477not evaluable Intrauterine deaths Intrauterine deaths (as a whole or unspecified) Arkilo (Topiramate), 2015 Trivedi (Topiramate) (Controls unexposed, sick), 2018 Meador (Topiramate) (Controls unexposed, sick), 2020 Vajda a (Topiramate) (Controls unexposed sick) (Epilepsy), 2024 413.39[3.16; 56.70]1364not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths Arkilo (Topiramate), 2015 AlSheikh (Topiramate) (Controls unexposed, sick), 2020 215.37[0.63; 376.77]-3not evaluable Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Babic (Topiramate), 2014 Arkilo (Topiramate), 2015 28.47[0.57; 125.19]34not evaluable Neuro-developmental disorders ASD (Autism spectrum disorder): Diagnosis/Risk Wood (Topiramate), 2015 Bjørk (Topiramate) (Controls exposed to Lamotrigine, sick), 2018 Bjørk (Topiramate) (Controls unexposed, sick), 2018 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Topiramate) (Controls unexposed NOS) (Mixed indications), 2022 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 Hernandez-Diaz (Topiramate) (Epilepsy), 2024 Madley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 91.41[0.92; 2.19]119,5932,473not evaluable ASD (Autism spectrum disorder): Diagnosis Wood (Topiramate), 2015 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 Hernandez-Diaz (Topiramate) (Epilepsy), 2024 Madley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 61.18[0.70; 1.97]81,1021,990not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Rihtman (Topiramate) (Mixed indications), 2012 Bromley (Topiramate), 2016 Richards (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2019 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 61.31[0.71; 2.44]164,793771not evaluable Cognitive developmental disorders/delay (3-6 years old) Rihtman (Topiramate) (Mixed indications), 2012 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 Madley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 42.65[1.33; 5.28]4,6551,111not evaluable Language disorders/delay Rihtman (Topiramate) (Mixed indications), 2012 Bromley (Topiramate), 2016 Husebye (Topiramate) (Controls unexposed, sick), 2020 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Meador (Topiramate) (Controls unexposed, disease free), 2021 51.52[1.10; 2.10]72,088522not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 Madley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 32.03[1.04; 3.96]4,6551,102not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 31.25[0.50; 3.10]152,952708not evaluable Cognitive developmental disorders/delay (> 6 years old) Bromley (Topiramate), 2016 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 32.31[1.34; 3.98]24,525581not evaluable Neuro-developmental disorders (as a whole) Arkilo (Topiramate), 2015 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 31.49[0.94; 2.35]10,474950not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 22.33[1.31; 4.14]24,519554not evaluable ADHD (Attention deficit hyperactivity disorder): Risk Rihtman (Topiramate) (Mixed indications), 2012 Bromley (Topiramate), 2016 Richards (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2019 31.41[0.46; 4.32]11,84163not evaluable ASD (Autism spectrum disorder): Risk Wood (Topiramate), 2015 Bjørk (Topiramate) (Controls unexposed, sick), 2018 22.65[0.36; 19.38]287not evaluable Psychomotor developmental disorders/delay Rihtman (Topiramate) (Mixed indications), 2012 Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022 21.45[0.19; 11.17]-15not evaluable Cognitive developmental disorders/delay (< 3 years old) Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022 11.05[0.24; 4.62]-6not evaluable0.0100.01.0

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