Topiramate (Epilepsy)

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 Hernández-Díaz (Topiramate), 2012 Veiby (Topiramate) (Controls unexposed, sick), 2014 Meador (Topiramate) (Controls unexposed, sick), 2020 Thomas (Topiramate) (Controls unexposed, sick), 2021 Battino, 2024 Vajda b (Topiramate) (Epilepsy) (Controls unexposed, sick), 2024 Hao (Controls unexposed, sick), 2025 102.07[1.42; 3.04]284408low Major congenital malformations Morrow (Topiramate) (Controls unexposed, sick), 2006 Ornoy (Topiramate), 2008 Mawer (Topiramate) (Controls unexposed, sick), 2010 Hernández-Díaz (Topiramate), 2012 Veiby (Topiramate) (Controls unexposed, sick), 2014 Meador (Topiramate) (Controls unexposed, sick), 2020 Thomas (Topiramate) (Controls unexposed, sick), 2021 Battino, 2024 Vajda b (Topiramate) (Epilepsy) (Controls unexposed, sick), 2024 Hao (Controls unexposed, sick), 2025 102.07[1.42; 3.04]284408low Congenital heart defects Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Vajda (Topiramate) (Controls unexposed, sick), 2013 Tomson (Topiramate), 2018 Thomas (Topiramate) (Controls unexposed, sick), 2021 42.75[0.99; 7.59]32233not 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 Neural Tube Defects Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Vajda (Topiramate) (Controls unexposed, sick), 2013 Tomson (Topiramate), 2018 35.56[0.78; 39.78]2224not 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 Hypospadias Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Topiramate), 2018 23.30[0.73; 14.97]14180not evaluable Microcephaly / Small head circumference for gestational age Christensen (Topiramate) (Epilepsy) (Controls unexposed, general population), 2024 11.30[0.70; 2.40]710290not evaluable Nervous system anomalies Thomas (Topiramate) (Controls unexposed, sick), 2021 139.94[0.75; 2134.65]-9not evaluable Oro-facial clefts Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Topiramate), 2018 27.95[0.83; 76.53]5180not evaluable Spina bifida Veiby (Topiramate) (Controls unexposed, sick), 2014 112.67[0.64; 249.11]343not evaluable Cleft lip with or without cleft palate Vajda (Topiramate) (Controls unexposed, sick), 2013 13.37[0.07; 172.23]-44not evaluable Polydactyly Tomson (Topiramate), 2018 116.59[0.33; 839.05]-152not evaluable Growth parameters and prematurity Small for gestational age (weight) Hernández-Díaz (Topiramate), 2017 Cohen (Topiramate) (Controls unexposed NOS), 2019 Christensen (Topiramate) (Epilepsy) (Controls unexposed, general population), 2024 31.95[1.40; 2.71]44,113684not evaluable Preterm (< 37 weeks) Arkilo (Topiramate), 2015 Cohen (Topiramate) (Controls unexposed NOS), 2019 20.75[0.49; 1.16]160,5982not evaluable Low birth weight (< 2500g) Christensen (Topiramate) (Epilepsy) (Controls unexposed, general population), 2024 11.66[1.05; 2.62]1,027290not evaluable Maternal consequences Abruptio placentae (retroplacental hematoma) Cohen (Topiramate) (Controls unexposed NOS), 2019 10.82[0.21; 3.18]20,260-not evaluable Preeclampsia Cohen (Topiramate) (Controls unexposed NOS), 2019 11.23[0.63; 2.41]53,625-not evaluable Maternal consequences (as a whole) Razaz (Topiramate), 2024 11.21[0.64; 2.30]666249not 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), 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 unexposed, sick), 2018 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Hernandez-Diaz, 2024 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024 61.54[0.85; 2.78]9521,034not evaluable ASD (Autism spectrum disorder): Diagnosis Wood (Topiramate), 2015 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024 Hernandez-Diaz, 2024 51.52[0.77; 3.00]9241,028not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Bromley (Topiramate), 2016 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024 41.51[0.89; 2.59]1,502431not evaluable Language disorders/delay Bromley (Topiramate), 2016 Husebye (Topiramate) (Controls unexposed, sick), 2020 Meador (Topiramate) (Controls unexposed, disease free), 2021 31.76[0.63; 4.86]4336not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024 31.82[1.03; 3.23]1,502404not evaluable Cognitive developmental disorders/delay (> 6 years old) Bromley (Topiramate), 2016 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024 33.32[1.70; 6.47]394388not evaluable ASD (Autism spectrum disorder): Risk Wood (Topiramate), 2015 Bjørk (Topiramate) (Controls unexposed, sick), 2018 22.65[0.36; 19.38]287not evaluable Neuro-developmental disorders (as a whole) Arkilo (Topiramate), 2015 Bjørk (Topiramate) (Controls unexposed, sick), 2022 22.15[1.15; 4.01]455248not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024 23.57[1.42; 9.01]388361not evaluable Cognitive developmental disorders/delay (< 3 years old) Thomas b (Controls unexposed, sick), 2022 11.05[0.24; 4.62]-6not evaluable Cognitive developmental disorders/delay (3-6 years old) Bjørk (Topiramate) (Controls unexposed, sick), 2022 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024 23.48[1.46; 8.27]143289not evaluable Psychomotor developmental disorders/delay Thomas b (Controls unexposed, sick), 2022 10.51[0.11; 2.32]-6not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Bjørk (Topiramate) (Controls unexposed, sick), 2022 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024 23.48[1.46; 8.27]143289not evaluable ADHD (Attention deficit hyperactivity disorder): Risk Bromley (Topiramate), 2016 11.00[0.43; 2.32]-27not evaluable0.0100.01.0

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