Levetiracetam (Epilepsy)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Morrow (Levetiracetam) (Controls unexposed, sick), 2006 Hernández-Díaz (Levetiracetam) (Controls unexposed, disease free), 2012 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Alsaadi (Controls unexposed sick), 2020 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Hosny (Levetiracetam) (Controls unexposed, sick), 2021 Mari (Levetiracetam), 2022 Cohen (Levetiracetam) (Epilepsy) (Controls unexposed, NOS), 2023 Battino, 2024 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 Wiggs, 2024 Vajda b (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2024 Hoeltzenbein (Levetiracetam), 2024 Hao (Controls unexposed, sick), 2025 160.93[0.75; 1.15]148,3414,151low Major congenital malformations Morrow (Levetiracetam) (Controls unexposed, sick), 2006 Hernández-Díaz (Levetiracetam) (Controls unexposed, disease free), 2012 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Alsaadi (Controls unexposed sick), 2020 Hosny (Levetiracetam) (Controls unexposed, sick), 2021 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Mari (Levetiracetam), 2022 Cohen (Levetiracetam) (Epilepsy) (Controls unexposed, NOS), 2023 Wiggs, 2024 Vajda b (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2024 Hoeltzenbein (Levetiracetam), 2024 Battino, 2024 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 Hao (Controls unexposed, sick), 2025 150.91[0.73; 1.13]148,3264,141low Congenital heart defects Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Levetiracetam), 2018 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs, 2024 51.21[0.63; 2.34]401,362not evaluable Minor congenital malformations Alsaadi (Controls unexposed sick), 2020 Mari (Levetiracetam), 2022 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 32.57[0.62; 10.76]1673not evaluable Digestive system anomalies Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs, 2024 31.90[0.47; 7.61]4313not evaluable Limb defects Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs, 2024 32.43[0.92; 6.40]6313not evaluable Hypospadias Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Levetiracetam), 2018 31.28[0.27; 6.13]131,071not evaluable Nervous system anomalies Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs, 2024 21.95[0.32; 11.86]-291not evaluable Neural Tube Defects Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Levetiracetam), 2018 32.59[0.50; 13.52]51,071not evaluable Oro-facial clefts Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Levetiracetam), 2018 31.34[0.20; 9.12]121,071not evaluable Spina bifida Vajda (Levetiracetam) (Controls unexposed, sick), 2013 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 23.67[0.34; 39.26]3177not evaluable Urinary malformations Tomson (Levetiracetam), 2018 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 20.53[0.12; 2.33]16705not evaluable Microcephaly / Small head circumference for gestational age Christensen (Levetiracetam) (Epilepsy) (Controls unexposed, general population), 2024 10.86[0.58; 1.27]7301,063not evaluable Cleft lip with or without cleft palate Vajda (Levetiracetam) (Controls unexposed, sick), 2013 12.34[0.05; 119.47]-63not evaluable Polydactyly Tomson (Levetiracetam), 2018 14.20[0.08; 211.88]-599not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Artama (Levetiracetam) (Controls unexposed, sick), 2013 Arkilo (Levetiracetam), 2015 Margulis, 2019 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 Hoeltzenbein (Levetiracetam), 2024 81.50[1.19; 1.89]91,4811,145not evaluable Small for gestational age (weight) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 Christensen (Levetiracetam) (Epilepsy) (Controls unexposed, general population), 2024 51.18[0.84; 1.67]170,0271,853not evaluable Large for gestational age (weight) Artama (Levetiracetam) (Controls unexposed, sick), 2013 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 21.28[0.13; 12.96]7123not evaluable Low birth weight (< 2500g) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Christensen (Levetiracetam) (Epilepsy) (Controls unexposed, general population), 2024 21.44[0.83; 2.49]92,5711,684not evaluable Very preterm (28 to 32 weeks) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 21.10[0.20; 5.96]8,593718not evaluable Extremely preterm (< 28 weeks) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 21.01[0.19; 5.41]2,043718not evaluable Macrosomia (> 4000g) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 10.67[0.56; 0.80]577,255621not evaluable Maternal consequences Caesarean Artama (Levetiracetam) (Controls unexposed, sick), 2013 Koc (Levetiracetam), 2018 21.50[0.67; 3.41]36541not evaluable Amniotic fluid problems (polyhydramnios and/or oligohydramnios) Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Mari (Levetiracetam), 2022 21.20[0.07; 20.23]-27not evaluable Gestational diabetes Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Mari (Levetiracetam), 2022 20.37[0.04; 3.82]227not evaluable Maternal consequences (as a whole) Alsfouk (Levetiracetam), 2022 Razaz (Levetiracetam), 2024 21.27[0.93; 1.73]7101,033not evaluable Preeclampsia Aydin (Levetiracetam) (Controls unexposed, sick), 2020 12.26[0.04; 122.79]-10not evaluable Maternal death Mari (Levetiracetam), 2022 10.64[0.01; 34.59]-17not evaluable Maternal liver disorder / failure during pregnancy Mari (Levetiracetam), 2022 10.64[0.01; 34.59]-17not evaluable Neonatal disorders Neonatal medical care Artama (Levetiracetam) (Controls unexposed, sick), 2013 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 31.50[0.63; 3.59]17092not evaluable Neonatal disorders (as a whole) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 21.06[0.85; 1.33]222,315691not evaluable Low Apgar score (< 7) (at 1 min) Artama (Levetiracetam) (Controls unexposed, sick), 2013 11.59[0.19; 13.19]7012not evaluable Low Apgar score (< 7) (at 5 min) Artama (Levetiracetam) (Controls unexposed, sick), 2013 18.06[0.39; 165.09]312not evaluable Long term consequences Child/Infant death (> 28 days of life) Artama (Levetiracetam) (Controls unexposed, sick), 2013 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 22.96[0.53; 16.41]4,703634not evaluable Intrauterine deaths Intrauterine deaths (as a whole or unspecified) Arkilo (Levetiracetam), 2015 Tomson (Levetiracetam), 2015 Koc (Levetiracetam), 2018 Trivedi (Levetiracetam) (Controls unexposed, sick), 2018 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Vajda a (Levetiracetam) (Controls unexposed sick), 2024 61.15[0.78; 1.69]201710not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths Arkilo (Levetiracetam), 2015 Tomson (Levetiracetam), 2015 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 AlSheikh (Levetiracetam) (Controls unexposed, sick), 2020 Mari (Levetiracetam), 2022 Hoeltzenbein (Levetiracetam), 2024 61.80[0.52; 6.28]11592not evaluable Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Babic (Levetiracetam), 2014 Arkilo (Levetiracetam), 2015 Tomson (Levetiracetam), 2015 Alsaadi (Controls unexposed sick), 2020 Hoeltzenbein (Levetiracetam), 2024 51.11[0.77; 1.60]220606not evaluable Elective/induced termination of pregnancy Hosny (Levetiracetam) (Controls unexposed, sick), 2021 Mari (Levetiracetam), 2022 Hoeltzenbein (Levetiracetam), 2024 30.88[0.25; 3.08]13305not evaluable Perinatal death Artama (Levetiracetam) (Controls unexposed, sick), 2013 Tomson (Levetiracetam), 2015 22.47[0.31; 19.60]13309not evaluable Neuro-developmental disorders Language disorders/delay Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Bromley (Levetiracetam), 2016 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Husebye (Levetiracetam) (Controls unexposed, sick), 2020 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 Meador (Controls unexposed, disease free), 2023 Stjerna (Levetiracetam) (Epilepsy), 2024 Bhaskaran, 2025 90.90[0.69; 1.15]72,094877not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Bjørk (Levetiracetam) (Controls unexposed, sick), 2018 Huber-Mollema (Levetiracetam), 2019 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 61.36[0.78; 2.37]5,1532,454not evaluable ASD (Autism spectrum disorder): Diagnosis Huber-Mollema (Levetiracetam), 2019 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 51.10[0.70; 1.71]5,1222,442not evaluable Cognitive developmental disorders/delay (< 3 years old) Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Thomas (Controls unexposed, sick), 2022 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 50.97[0.41; 2.30]23189not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Bromley (Levetiracetam), 2016 Huber-Mollema (Levetiracetam), 2019 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 51.17[0.82; 1.68]1,6951,863not evaluable Psychomotor developmental disorders/delay Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Thomas (Controls unexposed, sick), 2022 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 40.76[0.29; 2.00]9171not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Huber-Mollema (Levetiracetam), 2019 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 41.27[0.82; 1.97]1,6951,821not evaluable Neuro-developmental disorders (as a whole) Arkilo (Levetiracetam), 2015 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bjørk (Levetiracetam) (Controls unexposed, sick), 2022 31.08[0.65; 1.80]10,4701,636not evaluable Cognitive developmental disorders/delay (3-6 years old) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 30.85[0.33; 2.16]3,5971,351not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 30.85[0.33; 2.16]3,5971,351not evaluable ASD (Autism spectrum disorder): Risk Bjørk (Levetiracetam) (Controls unexposed, sick), 2018 Huber-Mollema (Levetiracetam), 2019 22.39[0.45; 12.72]3640not evaluable ADHD (Attention deficit hyperactivity disorder): Risk Bromley (Levetiracetam), 2016 Huber-Mollema (Levetiracetam), 2019 20.91[0.47; 1.79]770not evaluable Cognitive developmental disorders/delay (> 6 years old) Stjerna (Levetiracetam) (Epilepsy), 2024 11.23[0.46; 3.29]-16not evaluable0.0100.01.0

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