Levetiracetam (All indications)

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 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 Alsaadi (Levetiracetam) (Epilepsy) (Controls unexposed sick), 2020 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Hosny (Levetiracetam) (Controls unexposed, sick), 2021 Mari (Levetiracetam), 2022 The NAAED (Levetiracetam) (Controls unexposed, disease free) (Indications NOS), 2023 Cohen (Levetiracetam) (Epilepsy) (Controls unexposed, NOS), 2023 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 Wiggs (Epilepsy) (Levetiracetam), 2024 Vajda b (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2024 Hoeltzenbein (Levetiracetam), 2024 Battino (Levetiracetam) (Epilepsy), 2024 Hao (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2025 160.96[0.78; 1.19]148,3664,984low Major congenital malformations Morrow (Levetiracetam) (Controls unexposed, sick), 2006 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Alsaadi (Levetiracetam) (Epilepsy) (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 The NAAED (Levetiracetam) (Controls unexposed, disease free) (Indications NOS), 2023 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 Wiggs (Epilepsy) (Levetiracetam), 2024 Vajda b (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2024 Hoeltzenbein (Levetiracetam), 2024 Battino (Levetiracetam) (Epilepsy), 2024 Hao (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2025 150.94[0.76; 1.16]148,3514,974low Congenital heart defects Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Epilepsy), 2012 Tomson (Levetiracetam), 2018 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs (Epilepsy) (Levetiracetam), 2024 51.21[0.63; 2.34]401,362not evaluable Minor congenital malformations Alsaadi (Levetiracetam) (Epilepsy) (Controls unexposed sick), 2020 Mari (Levetiracetam), 2022 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 32.57[0.62; 10.76]1673not evaluable Hypospadias Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Epilepsy), 2012 Tomson (Levetiracetam), 2018 Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 41.01[0.26; 3.95]3,3841,650not evaluable Oro-facial clefts Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Epilepsy), 2012 Tomson (Levetiracetam), 2018 Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 41.24[0.37; 4.19]2,8281,650not evaluable Spina bifida Vajda (Levetiracetam) (Controls unexposed, sick), 2013 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 33.19[0.53; 19.33]619756not evaluable Digestive system anomalies Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs (Epilepsy) (Levetiracetam), 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 (Epilepsy) (Levetiracetam), 2024 32.43[0.92; 6.40]6313not evaluable Microcephaly / Small head circumference for gestational age Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 Christensen (Levetiracetam) (All indications) (Controls unexposed, general population), 2024 20.91[0.63; 1.33]134,4931,656not evaluable Cleft lip with or without cleft palate Vajda (Levetiracetam) (Controls unexposed, sick), 2013 Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 22.09[0.28; 15.72]1,638642not evaluable Nervous system anomalies Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs (Epilepsy) (Levetiracetam), 2024 21.95[0.32; 11.86]-291not evaluable Neural Tube Defects Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Epilepsy), 2012 Tomson (Levetiracetam), 2018 32.59[0.50; 13.52]51,071not evaluable Urinary malformations Tomson (Levetiracetam), 2018 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 20.53[0.12; 2.33]16705not evaluable Ano-rectal atresia and stenosis Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 12.98[0.19; 47.71]544579not evaluable Atrial septal defect Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 10.99[0.14; 7.05]3,269579not evaluable Atrioventricular septal defect Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 13.06[0.19; 49.06]529579not evaluable Bilateral renal agenesis including Potter syndrome Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 121.47[1.33; 346.88]75579not evaluable Bladder exstrophy and/or epispadia Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 119.65[1.22; 317.20]82579not evaluable Cleft palate Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 11.37[0.09; 22.02]1,178579not evaluable Club foot / Talipes equinovarus Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 11.93[0.27; 13.76]1,678579not evaluable Coarctation of aorta Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 14.20[0.27; 64.25]780579not evaluable Craniosynostosis Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 14.20[0.27; 64.79]767579not evaluable Diaphragmatic hernia Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 14.28[0.27; 68.68]378579not evaluable Ebstein's anomaly Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 132.10[1.98; 520.95]50579not evaluable Gastroschisis Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 16.66[0.41; 106.87]243579not evaluable Hypoplastic left heart (HLH/HLHS) Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 115.10[1.03; 220.38]217579not evaluable Hypoplastic right heart (HRH/HRHS) Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 124.38[1.51; 394.31]66579not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 14.13[0.26; 66.22]392579not evaluable Omphalocele Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 16.08[0.38; 97.62]266579not evaluable Pulmonary valve atresia Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 110.63[0.66; 170.93]152579not evaluable Tetralogy of Fallot Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 12.77[0.17; 44.44]584579not evaluable Ventricular septal defect Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019 10.70[0.10; 4.96]4,644579not 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 Kilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 Arkilo (Levetiracetam), 2015 Bank (Levetiracetam) (Mixed indications), 2017 Margulis (Levetiracetam) (Epilepsy), 2019 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Hoeltzenbein (Levetiracetam), 2024 101.48[1.17; 1.86]91,8661,178low Small for gestational age (weight) Bank (Levetiracetam) (Mixed indications), 2017 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Christensen (Levetiracetam) (All indications) (Controls unexposed, general population), 2024 61.19[0.86; 1.64]613,8821,874not 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) (All indications) (Controls unexposed, general population), 2024 21.46[0.87; 2.44]233,0071,698not 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) (Epilepsy), 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 Bank (Levetiracetam) (Mixed indications), 2017 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 41.40[0.62; 3.15]17799not evaluable Low Apgar score (< 7) (at 1 min) Artama (Levetiracetam) (Controls unexposed, sick), 2013 Bank (Levetiracetam) (Mixed indications), 2017 22.01[0.39; 10.26]7319not evaluable Low Apgar score (< 7) (at 5 min) Artama (Levetiracetam) (Controls unexposed, sick), 2013 Bank (Levetiracetam) (Mixed indications), 2017 27.00[0.63; 78.08]319not evaluable Neonatal disorders (as a whole) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 21.06[0.85; 1.33]222,315691not 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) Tomson (Levetiracetam), 2015 Arkilo (Levetiracetam), 2015 Trivedi (Levetiracetam) (Controls unexposed, sick), 2018 Koc (Levetiracetam), 2018 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Vajda a (Levetiracetam) (Controls unexposed sick) (Epilepsy), 2024 61.15[0.78; 1.69]201710not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths Tomson (Levetiracetam), 2015 Arkilo (Levetiracetam), 2015 AlSheikh (Levetiracetam) (Controls unexposed, sick), 2020 Aydin (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 (Levetiracetam) (Epilepsy) (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) (Epilepsy) (Controls unexposed, sick), 2023 Meador (Controls unexposed, disease free), 2023 Stjerna (Levetiracetam) (Epilepsy), 2024 Bhaskaran (Levetiracetam) (Epilepsy), 2025 90.90[0.69; 1.15]72,094877not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Bjørk (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2018 Bjørk (Levetiracetam) (Controls unexposed, sick), 2018 Huber-Mollema (Levetiracetam), 2019 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bjørk (Levetiracetam) (Controls unexposed NOS), 2022 Bjørk (Levetiracetam) (Controls unexposed, sick), 2022 Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 81.43[0.95; 2.15]119,4993,502not evaluable ASD (Autism spectrum disorder): Diagnosis Huber-Mollema (Levetiracetam), 2019 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bjørk (Levetiracetam) (Controls unexposed, sick), 2022 Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 51.09[0.71; 1.67]81,0072,461not 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) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 51.19[0.84; 1.70]152,9541,939not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Huber-Mollema (Levetiracetam), 2019 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 41.30[0.87; 1.96]152,9541,897not evaluable Cognitive developmental disorders/delay (< 3 years old) Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 50.97[0.41; 2.30]23189not evaluable Cognitive developmental disorders/delay (3-6 years old) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 30.71[0.28; 1.80]28,8321,427not evaluable Psychomotor developmental disorders/delay Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 40.76[0.29; 2.00]9171not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 30.71[0.28; 1.80]28,8321,427not 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 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) Bromley (Levetiracetam), 2016 Stjerna (Levetiracetam) (Epilepsy), 2024 21.50[0.66; 3.40]858not evaluable0.0100.01.0

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