Sertraline

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations Congenital heart defects Louik, 2007 Oberlander, 2008 Merlob, 2009 Reis (Controls unexposed, NOS), 2010 Colvin, 2011 Nordeng (Controls unexposed, sick), 2012 Ban (Controls unexposed, sick), 2014 Huybrechts (Controls unexposed, sick), 2014 Bérard (Controls unexposed, sick), 2015 Wemakor, 2015 Furu, 2015 Anderson, 2020 Chan (Controls unexposed, pop general), 2024 131.15[1.01; 1.31]55,99224,718critical All congenital malformations (majors, minors, majors and minors, or unspecified) Oberlander, 2008 Einarson, 2009 Reis (Controls unexposed, NOS), 2010 Colvin, 2011 Nordeng (Controls unexposed, sick), 2012 Ban (Controls unexposed, sick), 2014 Bérard (Controls unexposed, sick), 2015 Furu, 2015 Ozturk (Sertraline), 2016 Anderson, 2020 Chan (Controls unexposed, pop general), 2024 111.07[0.98; 1.16]135,15814,154low Major congenital malformations Oberlander, 2008 Einarson, 2009 Reis (Controls unexposed, NOS), 2010 Colvin, 2011 Nordeng (Controls unexposed, sick), 2012 Ban (Controls unexposed, sick), 2014 Bérard (Controls unexposed, sick), 2015 Furu, 2015 Ozturk (Sertraline), 2016 Anderson, 2020 Chan (Controls unexposed, pop general), 2024 111.07[0.98; 1.17]134,38414,154low Limb defects Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Ban (Controls unexposed, sick), 2014 Bérard (Controls unexposed, sick), 2015 Anderson, 2020 60.92[0.70; 1.21]1,7813,717not evaluable Digestive system anomalies Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Ban (Controls unexposed, disease free), 2014 Bérard (Controls unexposed, sick), 2015 Wemakor, 2015 61.16[0.71; 1.88]3,7663,732not evaluable Cleft palate Louik, 2007 Malm, 2011 Bérard (Controls unexposed, sick), 2015 Anderson, 2020 40.83[0.51; 1.35]4031,281not evaluable Craniosynostosis Louik, 2007 Malm, 2011 Bérard (Controls unexposed, sick), 2015 Wemakor, 2015 Furu, 2015 Anderson, 2020 61.88[1.41; 2.51]1,7058,542not evaluable Respiratory system anomalies Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Bérard (Controls unexposed, sick), 2015 Wemakor, 2015 62.30[1.22; 4.35]1,3353,733serious Ventricular septal defect Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Huybrechts (Controls unexposed, sick), 2014 Wemakor, 2015 Anderson, 2020 50.87[0.68; 1.12]12,45612,771not evaluable Cardiac septal defects Louik, 2007 Wemakor, 2015 Furu, 2015 Bérard (Controls unexposed, sick), 2015 Anderson, 2020 51.18[0.99; 1.41]27,1467,693not evaluable Genital anomalies Jimenez-Solem (Controls unexposed, sick), 2012 Ban (Controls unexposed, sick), 2014 Bérard (Controls unexposed, sick), 2015 30.68[0.29; 1.61]2251,940not evaluable Hypospadias Louik, 2007 Reis (Controls unexposed, NOS), 2010 Furu, 2015 Wemakor, 2015 Anderson, 2020 51.07[0.80; 1.42]8,07910,607not evaluable Nervous system anomalies Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Bérard (Controls unexposed, sick), 2015 51.39[0.83; 2.32]8583,717not evaluable Urinary malformations Louik, 2007 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Bérard (Controls unexposed, sick), 2015 41.07[0.57; 2.01]3,9291,992not evaluable Atrial septal defect Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Wemakor, 2015 Anderson, 2020 41.31[0.93; 1.83]3,9861,705not evaluable Cleft lip with or without cleft palate Louik, 2007 Malm, 2011 Anderson, 2020 30.80[0.55; 1.18]704918not evaluable Omphalocele Louik, 2007 Bérard (Controls unexposed, sick), 2015 Anderson, 2020 32.07[0.59; 7.21]142415not evaluable Oro-facial clefts Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Anderson, 2020 30.79[0.56; 1.11]4291,574not evaluable Ano-rectal atresia and stenosis Louik, 2007 Furu, 2015 Wemakor, 2015 Anderson, 2020 41.89[0.98; 3.65]1,3947,308not evaluable Club foot / Talipes equinovarus Louik, 2007 Yazdy, 2014 Furu, 2015 Wemakor, 2015 41.90[1.35; 2.67]6,2227,354not evaluable Ear, face and neck anomalies Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015 41.58[0.44; 5.66]1,0442,496not evaluable Eye defects Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015 40.84[0.24; 2.90]1,2152,496not evaluable Neural Tube Defects Louik, 2007 Malm, 2011 Wemakor, 2015 Anderson, 2020 40.85[0.54; 1.36]1,642931not evaluable Atrioventricular septal defect Furu, 2015 Wemakor, 2015 Anderson, 2020 31.62[0.91; 2.88]1,3697,260not evaluable Chromosomal abnormalities Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 31.77[0.77; 4.04]7492,482not evaluable Diaphragmatic hernia Louik, 2007 Anderson, 2020 21.20[0.66; 2.19]19247not evaluable Transposition of the great vessels Malm, 2011 Wemakor, 2015 Anderson, 2020 31.26[0.70; 2.28]854884not evaluable Abdominal wall defects Ban (Controls unexposed, disease free), 2014 14.90[0.67; 35.92]69757not evaluable Coarctation of aorta Wemakor, 2015 Anderson, 2020 21.29[0.15; 11.40]57016not evaluable Eye, ear, face and neck malformations Bérard (Controls unexposed, sick), 2015 10.46[0.06; 3.42]87366not evaluable Gastroschisis Given, 2017 Anderson, 2020 21.94[0.49; 7.62]-68not evaluable Hydrocephaly Anderson, 2020 11.10[0.48; 2.52]--not evaluable Hypoplastic left heart (HLH/HLHS) Wemakor, 2015 Anderson, 2020 21.69[0.93; 3.04]39814not evaluable Limb reduction defects (LRD) Louik, 2007 Wemakor, 2015 23.01[0.95; 9.47]97763not evaluable Microcephaly / Small head circumference for gestational age Kivistö, 2016 Kerr, 2018 21.14[0.38; 3.39]1,757142not evaluable Pulmonary valve stenosis Wemakor, 2015 Anderson, 2020 21.81[1.22; 2.68]77215not evaluable Spina bifida Anderson, 2020 10.69[0.35; 1.36]--not evaluable Tetralogy of Fallot Wemakor, 2015 Anderson, 2020 21.80[1.14; 2.84]42815not evaluable Anotia Anderson, 2020 10.75[0.27; 2.06]--not evaluable Aortic valve atresia/stenosis 0----- Congenital cataract Anderson, 2020 11.14[0.46; 2.83]--not evaluable Congenital glaucoma Anderson, 2020 12.79[1.12; 6.97]--not evaluable Congenital hydronephrosis 0----- Duodenal atresia or stenosis Anderson, 2020 11.63[0.59; 4.48]--not evaluable Ebstein's anomaly Wemakor, 2015 116.42[2.10; 128.38]9315not evaluable Encephalocele 0----- Hip dislocation and/or dysplasia 0----- Hirschsprung's disease 0----- Multicystic renal dysplasia Wemakor, 2015 11.02[0.06; 17.21]61814not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Anderson, 2020 11.04[0.52; 2.06]--not evaluable Patent ductus arterious 0----- Polydactyly 0----- Pulmonary valve atresia 0----- Severe congenital heart defect Wemakor, 2015 12.88[1.09; 7.61]2,93520not evaluable Syndactyly 0----- Growth parameters and prematurity Preterm (< 37 weeks) Calderon-Margalit, 2009 Colvin, 2011 Kivistö, 2016 Ozturk (Sertraline), 2016 Heinonen, 2021 Marks (Controls exposed to Bupropion), 2021 Martin, 2024 Lee (Controls unexposed, general pop), 2025 81.28[1.12; 1.45]161,05838,373not evaluable Low birth weight (< 2500g) Colvin, 2011 Kivistö, 2016 Lee (Controls unexposed, general pop), 2025 31.28[1.10; 1.50]39,8402,053not evaluable Small for gestational age (weight) Kivistö, 2016 Martin, 2024 Lee (Controls unexposed, general pop), 2025 30.99[0.75; 1.32]241,51431,047not evaluable Large for gestational age (weight) Kivistö, 2016 Lee (Controls unexposed, general pop), 2025 20.64[0.29; 1.39]11,932692not evaluable Large for gestational age (length) Kivistö, 2016 10.31[0.13; 0.72]1,472-not evaluable Large head circumference for gestational age Kivistö, 2016 10.93[0.33; 2.64]2,560-not evaluable Small for gestational age (length) Kivistö, 2016 11.68[0.68; 4.15]1,838-not evaluable Maternal consequences Caesarean Colvin, 2011 Kivistö, 2016 Lee (Controls unexposed, general pop), 2025 31.10[1.00; 1.21]146,3132,032not evaluable Postpartum hemorrhage Colvin, 2011 Palmsten b, 2013 Lee (Controls unexposed, general pop), 2025 31.25[1.12; 1.40]30,4576,509not evaluable Assisted deliveries (forceps, vacuum, ...) Kivistö, 2016 Lee (Controls unexposed, general pop), 2025 21.28[0.98; 1.68]47,693692not evaluable Preeclampsia De Vera, 2012 Palmsten (Controls unexposed, sick), 2013 21.17[0.72; 1.90]4,8297,143not evaluable Maternal consequences (as a whole) Lee (Controls unexposed, general pop), 2025 11.45[1.20; 1.75]311,586643not evaluable Gestational diabetes Dandjinou, 2019 11.01[0.80; 1.28]20,905823not evaluable Neonatal disorders Low Apgar score (< 7) (at 5 min) Colvin, 2011 Kivistö, 2016 Marks (Controls exposed to Bupropion), 2021 Heinonen, 2021 Martin, 2024 Lee (Controls unexposed, general pop), 2025 61.53[1.06; 2.21]35,90235,433not evaluable Neonatal medical care Oberlander, 2004 Kivistö, 2016 Marks (Controls exposed to Bupropion), 2021 Cornet, 2024 Lee (Controls unexposed, general pop), 2025 51.35[0.91; 2.02]23,5517,510not evaluable Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation Levinson-Castiel, 2006 Dave, 2019 Marks (Controls unexposed, sick), 2021 Heinonen, 2021 43.43[0.81; 14.60]6624,691not evaluable Low Apgar score (< 7) (at 1 min) Kivistö, 2016 Lee (Controls unexposed, general pop), 2025 21.35[0.93; 1.96]16,353692not evaluable Neonatal death (< 28 days of life) Lee (Controls unexposed, general pop), 2025 10.57[0.04; 9.20]627643not evaluable Persistent pulmonary hypertension Chambers, 2006 Kieler, 2012 Marks (Controls exposed to Bupropion), 2021 32.75[1.45; 5.23]2,3254,505not evaluable Neonatal disorders (as a whole) Lee (Controls unexposed, general pop), 2025 12.01[1.71; 2.36]161,729643not evaluable Fetal distress Colvin, 2011 11.18[1.02; 1.37]12,8831,340not evaluable Jaundice / Icterus Marks (Controls exposed to Bupropion), 2021 10.87[0.64; 1.18]2911,653not evaluable Low Apgar score (< 7) (at 10 min) Heinonen, 2021 10.33[0.01; 21.64]-8not evaluable Neonatal tachypnea Marks (Controls exposed to Bupropion), 2021 11.23[0.84; 1.80]2071,653not evaluable Long term consequences Child/Infant death (> 28 days of life) Colvin, 2012 Lee (Controls unexposed, general pop), 2025 21.47[0.97; 2.24]1,210643not evaluable Intrauterine deaths Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Yaris, 2005 Nakhai-Pour, 2010 Andersen, 2014 Ozturk (Sertraline), 2016 Kitchin, 2022 51.43[1.32; 1.55]162,4204,608not evaluable Intrauterine deaths (as a whole or unspecified) Colvin, 2011 Sjaarda, 2020 21.10[0.91; 1.33]24,7171,189not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths Colvin, 2011 11.48[0.85; 2.58]6251,361not evaluable Ectopic pregnancy Colvin, 2011 11.13[0.62; 2.05]1,4991,167not evaluable Elective/induced termination of pregnancy Ozturk (Sertraline), 2016 12.19[0.46; 10.45]1619not evaluable Neuro-developmental disorders ASD (Autism spectrum disorder): Diagnosis Bérard, 2016 Brown, 2017 Viktorin (Controls unexposed, sick), 2017 Rai (Controls unexposed, sick), 2017 Suarez (Controls unexposed, discontinuers), 2022 Heuvelman, 2023 61.25[1.03; 1.51]1,78659,686not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Bérard, 2016 Brown, 2017 Viktorin (Controls unexposed, sick), 2017 Rai (Controls unexposed, sick), 2017 Suarez (Controls unexposed, discontinuers), 2022 Heuvelman, 2023 61.25[1.03; 1.51]1,78659,686not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Suarez (Controls unexposed, discontinuers), 2022 Heuvelman, 2023 21.05[0.91; 1.21]1,86757,810not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Suarez (Controls unexposed, discontinuers), 2022 Heuvelman, 2023 21.05[0.91; 1.21]1,86757,810not evaluable Cognitive developmental disorders/delay (3-6 years old) Suarez (Controls unexposed, discontinuers), 2022 11.35[0.70; 2.59]7632,988not evaluable Language disorders/delay Suarez (Controls unexposed, discontinuers), 2022 11.16[0.98; 1.37]2,17455,722not evaluable Learning disorders Suarez (Controls unexposed, discontinuers), 2022 10.79[0.50; 1.25]14955,722not evaluable Neuro-developmental disorders (as a whole) Suarez (Controls unexposed, discontinuers), 2022 11.10[0.98; 1.23]4,39055,722not evaluable Psychomotor developmental disorders/delay Suarez (Controls unexposed, discontinuers), 2022 11.11[0.74; 1.67]28255,722not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Suarez (Controls unexposed, discontinuers), 2022 11.35[0.70; 2.59]7632,988not evaluable Cognitive developmental disorders/delay (> 6 years old) Heuvelman, 2023 10.61[0.23; 1.60]-2,088not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Heuvelman, 2023 10.61[0.23; 1.60]-2,088not evaluable0.0100.01.0

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