Selective Serotonin Reuptake Inhibitor (SSRI)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Pastuszak - Fluoxetine (Controls unexposed, NOS), 1993 Chambers - Fluoxetine, 1996 Nulman - Fluoxetine (Controls unexposed, NOS), 1997 Kulin, 1998 Heikkinen - Citalopram only, 2002 Sivojelezova - Citalopram, 2005 Vial - Paroxetine, 2006 Davis, 2007 Oberlander a, 2008 Diav-Citrin - Fluoxetine or Paroxetine, 2008 Davidson, 2009 Einarson, 2009 Reis (Controls unexposed, NOS), 2010 Manakova, 2011 Colvin, 2011 Nordeng (Controls unexposed, sick), 2012 Klieger-Grossmann - Escitalopram, 2012 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Ban (Controls unexposed, sick), 2014 Furu (Controls unexposed, NOS), 2015 Ozturk - Escitalopram, 2016 Bérard b (Controls unexposed, sick), 2017 Richardson, 2019 Anderson, 2020 Benevent, 2023 Chan (Controls unexposed, sick), 2024 261.10[1.06; 1.14]125,53372,492low Major congenital malformations Pastuszak - Fluoxetine (Controls unexposed, NOS), 1993 Chambers - Fluoxetine, 1996 Nulman - Fluoxetine (Controls unexposed, NOS), 1997 Kulin, 1998 Sivojelezova - Citalopram, 2005 Vial - Paroxetine, 2006 Oberlander a, 2008 Diav-Citrin - Fluoxetine or Paroxetine, 2008 Einarson, 2009 Reis (Controls unexposed, NOS), 2010 Manakova, 2011 Colvin, 2011 Klieger-Grossmann - Escitalopram, 2012 Nordeng (Controls unexposed, sick), 2012 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Ban (Controls unexposed, sick), 2014 Furu (Controls unexposed, NOS), 2015 Ozturk - Escitalopram, 2016 Bérard b (Controls unexposed, sick), 2017 Richardson, 2019 Anderson, 2020 Benevent, 2023 Chan (Controls unexposed, sick), 2024 231.10[1.06; 1.15]117,85071,656low Congenital heart defects Kulin, 1998 Vial - Paroxetine, 2006 Louik, 2007 Davis, 2007 Einarson - Paroxetine, 2008 Diav-Citrin - Fluoxetine or Paroxetine, 2008 Oberlander a, 2008 Merlob, 2009 Reis (Controls unexposed, NOS), 2010 Colvin, 2011 Nordeng (Controls unexposed, sick), 2012 Margulis, 2013 Huybrechts (Controls unexposed, sick), 2014 Ban (Controls unexposed, sick), 2014 Furu (Controls unexposed, NOS), 2015 Bérard - Non Sertraline SSRI, 2015 Wemakor, 2015 Anderson, 2020 Benevent, 2023 Kawai, 2023 Chan (Controls unexposed, sick), 2024 211.17[1.09; 1.25]52,054108,516low Limb defects Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 De Jonge - Paroxetine only, 2013 Ban (Controls unexposed, sick), 2014 Bérard - Non Sertraline SSRI, 2015 Anderson, 2020 Benevent, 2023 Chan (Controls unexposed, sick), 2024 90.99[0.83; 1.19]2,72626,054not evaluable Nervous system anomalies Källén, 2007 Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 De Jonge - Paroxetine only, 2013 Ban (Controls unexposed, sick), 2014 Bérard - Non Sertraline SSRI, 2015 Benevent, 2023 Chan (Controls unexposed, sick), 2024 101.09[0.88; 1.34]6,34234,434low Urinary malformations Davis, 2007 Louik, 2007 Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Ban (Controls unexposed, sick), 2014 Bérard - Non Sertraline SSRI, 2015 Benevent, 2023 Chan (Controls unexposed, sick), 2024 90.96[0.78; 1.19]5,04221,704not evaluable Ventricular septal defect Oberlander a, 2008 Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Huybrechts (Controls unexposed, sick), 2014 Louik, 2014 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015 Anderson, 2020 Chan (Controls unexposed, sick), 2024 101.04[0.90; 1.22]15,83962,197low Cardiac septal defects Davis, 2007 Louik, 2007 Reis (Controls unexposed, NOS), 2010 Margulis, 2013 Ban (Controls unexposed, disease free), 2014 Bérard - Non Sertraline SSRI, 2015 Wemakor, 2015 Furu (Controls unexposed, NOS), 2015 Anderson, 2020 Chan (Controls unexposed, sick), 2024 101.13[1.05; 1.22]28,34261,508low Respiratory system anomalies Davis, 2007 Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, sick), 2014 Bérard - Non Sertraline SSRI, 2015 Wemakor, 2015 Benevent, 2023 Chan (Controls unexposed, sick), 2024 91.13[0.76; 1.68]1,48626,784not evaluable Atrial septal defect Oberlander a, 2008 Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Louik, 2014 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015 Anderson, 2020 Chan (Controls unexposed, sick), 2024 91.43[1.17; 1.75]5,41325,338not evaluable Digestive system anomalies Davis, 2007 Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Ban (Controls unexposed, sick), 2014 Bérard - Non Sertraline SSRI, 2015 Wemakor, 2015 Benevent, 2023 81.04[0.83; 1.30]3,82026,082not evaluable Genital anomalies Davis, 2007 Colvin, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Ban (Controls unexposed, sick), 2014 Bérard - Non Sertraline SSRI, 2015 Benevent, 2023 70.84[0.66; 1.06]2,75820,813not evaluable Oro-facial clefts Källén, 2007 Davis, 2007 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, sick), 2014 Anderson, 2020 Benevent, 2023 60.95[0.79; 1.13]2,66220,879not evaluable Eye defects Källén, 2007 Davis, 2007 Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, sick), 2014 Wemakor, 2015 Benevent, 2023 71.14[0.87; 1.49]2,74723,686not evaluable Abdominal wall defects Källén, 2007 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, sick), 2014 Nishigori, 2017 Benevent, 2023 51.87[1.02; 3.43]1,58720,246not evaluable Ear, face and neck anomalies Davis, 2007 Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, sick), 2014 Wemakor, 2015 Benevent, 2023 61.03[0.64; 1.67]1,29117,127not evaluable Chromosomal abnormalities Davis, 2007 Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, sick), 2014 Benevent, 2023 51.03[0.69; 1.53]58317,025not evaluable Craniosynostosis Louik, 2007 Källén, 2007 Malm, 2011 Bérard - Non Sertraline SSRI, 2015 Wemakor, 2015 Furu (Controls unexposed, NOS), 2015 Anderson, 2020 71.59[1.17; 2.16]2,35552,532not evaluable Hypospadias Louik, 2007 Reis (Controls unexposed, NOS), 2010 Colvin, 2011 Wemakor, 2015 Furu (Controls unexposed, NOS), 2015 Anderson, 2020 61.09[0.95; 1.25]8,53149,941not evaluable Microcephaly / Small head circumference for gestational age Chambers - Fluoxetine, 1996 Davidson, 2009 Kivistö, 2016 Nishigori, 2017 Giardinelli (Controls unexposed, sick), 2018 Kerr, 2018 61.69[0.62; 4.59]1,851710not evaluable Minor congenital malformations Chambers - Fluoxetine, 1996 Manakova, 2011 22.74[1.21; 6.19]26144not evaluable Cleft palate Louik, 2007 Malm, 2011 Bérard - Non Sertraline SSRI, 2015 Anderson, 2020 40.98[0.76; 1.27]4049,106not evaluable Neural Tube Defects Källén, 2007 Louik, 2007 Malm, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Wemakor, 2015 Anderson, 2020 61.04[0.75; 1.45]2,35117,986not evaluable Omphalocele Louik, 2007 Malm, 2011 Bérard - Non Sertraline SSRI, 2015 Furu (Controls unexposed, NOS), 2015 Anderson, 2020 51.18[0.75; 1.85]42445,874not evaluable Ano-rectal atresia and stenosis Källén, 2007 Louik, 2007 Wemakor, 2015 Furu (Controls unexposed, NOS), 2015 Anderson, 2020 51.35[0.93; 1.96]1,90343,599not evaluable Atrioventricular septal defect Margulis, 2013 Louik, 2014 Furu (Controls unexposed, NOS), 2015 Wemakor, 2015 Anderson, 2020 51.34[1.03; 1.75]1,90740,230not evaluable Cleft lip with or without cleft palate Louik, 2007 Malm, 2011 Anderson, 2020 31.02[0.70; 1.50]7047,158not evaluable Club foot / Talipes equinovarus Louik, 2007 Colvin, 2011 Yazdy, 2014 Wemakor, 2015 Furu (Controls unexposed, NOS), 2015 51.77[1.36; 2.31]6,47139,873not evaluable Diaphragmatic hernia Källén, 2007 Louik, 2007 Anderson, 2020 31.29[0.92; 1.83]4406,721not evaluable Hypoplastic left heart (HLH/HLHS) Colvin, 2011 Louik, 2014 Wemakor, 2015 Anderson, 2020 41.48[1.08; 2.04]7323,101not evaluable Limb reduction defects (LRD) Källén, 2007 Louik, 2007 Wemakor, 2015 Furu (Controls unexposed, NOS), 2015 41.14[0.80; 1.62]2,69843,601not evaluable Coarctation of aorta Louik, 2014 Wemakor, 2015 Anderson, 2020 31.35[0.97; 1.88]1,041415not evaluable Eye, ear, face and neck malformations Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Bérard - Non Sertraline SSRI, 2015 20.83[0.46; 1.49]1103,788not evaluable Gastroschisis Furu (Controls unexposed, NOS), 2015 Given, 2017 Anderson, 2020 31.67[1.09; 2.55]42437,243not evaluable Hirschsprung's disease Nielsen, 2017 11.76[1.07; 2.91]60019,807not evaluable Hydrocephaly Nishigori, 2017 Anderson, 2020 23.69[0.24; 56.44]72172not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Källén, 2007 Nishigori, 2017 Anderson, 2020 32.70[0.69; 10.53]4436,727not evaluable Patent ductus arterious Colvin, 2011 13.07[1.65; 5.72]1222,701not evaluable Severe congenital heart defect Wemakor, 2015 Kolding (Controls unexposed, sick), 2021 21.46[1.01; 2.11]2,9672,894not evaluable Spina bifida Davis, 2007 Anderson, 2020 20.94[0.65; 1.36]29805not evaluable Transposition of the great vessels Malm, 2011 Wemakor, 2015 Anderson, 2020 31.13[0.79; 1.61]8557,078not evaluable Atresia or stenosis of other parts of small intestine Källén, 2007 Nishigori, 2017 27.19[0.31; 164.13]3516,727not evaluable Ebstein's anomaly Boyle, 2017 Anderson, 2020 22.08[0.32; 13.46]173238not evaluable Encephalocele Anderson, 2020 10.75[0.28; 2.03]--not evaluable Multicystic renal dysplasia Furu (Controls unexposed, NOS), 2015 Wemakor, 2015 21.83[0.71; 4.70]1,46736,883not evaluable Polydactyly Källén, 2007 11.09[0.61; 1.96]2,0566,555not evaluable Pulmonary valve stenosis Wemakor, 2015 Anderson, 2020 21.80[1.41; 2.29]772106not evaluable Tetralogy of Fallot Wemakor, 2015 Anderson, 2020 22.07[1.10; 3.90]428107not evaluable Anotia Anderson, 2020 11.21[0.73; 2.00]--not evaluable Aortic valve atresia/stenosis 0----- Arhinencephaly/holoprosencephaly Anderson, 2020 11.32[0.53; 3.28]--not evaluable Atresia of bile ducts Anderson, 2020 10.96[0.39; 2.37]--not evaluable Bilateral renal agenesis including Potter syndrome Anderson, 2020 10.75[0.28; 2.03]--not evaluable Choanal atresia Anderson, 2020 11.60[0.78; 3.30]--not evaluable Congenital cataract Anderson, 2020 10.86[0.45; 1.64]--not evaluable Congenital constriction bands/amniotic band Anderson, 2020 10.79[0.32; 1.95]--not evaluable Congenital glaucoma Anderson, 2020 11.95[0.98; 3.89]--not evaluable Congenital hydronephrosis 0----- Duodenal atresia or stenosis Anderson, 2020 11.08[0.50; 2.32]--not evaluable Ear malformations Källén, 2007 10.54[0.27; 1.07]2,1476,555not evaluable Genetic syndromes and microdeletions Jimenez-Solem (Controls unexposed, NOS), 2012 10.39[0.06; 2.65]-4,183not evaluable Hip dislocation and/or dysplasia 0----- Pulmonary valve atresia 0----- Syndactyly 0----- Total anomalous pulm venous return Anderson, 2020 11.16[0.59; 2.28]--not evaluable Tricuspid atresia and stenosis Anderson, 2020 10.97[0.35; 2.67]--not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Pastuszak - Fluoxetine (Controls unexposed, NOS), 1993 Chambers - Fluoxetine, 1996 Simon (Controls unexposed, NOS), 2002 Casper, 2003 Sivojelezova - Citalopram, 2005 Davis, 2007 Suri, 2007 Pearson (Controls unexposed, NOS), 2007 Diav-Citrin - Fluoxetine or Paroxetine, 2008 Calderon-Margalit, 2009 Wisner (Controls unexposed, sick), 2009 Toh b, 2009 Lund (Controls unexposed, sick), 2009 Reis (Controls unexposed, NOS), 2010 Roca, 2011 Mulder, 2011 Latendresse, 2011 Grzeskowiak a (Controls unexposed, sick), 2012 Colvin, 2012 El Marroun (Controls unexposed, sick), 2012 Klieger-Grossmann - Escitalopram, 2012 Nordeng (Controls unexposed, sick), 2012 de Vries, 2013 Engelstad (Controls unexposed, sick), 2014 Sahingöz (Controls unexposed, sick), 2014 Hannerfors (Controls unexposed, sick), 2015 Malm (Controls unexposed, sick), 2015 Ozturk - Escitalopram, 2016 Kivistö, 2016 Robinson-Wolrath, 2016 Cantarutti (Controls unexposed, sick), 2016 Giardinelli (Controls unexposed, sick), 2018 Ogawa, 2018 Richardson, 2019 Gungor (Controls unexposed, sick), 2019 Jaeger, 2019 Heinonen - Sertraline, 2021 Marks - Sertraline (Controls exposed to Bupropion), 2021 Chen, 2021 Rommel, 2022 Benevent, 2023 Martin - Sertraline, 2024 Lee (Controls unexposed, general pop), 2025 431.35[1.24; 1.47]237,91786,924low Low birth weight (< 2500g) Simon (Controls unexposed, NOS), 2002 Pearson (Controls exposed to TCA), 2007 Lund (Controls unexposed, sick), 2009 Calderon-Margalit, 2009 Reis (Controls unexposed, NOS), 2010 Roca, 2011 Klieger-Grossmann - Escitalopram, 2012 El Marroun (Controls unexposed, disease free), 2012 Colvin, 2012 Grzeskowiak a (Controls unexposed, sick), 2012 de Vries, 2013 Engelstad (Controls unexposed, sick), 2014 Sahingöz (Controls unexposed, sick), 2014 Kivistö, 2016 Cantarutti (Controls unexposed, sick), 2016 Norby, 2016 Ogawa, 2018 Giardinelli (Controls unexposed, sick), 2018 Gungor (Controls unexposed, sick), 2019 Levy, 2020 Rommel, 2022 Benevent, 2023 Lee (Controls unexposed, general pop), 2025 231.29[1.16; 1.43]87,49247,510low Small for gestational age (weight) Chambers - Fluoxetine, 1996 Zeskind, 2004 Calderon-Margalit, 2009 Davidson, 2009 Toh b, 2009 Reis (Controls unexposed, NOS), 2010 Roca, 2011 El Marroun (Controls unexposed, disease free), 2012 Grzeskowiak a (Controls unexposed, sick), 2012 Nordeng (Controls unexposed, sick), 2012 Hannerfors (Controls unexposed, sick), 2015 Malm (Controls unexposed, sick), 2015 Kivistö, 2016 Giardinelli (Controls unexposed, sick), 2018 Richardson, 2019 Rommel, 2022 Benevent, 2023 Gover, 2023 Martin - Sertraline, 2024 Lee (Controls unexposed, general pop), 2025 Raviv, 2025 211.18[1.02; 1.37]278,43274,962probable Large for gestational age (weight) Zeskind, 2004 Reis (Controls unexposed, NOS), 2010 Hannerfors (Controls unexposed, sick), 2015 Norby, 2016 Kivistö, 2016 Scannell, 2020 Gover, 2023 Raviv, 2025 Lee (Controls unexposed, general pop), 2025 90.90[0.74; 1.09]88,06527,083not evaluable Macrosomia (> 4000g) Pastuszak - Fluoxetine (Controls unexposed, NOS), 1993 Reis (Controls unexposed, NOS), 2010 Gungor (Controls unexposed, sick), 2019 Skalkidou (Controls unexposed, sick), 2020 40.87[0.82; 0.93]52,65413,445not evaluable Very preterm (28 to 32 weeks) Wisner (Controls unexposed, sick), 2009 Roca, 2011 Malm (Controls unexposed, sick), 2015 Norby, 2016 Rommel, 2022 Benevent, 2023 60.90[0.64; 1.25]1,29851,664not evaluable Extremely preterm (< 28 weeks) Rommel, 2022 Benevent, 2023 20.85[0.57; 1.27]24818,067not evaluable Small for gestational age (length) Davidson, 2009 Kivistö, 2016 21.63[0.41; 6.52]1,88521not evaluable Very low birth weight (< 1500g) Levy, 2020 Rommel, 2022 21.48[0.42; 5.21]916,511not evaluable Large for gestational age (length) Kivistö, 2016 10.64[0.38; 1.08]1,496-not evaluable Large head circumference for gestational age Kivistö, 2016 11.48[0.97; 2.25]2,594-not evaluable Maternal consequences Caesarean Chambers - Fluoxetine, 1996 Heikkinen - Citalopram only, 2002 Heikkinen - Fluoxetine only, 2003 Casper, 2003 Oberlander, 2004 Davidson, 2009 Roca, 2011 Mulder, 2011 Colvin, 2011 de Vries, 2013 Malm (Controls unexposed, sick), 2015 Salisbury (Controls unexposed, sick), 2016 Norby, 2016 Kivistö, 2016 Giardinelli (Controls unexposed, sick), 2018 Gungor (Controls unexposed, sick), 2019 Corti, 2019 Levy, 2020 Solé, 2020 Gover, 2023 Raviv, 2025 Lee (Controls unexposed, general pop), 2025 221.22[0.98; 1.53]174,32642,002low Preeclampsia Toh a, 2009 Palmsten (Controls unexposed, sick), 2012 De Vera, 2012 Palmsten (Controls unexposed, sick), 2013 Palmsten (control exposed to TCA), 2013 Hannerfors (Controls unexposed, sick), 2015 Avalos (Controls unexposed, sick), 2015 De Ocampo, 2016 Lupattelli (Controls unexposed, sick), 2017 Zakiyah, 2018 Bernard, 2019 Levy, 2020 Palmsten, 2020 Yang, 2021 Frayne, 2021 Tran (Controls unexposed, NOS), 2022 Benevent, 2023 171.26[1.06; 1.49]17,87752,605probable Postpartum hemorrhage Salkeld, 2008 Colvin, 2011 Palmsten b, 2013 Lupattelli (Controls unexposed, sick), 2014 Hanley, 2016 Skalkidou (Controls unexposed, sick), 2020 Palmsten, 2020 Jackson, 2024 Lee (Controls unexposed, general pop), 2025 91.24[1.14; 1.35]62,34538,238not evaluable Assisted deliveries (forceps, vacuum, ...) Roca, 2011 Kivistö, 2016 Raviv, 2025 Lee (Controls unexposed, general pop), 2025 41.24[0.81; 1.91]55,2374,228not evaluable Gestational diabetes Hannerfors (Controls unexposed, sick), 2015 Dandjinou, 2019 Levy, 2020 31.17[0.82; 1.66]20,9285,310not evaluable Abruptio placentae (retroplacental hematoma) Kivistö, 2016 10.39[0.05; 2.81]174358not evaluable Maternal consequences (as a whole) Lee (Controls unexposed, general pop), 2025 10.28[0.04; 2.02]312,1911,465not evaluable Placenta previa 0----- Amniotic fluid problems (polyhydramnios and/or oligohydramnios) Kivistö, 2016 11.23[0.94; 1.61]3,919358not evaluable Oligohydramnios Kivistö, 2016 11.06[0.77; 1.46]2,894358not evaluable Polyhydramnios Kivistö, 2016 11.60[1.05; 2.46]1,025358not evaluable Neonatal disorders Neonatal medical care Chambers - Fluoxetine, 1996 Costei - Paroxetine (Controls unexposed, sick), 2002 Casper, 2003 Suri - Fluoxetine (Controls unexposed, sick), 2004 Oberlander, 2004 Sivojelezova - Citalopram, 2005 Davis, 2007 Suri, 2007 Lennestal, 2007 Pearson (Controls unexposed, NOS), 2007 Maschi - Paroxetine, 2008 Lund (Controls unexposed, sick), 2009 Wisner (Controls unexposed, sick), 2009 Calderon-Margalit, 2009 Grzeskowiak a (Controls unexposed, sick), 2012 Klieger-Grossmann - Escitalopram, 2012 Colvin, 2012 Smith, 2013 Engelstad (Controls unexposed, sick), 2014 Malm (Controls unexposed, sick), 2015 Salisbury (Controls unexposed, sick), 2016 Robinson-Wolrath, 2016 Bracero, 2016 Norby, 2016 Kivistö, 2016 Hogue, 2017 Giardinelli (Controls unexposed, sick), 2018 Gungor (Controls unexposed, sick), 2019 Levy, 2020 Marks - Sertraline (Controls exposed to Bupropion), 2021 Ulbrich, 2021 Rommel, 2022 Gover, 2023 Cornet - SSRIs, 2024 Lee (Controls unexposed, general pop), 2025 Raviv, 2025 361.84[1.63; 2.07]106,97961,231critical Low Apgar score (< 7) (at 5 min) Simon (Controls unexposed, NOS), 2002 Lennestal, 2007 Calderon-Margalit, 2009 Lund (Controls unexposed, sick), 2009 Wisner (Controls unexposed, sick), 2009 Roca, 2011 Colvin, 2012 Jensen b, 2013 Malm (Controls unexposed, sick), 2015 Bakaysa, 2016 Kivistö, 2016 Hogue, 2017 Giardinelli (Controls unexposed, sick), 2018 Levy, 2020 Heinonen - Sertraline, 2021 Marks - Sertraline (Controls exposed to Bupropion), 2021 Lyn, 2023 Martin - Sertraline, 2024 Lee (Controls unexposed, general pop), 2025 191.90[1.58; 2.29]36,57160,446low Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation Chambers - Fluoxetine, 1996 Levinson-Castiel, 2006 Colvin, 2012 Engelstad (Controls unexposed, sick), 2014 Bracero, 2016 Yang (Controls unexposed, sick), 2017 Dave, 2019 Bhatt-Mehta, 2019 Edelson, 2020 Marks - Sertraline (Controls unexposed, sick), 2021 Heinonen - Sertraline, 2021 Morimoto, 2021 Rommel, 2022 Isohata, 2025 143.50[2.15; 5.69]92241,135low Persistent pulmonary hypertension Chambers, 2006 Andrade, 2009 Wichman, 2009 Reis (Controls unexposed, NOS), 2010 Wilson, 2011 Kieler, 2012 Huybrechts (Controls unexposed, sick), 2015 Norby, 2016 Bérard a, 2017 Levy, 2020 Marks - Sertraline (Controls exposed to Bupropion), 2021 Gover, 2023 Cornet - SSRIs, 2024 131.73[1.26; 2.37]7,523111,458probable Low Apgar score (< 7) (at 1 min) Wisner (Controls unexposed, sick), 2009 Bakaysa, 2016 Kivistö, 2016 Hogue, 2017 Lyn, 2023 Lee (Controls unexposed, general pop), 2025 61.84[1.38; 2.46]16,5492,230not evaluable Neonatal disorders (as a whole) Costei - Paroxetine (Controls unexposed, sick), 2002 Sivojelezova - Citalopram, 2005 Maschi - Paroxetine, 2008 Maschi - Fluoxetine, 2008 Levy, 2020 Lee (Controls unexposed, general pop), 2025 61.71[1.54; 1.90]162,2961,755not evaluable Jaundice / Icterus Källén (Controls unexposed, NOS), 2004 Colvin, 2012 Gungor (Controls unexposed, sick), 2019 Marks - Sertraline (Controls exposed to Bupropion), 2021 40.82[0.71; 0.94]27,8025,553not evaluable Neonatal hypoglycemia Lennestal, 2007 Engelstad (Controls unexposed, sick), 2014 Norby, 2016 Bracero, 2016 Levy, 2020 Gover, 2023 61.30[1.09; 1.54]18,25017,971not evaluable Neonatal death (< 28 days of life) Stephansson, 2013 Norby, 2016 Levy, 2020 Lee (Controls unexposed, general pop), 2025 41.11[0.81; 1.52]4,17619,283not evaluable Neonatal infections Engelstad (Controls unexposed, sick), 2014 Norby, 2016 Levy, 2020 Cornet - SSRIs, 2024 41.20[0.95; 1.50]2,71225,517not evaluable Neonatal tachypnea Levinson-Castiel, 2006 Norby, 2016 Bracero, 2016 Marks - Sertraline (Controls exposed to Bupropion), 2021 41.59[1.06; 2.37]16,90219,455not evaluable Feeding difficulty Davis, 2007 Colvin, 2012 Norby, 2016 31.11[0.98; 1.27]15,59821,907not evaluable Neonatal intracranial hemorrhage Batton, 2013 Norby, 2016 Gover, 2023 30.83[0.52; 1.32]1,96817,776not evaluable Very low Apgar score (< 5) (at 1 min) Simon (Controls unexposed, NOS), 2002 Roca, 2011 21.57[0.84; 2.96]49269not evaluable Very low Apgar score (< 5) (at 5 min) de Vries, 2013 Ulbrich, 2021 Cornet - SSRIs, 2024 32.45[1.98; 3.03]1,3657,794not evaluable Low Apgar score (< 7) (NOS) Källén (Controls unexposed, NOS), 2004 12.28[1.27; 4.10]4,983500not evaluable Necrotizing enterocolitis Batton, 2013 Levy, 2020 20.31[0.04; 2.25]5101not evaluable Fetal distress Davis, 2007 16.00[1.88; 19.16]47874not evaluable Infant health status Colvin, 2012 11.37[1.25; 1.51]10,6382,783not evaluable Low Apgar score (< 7) (at 10 min) Heinonen - Sertraline, 2021 10.33[0.01; 21.64]-8not evaluable Metabolic disorders in neonate/infant Davis, 2007 11.61[1.15; 2.26]1,805874not evaluable Long term consequences Child/Infant death (> 28 days of life) Lennestal, 2007 Colvin, 2012 Stephansson, 2013 Lee (Controls unexposed, general pop), 2025 41.37[1.09; 1.72]7,8865,229not evaluable Child/Infant weight abnormalities (> 1 year) Grzeskowiak b (Controls unexposed, sick), 2012 Grzeskowiak (Controls unexposed, sick), 2013 21.02[0.70; 1.49]-198not evaluable Childhood asthma Liu, 2015 10.95[0.88; 1.03]2,6097,186not evaluable Intrauterine deaths Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Pastuszak - Fluoxetine (Controls unexposed, NOS), 1993 Chambers - Fluoxetine, 1996 Kulin, 1998 Einarson, 2001 Yaris, 2005 Sivojelezova - Citalopram, 2005 Vial - Paroxetine, 2006 Diav-Citrin - Fluoxetine or Paroxetine, 2008 Nakhai-Pour, 2010 Manakova, 2011 Klieger-Grossmann - Escitalopram, 2012 Ban (Controls unexposed, sick), 2012 Andersen (Controls unexposed, sick), 2014 Ozturk - Escitalopram, 2016 Wu, 2019 Richardson, 2019 Kitchin, 2022 171.42[1.17; 1.71]31,49841,178critical Late intrauterine deaths (> 22 weeks) / Stillbirths Chambers - Fluoxetine, 1996 Kulin, 1998 Casper, 2003 Sivojelezova - Citalopram, 2005 Diav-Citrin - Fluoxetine or Paroxetine, 2008 Manakova, 2011 Klieger-Grossmann - Escitalopram, 2012 Colvin, 2012 Stephansson, 2013 Norby, 2016 Richardson, 2019 111.15[0.97; 1.35]6,61723,736low Elective/induced termination of pregnancy Pastuszak - Fluoxetine (Controls unexposed, NOS), 1993 Vial - Paroxetine, 2006 Diav-Citrin - Fluoxetine or Paroxetine, 2008 Manakova, 2011 Ban (Controls unexposed, sick), 2012 Kieler, 2015 Ozturk - Escitalopram, 2016 Richardson, 2019 81.82[1.48; 2.24]18,37716,741not evaluable Therapeutic terminations of pregnancy Chambers - Fluoxetine, 1996 Kulin, 1998 Einarson, 2001 Sivojelezova - Citalopram, 2005 Vial - Paroxetine, 2006 Klieger-Grossmann - Escitalopram, 2012 Kieler, 2015 72.70[1.27; 5.74]921,599serious Ectopic pregnancy Chambers - Fluoxetine, 1996 Colvin, 2011 Wall-Wieler, 2020 31.00[0.91; 1.09]3,81732,153not evaluable Intrauterine deaths (as a whole or unspecified) Casper, 2003 Lennestal, 2007 Diav-Citrin - Fluoxetine or Paroxetine, 2008 Colvin, 2011 Sjaarda, 2020 51.33[0.99; 1.79]28,8454,480not evaluable Perinatal death Ban (Controls unexposed, sick), 2012 Norby, 2016 Kivistö, 2016 31.22[1.00; 1.47]19332,285not evaluable Neuro-developmental disorders ASD (Autism spectrum disorder): Diagnosis/Risk Croen, 2011 Eriksson, 2012 Harrington, 2014 El Marroun (Control unexposed, sick), 2014 Man, 2015 Clements, 2015 Malm (Controls unexposed, sick), 2016 Boukhris (Controls unexposed, NOS), 2016 Rai (Controls unexposed, sick), 2017 Brown, 2017 Sujan (Controls unexposed, NOS), 2017 Liu, 2017 Hagberg (Controls unexposed, sick), 2018 Ames (Controls unexposed, sick), 2021 Suarez (Controls unexposed, discontinuers), 2022 Brennan, 2023 Heuvelman, 2023 Lee (Controls unexposed, general pop), 2024 181.32[1.16; 1.50]46,614206,609low ASD (Autism spectrum disorder): Diagnosis Croen, 2011 Eriksson, 2012 Harrington, 2014 Man, 2015 Clements, 2015 Malm (Controls unexposed, sick), 2016 Boukhris (Controls unexposed, NOS), 2016 Brown, 2017 Sujan (Controls unexposed, NOS), 2017 Liu, 2017 Rai (Controls unexposed, sick), 2017 Hagberg (Controls unexposed, sick), 2018 Ames (Controls unexposed, sick), 2021 Suarez (Controls unexposed, discontinuers), 2022 Brennan, 2023 Heuvelman, 2023 Lee (Controls unexposed, general pop), 2024 171.32[1.16; 1.51]46,614206,540low ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Oberlander, 2007 Figueroa, 2010 Laugesen, 2013 Clements, 2015 Malm (Controls unexposed, sick), 2016 Sujan (Controls unexposed, NOS), 2017 Boukhris (Controls unexposed, NOS), 2017 Man (Controls unexposed, NOS), 2017 Yeh, 2021 Hartwig, 2022 Suarez (Controls unexposed, discontinuers), 2022 Heuvelman, 2023 Olstad - (Es)citalopram (Controls unexposed, sick), 2023 Lee (Controls unexposed, general pop), 2024 141.25[1.09; 1.43]140,185182,301low ADHD (Attention deficit hyperactivity disorder): Diagnosis Figueroa, 2010 Laugesen, 2013 Clements, 2015 Malm (Controls unexposed, sick), 2016 Sujan (Controls unexposed, NOS), 2017 Boukhris (Controls unexposed, NOS), 2017 Man (Controls unexposed, NOS), 2017 Yeh, 2021 Hartwig, 2022 Suarez (Controls unexposed, discontinuers), 2022 Heuvelman, 2023 Olstad - (Es)citalopram (Controls unexposed, sick), 2023 Lee (Controls unexposed, general pop), 2024 131.26[1.09; 1.44]140,185182,279low Psychomotor developmental disorders/delay Nulman - Fluoxetine (Controls unexposed, disease free), 2002 Simon (Controls unexposed, NOS), 2002 Casper, 2003 Oberlander, 2004 Pedersen, 2010 Batton, 2013 Brown (Controls unexposed, sick), 2016 Hutchison a, 2019 Van der Veere, 2020 Suarez (Controls unexposed, discontinuers), 2022 101.36[1.10; 1.67]1,153131,025low Language disorders/delay Nulman - Fluoxetine (Controls unexposed, disease free), 2002 Simon (Controls unexposed, NOS), 2002 Nulman (Controls unexposed, sick), 2012 Skurtveit, 2014 Brown (Controls unexposed, sick), 2016 Suarez (Controls unexposed, discontinuers), 2022 61.18[1.09; 1.27]5,642130,940not evaluable Cognitive developmental disorders/delay (3-6 years old) Nulman - Fluoxetine (Controls unexposed, disease free), 2002 Nulman (Controls unexposed, sick), 2012 Batton, 2013 Harrington, 2014 Ames (Controls unexposed, sick), 2021 Suarez (Controls unexposed, discontinuers), 2022 61.23[0.97; 1.56]380115,388not evaluable Cognitive developmental disorders/delay (< 3 years old) Nulman - Fluoxetine (Controls unexposed, disease free), 2002 Casper, 2003 Oberlander, 2004 Batton, 2013 Van der Veere, 2020 51.24[0.65; 2.36]12172not evaluable Childhood autism (F84.0) Sørensen (Controls unexposed, sick), 2013 Viktorin b, 2017 21.03[0.73; 1.46]9604,653not evaluable Learning disorders Brown (Controls unexposed, sick), 2016 Suarez (Controls unexposed, discontinuers), 2022 20.86[0.68; 1.10]499130,656not evaluable Neuro-developmental disorders (as a whole) Heikkinen - Fluoxetine only, 2003 Kragholm, 2018 Suarez (Controls unexposed, discontinuers), 2022 31.14[1.07; 1.20]11,152117,350not evaluable ADHD (Attention deficit hyperactivity disorder): Risk Oberlander, 2007 Olstad - (Es)citalopram (Controls unexposed, sick), 2023 20.60[0.39; 0.94]-150not evaluable ASD (Autism spectrum disorder): Risk El Marroun (Control unexposed, sick), 2014 Brennan, 2023 21.28[0.69; 2.38]-69not evaluable Cognitive developmental disorders/delay (> 6 years old) Viktorin, 2017 Liu, 2017 Heuvelman, 2023 31.16[0.80; 1.68]8128,772not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Harrington, 2014 Suarez (Controls unexposed, discontinuers), 2022 21.02[0.71; 1.47]380115,079not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Viktorin, 2017 Liu, 2017 Heuvelman, 2023 31.16[0.80; 1.68]8128,772not evaluable Severe cognitive developmental delay (Mental retardation) (< 3 years old) Batton, 2013 10.37[0.09; 1.53]1219not evaluable0.0100.01.0

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