Fluoxetine

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Pastuszak (Controls unexposed, NOS), 1993 Chambers, 1996 Nulman - Fluoxetine (Controls unexposed, NOS), 1997 Oberlander, 2008 Diav-Citrin, 2008 Einarson, 2009 Reis (Controls unexposed, NOS), 2010 Colvin, 2011 Nordeng (Controls unexposed, sick), 2012 Ban (Controls unexposed, sick), 2014 Furu, 2015 Ozturk, 2016 Bérard, 2017 Anderson, 2020 Chan (Controls unexposed, pop general), 2024 151.17[1.04; 1.32]133,48913,595low Major congenital malformations Pastuszak (Controls unexposed, NOS), 1993 Chambers, 1996 Nulman - Fluoxetine (Controls unexposed, NOS), 1997 Oberlander, 2008 Diav-Citrin, 2008 Einarson, 2009 Reis (Controls unexposed, NOS), 2010 Colvin, 2011 Nordeng (Controls unexposed, sick), 2012 Ban (Controls unexposed, sick), 2014 Furu, 2015 Ozturk, 2016 Bérard, 2017 Anderson, 2020 Chan (Controls unexposed, pop general), 2024 151.16[1.03; 1.31]132,71813,595low Congenital heart defects Louik, 2007 Oberlander, 2008 Diav-Citrin, 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 Wemakor, 2015 Furu, 2015 Bérard, 2017 Anderson, 2020 Chan (Controls unexposed, pop general), 2024 141.24[1.07; 1.44]55,54021,744low Limb defects Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 De Jonge, 2013 Ban (Controls unexposed, sick), 2014 Bérard, 2017 Anderson, 2020 70.93[0.69; 1.27]1,3136,482not evaluable Digestive system anomalies Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015 Bérard, 2017 61.33[0.86; 2.06]3,5856,449not evaluable Ventricular septal defect Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Huybrechts (Controls unexposed, sick), 2014 Wemakor, 2015 Anderson, 2020 51.06[0.77; 1.46]12,46211,459not evaluable Genital anomalies Jimenez-Solem (Controls unexposed, sick), 2012 De Jonge, 2013 Ban (Controls unexposed, sick), 2014 Bérard, 2017 40.45[0.22; 0.92]3774,373not evaluable Hypospadias Louik, 2007 Reis (Controls unexposed, NOS), 2010 Furu, 2015 Wemakor, 2015 Anderson, 2020 51.00[0.70; 1.42]8,0827,865not evaluable Respiratory system anomalies Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015 Bérard, 2017 61.39[0.78; 2.50]1,2636,445not evaluable Atrial septal defect Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Wemakor, 2015 Anderson, 2020 41.27[0.88; 1.83]3,9902,779not evaluable Cardiac septal defects Louik, 2007 Furu, 2015 Wemakor, 2015 Bérard, 2017 Anderson, 2020 51.32[1.09; 1.58]26,8696,555serious Cleft lip with or without cleft palate Louik, 2007 Malm, 2011 Anderson, 2020 31.19[0.79; 1.81]7041,890not evaluable Cleft palate Louik, 2007 Malm, 2011 Anderson, 2020 31.04[0.64; 1.71]3771,882not evaluable Craniosynostosis Louik, 2007 Malm, 2011 Wemakor, 2015 Bérard, 2017 Anderson, 2020 51.89[1.24; 2.87]4222,099not evaluable Nervous system anomalies Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Bérard, 2017 51.27[0.79; 2.05]7456,417not evaluable Neural Tube Defects Louik, 2007 Malm, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Wemakor, 2015 Anderson, 2020 51.23[0.79; 1.89]1,6422,837not evaluable Oro-facial clefts Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Anderson, 2020 31.16[0.82; 1.65]4294,117not evaluable Urinary malformations Louik, 2007 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Bérard, 2017 40.99[0.61; 1.59]3,7834,374not evaluable Club foot / Talipes equinovarus Louik, 2007 Yazdy, 2014 Furu, 2015 Wemakor, 2015 41.19[0.76; 1.84]6,2136,362not evaluable Eye defects Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015 41.19[0.53; 2.69]1,1974,436not evaluable Ano-rectal atresia and stenosis Louik, 2007 Wemakor, 2015 Anderson, 2020 31.29[0.69; 2.41]60792not evaluable Chromosomal abnormalities Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 30.53[0.20; 1.43]7584,408not evaluable Diaphragmatic hernia Louik, 2007 Anderson, 2020 21.42[0.73; 2.73]19264not evaluable Ear, face and neck anomalies Colvin, 2011 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015 31.93[0.53; 7.07]1,0443,508not evaluable Microcephaly / Small head circumference for gestational age Chambers, 1996 Kivistö, 2016 Kerr, 2018 31.67[0.74; 3.79]1,761221not evaluable Omphalocele Louik, 2007 Malm, 2011 20.70[0.14; 3.57]1271,879not evaluable Transposition of the great vessels Malm, 2011 Wemakor, 2015 Anderson, 2020 31.46[0.76; 2.82]8531,845not evaluable Abdominal wall defects Ban (Controls unexposed, disease free), 2014 11.14[0.16; 8.16]603,189not evaluable Atrioventricular septal defect Wemakor, 2015 Anderson, 2020 22.29[0.85; 6.14]29029not evaluable Coarctation of aorta Wemakor, 2015 Anderson, 2020 21.75[1.01; 3.02]57027not evaluable Gastroschisis Given, 2017 Anderson, 2020 21.65[0.53; 5.16]-104not evaluable Hypoplastic left heart (HLH/HLHS) Wemakor, 2015 Anderson, 2020 21.79[0.90; 3.58]39828not evaluable Limb reduction defects (LRD) Louik, 2007 Wemakor, 2015 21.66[0.66; 4.21]97793not evaluable Pulmonary valve stenosis Wemakor, 2015 Anderson, 2020 21.89[1.18; 3.01]77230not evaluable Spina bifida Anderson, 2020 11.26[0.65; 2.45]--not evaluable Tetralogy of Fallot Wemakor, 2015 Anderson, 2020 22.57[0.83; 8.01]42831not evaluable Aortic valve atresia/stenosis 0----- Congenital hydronephrosis 0----- Ebstein's anomaly Wemakor, 2015 13.44[0.21; 56.90]9327not evaluable Encephalocele 0----- Eye, ear, face and neck malformations Bérard, 2017 10.85[0.12; 5.98]-191not evaluable Genetic syndromes and microdeletions Jimenez-Solem (Controls unexposed, NOS), 2012 11.79[0.25; 12.79]-928not evaluable Hip dislocation and/or dysplasia 0----- Hirschsprung's disease 0----- Hydrocephaly 0----- Minor congenital malformations Chambers, 1996 12.62[1.12; 6.09]2597not evaluable Multicystic renal dysplasia Wemakor, 2015 15.76[2.54; 13.07]61835not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Anderson, 2020 12.19[1.19; 4.04]--not evaluable Patent ductus arterious 0----- Polydactyly 0----- Pulmonary valve atresia 0----- Severe congenital heart defect Wemakor, 2015 11.46[0.66; 3.23]2,93535not evaluable Syndactyly 0----- Growth parameters and prematurity Preterm (< 37 weeks) Pastuszak (Controls unexposed, NOS), 1993 Chambers, 1996 Diav-Citrin, 2008 Calderon-Margalit, 2009 Colvin, 2011 Ozturk, 2016 Kivistö, 2016 Marks (Controls exposed to Bupropion), 2021 Martin, 2024 Lee (Controls unexposed, general pop), 2025 101.16[1.06; 1.26]159,53215,157low Small for gestational age (weight) Chambers, 1996 Kivistö, 2016 Martin, 2024 Lee (Controls unexposed, general pop), 2025 41.24[0.92; 1.66]239,73011,412not evaluable Low birth weight (< 2500g) Colvin, 2011 Kivistö, 2016 Lee (Controls unexposed, general pop), 2025 31.16[0.78; 1.72]39,7621,141not evaluable Large for gestational age (weight) Kivistö, 2016 Lee (Controls unexposed, general pop), 2025 20.79[0.50; 1.26]11,942770not evaluable Large for gestational age (length) Kivistö, 2016 10.48[0.11; 2.05]1,472-not evaluable Large head circumference for gestational age Kivistö, 2016 10.97[0.38; 2.50]2,560-not evaluable Macrosomia (> 4000g) Pastuszak (Controls unexposed, NOS), 1993 11.74[0.71; 4.23]2484not evaluable Small for gestational age (length) Kivistö, 2016 11.85[0.80; 4.27]1,838-not evaluable Maternal consequences Caesarean Chambers, 1996 Heikkinen, 2003 Colvin, 2011 Kivistö, 2016 Lee (Controls unexposed, general pop), 2025 51.30[0.98; 1.72]146,0851,218not evaluable Assisted deliveries (forceps, vacuum, ...) Kivistö, 2016 Lee (Controls unexposed, general pop), 2025 20.99[0.76; 1.29]47,695770not evaluable Postpartum hemorrhage Colvin, 2011 Palmsten b, 2013 Lee (Controls unexposed, general pop), 2025 31.36[1.08; 1.72]30,3504,405not evaluable Preeclampsia De Vera, 2012 Palmsten (Controls unexposed, sick), 2013 20.97[0.87; 1.09]4,7305,650not evaluable Maternal consequences (as a whole) Lee (Controls unexposed, general pop), 2025 10.95[0.80; 1.12]311,616719not evaluable Gestational diabetes Dandjinou, 2019 10.85[0.57; 1.26]20,905322not evaluable Neonatal disorders Neonatal medical care Chambers, 1996 Suri (Controls unexposed, sick), 2004 Oberlander, 2004 Kivistö, 2016 Marks (Controls exposed to Bupropion), 2021 Cornet, 2024 Lee (Controls unexposed, general pop), 2025 72.05[1.32; 3.17]23,3852,439not evaluable Low Apgar score (< 7) (at 5 min) Colvin, 2011 Kivistö, 2016 Marks (Controls exposed to Bupropion), 2021 Martin, 2024 Lee (Controls unexposed, general pop), 2025 51.62[1.43; 1.84]35,0229,743not evaluable Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation Chambers, 1996 Levinson-Castiel, 2006 Dave, 2019 Marks (Controls unexposed, sick), 2021 46.30[2.06; 19.21]6833,748not evaluable Low Apgar score (< 7) (at 1 min) Kivistö, 2016 Lee (Controls unexposed, general pop), 2025 21.59[0.93; 2.71]16,361770not evaluable Neonatal death (< 28 days of life) Lee (Controls unexposed, general pop), 2025 10.94[0.12; 7.23]628719not evaluable Neonatal disorders (as a whole) Maschi, 2008 Lee (Controls unexposed, general pop), 2025 21.55[1.33; 1.80]161,792751not evaluable Persistent pulmonary hypertension Chambers, 2006 Kieler, 2012 Marks (Controls exposed to Bupropion), 2021 31.99[1.09; 3.61]2,3233,901not evaluable Fetal distress Colvin, 2011 10.99[0.73; 1.34]12,722364not evaluable Jaundice / Icterus Marks (Controls exposed to Bupropion), 2021 11.02[0.72; 1.44]154579not evaluable Neonatal tachypnea Marks (Controls exposed to Bupropion), 2021 11.77[1.17; 2.69]118579not evaluable Long term consequences Child/Infant death (> 28 days of life) Colvin, 2012 Lee (Controls unexposed, general pop), 2025 21.51[0.70; 3.28]1,194719not evaluable Intrauterine deaths Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Pastuszak (Controls unexposed, NOS), 1993 Chambers, 1996 Yaris, 2005 Diav-Citrin, 2008 Nakhai-Pour, 2010 Andersen, 2014 Ozturk, 2016 Kitchin, 2022 81.24[1.07; 1.43]162,6344,964serious Elective/induced termination of pregnancy Pastuszak (Controls unexposed, NOS), 1993 Diav-Citrin, 2008 Ozturk, 2016 32.37[1.53; 3.65]103484not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths Chambers, 1996 Diav-Citrin, 2008 Colvin, 2011 30.85[0.30; 2.40]615791not evaluable Ectopic pregnancy Chambers, 1996 Colvin, 2011 21.28[0.49; 3.31]1,489548not evaluable Intrauterine deaths (as a whole or unspecified) Diav-Citrin, 2008 Colvin, 2011 Sjaarda, 2020 31.83[1.37; 2.45]24,788766not evaluable Therapeutic terminations of pregnancy Chambers, 1996 15.88[2.45; 14.13]29154not 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 61.28[1.01; 1.63]1,62532,313not 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 61.28[1.01; 1.63]1,62532,313not evaluable Cognitive developmental disorders/delay (3-6 years old) Nulman (Controls unexposed, disease free), 2002 Suarez (Controls unexposed, discontinuers), 2022 21.39[0.29; 6.70]6018,363not evaluable Language disorders/delay Nulman (Controls unexposed, disease free), 2002 Suarez (Controls unexposed, discontinuers), 2022 21.21[1.01; 1.45]1,25726,632not evaluable Psychomotor developmental disorders/delay Nulman (Controls unexposed, disease free), 2002 Suarez (Controls unexposed, discontinuers), 2022 21.28[0.76; 2.14]20126,628not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Suarez (Controls unexposed, discontinuers), 2022 Heuvelman, 2023 21.11[0.95; 1.29]1,28431,362not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Suarez (Controls unexposed, discontinuers), 2022 Heuvelman, 2023 21.11[0.95; 1.29]1,28431,362not evaluable Neuro-developmental disorders (as a whole) Heikkinen, 2003 Suarez (Controls unexposed, discontinuers), 2022 21.14[1.00; 1.29]2,81626,606not evaluable Cognitive developmental disorders/delay (< 3 years old) Nulman (Controls unexposed, disease free), 2002 10.96[0.34; 2.72]-33not evaluable Learning disorders Suarez (Controls unexposed, discontinuers), 2022 10.74[0.43; 1.27]10026,595not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Suarez (Controls unexposed, discontinuers), 2022 10.73[0.30; 1.77]6018,357not evaluable Cognitive developmental disorders/delay (> 6 years old) Heuvelman, 2023 10.93[0.58; 1.48]-4,767not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Heuvelman, 2023 10.93[0.58; 1.48]-4,767not evaluable0.0100.01.0

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