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Paroxetine
Overall results
Study description
Excluded studies
Table
Graphic
auto
during pregnancy (anytime or not specified)
1st trimester
2nd trimester
3rd trimester
2nd and/or 3rd trimester
throughout pregnancy
early pregnancy
days before delivery
late pregnancy
preconception-only
periconceptional
preconceptional for kinetic reason
at least 1st trimester
3 months (or more) before pregnancy or during pregnancy
1st and 2nd trimester
3 months or more before pregnancy or1st trimester
Paternal exp. genotoxic window only (0–3 months preconception)
Paternal exposure: epigenetic window only (3–xxx months preconception)
Paternal exposure: genotoxic/epigenetic window (0–xxx months preconception)
Paternal exposure: other window
Whatever the period exposition
individual studies
Outcome
TE
95% CI
n cases
n exposed
k
Pub. bias
Congenital malformations
Congenital heart defects
Vial, 2006 Louik, 2007 Davis, 2007 Einarson, 2008 Oberlander, 2008 Diav-Citrin, 2008 Merlob, 2009 Reis (Controls unexposed, NOS), 2010 Colvin, 2011 Nordeng (Controls unexposed, sick), 2012 Huybrechts (Controls unexposed, sick), 2014 Ban (Controls unexposed, sick), 2014 Furu, 2015 Wemakor, 2015 Bérard, 2017 Anderson, 2020 Chan (Controls unexposed, pop general), 2024
17
1.29
[
1.14
; 1.46]
56,683
19,308
probable
All congenital malformations (majors, minors, majors and minors, or unspecified)
Vial, 2006 Davis, 2007 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
14
1.18
[
1.04
; 1.34]
140,165
9,542
low
Major congenital malformations
Vial, 2006 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
13
1.21
[
1.06
; 1.38]
132,567
9,360
probable
Limb defects
Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 De Jonge, 2013 Ban (Controls unexposed, sick), 2014 Bérard, 2017 Anderson, 2020
7
1.00
[
0.79
; 1.25]
1,310
4,621
not evaluable
Digestive system anomalies
Davis, 2007 Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015 Bérard, 2017
7
0.99
[
0.65
; 1.51]
3,719
4,656
not evaluable
Respiratory system anomalies
Davis, 2007 Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015 Bérard, 2017
7
1.17
[
0.65
; 2.10]
1,511
4,649
not evaluable
Ventricular septal defect
Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Huybrechts (Controls unexposed, sick), 2014 Wemakor, 2015 Anderson, 2020
5
1.11
[
0.66
; 1.87]
12,432
10,341
not evaluable
Cardiac septal defects
Louik, 2007 Davis, 2007 Wemakor, 2015 Furu, 2015 Bérard, 2017 Anderson, 2020
6
1.42
[
1.17
; 1.73]
27,514
4,279
not evaluable
Genital anomalies
Davis, 2007 Jimenez-Solem (Controls unexposed, sick), 2012 Ban (Controls unexposed, sick), 2014 Bérard, 2017
4
0.90
[
0.46
; 1.76]
1,234
3,082
not evaluable
Nervous system anomalies
Colvin, 2011 Malm, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 De Jonge, 2013 Ban (Controls unexposed, disease free), 2014 Bérard, 2017
6
1.03
[
0.62
; 1.73]
962
4,621
serious
Urinary malformations
Davis, 2007 Louik, 2007 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Bérard, 2017
5
0.65
[
0.36
; 1.16]
4,253
3,116
not evaluable
Atrial septal defect
Malm, 2011 Jimenez-Solem (Controls unexposed, sick), 2012 Wemakor, 2015 Anderson, 2020
4
1.46
[
0.95
; 2.26]
3,985
1,568
not evaluable
Craniosynostosis
Louik, 2007 Malm, 2011 Wemakor, 2015 Bérard, 2017 Anderson, 2020
5
1.63
[
1.02
; 2.61]
422
2,159
not evaluable
Ear, face and neck anomalies
Davis, 2007 Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015
5
1.56
[
0.50
; 4.91]
1,264
2,549
not evaluable
Hypospadias
Louik, 2007 Reis (Controls unexposed, NOS), 2010 Wemakor, 2015 Anderson, 2020
4
1.46
[
0.95
; 2.24]
3,538
1,275
not evaluable
Chromosomal abnormalities
Davis, 2007 Colvin, 2011 Jimenez-Solem (Controls unexposed, NOS), 2012 Ban (Controls unexposed, disease free), 2014
4
2.31
[
1.14
; 4.70]
841
2,522
not evaluable
Cleft lip with or without cleft palate
Louik, 2007 Malm, 2011 Anderson, 2020
3
1.01
[
0.59
; 1.72]
704
1,002
not evaluable
Cleft palate
Louik, 2007 Malm, 2011 Anderson, 2020
3
1.54
[
0.88
; 2.70]
377
1,001
not evaluable
Eye defects
Davis, 2007 Colvin, 2011 Ban (Controls unexposed, disease free), 2014 Wemakor, 2015
4
1.87
[
1.08
; 3.26]
1,855
1,984
not evaluable
Oro-facial clefts
Davis, 2007 Ban (Controls unexposed, disease free), 2014 Anderson, 2020
3
1.04
[
0.62
; 1.75]
531
1,382
not evaluable
Club foot / Talipes equinovarus
Louik, 2007 Yazdy, 2014 Wemakor, 2015
3
4.14
[
2.43
; 7.04]
3,027
81
not evaluable
Diaphragmatic hernia
Louik, 2007 Anderson, 2020
2
1.24
[
0.50
; 3.06]
192
31
not evaluable
Neural Tube Defects
Louik, 2007 Wemakor, 2015 Anderson, 2020
3
1.62
[
0.64
; 4.07]
1,642
61
not evaluable
Omphalocele
Louik, 2007 Malm, 2011
2
1.37
[
0.27
; 6.93]
127
998
not evaluable
Spina bifida
Davis, 2007 Anderson, 2020
2
1.14
[
0.21
; 6.20]
29
182
not evaluable
Transposition of the great vessels
Malm, 2011 Wemakor, 2015 Anderson, 2020
3
1.28
[
0.54
; 3.04]
853
996
not evaluable
Abdominal wall defects
Ban (Controls unexposed, disease free), 2014
1
1.95
[
0.12
; 31.52]
69
1,200
not evaluable
Ano-rectal atresia and stenosis
Louik, 2007 Wemakor, 2015
2
2.05
[
0.61
; 6.86]
607
60
not evaluable
Coarctation of aorta
Wemakor, 2015 Anderson, 2020
2
1.26
[
0.55
; 2.89]
570
29
not evaluable
Gastroschisis
Wemakor, 2015 Anderson, 2020
2
2.73
[
1.49
; 5.03]
413
27
not evaluable
Limb reduction defects (LRD)
Louik, 2007 Wemakor, 2015
2
1.61
[
0.56
; 4.63]
977
60
not evaluable
Microcephaly / Small head circumference for gestational age
Kivistö, 2016 Kerr, 2018
2
1.09
[
0.30
; 3.93]
1,757
46
not evaluable
Pulmonary valve stenosis
Wemakor, 2015 Anderson, 2020
2
1.92
[
1.04
; 3.56]
772
28
not evaluable
Tetralogy of Fallot
Wemakor, 2015 Anderson, 2020
2
1.40
[
0.62
; 3.19]
428
27
not evaluable
Aortic valve atresia/stenosis
0
-
-
-
-
-
Atrioventricular septal defect
Wemakor, 2015
1
2.19
[
0.30
; 16.14]
290
28
not evaluable
Congenital hydronephrosis
0
-
-
-
-
-
Ebstein's anomaly
Wemakor, 2015
1
6.43
[
0.85
; 48.59]
93
28
not evaluable
Encephalocele
0
-
-
-
-
-
Eye, ear, face and neck malformations
Bérard, 2017
1
0.75
[
0.30
; 1.87]
-
1,132
not evaluable
Hip dislocation and/or dysplasia
0
-
-
-
-
-
Hirschsprung's disease
0
-
-
-
-
-
Hydrocephaly
0
-
-
-
-
-
Hypoplastic left heart (HLH/HLHS)
Wemakor, 2015
1
1.59
[
0.22
; 11.74]
398
28
not evaluable
Multicystic renal dysplasia
Wemakor, 2015
1
1.62
[
0.38
; 6.93]
618
29
not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula
Anderson, 2020
1
1.36
[
0.49
; 3.80]
-
-
not evaluable
Patent ductus arterious
0
-
-
-
-
-
Polydactyly
0
-
-
-
-
-
Pulmonary valve atresia
0
-
-
-
-
-
Severe congenital heart defect
Wemakor, 2015
1
1.08
[
0.44
; 2.64]
2,935
33
not evaluable
Syndactyly
0
-
-
-
-
-
Total anomalous pulm venous return
Anderson, 2020
1
4.00
[
1.42
; 11.28]
-
-
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
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
8
1.24
[
1.00
; 1.55]
158,601
4,058
not evaluable
Low birth weight (< 2500g)
Colvin, 2011 Kivistö, 2016 Lee (Controls unexposed, general pop), 2025
3
1.00
[
0.51
; 1.98]
39,728
794
not evaluable
Small for gestational age (weight)
Kivistö, 2016 Martin, 2024 Lee (Controls unexposed, general pop), 2025
3
1.19
[
1.04
; 1.36]
238,656
2,246
not evaluable
Large for gestational age (weight)
Kivistö, 2016 Lee (Controls unexposed, general pop), 2025
2
0.92
[
0.30
; 2.81]
11,926
109
not evaluable
Large for gestational age (length)
Kivistö, 2016
1
0.50
[
0.07
; 3.65]
1,472
-
not evaluable
Large head circumference for gestational age
Kivistö, 2016
1
1.33
[
0.46
; 3.87]
2,560
-
not evaluable
Small for gestational age (length)
Kivistö, 2016
1
1.09
[
0.32
; 3.74]
1,838
-
not evaluable
Maternal consequences
Caesarean
Colvin, 2011 Kivistö, 2016 Lee (Controls unexposed, general pop), 2025
3
1.17
[
1.00
; 1.38]
145,914
785
not evaluable
Postpartum hemorrhage
Colvin, 2011 Palmsten b, 2013 Lee (Controls unexposed, general pop), 2025
3
1.27
[
1.08
; 1.50]
30,267
2,808
not evaluable
Assisted deliveries (forceps, vacuum, ...)
Kivistö, 2016 Lee (Controls unexposed, general pop), 2025
2
0.83
[
0.42
; 1.66]
47,643
109
not evaluable
Preeclampsia
De Vera, 2012 Palmsten (Controls unexposed, sick), 2013
2
1.25
[
0.70
; 2.23]
4,614
3,526
not evaluable
Maternal consequences (as a whole)
Lee (Controls unexposed, general pop), 2025
1
0.84
[
0.50
; 1.41]
311,151
77
not evaluable
Gestational diabetes
Dandjinou, 2019
1
1.13
[
0.94
; 1.36]
20,905
1,362
not evaluable
Neonatal disorders
Neonatal medical care
Costei (Controls unexposed, sick), 2002 Oberlander, 2004 Maschi, 2008 Kivistö, 2016 Marks (Controls exposed to Bupropion), 2021 Lee (Controls unexposed, general pop), 2025
6
2.07
[
1.29
; 3.32]
11,119
294
not 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
5
1.55
[
1.19
; 2.03]
34,743
2,455
not evaluable
Neonatal disorders (as a whole)
Costei (Controls unexposed, sick), 2002 Maschi, 2008 Lee (Controls unexposed, general pop), 2025
3
1.12
[
0.63
; 2.00]
161,472
190
not evaluable
Low Apgar score (< 7) (at 1 min)
Kivistö, 2016 Lee (Controls unexposed, general pop), 2025
2
1.57
[
0.76
; 3.27]
16,330
109
not evaluable
Neonatal death (< 28 days of life)
Lee (Controls unexposed, general pop), 2025
1
4.82
[
0.30
; 77.86]
627
77
not evaluable
Persistent pulmonary hypertension
Chambers, 2006 Kieler, 2012 Marks (Controls exposed to Bupropion), 2021
3
3.32
[
1.48
; 7.44]
2,317
1,340
not evaluable
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation
Levinson-Castiel, 2006 Marks (Controls unexposed, sick), 2021
2
6.26
[
0.96
; 40.75]
6
47
not evaluable
Fetal distress
Colvin, 2011
1
1.18
[
0.96
; 1.45]
12,779
676
not evaluable
Jaundice / Icterus
Marks (Controls exposed to Bupropion), 2021
1
0.67
[
0.27
; 1.62]
69
55
not evaluable
Neonatal tachypnea
Marks (Controls exposed to Bupropion), 2021
1
2.07
[
0.94
; 4.59]
44
55
not evaluable
Long term consequences
Child/Infant death (> 28 days of life)
Colvin, 2012 Lee (Controls unexposed, general pop), 2025
2
4.09
[
0.29
; 57.17]
1,199
77
not evaluable
Intrauterine deaths
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions
Yaris, 2005 Vial, 2006 Diav-Citrin, 2008 Nakhai-Pour, 2010 Andersen, 2014 Ozturk, 2016 Kitchin, 2022
7
1.46
[
1.15
; 1.86]
162,669
4,204
not evaluable
Elective/induced termination of pregnancy
Vial, 2006 Diav-Citrin, 2008 Ozturk, 2016
3
2.32
[
1.45
; 3.74]
162
1,160
not evaluable
Late intrauterine deaths (> 22 weeks) / Stillbirths
Diav-Citrin, 2008 Colvin, 2011
2
1.13
[
0.53
; 2.42]
615
1,148
not evaluable
Ectopic pregnancy
Colvin, 2011
1
0.68
[
0.42
; 1.10]
1,489
763
not evaluable
Intrauterine deaths (as a whole or unspecified)
Diav-Citrin, 2008 Colvin, 2011
2
1.43
[
1.14
; 1.80]
24,724
1,226
not evaluable
Therapeutic terminations of pregnancy
Vial, 2006
1
2.63
[
0.93
; 7.42]
18
683
not evaluable
Neuro-developmental disorders
ASD (Autism spectrum disorder): Diagnosis
Bérard, 2016 Brown, 2017 Viktorin (Controls unexposed, sick), 2017 Rai (Controls unexposed, sick), 2017 Heuvelman, 2023
5
1.33
[
0.80
; 2.21]
1,373
2,098
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Bérard, 2016 Brown, 2017 Viktorin (Controls unexposed, sick), 2017 Rai (Controls unexposed, sick), 2017 Heuvelman, 2023
5
1.33
[
0.80
; 2.21]
1,373
2,098
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Heuvelman, 2023
1
1.06
[
0.61
; 1.84]
-
982
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Heuvelman, 2023
1
1.06
[
0.61
; 1.84]
-
982
not evaluable
Cognitive developmental disorders/delay (< 3 years old)
Van der Veere, 2020
1
3.40
[
1.37
; 8.43]
-
27
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
0
-
-
-
-
-
Cognitive developmental disorders/delay (> 6 years old)
Heuvelman, 2023
1
0.77
[
0.32
; 1.85]
-
982
not evaluable
Psychomotor developmental disorders/delay
Van der Veere, 2020
1
2.58
[
1.05
; 6.33]
-
27
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Heuvelman, 2023
1
0.77
[
0.32
; 1.85]
-
982
not evaluable
0.0
100.0
1.0