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Mirtazapine
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
All congenital malformations (majors, minors, majors and minors, or unspecified)
Djulus (Controls unexposed, disease free), 2006 Einarson, 2009 Källen, 2013 Winterfeld (Controls unexposed, NOS), 2015 Ozturk, 2016 Anderson, 2020 Ostenfeld, 2022 Chan (Controls unexposed, pop general), 2024
8
1.02
[
0.72
; 1.43]
53,507
2,003
not evaluable
Major congenital malformations
Djulus (Controls unexposed, disease free), 2006 Einarson, 2009 Källen, 2013 Winterfeld (Controls unexposed, NOS), 2015 Ozturk, 2016 Anderson, 2020 Ostenfeld, 2022 Chan (Controls unexposed, pop general), 2024
8
1.02
[
0.72
; 1.43]
53,507
2,003
not evaluable
Congenital heart defects
Källen, 2013 Chan (Controls unexposed, pop general), 2024
2
1.14
[
0.56
; 2.32]
8,109
661
not evaluable
Cardiac septal defects
Källen, 2013
1
1.22
[
0.50
; 2.96]
-
585
not evaluable
Cleft lip with or without cleft palate
0
-
-
-
-
-
Cleft palate
0
-
-
-
-
-
Oro-facial clefts
0
-
-
-
-
-
Growth parameters and prematurity
Preterm (< 37 weeks)
Djulus (Controls unexposed, disease free), 2006 Winterfeld (Controls unexposed, NOS), 2015 Ozturk, 2016 Gungor (Controls unexposed, sick), 2019 Martin, 2024 Lee (Controls unexposed, general pop), 2025
6
1.48
[
1.29
; 1.69]
148,813
3,111
not evaluable
Low birth weight (< 2500g)
Gungor (Controls unexposed, sick), 2019 Lee (Controls unexposed, general pop), 2025
2
1.47
[
0.48
; 4.46]
31,363
93
not evaluable
Macrosomia (> 4000g)
Gungor (Controls unexposed, sick), 2019
1
1.45
[
0.03
; 77.15]
-
16
not evaluable
Small for gestational age (weight)
Martin, 2024 Lee (Controls unexposed, general pop), 2025
2
1.56
[
0.87
; 2.79]
236,438
2,427
not evaluable
Large for gestational age (weight)
Lee (Controls unexposed, general pop), 2025
1
0.62
[
0.09
; 4.37]
9,745
77
not evaluable
Maternal consequences
Caesarean
Gungor (Controls unexposed, sick), 2019 Lee (Controls unexposed, general pop), 2025
2
1.01
[
0.64
; 1.58]
111,692
93
not evaluable
Postpartum hemorrhage
Palmsten b, 2013 Lee (Controls unexposed, general pop), 2025
2
0.71
[
0.30
; 1.70]
21,644
206
not evaluable
Assisted deliveries (forceps, vacuum, ...)
Lee (Controls unexposed, general pop), 2025
1
0.69
[
0.28
; 1.71]
46,041
77
not evaluable
Maternal consequences (as a whole)
Lee (Controls unexposed, general pop), 2025
1
0.85
[
0.51
; 1.41]
311,149
77
not evaluable
Preeclampsia
Palmsten a (Controls unexposed, sick), 2013
1
0.81
[
0.49
; 1.33]
3,229
253
not evaluable
Neonatal disorders
Neonatal medical care
Gungor (Controls unexposed, sick), 2019 Lee (Controls unexposed, general pop), 2025
2
0.96
[
0.31
; 2.99]
8,573
93
not evaluable
Jaundice / Icterus
Gungor (Controls unexposed, sick), 2019
1
0.25
[
0.06
; 1.13]
14
16
not evaluable
Low Apgar score (< 7) (at 5 min)
Martin, 2024 Lee (Controls unexposed, general pop), 2025
2
1.11
[
0.81
; 1.52]
32,761
2,309
not evaluable
Neonatal death (< 28 days of life)
Ostenfeld, 2022 Lee (Controls unexposed, general pop), 2025
2
2.08
[
0.14
; 30.02]
651
974
not evaluable
Low Apgar score (< 7) (at 1 min)
Lee (Controls unexposed, general pop), 2025
1
1.82
[
0.73
; 4.54]
14,888
77
not evaluable
Neonatal disorders (as a whole)
Lee (Controls unexposed, general pop), 2025
1
1.56
[
1.00
; 2.44]
161,445
77
not evaluable
Long term consequences
Child/Infant death (> 28 days of life)
Lee (Controls unexposed, general pop), 2025
1
23.20
[
1.43
; 376.35]
130
77
not evaluable
Intrauterine deaths
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions
Yaris, 2005 Djulus (Controls unexposed, disease free), 2006 Ozturk, 2016 Ostenfeld, 2022
4
1.53
[
0.83
; 2.85]
1,225
2,016
not evaluable
Therapeutic terminations of pregnancy
Djulus (Controls unexposed, disease free), 2006 Kieler, 2015 Winterfeld (Controls unexposed, NOS), 2015
3
2.13
[
1.17
; 3.87]
16
461
not evaluable
Elective/induced termination of pregnancy
Kieler, 2015 Winterfeld (Controls unexposed, NOS), 2015 Ozturk, 2016
3
2.29
[
1.25
; 4.21]
14,966
364
not evaluable
Late intrauterine deaths (> 22 weeks) / Stillbirths
Djulus (Controls unexposed, disease free), 2006 Ostenfeld, 2022
2
0.97
[
0.39
; 2.43]
34
2,049
not evaluable
Intrauterine deaths (as a whole or unspecified)
Winterfeld (Controls unexposed, NOS), 2015
1
1.34
[
0.81
; 2.21]
70
323
not evaluable
Neuro-developmental disorders
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Heuvelman, 2023
1
2.03
[
0.99
; 4.16]
-
552
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Heuvelman, 2023
1
2.03
[
0.99
; 4.16]
-
552
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Heuvelman, 2023
1
1.45
[
0.67
; 3.14]
-
552
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Heuvelman, 2023
1
1.45
[
0.67
; 3.14]
-
552
not evaluable
0.0
100.0
1.0
