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Carbamazepine (All indications)
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
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)
Robert (Carbamazepine), 1986 D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Nulman (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 1997 Kaneko (Carbamazepine), 1999 Samrén (Carbamazepine), 1999 Canger (Carbamazepine), 1999 Hvas (Carbamazepine) (Controls unexposed, sick), 2000 Diav-Citrin (Carbamazepine), 2001 Dean (Carbamazepine), 2002 Kaaja (Carbamazepine), 2003 Endo (Carbamazepine) (Controls unexposed, sick), 2004 Artama (Carbamazepine), 2005 Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Mawer (Carbamazepine) (Controls unexposed, sick), 2010 Bànhidy (Carbamazepine), 2011 Charlton (Carbamazepine) (Controls unexposed, sick), 2011 Arteaga-Vázquez (Carbamazepine), 2012 Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Cassina (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2013 Campbell (Carbamazepine) (Controls unexposed, sick), 2014 Veiby (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Vanya (Carbamazepine) (Controls unexposed, sick), 2015 Tomson (Carbamazepine), 2018 Huber-Mollema (Carbamazepine), 2019 Vajda (Carbamazepine) (Controls unexposed, sick), 2019 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Meador (Carbamazepine) (Controls unexposed, sick), 2020 Hosny (Carbamazepine) (Controls unexposed, sick), 2021 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Mari (Carbamazepine), 2022 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023
33
1.50
[
1.26
; 1.78]
205,309
13,674
critical
Major congenital malformations
Robert (Carbamazepine), 1986 Nulman (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 1997 Samrén (Carbamazepine), 1999 Canger (Carbamazepine), 1999 Hvas (Carbamazepine) (Controls unexposed, sick), 2000 Diav-Citrin (Carbamazepine), 2001 Dean (Carbamazepine), 2002 Kaaja (Carbamazepine), 2003 Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Mawer (Carbamazepine) (Controls unexposed, sick), 2010 Charlton (Carbamazepine) (Controls unexposed, sick), 2011 Bànhidy (Carbamazepine), 2011 Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Cassina (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2013 Veiby (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 Campbell (Carbamazepine) (Controls unexposed, sick), 2014 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Vanya (Carbamazepine) (Controls unexposed, sick), 2015 Tomson (Carbamazepine), 2018 Huber-Mollema (Carbamazepine), 2019 Vajda (Carbamazepine) (Controls unexposed, sick), 2019 Meador (Carbamazepine) (Controls unexposed, sick), 2020 Hosny (Carbamazepine) (Controls unexposed, sick), 2021 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Mari (Carbamazepine), 2022 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023
27
1.48
[
1.23
; 1.77]
205,182
12,653
critical
Congenital heart defects
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Canger (Carbamazepine), 1999 Artama (Carbamazepine), 2005 Mawer (Carbamazepine) (Controls unexposed, sick), 2010 Bànhidy (Carbamazepine), 2011 Hernández-Díaz (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2012 Vajda (Carbamazepine) (Controls unexposed, sick), 2013 Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Tomson (Carbamazepine), 2018 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023
15
1.06
[
0.76
; 1.47]
18,341
11,723
low
Hypospadias
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Jentink (Carbamazepine), 2010 Bànhidy (Carbamazepine), 2011 Hernández-Díaz (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2012 Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2014 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2018 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023
11
1.20
[
0.84
; 1.71]
9,511
10,054
low
Spina bifida
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Czeizel (Carbamazepine) (Mixed indications), 1992 Artama (Carbamazepine), 2005 Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Jentink (Carbamazepine), 2010 Charlton (Carbamazepine) (Controls unexposed, sick), 2011 Veiby (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
8
2.11
[
1.12
; 3.95]
626
2,403
not evaluable
Limb defects
Artama (Carbamazepine), 2005 Mawer (Carbamazepine) (Controls unexposed, sick), 2010 Vajda (Carbamazepine) (Controls unexposed, sick), 2013 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Thomas (Carbamazepine) (Controls unexposed, sick), 2021
7
1.26
[
0.78
; 2.03]
1,326
4,407
not evaluable
Minor congenital malformations
Robert (Carbamazepine), 1986 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Battino (Carbamazepine), 1992 Nulman (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 1997 Wide (Carbamazepine), 2000 Dean (Carbamazepine), 2002 Mari (Carbamazepine), 2022
7
2.63
[
1.25
; 5.54]
118
244
not evaluable
Neural Tube Defects
Canger (Carbamazepine), 1999 Mawer (Carbamazepine) (Controls unexposed, sick), 2010 Bànhidy (Carbamazepine), 2011 Hernández-Díaz (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2012 Vajda (Carbamazepine) (Controls unexposed, sick), 2013 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2018
7
2.40
[
1.00
; 5.77]
24
5,199
not evaluable
Microcephaly / Small head circumference for gestational age
Nulman (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 1997 Battino (Carbamazepine), 1999 Díaz-Romero (Carbamazepine), 1999 Holmes (Carbamazepine) (Controls unexposed, sick), 2001 Kini (Carbamazepine) (Controls unexposed, sick), 2006 Pennell (Carbamazepine), 2012 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
7
1.26
[
0.58
; 2.73]
482
919
not evaluable
Oro-facial clefts
Hernández-Díaz (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2012 Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Tomson (Carbamazepine), 2018 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023
7
1.23
[
0.71
; 2.12]
5,602
10,029
not evaluable
Club foot / Talipes equinovarus
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Bànhidy (Carbamazepine), 2011 Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023
5
1.21
[
0.48
; 3.01]
3,811
4,720
not evaluable
Polydactyly
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Bànhidy (Carbamazepine), 2011 Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Tomson (Carbamazepine), 2018
5
1.65
[
0.71
; 3.83]
3,095
3,553
not evaluable
Cleft lip with or without cleft palate
Artama (Carbamazepine), 2005 Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Jentink (Carbamazepine), 2010 Vajda (Carbamazepine) (Controls unexposed, sick), 2013 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
5
0.73
[
0.15
; 3.55]
1,640
1,750
not evaluable
Nervous system anomalies
Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 Thomas (Carbamazepine) (Controls unexposed, sick), 2021 Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023
4
1.12
[
0.41
; 3.07]
375
4,192
not evaluable
Urinary malformations
Artama (Carbamazepine), 2005 Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Tomson (Carbamazepine), 2018 Thomas (Carbamazepine) (Controls unexposed, sick), 2021
4
1.30
[
0.60
; 2.80]
38
3,937
not evaluable
Ano-rectal atresia and stenosis
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
2
1.70
[
0.20
; 14.15]
545
523
not evaluable
Cardiac septal defects
Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2014
2
0.88
[
0.54
; 1.43]
16,571
2,196
not evaluable
Craniosynostosis
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
2
2.56
[
0.25
; 25.83]
766
515
not evaluable
Digestive system anomalies
Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Thomas (Carbamazepine) (Controls unexposed, sick), 2021
3
0.76
[
0.32
; 1.80]
21
2,832
not evaluable
Genital anomalies
Artama (Carbamazepine), 2005 Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015
3
1.37
[
0.64
; 2.93]
1,044
1,833
not evaluable
Hip dislocation and/or dysplasia
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991
2
2.46
[
0.14
; 43.93]
-
14
not evaluable
Cleft palate
Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
2
5.03
[
1.14
; 22.26]
1,181
584
not evaluable
Diaphragmatic hernia
Jentink (Carbamazepine), 2010 Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
2
1.66
[
0.31
; 8.82]
378
512
not evaluable
Atrial septal defect
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
0.56
[
0.03
; 8.97]
3,268
512
not evaluable
Atrioventricular septal defect
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
3.46
[
0.22
; 55.50]
529
512
not evaluable
Bilateral renal agenesis including Potter syndrome
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
24.28
[
1.50
; 392.37]
75
512
not evaluable
Bladder exstrophy and/or epispadia
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
22.22
[
1.38
; 358.80]
82
512
not evaluable
Coarctation of aorta
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
2.35
[
0.15
; 37.68]
779
512
not evaluable
Congenital cataract
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991
1
0.65
[
0.02
; 17.40]
1
11
not evaluable
Down syndrom / Trisomy 21
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991
1
3.00
[
0.05
; 194.76]
-
3
not evaluable
Ebstein's anomaly
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
36.31
[
2.24
; 589.29]
50
512
not evaluable
Eye defects
Dean (Carbamazepine), 2002 Artama (Carbamazepine), 2005
2
0.49
[
0.16
; 1.52]
13
874
not evaluable
Gastroschisis
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
7.53
[
0.47
; 120.88]
243
512
not evaluable
Hypoplastic left heart (HLH/HLHS)
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
8.47
[
0.53
; 136.01]
216
512
not evaluable
Hypoplastic right heart (HRH/HRHS)
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
27.57
[
1.70
; 446.03]
66
512
not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
4.67
[
0.29
; 74.91]
392
512
not evaluable
Omphalocele
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
6.88
[
0.43
; 110.42]
266
512
not evaluable
Pulmonary valve atresia
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
12.02
[
0.75
; 193.35]
152
512
not evaluable
Tetralogy of Fallot
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
3.14
[
0.20
; 50.27]
584
512
not evaluable
Ventricular septal defect
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
0.39
[
0.02
; 6.31]
4,643
512
not evaluable
Chromosomal abnormalities
Artama (Carbamazepine), 2005
1
8.20
[
0.42
; 158.93]
3
805
not evaluable
Ear, face and neck anomalies
Artama (Carbamazepine), 2005
1
0.23
[
0.01
; 4.86]
2
805
not evaluable
Eye, ear, face and neck malformations
Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014
1
0.40
[
0.02
; 9.96]
1
685
not evaluable
Respiratory system anomalies
Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014
1
1.83
[
0.30
; 10.97]
5
685
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Diav-Citrin (Carbamazepine), 2001 Endo (Carbamazepine) (Controls unexposed, sick), 2004 McVearry (Carbamazepine), 2009 Cummings (Carbamazepine) (Controls unexposed, disease free), 2011 Nadebaum (Carbamazepine), 2011 Pennell (Carbamazepine), 2012 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Kilic (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 Arkilo (Carbamazepine), 2015 Bank (Carbamazepine) (Mixed indications), 2017 Cohen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
16
1.06
[
0.88
; 1.27]
252,464
3,556
critical
Small for gestational age (weight)
Wide (Carbamazepine), 2000 Endo (Carbamazepine) (Controls unexposed, sick), 2004 Burja (Carbamazepine) (Controls unexposed, sick), 2006 Pennell (Carbamazepine), 2012 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Kilic (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 Bank (Carbamazepine) (Mixed indications), 2017 Cohen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Dreier (Carbamazepine), 2021 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
13
1.12
[
0.93
; 1.36]
209,547
6,050
low
Low birth weight (< 2500g)
Kini (Carbamazepine) (Controls unexposed, sick), 2006 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Kilic (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020
5
1.26
[
0.93
; 1.70]
91,626
2,053
not evaluable
Large for gestational age (weight)
Artama (Carbamazepine) (Controls unexposed, sick), 2013 Aydin (Carbamazepine) (Controls unexposed, sick), 2020
2
0.88
[
0.59
; 1.32]
110
1,092
not evaluable
Macrosomia (> 4000g)
Endo (Carbamazepine) (Controls unexposed, sick), 2004 Kini (Carbamazepine) (Controls unexposed, sick), 2006 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020
3
0.99
[
0.82
; 1.20]
576,481
570
not evaluable
Very preterm (28 to 32 weeks)
Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020
1
1.28
[
0.41
; 3.99]
8,559
468
not evaluable
Extremely preterm (< 28 weeks)
Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020
1
0.90
[
0.06
; 14.35]
2,036
468
not evaluable
Large head circumference for gestational age
Díaz-Romero (Carbamazepine), 1999
1
0.29
[
0.01
; 16.12]
-
26
not evaluable
Maternal consequences
Caesarean
Endo (Carbamazepine) (Controls unexposed, sick), 2004 Borthen (Carbamazepine) (Controls unexposed, sick), 2010 Artama (Carbamazepine) (Controls unexposed, sick), 2013
3
1.03
[
0.88
; 1.21]
944
1,480
not evaluable
Preeclampsia
Borthen (Carbamazepine) (Controls unexposed, sick), 2011 Pennell (Carbamazepine), 2012 Cohen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 Aydin (Carbamazepine) (Controls unexposed, sick), 2020
4
1.24
[
0.92
; 1.67]
53,735
1,367
not evaluable
Assisted deliveries (forceps, vacuum, ...)
Endo (Carbamazepine) (Controls unexposed, sick), 2004 Borthen (Carbamazepine) (Controls unexposed, sick), 2010
2
0.82
[
0.11
; 5.98]
194
396
not evaluable
Gestational diabetes
McVearry (Carbamazepine), 2009 Pennell (Carbamazepine), 2012 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Mari (Carbamazepine), 2022
4
0.42
[
0.11
; 1.61]
11
152
not evaluable
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)
Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Mari (Carbamazepine), 2022
2
1.77
[
0.15
; 20.65]
2
44
not evaluable
Postpartum hemorrhage
Borthen (Carbamazepine) (Controls unexposed, sick), 2010
1
1.18
[
0.88
; 1.58]
342
388
not evaluable
Abruptio placentae (retroplacental hematoma)
Cohen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
0.92
[
0.52
; 1.63]
20,288
1,232
not evaluable
Polyhydramnios
Endo (Carbamazepine) (Controls unexposed, sick), 2004
1
0.23
[
0.00
; 17.06]
1
8
not evaluable
Maternal consequences (as a whole)
Alsfouk (Carbamazepine), 2022
1
2.53
[
0.59
; 10.85]
15
31
not evaluable
Maternal death
Mari (Carbamazepine), 2022
1
0.37
[
0.01
; 19.78]
-
29
not evaluable
Maternal liver disorder / failure during pregnancy
Mari (Carbamazepine), 2022
1
1.15
[
0.04
; 30.40]
1
29
not evaluable
Neonatal disorders
Low Apgar score (< 7) (at 5 min)
Borthen (Carbamazepine) (Controls unexposed, sick), 2010 Pennell (Carbamazepine), 2012 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Christensen (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2015 Bank (Carbamazepine) (Mixed indications), 2017
6
1.79
[
1.13
; 2.84]
132
1,146
not evaluable
Neonatal medical care
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Viinikainen (Carbamazepine) (Controls unexposed, disease free) a, 2006 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Bank (Carbamazepine) (Mixed indications), 2017 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
6
1.20
[
0.92
; 1.55]
2,090
1,029
serious
Low Apgar score (< 7) (at 1 min)
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Endo (Carbamazepine) (Controls unexposed, sick), 2004 Pennell (Carbamazepine), 2012 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Bank (Carbamazepine) (Mixed indications), 2017
5
1.18
[
0.80
; 1.73]
124
1,022
not evaluable
Neonatal disorders (as a whole)
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
3
0.97
[
0.75
; 1.26]
221,852
498
not evaluable
Feeding difficulty
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Yerby (Carbamazepine), 1992 Burja (Carbamazepine) (Controls unexposed, sick), 2006
3
1.49
[
0.22
; 9.94]
3
41
not evaluable
Neonatal intracranial hemorrhage
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 Burja (Carbamazepine) (Controls unexposed, sick), 2006
2
3.82
[
0.73
; 20.07]
6
22
not evaluable
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation
Burja (Carbamazepine) (Controls unexposed, sick), 2006
1
1.70
[
0.03
; 89.48]
-
19
not evaluable
Cerebral palsy
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991
1
6.79
[
0.25
; 182.34]
1
11
not evaluable
Jaundice
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991
1
3.50
[
0.14
; 84.70]
2
3
not evaluable
Neonatal death (< 28 days of life)
Holmes (Carbamazepine) (Controls unexposed, disease free), 2011
1
1.66
[
0.19
; 14.33]
6
573
not evaluable
Neonatal hypotonia
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991
1
3.00
[
0.05
; 194.76]
-
3
not evaluable
Neonatal infections
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991
1
3.00
[
0.05
; 194.76]
-
3
not evaluable
Neonatal tachypnea
D'Souza (Carbamazepine) (Controls unexposed, sick), 1991
1
3.00
[
0.05
; 194.76]
-
3
not evaluable
Fetal distress
McVearry (Carbamazepine), 2009
1
0.75
[
0.14
; 4.04]
7
16
not evaluable
Long term consequences
Behavioral disorders
Cohen (Carbamazepine), 2013 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Huber-Mollema (Carbamazepine), 2019 Dreier (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
4
1.12
[
0.67
; 1.87]
161
2,785
not evaluable
Child/Infant death (> 28 days of life)
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020
3
1.65
[
0.59
; 4.67]
4,708
1,557
not evaluable
Emotional disorders
Cohen (Carbamazepine), 2013 Huber-Mollema (Carbamazepine), 2019 Dreier (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
3
0.89
[
0.61
; 1.30]
128
2,754
not evaluable
Child/Infant growth abnormalities (> 1 year)
Pennell (Carbamazepine), 2012
1
0.52
[
0.12
; 2.16]
9
63
not evaluable
Child/Infant head circumference abnormalities (> 1 year)
Pennell (Carbamazepine), 2012
1
5.81
[
0.27
; 123.89]
2
52
not evaluable
Child/Infant lenght abnormalities (> 1 year)
Kini (Carbamazepine) (Controls unexposed, sick), 2006
1
1.65
[
0.45
; 6.05]
10
94
not evaluable
Child/Infant weight abnormalities (> 1 year)
Kini (Carbamazepine) (Controls unexposed, sick), 2006
1
1.25
[
0.43
; 3.59]
15
94
not evaluable
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Diav-Citrin (Carbamazepine), 2001 Meador (Carbamazepine), 2006 Holmes (Carbamazepine) (Controls unexposed, disease free), 2011 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2015 Arkilo (Carbamazepine), 2015 Miškov (Carbamazepine) (Controls unexposed, sick), 2016 Trivedi (Carbamazepine) (Controls unexposed, sick), 2018 Vajda (Carbamazepine) (Controls unexposed, sick), 2018 Meador (Carbamazepine) (Controls unexposed, sick), 2020
10
1.29
[
0.91
; 1.83]
584
5,135
critical
Late intrauterine deaths (> 22 weeks)
Diav-Citrin (Carbamazepine), 2001 Holmes (Carbamazepine) (Controls unexposed, disease free), 2011 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2015 Arkilo (Carbamazepine), 2015 AlSheikh (Carbamazepine) (Controls unexposed, sick), 2020 Aydin (Carbamazepine) (Controls unexposed, sick), 2020 Mari (Carbamazepine), 2022
8
1.53
[
0.71
; 3.30]
49
4,177
not evaluable
Elective/induced termination of pregnancy
Diav-Citrin (Carbamazepine), 2001 Holmes (Carbamazepine) (Controls unexposed, disease free), 2011 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Miškov (Carbamazepine) (Controls unexposed, sick), 2016 Hosny (Carbamazepine) (Controls unexposed, sick), 2021 Mari (Carbamazepine), 2022
6
1.82
[
1.01
; 3.28]
43
2,472
serious
Early intrauterine death (< 22 weeks)
Diav-Citrin (Carbamazepine), 2001 Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 Tomson (Carbamazepine), 2015 Arkilo (Carbamazepine), 2015 Miškov (Carbamazepine) (Controls unexposed, sick), 2016
5
0.90
[
0.74
; 1.10]
431
3,569
not evaluable
Perinatal death
Canger (Carbamazepine), 1999 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Tomson (Carbamazepine), 2015
3
1.42
[
0.62
; 3.25]
26
2,767
not evaluable
Therapeutic terminations of pregnancy
Miškov (Carbamazepine) (Controls unexposed, sick), 2016
1
0.28
[
0.00
; 16.82]
-
13
not evaluable
Ectopic pregnancy
Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014
1
3.84
[
0.16
; 94.34]
1
1,718
not evaluable
Neuro-developmental disorders
Language disorders/delay
Gaily (Carbamazepine) (Controls unexposed, sick), 2004 Adab (Carbamazepine), 2004 Eriksson (Carbamazepine), 2005 Nadebaum (Carbamazepine), 2011 Meador (Carbamazepine), 2013 Baker (Carbamazepine) (Controls unexposed, sick), 2015 Deshmukh (Carbamazepine), 2016 Videman (Carbamazepine) (Controls unexposed, disease free), 2016 Kasradze (Carbamazepine) (Controls unexposed, disease free), 2017 Husebye (Carbamazepine) (Controls unexposed, sick), 2020 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Meador (Carbamazepine) (Controls unexposed, disease free), 2021 Adams (Carbamazepine), 2022 Thomas (Carbamazepine), 2022 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
15
1.62
[
1.13
; 2.33]
71,992
1,021
probable
Cognitive developmental disorders/delay (> 6 years old)
Adab (Carbamazepine), 2004 Gaily (Carbamazepine) (Controls unexposed, sick), 2004 Vinten (Carbamazepine), 2005 Viinikainen (Carbamazepine) b, 2006 Titze (Carbamazepine) (Controls unexposed, sick), 2008 Nadebaum (Carbamazepine), 2011 Meador (Carbamazepine), 2013 Baker (Carbamazepine) (Controls unexposed, sick), 2015 Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022 Adams (Carbamazepine), 2022 Thomas (Carbamazepine), 2022
11
1.34
[
0.94
; 1.92]
195
3,687
low
Neuro-developmental disorders (as a whole)
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Katz (Carbamazepine), 2001 Adab (Carbamazepine), 2004 Viinikainen (Carbamazepine) b, 2006 Dean (Carbamazepine) (Controls unexposed, sick), 2007 Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Arkilo (Carbamazepine), 2015 Charlton (Carbamazepine) (Controls unexposed, sick), 2017 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022
10
1.46
[
1.05
; 2.03]
10,594
4,118
low
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Viinikainen (Carbamazepine) b, 2006 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Cohen (Carbamazepine), 2013 Richards (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2019 Huber-Mollema (Carbamazepine), 2019 Wiggs (Carbamazepine), 2020 Dreier (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
8
1.18
[
1.00
; 1.40]
12,499
3,028
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Wood (Carbamazepine), 2015 Bjørk (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2018 Bjørk (Carbamazepine) (Controls unexposed, sick), 2018 Huber-Mollema (Carbamazepine), 2019 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Wiggs (Carbamazepine), 2020 Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022 Bjørk (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2022
9
1.21
[
1.01
; 1.45]
43,102
7,183
not evaluable
Psychomotor developmental disorders/delay
Ornoy (Carbamazepine), 1996 Adab (Carbamazepine), 2004 Viinikainen (Carbamazepine) b, 2006 Thomas b (Carbamazepine), 2008 Cohen (Carbamazepine), 2011 Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Deshmukh (Carbamazepine), 2016 Videman (Carbamazepine) (Controls unexposed, disease free), 2016 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
9
1.01
[
0.69
; 1.47]
65
425
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Wood (Carbamazepine), 2015 Huber-Mollema (Carbamazepine), 2019 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Wiggs (Carbamazepine), 2020 Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022
6
1.14
[
0.90
; 1.44]
4,572
3,845
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Gaily (Carbamazepine) (Controls unexposed, sick), 2004 Vinten (Carbamazepine), 2005 Viinikainen (Carbamazepine) b, 2006 Titze (Carbamazepine) (Controls unexposed, sick), 2008 Meador (Carbamazepine), 2013 Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022
6
1.60
[
1.14
; 2.27]
190
3,472
not evaluable
Cognitive developmental disorders/delay (< 3 years old)
Ornoy (Carbamazepine), 1996 Wide (Carbamazepine), 2000 Thomas b (Carbamazepine), 2008 Bromley (Carbamazepine) (Controls unexposed, sick), 2010 Meador (Carbamazepine), 2013 Videman (Carbamazepine) (Controls unexposed, disease free), 2016 Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
7
1.71
[
0.73
; 4.01]
85
303
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Bromley (Carbamazepine) (Controls unexposed, sick), 2013 Cohen (Carbamazepine), 2013 Huber-Mollema (Carbamazepine), 2019 Wiggs (Carbamazepine), 2020 Dreier (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023
5
1.11
[
0.93
; 1.33]
633
2,784
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Cummings (Carbamazepine) (Controls unexposed, disease free), 2011 Meador (Carbamazepine), 2013 Deshmukh (Carbamazepine), 2016 Kasradze (Carbamazepine) (Controls unexposed, disease free), 2017 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020
5
2.75
[
1.33
; 5.68]
3,419
684
not evaluable
ADHD (Attention deficit hyperactivity disorder): Risk
Viinikainen (Carbamazepine) b, 2006 Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 Cohen (Carbamazepine), 2013 Huber-Mollema (Carbamazepine), 2019 Richards (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2019
5
1.66
[
1.08
; 2.54]
11,888
332
not evaluable
Learning disorders
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Forsberg (Carbamazepine) (Controls unexposed, sick), 2011 Ren (Carbamazepine) (Mixed indications), 2023
3
1.24
[
0.94
; 1.65]
51
455
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Cummings (Carbamazepine) (Controls unexposed, disease free), 2011 Meador (Carbamazepine), 2013 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020
3
2.02
[
0.65
; 6.23]
3,392
571
not evaluable
ASD (Autism spectrum disorder): Risk
Wood (Carbamazepine), 2015 Bjørk (Carbamazepine) (Controls unexposed, sick), 2018 Huber-Mollema (Carbamazepine), 2019
3
1.27
[
0.53
; 3.03]
38
111
not evaluable
Childhood autism (F84.0)
Christensen (Carbamazepine) (Controls unexposed NOS) (Indications NOS), 2013
1
1.40
[
0.37
; 5.33]
2,067
386
not evaluable
Severe cognitive developmental delay (Mental retardation) (< 3 years old)
Meador (Carbamazepine), 2013
1
1.48
[
0.45
; 4.89]
12
48
not evaluable
0.0
100.0
1.0