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Levetiracetam (Epilepsy)
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)
Morrow (Levetiracetam) (Controls unexposed, sick), 2006 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Alsaadi (Controls unexposed sick), 2020 Hosny (Levetiracetam) (Controls unexposed, sick), 2021 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Mari (Levetiracetam), 2022 Cohen (Levetiracetam) (Epilepsy) (Controls unexposed, NOS), 2023 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 Wiggs, 2024 Hoeltzenbein (Levetiracetam), 2024 Battino, 2024 Vajda (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2025 Hao (Controls unexposed, sick), 2025 The NAAED (Levetiracetam) (Epilepsy), 2025 Seo (Levetiracetam) (Epilepsy), 2026
17
0.93
[
0.79
; 1.10]
148,392
5,018
low
Major congenital malformations
Morrow (Levetiracetam) (Controls unexposed, sick), 2006 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Alsaadi (Controls unexposed sick), 2020 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Hosny (Levetiracetam) (Controls unexposed, sick), 2021 Mari (Levetiracetam), 2022 Cohen (Levetiracetam) (Epilepsy) (Controls unexposed, NOS), 2023 Hoeltzenbein (Levetiracetam), 2024 Battino, 2024 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 Wiggs, 2024 Vajda (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2025 Hao (Controls unexposed, sick), 2025 The NAAED (Levetiracetam) (Epilepsy), 2025 Seo (Levetiracetam) (Epilepsy), 2026
16
0.91
[
0.77
; 1.08]
148,377
5,008
low
Congenital heart defects
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Epilepsy), 2012 Tomson (Levetiracetam), 2018 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs, 2024 Seo (Levetiracetam) (Epilepsy), 2026
6
1.00
[
0.70
; 1.43]
40
1,362
not evaluable
Minor congenital malformations
Alsaadi (Controls unexposed sick), 2020 Mari (Levetiracetam), 2022 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024
3
2.57
[
0.62
; 10.76]
16
73
not evaluable
Limb defects
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs, 2024 Seo (Levetiracetam) (Epilepsy), 2026
4
1.39
[
0.62
; 3.11]
6
313
not evaluable
Digestive system anomalies
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs, 2024
3
1.90
[
0.47
; 7.61]
4
313
not evaluable
Hypospadias
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Epilepsy), 2012 Tomson (Levetiracetam), 2018
3
1.28
[
0.27
; 6.13]
13
1,071
not evaluable
Nervous system anomalies
Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Wiggs, 2024
2
1.95
[
0.32
; 11.86]
-
291
not evaluable
Neural Tube Defects
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Epilepsy), 2012 Tomson (Levetiracetam), 2018
3
2.59
[
0.50
; 13.52]
5
1,071
not evaluable
Oro-facial clefts
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Epilepsy), 2012 Tomson (Levetiracetam), 2018
3
1.34
[
0.20
; 9.12]
12
1,071
not evaluable
Spina bifida
Vajda (Levetiracetam) (Controls unexposed, sick), 2013 Veiby (Levetiracetam) (Controls unexposed, sick), 2014
2
3.67
[
0.34
; 39.26]
3
177
not evaluable
Urinary malformations
Tomson (Levetiracetam), 2018 Thomas (Levetiracetam) (Controls unexposed, sick), 2021
2
0.53
[
0.12
; 2.33]
16
705
not evaluable
Microcephaly / Small head circumference for gestational age
Christensen (Levetiracetam) (Epilepsy) (Controls unexposed, general population), 2024
1
0.86
[
0.58
; 1.27]
730
1,063
not evaluable
Cleft lip with or without cleft palate
Vajda (Levetiracetam) (Controls unexposed, sick), 2013
1
2.34
[
0.05
; 119.47]
-
63
not evaluable
Polydactyly
Tomson (Levetiracetam), 2018
1
4.20
[
0.08
; 211.88]
-
599
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Arkilo (Levetiracetam), 2015 Margulis, 2019 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 Hoeltzenbein (Levetiracetam), 2024
8
1.50
[
1.19
; 1.89]
91,481
1,145
not evaluable
Small for gestational age (weight)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 Christensen (Levetiracetam) (Epilepsy) (Controls unexposed, general population), 2024
5
1.18
[
0.84
; 1.67]
170,027
1,853
not evaluable
Large for gestational age (weight)
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Aydin (Levetiracetam) (Controls unexposed, sick), 2020
2
1.28
[
0.13
; 12.96]
71
23
not evaluable
Low birth weight (< 2500g)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Christensen (Levetiracetam) (Epilepsy) (Controls unexposed, general population), 2024
2
1.44
[
0.83
; 2.49]
92,571
1,684
not evaluable
Very preterm (28 to 32 weeks)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021
2
1.10
[
0.20
; 5.96]
8,593
718
not evaluable
Extremely preterm (< 28 weeks)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021
2
1.01
[
0.19
; 5.41]
2,043
718
not evaluable
Macrosomia (> 4000g)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020
1
0.67
[
0.56
; 0.80]
577,255
621
not evaluable
Maternal consequences
Caesarean
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Koc (Levetiracetam), 2018
2
1.50
[
0.67
; 3.41]
365
41
not evaluable
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)
Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Mari (Levetiracetam), 2022
2
1.20
[
0.07
; 20.23]
-
27
not evaluable
Gestational diabetes
Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Mari (Levetiracetam), 2022
2
0.37
[
0.04
; 3.82]
2
27
not evaluable
Maternal consequences (as a whole)
Alsfouk (Levetiracetam), 2022 Razaz (Levetiracetam), 2024
2
1.27
[
0.93
; 1.73]
710
1,033
not evaluable
Preeclampsia
Aydin (Levetiracetam) (Controls unexposed, sick), 2020
1
2.26
[
0.04
; 122.79]
-
10
not evaluable
Maternal death
Mari (Levetiracetam), 2022
1
0.64
[
0.01
; 34.59]
-
17
not evaluable
Maternal liver disorder / failure during pregnancy or Intrahepatic cholestasis of pregnancy
Mari (Levetiracetam), 2022
1
0.64
[
0.01
; 34.59]
-
17
not evaluable
Neonatal disorders
Neonatal medical care
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Bromley (Levetiracetam) (Controls unexposed, sick), 2023
3
1.50
[
0.63
; 3.59]
170
92
not evaluable
Neonatal disorders (as a whole)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bromley (Levetiracetam) (Controls unexposed, sick), 2023
2
1.06
[
0.85
; 1.33]
222,315
691
not evaluable
Low Apgar score (< 7) (at 1 min)
Artama (Levetiracetam) (Controls unexposed, sick), 2013
1
1.59
[
0.19
; 13.19]
70
12
not evaluable
Low Apgar score (< 7) (at 5 min)
Artama (Levetiracetam) (Controls unexposed, sick), 2013
1
8.06
[
0.39
; 165.09]
3
12
not evaluable
Long term consequences
Child/Infant death (> 28 days of life)
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Coste (Levetiracetam) (Controls unexposed, NOS), 2020
2
2.96
[
0.53
; 16.41]
4,703
634
not evaluable
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Arkilo (Levetiracetam), 2015 Tomson (Levetiracetam), 2015 Koc (Levetiracetam), 2018 Trivedi (Levetiracetam) (Controls unexposed, sick), 2018 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Vajda (Levetiracetam) (Controls unexposed sick), 2024 Moore (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2025
7
0.87
[
0.72
; 1.05]
1,662
1,271
not evaluable
Late intrauterine deaths (> 22 weeks) / Stillbirths
Arkilo (Levetiracetam), 2015 Tomson (Levetiracetam), 2015 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 AlSheikh (Levetiracetam) (Controls unexposed, sick), 2020 Mari (Levetiracetam), 2022 Hoeltzenbein (Levetiracetam), 2024
6
1.80
[
0.52
; 6.28]
11
592
not evaluable
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions
Babic (Levetiracetam), 2014 Arkilo (Levetiracetam), 2015 Tomson (Levetiracetam), 2015 Alsaadi (Controls unexposed sick), 2020 Hoeltzenbein (Levetiracetam), 2024
5
1.11
[
0.77
; 1.60]
220
606
not evaluable
Elective/induced termination of pregnancy
Hosny (Levetiracetam) (Controls unexposed, sick), 2021 Mari (Levetiracetam), 2022 Hoeltzenbein (Levetiracetam), 2024
3
0.88
[
0.25
; 3.08]
13
305
not evaluable
Perinatal death
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Tomson (Levetiracetam), 2015
2
2.47
[
0.31
; 19.60]
13
309
not evaluable
Neuro-developmental disorders
Language disorders/delay
Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Bromley (Levetiracetam), 2016 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Husebye (Levetiracetam) (Controls unexposed, sick), 2020 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 Stjerna (Levetiracetam) (Epilepsy), 2024 Bhaskaran, 2025 Honybun (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026 Li (Controls unexposed, disease free) (Levetiracetam) (Epilepsy), 2026 Straub (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026
11
1.01
[
0.78
; 1.29]
72,724
4,826
low
ASD (Autism spectrum disorder): Diagnosis/Risk
Bjørk (Levetiracetam) (Controls unexposed, sick), 2018 Huber-Mollema (Levetiracetam), 2019 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 Karayagmurlu (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026 Straub (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026
8
1.25
[
0.67
; 2.33]
5,283
6,385
serious
ASD (Autism spectrum disorder): Diagnosis
Huber-Mollema (Levetiracetam), 2019 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 Karayagmurlu (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026 Straub (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026
7
1.01
[
0.57
; 1.77]
5,252
6,373
not evaluable
Psychomotor developmental disorders/delay
Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Thomas (Controls unexposed, sick), 2022 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 Honybun (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026 Li (Controls unexposed, disease free) (Levetiracetam) (Epilepsy), 2026 Straub (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026
7
0.95
[
0.53
; 1.71]
136
4,187
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Bromley (Levetiracetam), 2016 Huber-Mollema (Levetiracetam), 2019 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 Straub (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026
6
1.03
[
0.79
; 1.34]
2,130
5,792
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Huber-Mollema (Levetiracetam), 2019 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Straub (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026
5
1.07
[
0.77
; 1.51]
2,130
5,750
not evaluable
Cognitive developmental disorders/delay (< 3 years old)
Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Thomas (Controls unexposed, sick), 2022 Bromley (Levetiracetam) (Controls unexposed, sick), 2023 Ertürk Çetin (Epilepsy) (Levetiracetam), 2024
5
0.97
[
0.41
; 2.30]
23
189
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 Straub (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026
4
0.80
[
0.39
; 1.65]
3,614
5,280
not evaluable
Neuro-developmental disorders (as a whole)
Arkilo (Levetiracetam), 2015 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bjørk (Levetiracetam) (Controls unexposed, sick), 2022
3
1.08
[
0.65
; 1.80]
10,470
1,636
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 Straub (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026
4
0.80
[
0.39
; 1.65]
3,614
5,280
not evaluable
ASD (Autism spectrum disorder): Risk
Bjørk (Levetiracetam) (Controls unexposed, sick), 2018 Huber-Mollema (Levetiracetam), 2019
2
2.39
[
0.45
; 12.72]
36
40
not evaluable
Cognitive developmental disorders/delay (> 6 years old)
Stjerna (Levetiracetam) (Epilepsy), 2024 Honybun (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026
2
2.40
[
0.60
; 9.67]
-
36
not evaluable
Learning disorders
Honybun (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026 Straub (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026
2
2.97
[
0.30
; 29.44]
34
3,943
not evaluable
ADHD (Attention deficit hyperactivity disorder): Risk
Bromley (Levetiracetam), 2016 Huber-Mollema (Levetiracetam), 2019
2
0.91
[
0.47
; 1.79]
7
70
not evaluable
0.0
100.0
1.0
