Levetiracetam (All indications) updated on 06-15-2026

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Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
All congenital malformations (majors, minors, majors and minors, or unspecified)0.97 [0.82, 1.15]0%17 studies148,3695,162low ROB-
Major congenital malformations0.95 [0.80, 1.13]0%16 studies148,3545,152low ROB-
Congenital heart defects1.00 [0.70, 1.43]0%6 studies401,362not evaluable ROB-
Hypospadias1.79 [0.48, 6.63]10%5 studies5,8132,192not evaluable ROB-
Microcephaly / Small head circumference for gestational age0.92 [0.64, 1.34]0%3 studies136,9672,198not evaluable ROB-
Minor congenital malformations2.57 [0.62, 10.76]0%3 studies1673not evaluable ROB-
Cleft lip with or without cleft palate1.74 [0.37, 8.18]0%3 studies3,5491,184not evaluable ROB-
Limb defects1.39 [0.62, 3.11]28%4 studies6313not evaluable ROB-
Oro-facial clefts1.24 [0.37, 4.19]0%4 studies2,8281,650not evaluable ROB-
Spina bifida3.19 [0.53, 19.33]0%3 studies619756not evaluable ROB-
Atrial septal defect1.31 [0.84, 2.05]0%2 studies84,5481,121not evaluable ROB-
Cleft palate1.08 [0.19, 6.14]0%2 studies4,2651,121not evaluable ROB-
Club foot / Talipes equinovarus1.72 [0.61, 4.81]0%2 studies20,0551,121not evaluable ROB-
Diaphragmatic hernia1.93 [0.45, 8.19]0%2 studies3,7791,121not evaluable ROB-
Digestive system anomalies1.90 [0.47, 7.61]0%3 studies4313not evaluable ROB-
Ventricular septal defect1.09 [0.49, 2.46]0%2 studies25,6411,121not evaluable ROB-
Nervous system anomalies1.95 [0.32, 11.86]0%2 studies291not evaluable ROB-
Neural Tube Defects2.59 [0.50, 13.52]0%3 studies51,071not evaluable ROB-
Urinary malformations0.53 [0.12, 2.33]0%2 studies16705not evaluable ROB-
Ano-rectal atresia and stenosis2.98 [0.19, 47.71]-1 study544579not evaluable ROB-
Atrioventricular septal defect3.06 [0.19, 49.06]-1 study529579not evaluable ROB-
Bilateral renal agenesis including Potter syndrome21.47 [1.33, 346.88]-1 study75579not evaluable ROB42.44 [1.99; .]
Bladder exstrophy and/or epispadia19.65 [1.22, 317.20]-1 study82579not evaluable ROB38.79 [1.73; .]
Coarctation of aorta4.20 [0.27, 64.25]-1 study780579not evaluable ROB-
Craniosynostosis4.20 [0.27, 64.79]-1 study767579not evaluable ROB-
Ebstein's anomaly32.10 [1.98, 520.95]-1 study50579not evaluable ROB63.70 [3.37; .]
Gastroschisis6.66 [0.41, 106.87]-1 study243579not evaluable ROB-
Hypoplastic left heart (HLH/HLHS)15.10 [1.03, 220.38]-1 study217579not evaluable ROB29.69 [1.22; .]
Hypoplastic right heart (HRH/HRHS)24.38 [1.51, 394.31]-1 study66579not evaluable ROB48.25 [2.38; .]
Oesophageal atresia with or without tracheo-oesophageal fistula4.13 [0.26, 66.22]-1 study392579not evaluable ROB-
Omphalocele6.08 [0.38, 97.62]-1 study266579not evaluable ROB-
Pulmonary valve atresia10.63 [0.66, 170.93]-1 study152579not evaluable ROB-
Tetralogy of Fallot2.77 [0.17, 44.44]-1 study584579not evaluable ROB-
Hydrocephaly18.30 [0.35, 960.46]-1 study1,067542not evaluable ROB-
Polydactyly4.20 [0.08, 211.88]-1 study599not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.24 [0.82, 1.88]75%12 studies128,8763,293low ROB-
Small for gestational age (weight)1.11 [0.86, 1.43]51%7 studies614,1193,157not evaluable ROB-
Low birth weight (< 2500g)1.53 [1.11, 2.11]72%3 studies263,9862,530not evaluable ROB2.43 [1.46; .]
Large for gestational age (weight)1.28 [0.13, 12.96]0%2 studies7123not evaluable ROB-
Very preterm (28 to 32 weeks)1.10 [0.20, 5.96]51%2 studies8,593718not evaluable ROB-
Extremely preterm (< 28 weeks)1.01 [0.19, 5.41]0%2 studies2,043718not evaluable ROB-
Macrosomia (> 4000g)0.67 [0.56, 0.80]-1 study577,255621not evaluable ROB2.35 [.; 1.80]

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.32 [1.06, 1.65]0%3 studies186,932873not evaluable ROB1.98 [1.32; .]
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)1.20 [0.07, 20.23]0%2 studies27not evaluable ROB-
Gestational diabetes0.37 [0.04, 3.82]0%2 studies227not evaluable ROB-
Maternal consequences (as a whole)1.27 [0.93, 1.73]0%2 studies7101,033not evaluable ROB-
Postpartum hemorrhage1.05 [0.85, 1.29]-1 study203,497832not evaluable ROB-
Preeclampsia2.26 [0.04, 122.79]-1 study10not evaluable ROB-
Maternal death0.64 [0.01, 34.59]-1 study17not evaluable ROB-
Maternal liver disorder / failure during pregnancy or Intrahepatic cholestasis of pregnancy0.64 [0.01, 34.59]-1 study17not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal medical care1.44 [1.10, 1.90]0%5 studies45,039931not evaluable ROB2.24 [1.42; .]
Low Apgar score (< 7) (at 5 min)1.50 [0.97, 2.31]0%3 studies16,382851not evaluable ROB-
Low Apgar score (< 7) (at 1 min)2.01 [0.39, 10.26]0%2 studies7319not evaluable ROB-
Neonatal disorders (as a whole)1.06 [0.85, 1.33]0%2 studies222,315691not evaluable ROB-

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)2.96 [0.53, 16.41]35%2 studies4,703634not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)0.95 [0.81, 1.12]0%7 studies2,5701,796not evaluable ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths1.80 [0.52, 6.28]0%6 studies11592not evaluable ROB-
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.11 [0.77, 1.60]0%5 studies220606not evaluable ROB-
Elective/induced termination of pregnancy0.82 [0.64, 1.06]0%4 studies1,6321,316not evaluable ROB-
Perinatal death2.47 [0.31, 19.60]0%2 studies13309not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Language disorders/delay1.10 [0.86, 1.42]48%12 studies73,4575,353low ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.25 [0.68, 2.29]64%8 studies73,5206,404serious ROB-
ASD (Autism spectrum disorder): Diagnosis1.01 [0.58, 1.75]53%7 studies73,4896,392not evaluable ROB-
Psychomotor developmental disorders/delay0.94 [0.57, 1.53]74%8 studies1924,714not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.04 [0.79, 1.37]20%6 studies148,6045,868not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.09 [0.78, 1.54]34%5 studies148,6045,826not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)0.97 [0.41, 2.30]52%5 studies23189not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)0.72 [0.35, 1.48]0%4 studies4,5185,356not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)0.72 [0.35, 1.48]0%4 studies4,5185,356not evaluable ROB-
Neuro-developmental disorders (as a whole)1.08 [0.65, 1.80]0%3 studies10,4701,636not evaluable ROB-
ASD (Autism spectrum disorder): Risk2.39 [0.45, 12.72]46%2 studies3640not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)2.32 [0.96, 5.62]38%3 studies878not evaluable ROB-
Learning disorders 2.97 [0.30, 29.44]86%2 studies3,943not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk0.91 [0.47, 1.79]0%2 studies770not evaluable ROB-

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