Oxcarbazepine (Epilepsy) updated on 12-01-2025

Table   Graphic     exposition period:

Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
All congenital malformations (majors, minors, majors and minors, or unspecified)1.36 [0.95, 1.94]20%15 studies148,3712,415low ROB-
Major congenital malformations1.38 [0.95, 2.01]25%13 studies148,3442,312low ROB-
Congenital heart defects1.93 [0.87, 4.24]0%4 studies42510not evaluable ROB-
Limb defects2.81 [0.46, 17.19]22%3 studies12177not evaluable ROB-
Spina bifida13.65 [1.72, 108.21]0%3 studies3152not evaluable ROB26.79 [2.84; .]
Urinary malformations0.92 [0.20, 4.14]0%3 studies16503not evaluable ROB-
Digestive system anomalies5.01 [0.55, 45.94]0%2 studies478not evaluable ROB-
Cleft lip with or without cleft palate5.45 [0.36, 83.53]15%2 studies2101not evaluable ROB-
Hypospadias2.04 [0.16, 25.25]32%2 studies12340not evaluable ROB-
Microcephaly / Small head circumference for gestational age0.96 [0.66, 1.39]-1 study7471,462not evaluable ROB-
Nervous system anomalies4.82 [0.09, 244.75]-1 study71not evaluable ROB-
Neural Tube Defects8.87 [0.71, 110.59]17%2 studies2340not evaluable ROB-
Oro-facial clefts6.85 [0.59, 80.08]37%2 studies5340not evaluable ROB-
Polydactyly26.41 [2.05, 340.38]0%2 studies1335not evaluable ROB52.32 [3.52; .]
Chromosomal abnormalities9.53 [0.19, 482.86]-1 study99not evaluable ROB-
Cleft palate34.33 [0.49, 2389.88]-1 study2not evaluable ROB-
Ear, face and neck anomalies1.90 [0.09, 39.89]-1 study299not evaluable ROB-
Eye defects3.17 [0.13, 78.41]-1 study199not evaluable ROB-
Genital anomalies1.91 [0.22, 16.48]-1 study699not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.16 [0.88, 1.53]0%4 studies91,375674not evaluable ROB-
Small for gestational age (weight)1.37 [0.99, 1.89]31%4 studies170,0291,609not evaluable ROB-
Large for gestational age (weight)0.78 [0.26, 2.30]10%2 studies86531not evaluable ROB-
Low birth weight (< 2500g)1.24 [0.94, 1.62]4%2 studies92,5441,605not evaluable ROB-
Macrosomia (> 4000g)0.79 [0.55, 1.13]-1 study577,138143not evaluable ROB-
Very preterm (28 to 32 weeks)0.70 [0.04, 11.18]-1 study8,584143not evaluable ROB-
Extremely preterm (< 28 weeks)5.89 [0.82, 42.16]-1 study2,042143not evaluable ROB-

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preeclampsia1.61 [0.75, 3.47]0%2 studies4not evaluable ROB-
Caesarean0.98 [0.76, 1.27]-1 study430532not evaluable ROB-
Abruptio placentae (retroplacental hematoma)1.34 [0.26, 6.90]-1 studynot evaluable ROB-
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)6.14 [0.10, 363.16]-1 study4not evaluable ROB-
Gestational diabetes1.95 [0.07, 58.24]-1 study14not evaluable ROB-
Maternal consequences (as a whole)1.53 [1.08, 2.17]-1 study7121,439not evaluable ROB2.43 [1.37; .]

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal medical care3.13 [0.43, 22.52]63%3 studies2,025471not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.33 [0.83, 2.13]-1 study96465not evaluable ROB-
Low Apgar score (< 7) (at 5 min)0.70 [0.14, 3.49]-1 study5230not evaluable ROB-
Neonatal disorders (as a whole)0.90 [0.54, 1.50]-1 study222,218143not evaluable ROB-

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)1.87 [0.52, 6.65]0%2 studies4,704670not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)4.29 [0.62, 29.59]78%3 studies183332not evaluable ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths2.79 [0.68, 11.38]0%3 studies8269not evaluable ROB-
Perinatal death2.56 [0.96, 6.84]0%2 studies20772not evaluable ROB-
Elective/induced termination of pregnancy8.20 [0.13, 511.93]-1 study3not evaluable ROB-
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.01 [0.62, 1.65]-1 study164262not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis/Risk1.24 [0.82, 1.87]0%3 studies4,6621,607not evaluable ROB-
Language disorders/delay2.52 [0.94, 6.73]70%3 studies72,025166not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.24 [0.82, 1.87]0%2 studies4,6351,603not evaluable ROB-
Neuro-developmental disorders (as a whole)0.96 [0.68, 1.36]0%2 studies10,0111,572not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)1.71 [0.18, 16.19]90%2 studies52not evaluable ROB-
Psychomotor developmental disorders/delay1.24 [0.51, 3.06]47%2 studies52not evaluable ROB-
ASD (Autism spectrum disorder): Risk1.27 [0.06, 25.24]-1 study274not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)1.76 [0.11, 28.32]-1 study3,398143not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)1.76 [0.11, 28.32]-1 study3,398143not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis0.99 [0.70, 1.40]-1 study5801,460not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk0.99 [0.70, 1.40]-1 study5801,460not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)1.15 [0.70, 1.88]-1 study2081,460not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.15 [0.70, 1.88]-1 study2081,460not evaluable ROB-

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