Oxcarbazepine (All indications) updated on 04-22-2025

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)1.46 [1.07, 1.98]12%16 studies197,8492,497low ROB2.27 [1.34; .]
Major congenital malformations1.48 [1.07, 2.05]17%14 studies197,8222,394probable ROB2.32 [1.33; .]
Spina bifida12.20 [2.32, 64.13]0%4 studies619297not evaluable ROB23.88 [4.07; .]
Congenital heart defects1.93 [0.87, 4.24]0%4 studies42510not evaluable ROB-
Oro-facial clefts4.48 [1.11, 18.10]0%4 studies2,821536not evaluable ROB8.44 [1.46; .]
Cleft lip with or without cleft palate4.64 [0.73, 29.40]0%3 studies1,639240not evaluable ROB-
Hypospadias2.01 [0.38, 10.55]0%3 studies3,383479not evaluable ROB-
Limb defects2.81 [0.46, 17.19]22%3 studies12177not evaluable ROB-
Microcephaly / Small head circumference for gestational age2.75 [0.21, 35.80]72%2 studies134,5131,730not evaluable ROB-
Urinary malformations0.92 [0.20, 4.14]0%3 studies16503not evaluable ROB-
Cleft palate9.82 [0.96, 100.29]0%2 studies1,178141not evaluable ROB-
Digestive system anomalies5.01 [0.55, 45.94]0%2 studies478not evaluable ROB-
Ano-rectal atresia and stenosis12.43 [0.77, 200.03]-1 study544139not evaluable ROB-
Atrial septal defect4.10 [0.27, 62.58]-1 study3,269139not evaluable ROB-
Atrioventricular septal defect12.79 [0.79, 205.70]-1 study529139not evaluable ROB-
Bilateral renal agenesis including Potter syndrome89.69 [5.53, 1454.36]-1 study75139not evaluable ROB178.87 [10.54; .]
Bladder exstrophy and/or epispadia82.08 [5.07, 1329.93]-1 study82139not evaluable ROB163.65 [9.60; .]
Club foot / Talipes equinovarus4.03 [0.25, 64.83]-1 study1,677139not evaluable ROB-
Coarctation of aorta8.68 [0.54, 139.65]-1 study779139not evaluable ROB-
Craniosynostosis8.83 [0.55, 142.03]-1 study766139not evaluable ROB-
Diaphragmatic hernia17.89 [1.11, 287.94]-1 study378139not evaluable ROB35.27 [1.46; .]
Ebstein's anomaly134.09 [8.23, 2184.22]-1 study50139not evaluable ROB267.67 [15.95; .]
Gastroschisis27.81 [1.73, 448.07]-1 study243139not evaluable ROB55.11 [2.84; .]
Hypoplastic left heart (HLH/HLHS)31.27 [1.94, 504.13]-1 study216139not evaluable ROB62.04 [3.29; .]
Hypoplastic right heart (HRH/HRHS)101.82 [6.27, 1653.25]-1 study66139not evaluable ROB203.15 [12.02; .]
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-
Oesophageal atresia with or without tracheo-oesophageal fistula17.25 [1.07, 277.65]-1 study392139not evaluable ROB33.99 [1.35; .]
Omphalocele25.41 [1.58, 409.29]-1 study266139not evaluable ROB50.31 [2.53; .]
Polydactyly26.41 [2.05, 340.38]0%2 studies1335not evaluable ROB52.32 [3.52; .]
Pulmonary valve atresia44.40 [2.75, 716.69]-1 study152139not evaluable ROB88.30 [4.95; .]
Tetralogy of Fallot11.58 [0.72, 186.32]-1 study584139not evaluable ROB-
Ventricular septal defect1.45 [0.09, 23.38]-1 study4,643139not evaluable ROB-
Chromosomal abnormalities9.53 [0.19, 482.86]-1 study99not 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)1.07 [0.94, 1.21]0%6 studies252,5702,097not evaluable ROB-
Small for gestational age (weight)1.23 [0.85, 1.77]65%5 studies655,6032,851not evaluable ROB-
Large for gestational age (weight)0.78 [0.26, 2.30]10%2 studies86531not evaluable ROB-
Low birth weight (< 2500g)1.28 [1.03, 1.59]0%2 studies232,9881,734not evaluable ROB1.87 [1.19; .]
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
Preeclampsia1.12 [0.86, 1.45]0%2 studies53,6901,113not evaluable ROB-
Caesarean0.98 [0.76, 1.27]-1 study430532not evaluable ROB-
Abruptio placentae (retroplacental hematoma)0.92 [0.57, 1.50]-1 study20,2861,109not 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 care2.02 [0.48, 8.47]46%4 studies2,031475not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.34 [0.84, 2.13]0%2 studies98469not evaluable ROB-
Low Apgar score (< 7) (at 5 min)1.35 [0.14, 12.85]30%2 studies5234not 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/Risk1.34 [0.85, 2.12]0%3 studies4,3081,576not evaluable ROB-
Language disorders/delay2.52 [0.94, 6.73]70%3 studies72,025166not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.35 [0.85, 2.13]0%2 studies4,2811,572not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)0.87 [0.48, 1.58]-1 study1,429not evaluable ROB-
Neuro-developmental disorders (as a whole)0.96 [0.68, 1.36]0%2 studies10,0111,572not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)0.87 [0.48, 1.58]-1 study1,429not 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 (< 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-
Childhood autism (F84.0)1.00 [0.12, 8.31]-1 study2,065321not evaluable ROB-
Learning disorders 1.06 [1.01, 1.12]-1 study124not evaluable ROB1.31 [1.08; .]

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