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

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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)1.47 [1.22, 1.77]33%35 studies155,82514,006critical ROB2.30 [1.73; .]
Major congenital malformations1.42 [1.18, 1.72]31%29 studies155,69012,985critical ROB2.20 [1.63; .]
Congenital heart defects1.01 [0.69, 1.48]46%15 studies2,18311,668low ROB-
Hypospadias1.20 [0.84, 1.71]0%11 studies9,51110,054low ROB-
Minor congenital malformations2.97 [1.57, 5.62]9%9 studies127271not evaluable ROB5.39 [2.51; .]
Limb defects1.11 [0.81, 1.51]0%8 studies1,3265,863not evaluable ROB-
Spina bifida2.11 [1.12, 3.95]0%8 studies6262,403not evaluable ROB3.63 [1.50; .]
Microcephaly / Small head circumference for gestational age1.39 [1.16, 1.67]0%9 studies134,6406,071not evaluable ROB2.13 [1.60; .]
Neural Tube Defects2.40 [1.00, 5.77]0%7 studies245,199not evaluable ROB-
Club foot / Talipes equinovarus1.15 [0.48, 2.71]24%5 studies3,8114,720not evaluable ROB-
Oro-facial clefts1.29 [0.75, 2.21]0%7 studies2,8429,974not evaluable ROB-
Nervous system anomalies0.97 [0.50, 1.88]0%5 studies3755,648not evaluable ROB-
Polydactyly1.71 [0.74, 3.99]0%5 studies3,0953,553not evaluable ROB-
Cleft lip with or without cleft palate0.73 [0.15, 3.55]0%4 studies1,6401,750not evaluable ROB-
Urinary malformations1.23 [0.72, 2.09]0%5 studies385,393not evaluable ROB-
Digestive system anomalies0.67 [0.38, 1.19]0%4 studies214,288not evaluable ROB-
Genital anomalies1.48 [0.97, 2.26]0%4 studies1,0443,289not evaluable ROB-
Ano-rectal atresia and stenosis1.70 [0.20, 14.15]0%2 studies545523not evaluable ROB-
Cardiac septal defects0.88 [0.54, 1.43]0%2 studies16,5712,196not evaluable ROB-
Craniosynostosis2.56 [0.25, 25.83]0%2 studies766515not evaluable ROB-
Hip dislocation and/or dysplasia2.46 [0.14, 43.93]0%2 studies14not evaluable ROB-
Cleft palate5.03 [1.14, 22.26]0%2 studies1,181584not evaluable ROB9.53 [1.53; .]
Diaphragmatic hernia1.66 [0.31, 8.82]0%2 studies378512not evaluable ROB-
Bilateral renal agenesis including Potter syndrome24.28 [1.50, 392.37]-1 study75512not evaluable ROB48.06 [2.37; .]
Bladder exstrophy and/or epispadia22.22 [1.38, 358.80]-1 study82512not evaluable ROB43.94 [2.10; .]
Chromosomal abnormalities1.74 [0.20, 15.47]49%2 studies32,261not evaluable ROB-
Ebstein's anomaly36.31 [2.24, 589.29]-1 study50512not evaluable ROB72.11 [3.90; .]
Eye defects0.49 [0.16, 1.52]0%2 studies13874not evaluable ROB-
Eye, ear, face and neck malformations0.54 [0.21, 1.35]0%2 studies12,141not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)27.57 [1.70, 446.03]-1 study66512not evaluable ROB54.64 [2.80; .]
Respiratory system anomalies1.90 [0.92, 3.96]0%2 studies52,141not evaluable ROB-
13 non statistically significant endpoints reported in only one study

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.07 [0.93, 1.24]7%18 studies252,4645,393critical ROB-
Small for gestational age (weight)1.20 [1.03, 1.40]13%12 studies655,5487,221low ROB1.69 [1.20; .]
Low birth weight (< 2500g)1.35 [0.96, 1.90]50%5 studies232,8784,082not evaluable ROB-
Large for gestational age (weight)0.88 [0.59, 1.32]0%2 studies1101,092not evaluable ROB-
Macrosomia (> 4000g)0.99 [0.82, 1.20]0%3 studies576,481570not evaluable ROB-
3 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.03 [0.88, 1.21]0%3 studies9441,480not evaluable ROB-
Preeclampsia1.25 [0.92, 1.70]0%3 studies53,7251,275not evaluable ROB-
Assisted deliveries (forceps, vacuum, ...)0.82 [0.11, 5.98]27%2 studies194396not evaluable ROB-
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)1.77 [0.15, 20.65]0%2 studies244not evaluable ROB-
Gestational diabetes0.47 [0.04, 5.89]27%2 studies344not evaluable ROB-
Maternal consequences (as a whole)1.48 [1.16, 1.89]0%2 studies7742,659not evaluable ROB2.33 [1.60; .]
5 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low Apgar score (< 7) (at 5 min)1.79 [1.13, 2.84]0%6 studies1321,146not evaluable ROB2.98 [1.51; .]
Neonatal medical care1.20 [0.92, 1.55]0%6 studies2,0901,029serious ROB-
Low Apgar score (< 7) (at 1 min)1.18 [0.80, 1.73]0%5 studies1241,022not evaluable ROB-
Neonatal disorders (as a whole)0.97 [0.75, 1.26]0%3 studies221,852498not evaluable ROB-
Feeding difficulty1.49 [0.22, 9.94]0%3 studies341not evaluable ROB-
Neonatal intracranial hemorrhage3.82 [0.73, 20.07]0%2 studies622not evaluable ROB-
8 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)1.65 [0.59, 4.67]0%3 studies4,7081,557not evaluable ROB-
4 non statistically significant endpoints reported in only one study

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)1.21 [0.88, 1.67]32%10 studies5725,011critical ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths1.53 [0.71, 3.30]18%8 studies494,177not evaluable ROB-
Elective/induced termination of pregnancy1.82 [1.01, 3.28]0%6 studies432,472serious ROB3.03 [1.09; .]
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions0.91 [0.69, 1.21]20%6 studies4393,598not evaluable ROB-
Perinatal death1.42 [0.62, 3.25]0%3 studies262,767not evaluable ROB-
2 non statistically significant endpoints reported in only one study

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Language disorders/delay1.57 [1.13, 2.19]53%16 studies71,9921,057probable ROB2.52 [1.51; .]
Cognitive developmental disorders/delay (> 6 years old)1.30 [1.03, 1.64]23%14 studies24,5826,753low ROB1.93 [1.21; .]
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.11 [0.98, 1.27]5%9 studies165,1716,058not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.21 [1.04, 1.40]0%8 studies81,2076,916not evaluable ROB1.71 [1.25; .]
Neuro-developmental disorders (as a whole)1.46 [1.05, 2.03]17%10 studies10,5944,118low ROB2.27 [1.27; .]
ASD (Autism spectrum disorder): Diagnosis1.20 [1.03, 1.39]0%7 studies81,1746,875not evaluable ROB1.69 [1.22; .]
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.40 [1.14, 1.73]0%8 studies24,5776,502not evaluable ROB2.16 [1.54; .]
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.07 [0.95, 1.19]0%6 studies153,3055,814not evaluable ROB-
Psychomotor developmental disorders/delay1.04 [0.78, 1.39]0%9 studies25641not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)1.90 [0.90, 3.98]67%8 studies47523not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)2.75 [1.33, 5.68]27%5 studies3,419684not evaluable ROB4.95 [2.00; .]
ADHD (Attention deficit hyperactivity disorder): Risk1.66 [1.08, 2.54]0%5 studies11,888332not evaluable ROB2.71 [1.39; .]
Severe cognitive developmental delay (Mental retardation) (3-6 years old)2.02 [0.65, 6.23]0%3 studies3,392571not evaluable ROB-
ASD (Autism spectrum disorder): Risk1.27 [0.53, 3.03]0%3 studies38111not evaluable ROB-
Learning disorders 1.24 [0.94, 1.65]0%3 studies51455not evaluable ROB-
2 non statistically significant endpoints reported in only one study

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