Carbamazepine (Epilepsy) 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)1.50 [1.21, 1.87]31%32 studies85010,751probable ROB2.37 [1.70; .]
Major congenital malformations1.45 [1.15, 1.82]27%26 studies7159,730probable ROB2.25 [1.57; .]
Congenital heart defects1.00 [0.58, 1.74]50%12 studies1137,966low ROB-
Minor congenital malformations2.75 [1.20, 6.31]19%8 studies84238not evaluable ROB4.95 [1.69; .]
Limb defects1.09 [0.76, 1.56]0%6 studies324,835not evaluable ROB-
Neural Tube Defects2.40 [1.00, 5.77]0%7 studies245,199not evaluable ROB-
Spina bifida2.04 [1.05, 3.97]0%6 studies61,812serious ROB3.49 [1.27; .]
Hypospadias0.97 [0.58, 1.64]0%7 studies364,672not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.34 [0.85, 2.12]17%6 studies8443,042not evaluable ROB-
Polydactyly2.73 [0.53, 14.09]0%4 studies62,042not evaluable ROB-
Urinary malformations1.16 [0.61, 2.20]18%4 studies334,708not evaluable ROB-
Cleft lip with or without cleft palate0.59 [0.09, 4.07]0%3 studies31,238not evaluable ROB-
Digestive system anomalies0.64 [0.34, 1.19]0%3 studies143,603not evaluable ROB-
Hip dislocation and/or dysplasia2.46 [0.14, 43.93]0%2 studies14not evaluable ROB-
Oro-facial clefts1.35 [0.69, 2.63]0%4 studies236,103not evaluable ROB-
Club foot / Talipes equinovarus2.72 [0.21, 34.91]0%2 studies223not evaluable ROB-
Nervous system anomalies1.94 [0.23, 16.21]53%2 studies61,946not evaluable ROB-
Chromosomal abnormalities1.74 [0.20, 15.47]49%2 studies32,261not evaluable ROB-
Eye defects0.49 [0.16, 1.52]0%2 studies13874not evaluable ROB-
Genital anomalies1.44 [0.90, 2.31]0%2 studies92,261not evaluable ROB-
9 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)1.05 [0.86, 1.29]0%15 studies3871,706probable ROB-
Small for gestational age (weight)1.29 [0.84, 2.00]34%9 studies2,8342,937not evaluable ROB-
Low birth weight (< 2500g)1.35 [0.89, 2.04]47%5 studies1,3363,035not evaluable ROB-
Large for gestational age (weight)0.88 [0.59, 1.32]0%2 studies1101,092not evaluable ROB-
Macrosomia (> 4000g)1.04 [0.77, 1.42]0%3 studies727278not evaluable ROB-
2 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-
Preeclampsia1.07 [0.54, 2.11]0%3 studies1343not 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)1.56 [0.84, 2.89]0%4 studies56794not evaluable ROB-
Neonatal medical care1.19 [0.91, 1.54]0%5 studies2,0821,021not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.16 [0.79, 1.71]0%4 studies1211,014not evaluable ROB-
Feeding difficulty1.49 [0.22, 9.94]0%3 studies341not evaluable ROB-
Neonatal disorders (as a whole)1.04 [0.37, 2.96]0%2 studies2330not 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)2.22 [0.65, 7.53]0%2 studies121,089not 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/delay1.49 [0.96, 2.30]67%16 studies257765probable ROB-
Cognitive developmental disorders/delay (> 6 years old)1.22 [0.98, 1.53]14%14 studies4905,434low ROB-
Neuro-developmental disorders (as a whole)1.09 [0.71, 1.65]20%9 studies6033,003not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.07 [0.90, 1.28]9%8 studies1,8095,129not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.17 [0.98, 1.41]0%8 studies1,0305,305not evaluable ROB-
Psychomotor developmental disorders/delay1.04 [0.78, 1.39]0%9 studies25641not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.16 [0.97, 1.40]0%7 studies9975,264not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)1.90 [0.90, 3.98]67%8 studies47523not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.05 [0.91, 1.23]4%6 studies1,8015,086not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.30 [1.02, 1.65]0%8 studies4855,183not evaluable ROB1.93 [1.18; .]
Cognitive developmental disorders/delay (3-6 years old)2.74 [1.17, 6.42]34%5 studies42392not evaluable ROB4.92 [1.61; .]
ADHD (Attention deficit hyperactivity disorder): Risk1.23 [0.49, 3.05]12%4 studies30131not evaluable ROB-
ASD (Autism spectrum disorder): Risk1.27 [0.53, 3.03]0%3 studies38111not evaluable ROB-
Learning disorders 1.18 [0.96, 1.45]0%3 studies51391not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)1.83 [0.38, 8.89]0%3 studies15279not evaluable ROB-
1 non statistically significant endpoints reported in only one study

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