Topiramate (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)2.29 [1.80, 2.91]0%13 studies231,4101,502low ROB4.01 [3.01; .]
Major congenital malformations2.29 [1.80, 2.91]0%13 studies231,4101,502low ROB4.01 [3.01; .]
Oro-facial clefts3.15 [2.12, 4.69]0%8 studies2,8614,639not evaluable ROB5.76 [3.66; .]
Congenital heart defects2.47 [0.98, 6.24]0%5 studies36592not evaluable ROB-
Cleft lip with or without cleft palate4.24 [2.15, 8.38]0%4 studies4,7002,319not evaluable ROB7.96 [3.72; .]
Hypospadias4.03 [1.56, 10.45]0%4 studies3,3901,056not evaluable ROB7.53 [2.49; .]
Limb defects3.56 [0.59, 21.68]0%3 studies581not evaluable ROB-
Microcephaly / Small head circumference for gestational age3.61 [0.85, 15.40]87%3 studies153,0111,203not evaluable ROB-
Neural Tube Defects3.21 [0.62, 16.76]0%4 studies4583not evaluable ROB-
Spina bifida5.51 [0.72, 41.94]0%2 studies619565not evaluable ROB-
Cleft palate0.97 [0.13, 7.18]0%2 studies1,1842,262not evaluable ROB-
Digestive system anomalies6.26 [0.69, 56.84]0%2 studies437not evaluable ROB-
Urinary malformations1.68 [0.22, 13.11]0%2 studies14161not evaluable ROB-
Ano-rectal atresia and stenosis3.33 [0.21, 53.44]-1 study544517not evaluable ROB-
Atrial septal defect2.30 [0.44, 12.02]-1 study3,270517not evaluable ROB-
Atrioventricular septal defect3.43 [0.21, 54.96]-1 study529517not evaluable ROB-
Bilateral renal agenesis including Potter syndrome24.05 [1.49, 388.57]-1 study75517not evaluable ROB47.59 [2.34; .]
Bladder exstrophy and/or epispadia22.01 [1.36, 355.32]-1 study82517not evaluable ROB43.51 [2.07; .]
Club foot / Talipes equinovarus2.20 [0.20, 24.50]-1 study1,678517not evaluable ROB-
Coarctation of aorta2.33 [0.15, 37.31]-1 study779517not evaluable ROB-
Craniosynostosis2.37 [0.15, 37.95]-1 study766517not evaluable ROB-
Diaphragmatic hernia9.80 [0.59, 162.81]-1 study379517not evaluable ROB-
Ebstein's anomaly35.96 [2.22, 583.57]-1 study50517not evaluable ROB71.41 [3.86; .]
Gastroschisis7.46 [0.46, 119.71]-1 study243517not evaluable ROB-
Hypoplastic left heart (HLH/HLHS)8.39 [0.52, 134.69]-1 study216517not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)27.30 [1.69, 441.71]-1 study66517not evaluable ROB54.10 [2.77; .]
Nervous system anomalies39.94 [0.75, 2134.65]-1 study9not evaluable ROB-
Oesophageal atresia with or without tracheo-oesophageal fistula9.40 [0.58, 153.31]-1 study393517not evaluable ROB-
Omphalocele6.81 [0.42, 109.35]-1 study266517not evaluable ROB-
Pulmonary valve atresia11.91 [0.74, 191.48]-1 study152517not evaluable ROB-
Tetralogy of Fallot3.11 [0.19, 49.78]-1 study584517not evaluable ROB-
Ventricular septal defect1.60 [0.30, 8.62]-1 study4,645517not evaluable ROB-
Polydactyly16.59 [0.33, 839.05]-1 study152not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.34 [0.87, 2.05]72%6 studies252,6563,167not evaluable ROB-
Small for gestational age (weight)1.60 [1.11, 2.32]86%6 studies655,9403,839not evaluable ROB2.58 [1.45; .]
Low birth weight (< 2500g)1.50 [1.17, 1.94]18%3 studies233,0161,462not evaluable ROB2.37 [1.61; .]
Macrosomia (> 4000g)0.92 [0.76, 1.11]-1 study577,249477not evaluable ROB-
Very preterm (28 to 32 weeks)2.53 [1.13, 5.65]-1 study8,590477not evaluable ROB4.49 [1.51; .]
Extremely preterm (< 28 weeks)1.76 [0.25, 12.52]-1 study2,042477not evaluable ROB-

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Abruptio placentae (retroplacental hematoma)1.27 [0.96, 1.68]-1 study20,3232,280not evaluable ROB-
Preeclampsia1.06 [0.89, 1.26]-1 study53,7652,280not evaluable ROB-
Maternal consequences (as a whole)1.21 [0.64, 2.30]-1 study666249not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal disorders (as a whole)1.23 [0.96, 1.58]-1 study222,275477not evaluable ROB-
Low Apgar score (< 7) (at 1 min)4.47 [0.14, 140.56]-1 study22not evaluable ROB-
Low Apgar score (< 7) (at 5 min)23.67 [0.34, 1653.93]-1 study2not evaluable ROB-
Neonatal medical care5.00 [0.27, 91.52]-1 study72not evaluable ROB-

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)0.76 [0.11, 5.43]-1 study4,696477not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)13.39 [3.16, 56.70]0%4 studies1364not evaluable ROB26.27 [5.78; .]
Late intrauterine deaths (> 22 weeks) / Stillbirths15.37 [0.63, 376.77]0%2 studies3not evaluable ROB-
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions8.47 [0.57, 125.19]0%2 studies34not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis/Risk1.22 [0.77, 1.93]29%7 studies73,3891,996not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.18 [0.70, 1.97]40%6 studies73,3611,990not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.31 [0.71, 2.44]59%6 studies160,008771not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)2.65 [1.33, 5.28]12%4 studies3,5451,111not evaluable ROB4.75 [2.00; .]
Language disorders/delay1.52 [1.10, 2.10]0%5 studies72,088522not evaluable ROB2.41 [1.44; .]
Severe cognitive developmental delay (Mental retardation) (3-6 years old)2.03 [1.04, 3.96]0%3 studies3,5451,102not evaluable ROB3.47 [1.23; .]
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.25 [0.50, 3.10]77%3 studies148,167708not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)2.31 [1.34, 3.98]0%3 studies24,525581not evaluable ROB4.05 [2.02; .]
Neuro-developmental disorders (as a whole)1.49 [0.94, 2.35]0%3 studies10,474950not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)2.33 [1.31, 4.14]0%2 studies24,519554not evaluable ROB4.09 [1.95; .]
ADHD (Attention deficit hyperactivity disorder): Risk1.41 [0.46, 4.32]39%3 studies11,84163not evaluable ROB-
ASD (Autism spectrum disorder): Risk2.65 [0.36, 19.38]0%2 studies287not evaluable ROB-
Psychomotor developmental disorders/delay1.45 [0.19, 11.17]73%2 studies15not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)1.05 [0.24, 4.62]-1 study6not evaluable ROB-

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