Topiramate (Epilepsy) updated on 06-15-2026

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)1.99 [1.48, 2.67]0%11 studies347784low ROB3.39 [2.33; .]
Major congenital malformations1.99 [1.48, 2.67]0%11 studies347784low ROB3.39 [2.33; .]
Congenital heart defects1.62 [0.84, 3.13]0%5 studies32233not evaluable ROB-
Limb defects3.53 [1.09, 11.44]0%4 studies581not evaluable ROB6.51 [1.39; .]
Neural Tube Defects5.56 [0.78, 39.78]0%3 studies2224not 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-
Hypospadias3.30 [0.73, 14.97]0%2 studies14180not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.30 [0.70, 2.40]-1 study710290not evaluable ROB-
Nervous system anomalies39.94 [0.75, 2134.65]-1 study9not evaluable ROB-
Oro-facial clefts7.95 [0.83, 76.53]19%2 studies5180not evaluable ROB-
Spina bifida12.67 [0.64, 249.11]-1 study343not evaluable ROB-
Cleft lip with or without cleft palate3.37 [0.07, 172.23]-1 study44not 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
Small for gestational age (weight)1.95 [1.40, 2.71]52%3 studies2,469684not evaluable ROB3.31 [2.16; .]
Preterm (< 37 weeks)0.75 [0.49, 1.16]0%2 studies32not evaluable ROB-
Low birth weight (< 2500g)1.66 [1.05, 2.62]-1 study1,027290not evaluable ROB2.71 [1.29; .]

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Abruptio placentae (retroplacental hematoma)0.82 [0.21, 3.18]-1 studynot evaluable ROB-
Preeclampsia1.23 [0.63, 2.41]-1 studynot evaluable ROB-
Maternal consequences (as a whole)1.21 [0.64, 2.30]-1 study666249not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)4.15 [0.51, 33.43]73%5 studies10698not evaluable ROB-
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/Risk1.54 [0.87, 2.73]38%6 studies9111,372not evaluable ROB-
Language disorders/delay1.90 [0.73, 4.94]67%5 studies5551,016not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.33 [0.88, 1.99]42%5 studies1,0041,392not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.53 [0.80, 2.94]50%5 studies8831,366not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.41 [0.84, 2.35]54%4 studies1,0041,365not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)3.87 [2.04, 7.37]21%4 studies394399not evaluable ROB7.21 [3.49; .]
Psychomotor developmental disorders/delay0.94 [0.33, 2.70]61%3 studies986not evaluable ROB-
ASD (Autism spectrum disorder): Risk2.65 [0.36, 19.38]0%2 studies287not evaluable ROB-
Neuro-developmental disorders (as a whole)2.15 [1.15, 4.01]0%2 studies455248not evaluable ROB3.72 [1.57; .]
Severe cognitive developmental delay (Mental retardation) (> 6 years old)3.57 [1.42, 9.01]52%2 studies388361not evaluable ROB6.60 [2.18; .]
Cognitive developmental disorders/delay (3-6 years old)2.44 [1.27, 4.72]0%3 studies131,250not evaluable ROB4.32 [1.85; .]
Learning disorders 2.11 [0.15, 29.13]84%2 studies970not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)2.44 [1.27, 4.72]0%3 studies131,250not evaluable ROB4.32 [1.85; .]
Cognitive developmental disorders/delay (< 3 years old)1.05 [0.24, 4.62]-1 study6not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk1.00 [0.43, 2.32]-1 study27not evaluable ROB-

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