Gabapentin (All indications) updated on 06-15-2026

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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)1.11 [0.91, 1.36]0%8 studies223,6251,631not evaluable ROB-
Major congenital malformations1.11 [0.91, 1.36]0%8 studies223,6201,631not evaluable ROB-
Atrial septal defect1.15 [0.86, 1.52]0%2 studies84,5731,496not evaluable ROB-
Hypospadias1.69 [0.59, 4.86]0%3 studies5,8081,527not evaluable ROB-
Ventricular septal defect1.20 [0.51, 2.83]39%3 studies54,1181,507not evaluable ROB-
Cleft lip with or without cleft palate1.33 [0.27, 6.66]0%2 studies3,5491,496not evaluable ROB-
Cleft palate1.31 [0.38, 4.51]0%2 studies4,2661,496not evaluable ROB-
Club foot / Talipes equinovarus0.58 [0.23, 1.46]0%2 studies20,0531,496not evaluable ROB-
Congenital heart defects1.94 [0.66, 5.70]6%2 studies52,23942not evaluable ROB-
Diaphragmatic hernia1.65 [0.16, 16.84]49%2 studies3,7781,496not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.26 [0.18, 8.69]57%2 studies134,4931,701not evaluable ROB-
Spina bifida2.16 [0.51, 9.12]29%2 studies6,1251,496not evaluable ROB-
Coarctation of aorta2.55 [0.51, 12.72]0%2 studies1,7891,496not evaluable ROB-
Oro-facial clefts2.18 [0.27, 17.84]0%2 studies2,816396not evaluable ROB-
Ano-rectal atresia and stenosis4.72 [0.29, 75.77]-1 study544365not evaluable ROB-
Atrioventricular septal defect4.86 [0.30, 77.92]-1 study529365not evaluable ROB-
Bilateral renal agenesis including Potter syndrome34.08 [2.11, 550.91]-1 study75365not evaluable ROB67.65 [3.64; .]
Bladder exstrophy and/or epispadia31.19 [1.93, 503.78]-1 study82365not evaluable ROB61.87 [3.27; .]
Craniosynostosis3.36 [0.21, 53.80]-1 study766365not evaluable ROB-
Ebstein's anomaly50.95 [3.14, 827.39]-1 study50365not evaluable ROB101.40 [5.73; .]
Gastroschisis10.57 [0.66, 169.73]-1 study243365not evaluable ROB-
Hypoplastic left heart (HLH/HLHS)11.88 [0.74, 190.96]-1 study216365not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)38.69 [2.39, 626.25]-1 study66365not evaluable ROB76.88 [4.21; .]
Oesophageal atresia with or without tracheo-oesophageal fistula6.55 [0.41, 105.17]-1 study392365not evaluable ROB-
Omphalocele9.65 [0.60, 155.04]-1 study266365not evaluable ROB-
Pulmonary valve atresia16.87 [1.05, 271.48]-1 study152365not evaluable ROB33.23 [1.27; .]
Pulmonary valve stenosis0.96 [0.24, 3.83]-1 study4,0491,131not evaluable ROB-
Tetralogy of Fallot4.40 [0.27, 70.58]-1 study584365not evaluable ROB-
Digestive system anomalies3.01 [0.15, 59.66]-1 study331not evaluable ROB-
Eye defects4.85 [0.09, 267.23]-1 study61not evaluable ROB-
Hydrocephaly2.13 [0.30, 15.14]-1 study1,0671,131not evaluable ROB-
Limb defects4.23 [0.20, 89.96]-1 study231not evaluable ROB-
Minor congenital malformations5.91 [0.11, 330.07]-1 study51not evaluable ROB-
Neural Tube Defects7.05 [0.28, 176.78]-1 study131not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.67 [0.72, 3.87]84%5 studies91,914723not evaluable ROB-
Small for gestational age (weight)1.13 [0.98, 1.30]0%3 studies614,0031,984not evaluable ROB-
Low birth weight (< 2500g)1.76 [0.89, 3.49]92%2 studies233,0201,714not evaluable ROB-
Macrosomia (> 4000g)0.89 [0.72, 1.11]-1 study577,215378not evaluable ROB-
Very preterm (28 to 32 weeks)1.05 [0.26, 4.23]-1 study8,586378not evaluable ROB-
Extremely preterm (< 28 weeks)1.11 [0.07, 17.76]-1 study2,041378not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal disorders (as a whole)1.09 [0.82, 1.46]-1 study222,254378not evaluable ROB-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation--0 study-

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)0.96 [0.14, 6.86]-1 study4,696378not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)1.33 [1.21, 1.46]0%4 studies6,8072,641not evaluable ROB2.00 [1.72; .]
Elective/induced termination of pregnancy1.32 [1.17, 1.49]0%2 studies4,4482,365not evaluable ROB1.97 [1.62; .]
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions4.64 [0.23, 93.20]0%2 studies23not evaluable ROB-
Therapeutic terminations of pregnancy2.33 [0.03, 182.92]-1 study2not evaluable ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths47.00 [0.38, 5814.69]-1 study1not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis1.14 [0.76, 1.70]36%5 studies81,0402,772not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.14 [0.76, 1.70]36%5 studies81,0402,772not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.20 [0.91, 1.58]0%3 studies152,4501,442not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)0.94 [0.47, 1.87]0%3 studies28,8471,806not evaluable ROB-
Neuro-developmental disorders (as a whole)0.96 [0.44, 2.10]32%4 studies10,4751,345not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)0.94 [0.47, 1.87]0%3 studies28,8471,806not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.28 [0.86, 1.91]31%2 studies152,4501,428not evaluable ROB-
Language disorders/delay1.09 [0.40, 2.93]87%3 studies73,5791,520not evaluable ROB-
Psychomotor developmental disorders/delay2.74 [2.14, 3.50]-1 study4211,128not evaluable ROB4.92 [3.71; .]
ADHD (Attention deficit hyperactivity disorder): Risk0.87 [0.30, 2.52]-1 study14not evaluable ROB-
ASD (Autism spectrum disorder): Risk17.00 [0.13, 2166.90]-1 study1not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)1.33 [0.13, 13.89]-1 study414not evaluable ROB-

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