Gabapentin (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)1.04 [0.52, 2.09]0%7 studies49,653474not evaluable ROB-
Major congenital malformations1.08 [0.53, 2.16]0%7 studies49,648474not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.26 [0.18, 8.69]57%2 studies134,4931,701not evaluable ROB-
Hypospadias1.55 [0.31, 7.89]0%2 studies3,378396not evaluable ROB-
Oro-facial clefts2.18 [0.27, 17.84]0%2 studies2,816396not 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; .]
Ebstein's anomaly50.95 [3.14, 827.39]-1 study50365not evaluable ROB101.40 [5.73; .]
Hypoplastic right heart (HRH/HRHS)38.69 [2.39, 626.25]-1 study66365not evaluable ROB76.88 [4.21; .]
Pulmonary valve atresia16.87 [1.05, 271.48]-1 study152365not evaluable ROB33.23 [1.27; .]
22 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)2.38 [1.79, 3.15]0%4 studies91,697453not evaluable ROB4.19 [2.99; .]
Low birth weight (< 2500g)1.76 [0.89, 3.49]92%2 studies233,0201,714not evaluable ROB-
Small for gestational age (weight)1.15 [1.00, 1.34]0%2 studies613,8561,714not evaluable ROB-
3 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation--0 study-
1 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
1 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)4.41 [0.49, 39.98]0%3 studies317not evaluable ROB-
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions4.64 [0.23, 93.20]0%2 studies23not evaluable ROB-
3 non statistically significant endpoints reported in only one study

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/delay0.62 [0.36, 1.05]0%2 studies72,028392not evaluable ROB-
3 non statistically significant endpoints reported in only one study