Pregabalin (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)1.78 [0.81, 3.93]51%7 studies87,899701not evaluable ROB-
Major congenital malformations1.78 [0.81, 3.93]51%7 studies87,899701not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.00 [0.80, 1.25]0%3 studies134,5444,372not evaluable ROB-
Oro-facial clefts1.89 [0.35, 10.09]29%2 studies2,8191,701not evaluable ROB-
Spina bifida4.33 [0.49, 38.62]37%2 studies6201,701not evaluable ROB-
Ano-rectal atresia and stenosis2.10 [0.19, 22.62]-1 study5451,671not evaluable ROB-
Atrial septal defect1.90 [0.84, 4.30]-1 study3,2741,671not evaluable ROB-
Atrioventricular septal defect1.06 [0.07, 16.98]-1 study5291,671not evaluable ROB-
Bilateral renal agenesis including Potter syndrome7.44 [0.46, 120.03]-1 study751,671not evaluable ROB-
Bladder exstrophy and/or epispadia6.80 [0.42, 109.76]-1 study821,671not evaluable ROB-
Cleft lip with or without cleft palate0.69 [0.10, 4.87]-1 study1,6381,671not evaluable ROB-
Cleft palate1.90 [0.32, 11.16]-1 study1,1801,671not evaluable ROB-
Club foot / Talipes equinovarus0.33 [0.02, 5.35]-1 study1,6771,671not evaluable ROB-
Coarctation of aorta5.80 [1.90, 17.70]-1 study7831,671not evaluable ROB11.08 [3.21; .]
Congenital heart defects--0 study-
Craniosynostosis4.40 [1.16, 16.72]-1 study7691,671not evaluable ROB8.27 [1.59; .]
Diaphragmatic hernia1.48 [0.09, 23.76]-1 study3781,671not evaluable ROB-
Digestive system anomalies--0 study-
Ebstein's anomaly11.12 [0.69, 180.27]-1 study501,671not evaluable ROB-
Eye defects--0 study-
Gastroschisis2.31 [0.14, 36.98]-1 study2431,671not evaluable ROB-
Genital anomalies--0 study-
Hypoplastic left heart (HLH/HLHS)5.20 [0.30, 89.16]-1 study2171,671not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)8.44 [0.52, 136.44]-1 study661,671not evaluable ROB-
Hypospadias0.70 [0.14, 3.57]-1 study3,3731,671not evaluable ROB-
Limb defects--0 study-
Nervous system anomalies--0 study-
Oesophageal atresia with or without tracheo-oesophageal fistula1.43 [0.09, 22.91]-1 study3921,671not evaluable ROB-
Omphalocele2.11 [0.13, 33.78]-1 study2661,671not evaluable ROB-
Pulmonary valve atresia3.68 [0.23, 59.15]-1 study1521,671not evaluable ROB-
Tetralogy of Fallot0.96 [0.06, 15.38]-1 study5841,671not evaluable ROB-
Urinary malformations--0 study-
Ventricular septal defect1.10 [0.46, 2.60]-1 study4,6481,671not evaluable ROB-
Respiratory system anomalies--0 study-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.60 [1.08, 2.38]42%4 studies91,7612,159not evaluable ROB2.58 [1.37; .]
Low birth weight (< 2500g)1.35 [1.08, 1.69]52%3 studies233,1623,868not evaluable ROB2.04 [1.37; .]
Small for gestational age (weight)1.15 [1.05, 1.27]0%3 studies614,1384,339not evaluable ROB1.57 [1.26; .]
Macrosomia (> 4000g)1.02 [0.92, 1.13]-1 study577,6521,627not evaluable ROB-
Very preterm (28 to 32 weeks)1.10 [0.57, 2.12]-1 study8,5931,627not evaluable ROB-
Extremely preterm (< 28 weeks)1.55 [0.50, 4.80]-1 study2,0441,627not evaluable ROB-

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Maternal consequences (as a whole)1.41 [0.66, 3.02]-1 study66389not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low Apgar score (< 7) (at 5 min)--0 study-
Neonatal disorders (as a whole)1.11 [0.96, 1.27]-1 study222,4321,627not evaluable ROB-

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)0.90 [0.34, 2.39]-1 study4,6991,627not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Late intrauterine deaths (> 22 weeks) / Stillbirths--0 study-
Therapeutic terminations of pregnancy6.34 [0.55, 72.54]-1 study331not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis0.78 [0.62, 0.99]5%4 studies81,0695,008not evaluable ROB1.89 [.; 1.14]
ASD (Autism spectrum disorder): Diagnosis/Risk0.78 [0.62, 0.99]5%4 studies81,0695,008not evaluable ROB1.89 [.; 1.14]
ADHD (Attention deficit hyperactivity disorder): Diagnosis0.68 [0.55, 0.83]0%2 studies147,6961,715not evaluable ROB2.32 [.; 1.70]
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk0.68 [0.55, 0.83]0%2 studies147,6961,715not evaluable ROB2.32 [.; 1.70]
Cognitive developmental disorders/delay (3-6 years old)0.87 [0.31, 2.44]59%3 studies4,6683,701not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)0.87 [0.31, 2.44]59%3 studies4,6683,701not evaluable ROB-
Neuro-developmental disorders (as a whole)0.95 [0.54, 1.68]67%2 studies10,4943,293not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)0.86 [0.52, 1.41]-1 study24,3391,307not evaluable ROB-
Language disorders/delay0.90 [0.69, 1.18]-1 study72,0731,627not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)0.86 [0.52, 1.41]-1 study24,3391,307not evaluable ROB-

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