Pregabalin (All indications)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Källén (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Controls unexposed, sick) (Mixed indications), 2014 Winterfeld (Other indications), 2016 Patorno_MAX and MaketScan (Other indications), 2017 Vajda (Controls unexposed, sick), 2019 Battino (Epilepsy), 2024 The NAAED (Controls unexposed, disease free) (Indications NOS), 2025 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 81.37[0.89; 2.13]261,8141,161not evaluable Major congenital malformations Källén (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Controls unexposed, sick) (Mixed indications), 2014 Winterfeld (Other indications), 2016 Patorno_MAX and MaketScan (Other indications), 2017 Vajda (Controls unexposed, sick), 2019 Battino (Epilepsy), 2024 The NAAED (Controls unexposed, disease free) (Indications NOS), 2025 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 81.37[0.89; 2.13]261,8141,161not evaluable Microcephaly / Small head circumference for gestational age Blotière (Controls unexposed NOS) (Other indications), 2019 Margulis (Pregabalin) (Indications other than epilepsy), 2019 Christensen (All indications) (Controls unexposed, general population), 2024 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 41.01[0.81; 1.26]137,0184,821not evaluable Spina bifida Veiby (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Controls unexposed NOS) (Other indications), 2019 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 32.33[0.76; 7.16]6,1252,150not evaluable Oro-facial clefts Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Blotière (Controls unexposed NOS) (Other indications), 2019 21.89[0.35; 10.09]2,8191,701not evaluable Ventricular septal defect Blotière (Controls unexposed NOS) (Other indications), 2019 Beau (Indications NOS), 2026 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 31.39[0.82; 2.36]54,1202,137not evaluable Atrial septal defect Blotière (Controls unexposed NOS) (Other indications), 2019 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 21.30[0.88; 1.93]84,5522,120not evaluable Cleft palate Blotière (Controls unexposed NOS) (Other indications), 2019 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 21.86[0.50; 6.96]4,2672,120not evaluable Club foot / Talipes equinovarus Blotière (Controls unexposed NOS) (Other indications), 2019 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 21.32[0.39; 4.42]20,0542,120not evaluable Diaphragmatic hernia Blotière (Controls unexposed NOS) (Other indications), 2019 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 21.45[0.29; 7.25]3,7782,120not evaluable Tetralogy of Fallot Blotière (Controls unexposed NOS) (Other indications), 2019 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 22.09[0.42; 10.47]1,7822,120not evaluable Coarctation of aorta Blotière (Controls unexposed NOS) (Other indications), 2019 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 25.53[2.09; 14.59]1,7932,120not evaluable Congenital heart defects Beau (Indications NOS), 2026 11.72[0.70; 4.24]52,23920not evaluable Urinary malformations Beau (Indications NOS), 2026 10.81[0.26; 2.55]22,29320not evaluable Ano-rectal atresia and stenosis Blotière (Controls unexposed NOS) (Other indications), 2019 12.10[0.19; 22.62]5451,671not evaluable Atrioventricular septal defect Blotière (Controls unexposed NOS) (Other indications), 2019 11.06[0.07; 16.98]5291,671not evaluable Bilateral renal agenesis including Potter syndrome Blotière (Controls unexposed NOS) (Other indications), 2019 17.44[0.46; 120.03]751,671not evaluable Bladder exstrophy and/or epispadia Blotière (Controls unexposed NOS) (Other indications), 2019 16.80[0.42; 109.76]821,671not evaluable Cleft lip with or without cleft palate Blotière (Controls unexposed NOS) (Other indications), 2019 10.69[0.10; 4.87]1,6381,671not evaluable Craniosynostosis Blotière (Controls unexposed NOS) (Other indications), 2019 14.40[1.16; 16.72]7691,671not evaluable Digestive system anomalies 0----- Ebstein's anomaly Blotière (Controls unexposed NOS) (Other indications), 2019 111.12[0.69; 180.27]501,671not evaluable Eye defects 0----- Gastroschisis Blotière (Controls unexposed NOS) (Other indications), 2019 12.31[0.14; 36.98]2431,671not evaluable Genital anomalies 0----- Hypoplastic left heart (HLH/HLHS) Blotière (Controls unexposed NOS) (Other indications), 2019 15.20[0.30; 89.16]2171,671not evaluable Hypoplastic right heart (HRH/HRHS) Blotière (Controls unexposed NOS) (Other indications), 2019 18.44[0.52; 136.44]661,671not evaluable Hypospadias Blotière (Controls unexposed NOS) (Other indications), 2019 10.70[0.14; 3.57]3,3731,671not evaluable Limb defects 0----- Nervous system anomalies 0----- Oesophageal atresia with or without tracheo-oesophageal fistula Blotière (Controls unexposed NOS) (Other indications), 2019 11.43[0.09; 22.91]3921,671not evaluable Omphalocele Blotière (Controls unexposed NOS) (Other indications), 2019 12.11[0.13; 33.78]2661,671not evaluable Pulmonary valve atresia Blotière (Controls unexposed NOS) (Other indications), 2019 13.68[0.23; 59.15]1521,671not evaluable Pulmonary valve stenosis Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 11.07[0.15; 7.62]4,048449not evaluable Hydrocephaly Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 14.53[0.63; 32.53]1,067449not evaluable Respiratory system anomalies 0----- Severe congenital heart defect Beau (Indications NOS), 2026 12.87[0.85; 9.71]11,84513not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Kilic (Controls unexposed, sick) (Mixed indications), 2014 Margulis (Pregabalin) (Indications other than epilepsy), 2019 Coste (Controls unexposed, NOS) (Mixed indications), 2020 Kaskal (Indications NOS), 2024 The NAAED (Controls unexposed, disease free) (Indications NOS), 2025 51.45[1.08; 1.94]91,9602,221not evaluable Small for gestational age (weight) Margulis (Pregabalin) (Indications other than epilepsy), 2019 Coste (Controls unexposed, NOS) (Mixed indications), 2020 Christensen (All indications) (Controls unexposed, general population), 2024 The NAAED (Controls unexposed, disease free) (Indications NOS), 2025 41.15[1.04; 1.26]614,2674,401not evaluable Low birth weight (< 2500g) Coste (Controls unexposed, NOS) (Mixed indications), 2020 Christensen (All indications) (Controls unexposed, general population), 2024 Kaskal (Indications NOS), 2024 31.35[1.08; 1.69]233,1623,868not evaluable Macrosomia (> 4000g) Coste (Controls unexposed, NOS) (Mixed indications), 2020 11.02[0.92; 1.13]577,6521,627not evaluable Very preterm (28 to 32 weeks) Coste (Controls unexposed, NOS) (Mixed indications), 2020 11.10[0.57; 2.12]8,5931,627not evaluable Extremely preterm (< 28 weeks) Coste (Controls unexposed, NOS) (Mixed indications), 2020 11.55[0.50; 4.80]2,0441,627not evaluable Maternal consequences Maternal consequences (as a whole) Razaz (Epilepsy), 2024 11.41[0.66; 3.02]66389not evaluable Neonatal disorders Low Apgar score (< 7) (at 5 min) 0----- Neonatal disorders (as a whole) Coste (Controls unexposed, NOS) (Mixed indications), 2020 11.11[0.96; 1.27]222,4321,627not evaluable Long term consequences Child/Infant death (> 28 days of life) Coste (Controls unexposed, NOS) (Mixed indications), 2020 10.90[0.34; 2.39]4,6991,627not evaluable Intrauterine deaths Elective/induced termination of pregnancy Moore (Controls unexposed, general pop) (Pregabalin) (Indication NOS), 2025 11.42[1.26; 1.61]4,2492,107not evaluable Intrauterine deaths (as a whole or unspecified) Moore (Controls unexposed, general pop) (Pregabalin) (Indication NOS), 2025 11.44[1.31; 1.59]6,3882,337not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths 0----- Therapeutic terminations of pregnancy Kaskal (Indications NOS), 2024 16.34[0.55; 72.54]331not evaluable Neuro-developmental disorders ASD (Autism spectrum disorder): Diagnosis Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Mixed indications), 2022 Madley-Dowd_SE (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 40.78[0.62; 0.99]81,0695,008not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Mixed indications), 2022 Madley-Dowd_SE (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 40.78[0.62; 0.99]81,0695,008not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Madley-Dowd_UK (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 20.68[0.55; 0.83]152,4811,715not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Madley-Dowd_UK (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_SE (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 20.68[0.55; 0.83]152,4811,715not evaluable Cognitive developmental disorders/delay (3-6 years old) Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Mixed indications), 2022 Madley-Dowd_UK (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 30.87[0.31; 2.44]4,6683,701not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Mixed indications), 2022 Madley-Dowd_UK (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 30.87[0.31; 2.44]4,6683,701not evaluable Language disorders/delay Coste (Controls unexposed, NOS) (Mixed indications), 2020 Moore (Controls unexposed, general pop) (Pregabalin) (Indication NOS), 2025 21.32[0.63; 2.79]73,1382,422not evaluable Neuro-developmental disorders (as a whole) Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Mixed indications), 2022 20.95[0.54; 1.68]10,4943,293not evaluable Cognitive developmental disorders/delay (> 6 years old) Madley-Dowd_SE (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 10.86[0.52; 1.41]24,3391,307not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Madley-Dowd_SE (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 10.86[0.52; 1.41]24,3391,307not evaluable Psychomotor developmental disorders/delay Moore (Controls unexposed, general pop) (Pregabalin) (Indication NOS), 2025 12.96[2.15; 4.09]226795not evaluable0.0100.01.0

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