Thiopurines (Azathioprine, Mercaptopurin)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Francella, 2003 Langagergaard (Controls unexposed, sick), 2007 Goldstein, 2007 Cleary (Controls unexposed, sick), 2009 Colvin, 2010 Ban (Controls unexposed, sick), 2014 Alami, 2017 Kanis, 2021 Reynolds, 2022 91.33[1.02; 1.75]5,2361,332not evaluable Major congenital malformations Francella, 2003 Goldstein, 2007 Cleary (Controls unexposed, NOS), 2009 Colvin, 2010 Ban (Controls unexposed, sick), 2014 Alami, 2017 Kanis, 2021 Reynolds, 2022 Meyer, 2025 91.25[1.05; 1.49]43,9466,491serious Congenital heart defects Cleary (Controls unexposed, NOS), 2009 Ban (Controls unexposed, sick), 2014 Alami, 2017 Meyer, 2025 41.42[1.04; 1.93]12,8215,950not evaluable Limb defects Ban (Controls unexposed, sick), 2014 Alami, 2017 Meyer, 2025 31.09[0.62; 1.91]955,469not evaluable Genital anomalies Ban (Controls unexposed, sick), 2014 Meyer, 2025 21.60[0.94; 2.75]865,372not evaluable Cardiac septal defects Cleary (Controls unexposed, sick), 2009 11.91[0.77; 4.71]26481not evaluable Chromosomal abnormalities Alami, 2017 Meyer, 2025 22.68[0.86; 8.42]155,320not evaluable Hypospadias Cleary (Controls unexposed, NOS), 2009 Meyer, 2025 21.50[0.88; 2.56]3,4425,704not evaluable Nervous system anomalies Alami, 2017 Meyer, 2025 20.73[0.30; 1.81]435,320not evaluable Urinary malformations Alami, 2017 Meyer, 2025 20.89[0.51; 1.56]1045,320not evaluable Abdominal wall defects Meyer, 2025 11.05[0.19; 5.76]85,223not evaluable Annular pancreas Meyer, 2025 15.52[0.11; 278.22]-5,223not evaluable Ano-rectal atresia and stenosis Meyer, 2025 10.37[0.02; 6.44]75,223not evaluable Anophthalmos/micropthalmos Meyer, 2025 11.10[0.05; 23.00]25,223not evaluable Aortic atresia/interrupted aortic arch Meyer, 2025 11.10[0.05; 23.00]25,223not evaluable Aortic valve atresia/stenosis Meyer, 2025 11.10[0.05; 23.00]25,223not evaluable Arhinencephaly/holoprosencephaly Meyer, 2025 15.52[0.11; 278.22]-5,223not evaluable Atresia of bile ducts Meyer, 2025 15.52[0.11; 278.22]-5,223not evaluable Atresia or stenosis of other parts of small intestine Meyer, 2025 11.38[0.15; 12.77]55,223not evaluable Atrial septal defect Meyer, 2025 11.75[1.00; 3.06]834,160not evaluable Atrioventricular septal defect Meyer, 2025 12.41[0.52; 11.20]134,160not evaluable Bilateral renal agenesis including Potter syndrome Meyer, 2025 17.22[0.45; 115.61]25,223not evaluable Bladder exstrophy and/or epispadia Meyer, 2025 11.84[0.07; 45.17]15,223not evaluable Choanal atresia Meyer, 2025 12.58[0.26; 25.43]45,223not evaluable Cleft lip with or without cleft palate Meyer, 2025 12.59[1.08; 6.21]274,160not evaluable Cleft palate Meyer, 2025 11.37[0.29; 6.42]125,223not evaluable Club foot / Talipes equinovarus Meyer, 2025 10.73[0.25; 2.13]305,223not evaluable Coarctation of aorta Meyer, 2025 10.42[0.05; 3.39]155,223not evaluable Common arterial truncus Meyer, 2025 11.84[0.07; 45.17]15,223not evaluable Congenital cataract Meyer, 2025 10.42[0.02; 7.54]65,223not evaluable Congenital glaucoma Meyer, 2025 11.84[0.07; 45.17]15,223not evaluable Craniosynostosis Meyer, 2025 11.00[0.21; 4.73]135,223not evaluable Diaphragmatic hernia Meyer, 2025 10.37[0.02; 6.44]75,223not evaluable Digestive system anomalies Meyer, 2025 10.65[0.20; 2.13]345,223not evaluable Double outlet right ventricle Meyer, 2025 12.58[0.23; 29.05]35,223not evaluable Down syndrom / Trisomy 21 Meyer, 2025 11.01[0.12; 8.60]85,223not evaluable Duodenal atresia or stenosis Meyer, 2025 10.50[0.03; 9.07]55,223not evaluable Ear, face and neck anomalies Meyer, 2025 15.52[0.11; 278.22]-5,223not evaluable Ebstein's anomaly Meyer, 2025 15.52[0.11; 278.22]-5,223not evaluable Edward syndrome / Trisomy 18 Meyer, 2025 15.52[0.11; 278.22]-5,223not evaluable Encephalocele Meyer, 2025 11.84[0.07; 45.17]15,223not evaluable Eye defects Meyer, 2025 10.29[0.02; 4.99]95,223not evaluable Gastroschisis Meyer, 2025 11.84[0.07; 45.17]15,223not evaluable Hip dislocation and/or dysplasia Meyer, 2025 11.44[0.58; 3.59]295,223not evaluable Hirschsprung's disease Meyer, 2025 16.61[0.41; 106.12]25,223not evaluable Hydrocephaly Meyer, 2025 10.89[0.10; 7.77]75,223not evaluable Hypoplastic left heart (HLH/HLHS) Meyer, 2025 10.32[0.02; 5.62]85,223not evaluable Hypoplastic right heart (HRH/HRHS) Meyer, 2025 15.52[0.11; 278.22]-5,223not evaluable Indeterminate sex Meyer, 2025 15.83[0.36; 93.82]25,223not evaluable Laterality anomalies Meyer, 2025 11.10[0.05; 23.00]25,223not evaluable Limb reduction defects (LRD) Meyer, 2025 12.28[0.24; 21.91]45,223not evaluable Microcephaly / Small head circumference for gestational age Meyer, 2025 11.09[0.24; 4.95]145,223not evaluable Minor congenital malformations Alami, 2017 10.56[0.10; 3.14]697not evaluable Mitral valve anomalies Meyer, 2025 11.10[0.05; 23.00]25,223not evaluable Multicystic renal dysplasia Meyer, 2025 10.92[0.11; 7.60]95,223not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Meyer, 2025 10.37[0.02; 6.44]75,223not evaluable Omphalocele Meyer, 2025 11.19[0.21; 6.82]75,223not evaluable Oro-facial clefts Meyer, 2025 12.00[0.97; 4.13]405,223not evaluable Patau syndrome / Trisomy 13 Meyer, 2025 116.56[0.67; 406.64]15,223not evaluable Patent ductus arterious Meyer, 2025 10.61[0.03; 11.39]45,223not evaluable Polydactyly Meyer, 2025 11.02[0.30; 3.48]225,223not evaluable Posterior urethral valve and/or prune belly Meyer, 2025 10.61[0.03; 11.39]45,223not evaluable Pulmonary valve atresia Meyer, 2025 10.61[0.03; 11.39]45,223not evaluable Pulmonary valve stenosis Meyer, 2025 10.99[0.12; 8.18]85,223not evaluable Respiratory system anomalies Meyer, 2025 12.58[0.26; 25.43]45,223not evaluable Situs inversus Meyer, 2025 11.84[0.07; 45.17]15,223not evaluable Skeletal dysplasias Meyer, 2025 13.83[0.32; 45.92]35,223not evaluable Spina bifida Meyer, 2025 11.77[0.32; 9.82]75,223not evaluable Syndactyly Meyer, 2025 11.58[0.16; 15.59]45,223not evaluable Tetralogy of Fallot Meyer, 2025 10.26[0.02; 4.48]105,223not evaluable Total anomalous pulm venous return Meyer, 2025 10.79[0.04; 15.27]35,223not evaluable Tricuspid atresia and stenosis Meyer, 2025 15.52[0.11; 278.22]-5,223not evaluable Turner syndrome Meyer, 2025 116.56[0.67; 406.64]15,223not evaluable Ventricular septal defect Meyer, 2025 11.09[0.65; 1.83]1115,223not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Francella, 2003 Dejaco, 2005 Schramm, 2006 Langagergaard (Controls unexposed, sick), 2007 Goldstein, 2007 Cleary (Controls unexposed, sick), 2009 Coelho (Controls unexposed, sick), 2011 Shim, 2011 Komoto, 2016 Bröms, 2016 Koslowsky, 2019 Nguyen, 2019 Lazzaroni, 2020 Kanis, 2021 Meyer b (Controls unexposed, sick), 2021 Reynolds, 2022 Yeaman (Controls unexposed, disease free), 2023 Vestergaard, 2024 181.80[1.60; 2.02]2,8934,943low Low birth weight (< 2500g) Francella, 2003 Dejaco, 2005 Langagergaard (Controls unexposed, sick), 2007 Goldstein, 2007 Cleary (Controls unexposed, sick), 2009 Coelho (Controls unexposed, sick), 2011 Shim, 2011 Bröms (Crohn’s disease, stable disease), 2014 Komoto, 2016 Kanis, 2017 Koslowsky, 2019 Reynolds, 2022 Vestergaard, 2024 131.51[1.04; 2.19]16,3821,096low Small for gestational age (weight) Cleary (Controls unexposed, sick), 2009 Coelho (Controls unexposed, sick), 2011 Bröms (Crohn’s disease, stable disease), 2014 Lazzaroni, 2020 Howren, 2020 Kanis, 2021 Meyer b (Controls unexposed, sick), 2021 Reynolds, 2022 Vestergaard, 2024 90.86[0.61; 1.20]48,7874,541not evaluable Large for gestational age (weight) Cleary (Controls unexposed, NOS), 2009 Coelho (Controls unexposed, sick), 2011 Meyer b (Controls unexposed, sick), 2021 30.95[0.42; 2.16]70,4084,060not evaluable Very preterm (28 to 32 weeks) Lazzaroni, 2020 Meyer b (Controls unexposed, sick), 2021 Vestergaard, 2024 31.89[1.40; 2.54]2953,692not evaluable Macrosomia (> 4000g) Cleary (Controls unexposed, NOS), 2009 10.59[0.32; 1.10]46,060467not evaluable Maternal consequences Caesarean Shim, 2011 Kanis, 2021 Meyer b (Controls unexposed, sick), 2021 Reynolds, 2022 Yeaman (Controls unexposed, disease free), 2023 Vestergaard, 2024 61.20[1.03; 1.40]6,1844,030not evaluable Maternal liver disorder / failure during pregnancy or Intrahepatic cholestasis of pregnancy Kanis, 2021 Selinger (Controls unexposed, sick), 2023 Nguyen_IBD (Controls unexposed, sick), 2025 Nguyen_SLE (Controls unexposed, sick), 2025 45.90[3.69; 9.43]2282,572not evaluable Preeclampsia Kanis, 2021 Reynolds, 2022 21.26[0.75; 2.11]69322not evaluable Assisted deliveries (forceps, vacuum, ...) Reynolds, 2022 10.42[0.16; 1.14]3087not evaluable Gestational diabetes Kanis, 2021 10.58[0.19; 1.75]20240not evaluable Placenta previa 0----- Polyhydramnios 0----- Neonatal disorders Neonatal infections Francella, 2003 Meyer a (Controls unexposed, sick), 2021 Vestergaard, 2024 31.52[0.62; 3.72]43,517not evaluable Neonatal medical care Shim, 2011 Koslowsky, 2019 Yeaman (Controls unexposed, disease free), 2023 31.07[0.22; 5.15]2059not evaluable Neonatal anemia Koslowsky, 2019 Yeaman (Controls unexposed, disease free), 2023 21.03[0.19; 5.51]1942not evaluable Low Apgar score (< 7) (at 5 min) Koslowsky, 2019 Vestergaard, 2024 20.88[0.07; 10.71]1132not evaluable Hearing loss / Auditory deficit Marder, 2013 112.13[0.46; 317.61]113not evaluable Jaundice / Icterus Koslowsky, 2019 13.75[0.39; 36.44]621not evaluable Neonatal death (< 28 days of life) 0----- Long term consequences Child/Infant infections (> 1 year) Angelberger, 2011 Meyer a (Controls unexposed, sick), 2021 Kanis, 2021 Reynolds, 2022 41.19[0.79; 1.80]1453,734not evaluable Cancer (all kind) in children or adults Francella, 2003 Angelberger, 2011 22.65[0.16; 43.99]-29not evaluable Child/Infant growth abnormalities (> 1 year) Kanis, 2021 10.78[0.21; 2.91]12240not evaluable Childhood asthma 0----- Infant allergies Kanis, 2017 11.72[0.67; 4.40]2083not evaluable Intrauterine deaths Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Tennenbaum, 1999 Dejaco, 2005 Schramm, 2006 Kanis, 2017 Alami, 2017 51.12[0.71; 1.76]112306not evaluable Intrauterine deaths (as a whole or unspecified) Francella, 2003 Schramm, 2006 Shim, 2011 Komoto, 2016 Nguyen, 2019 50.58[0.17; 2.03]9459serious Late intrauterine deaths (> 22 weeks) / Stillbirths Dejaco, 2005 Goldstein, 2007 Alami, 2017 Meyer b (Controls unexposed, sick), 2021 42.36[1.40; 3.97]1493,891not evaluable Therapeutic terminations of pregnancy Tennenbaum, 1999 Goldstein, 2007 Alami, 2017 31.46[0.70; 3.05]30313not evaluable Ectopic pregnancy Francella, 2003 Alami, 2017 23.01[0.31; 29.53]2139not evaluable Elective/induced termination of pregnancy Alami, 2017 Nguyen, 2019 22.00[0.88; 4.55]52128not evaluable Perinatal death Norgard (Controls unexposed, sick), 2003 13.20[0.19; 53.97]210not evaluable Neuro-developmental disorders Neuro-developmental disorders (as a whole) Marder, 2013 Lazzaroni, 2020 Andreoli, 2022 Reynolds, 2022 42.03[0.49; 8.43]52130not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Marder, 2013 Lazzaroni, 2020 Reynolds, 2022 32.15[0.34; 13.70]8127not evaluable Learning disorders Marder, 2013 Lazzaroni, 2020 Reynolds, 2022 30.65[0.17; 2.46]15127not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Marder, 2013 Lazzaroni, 2020 24.88[0.76; 31.47]540not evaluable Language disorders/delay Marder, 2013 Lazzaroni, 2020 23.93[0.75; 20.56]1440not evaluable Psychomotor developmental disorders/delay Marder, 2013 Lazzaroni, 2020 23.08[0.21; 44.32]240not evaluable ADHD (Attention deficit hyperactivity disorder): Risk Reynolds, 2022 10.32[0.02; 6.22]387not evaluable Cognitive developmental disorders/delay (3-6 years old) Reynolds, 2022 11.27[0.41; 3.90]1487not evaluable0.0100.01.0

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