Thiopurines (Azathioprine, Mercaptopurin) updated on 07-28-2025

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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)1.33 [1.02, 1.75]0%9 studies5,2361,332not evaluable ROB2.00 [1.14; .]
Major congenital malformations1.25 [1.05, 1.49]0%9 studies43,9466,491serious ROB1.81 [1.26; .]
Congenital heart defects1.42 [1.04, 1.93]0%4 studies12,8215,950not evaluable ROB2.19 [1.25; .]
Limb defects1.09 [0.62, 1.91]0%3 studies955,469not evaluable ROB-
Genital anomalies1.60 [0.94, 2.75]0%2 studies865,372not evaluable ROB-
Cardiac septal defects1.91 [0.77, 4.71]-1 study26481not evaluable ROB-
Chromosomal abnormalities2.68 [0.86, 8.42]0%2 studies155,320not evaluable ROB-
Hypospadias1.50 [0.88, 2.56]0%2 studies3,4425,704not evaluable ROB-
Nervous system anomalies0.73 [0.30, 1.81]0%2 studies435,320not evaluable ROB-
Urinary malformations0.89 [0.51, 1.56]0%2 studies1045,320not evaluable ROB-
Abdominal wall defects1.05 [0.19, 5.76]-1 study85,223not evaluable ROB-
Annular pancreas5.52 [0.11, 278.22]-1 study5,223not evaluable ROB-
Ano-rectal atresia and stenosis0.37 [0.02, 6.44]-1 study75,223not evaluable ROB-
Anophthalmos/micropthalmos1.10 [0.05, 23.00]-1 study25,223not evaluable ROB-
Aortic atresia/interrupted aortic arch1.10 [0.05, 23.00]-1 study25,223not evaluable ROB-
Aortic valve atresia/stenosis1.10 [0.05, 23.00]-1 study25,223not evaluable ROB-
Arhinencephaly/holoprosencephaly5.52 [0.11, 278.22]-1 study5,223not evaluable ROB-
Atresia of bile ducts5.52 [0.11, 278.22]-1 study5,223not evaluable ROB-
Atresia or stenosis of other parts of small intestine1.38 [0.15, 12.77]-1 study55,223not evaluable ROB-
Atrial septal defect1.75 [1.00, 3.06]-1 study834,160not evaluable ROB2.90 [1.02; .]
Atrioventricular septal defect2.41 [0.52, 11.20]-1 study134,160not evaluable ROB-
Bilateral renal agenesis including Potter syndrome7.22 [0.45, 115.61]-1 study25,223not evaluable ROB-
Bladder exstrophy and/or epispadia1.84 [0.07, 45.17]-1 study15,223not evaluable ROB-
Choanal atresia2.58 [0.26, 25.43]-1 study45,223not evaluable ROB-
Cleft lip with or without cleft palate2.59 [1.08, 6.21]-1 study274,160not evaluable ROB4.62 [1.38; .]
Cleft palate1.37 [0.29, 6.42]-1 study125,223not evaluable ROB-
Club foot / Talipes equinovarus0.73 [0.25, 2.13]-1 study305,223not evaluable ROB-
Coarctation of aorta0.42 [0.05, 3.39]-1 study155,223not evaluable ROB-
Common arterial truncus1.84 [0.07, 45.17]-1 study15,223not evaluable ROB-
Congenital cataract0.42 [0.02, 7.54]-1 study65,223not evaluable ROB-
Congenital glaucoma1.84 [0.07, 45.17]-1 study15,223not evaluable ROB-
Craniosynostosis1.00 [0.21, 4.73]-1 study135,223not evaluable ROB-
Diaphragmatic hernia0.37 [0.02, 6.44]-1 study75,223not evaluable ROB-
Digestive system anomalies0.65 [0.20, 2.13]-1 study345,223not evaluable ROB-
Double outlet right ventricle2.58 [0.23, 29.05]-1 study35,223not evaluable ROB-
Down syndrom / Trisomy 211.01 [0.12, 8.60]-1 study85,223not evaluable ROB-
Duodenal atresia or stenosis0.50 [0.03, 9.07]-1 study55,223not evaluable ROB-
Ear, face and neck anomalies5.52 [0.11, 278.22]-1 study5,223not evaluable ROB-
Ebstein's anomaly5.52 [0.11, 278.22]-1 study5,223not evaluable ROB-
Edward syndrome / Trisomy 185.52 [0.11, 278.22]-1 study5,223not evaluable ROB-
Encephalocele1.84 [0.07, 45.17]-1 study15,223not evaluable ROB-
Eye defects0.29 [0.02, 4.99]-1 study95,223not evaluable ROB-
Gastroschisis1.84 [0.07, 45.17]-1 study15,223not evaluable ROB-
Hip dislocation and/or dysplasia1.44 [0.58, 3.59]-1 study295,223not evaluable ROB-
Hirschsprung's disease6.61 [0.41, 106.12]-1 study25,223not evaluable ROB-
Hydrocephaly0.89 [0.10, 7.77]-1 study75,223not evaluable ROB-
Hypoplastic left heart (HLH/HLHS)0.32 [0.02, 5.62]-1 study85,223not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)5.52 [0.11, 278.22]-1 study5,223not evaluable ROB-
Indeterminate sex5.83 [0.36, 93.82]-1 study25,223not evaluable ROB-
Laterality anomalies1.10 [0.05, 23.00]-1 study25,223not evaluable ROB-
Limb reduction defects (LRD)2.28 [0.24, 21.91]-1 study45,223not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.09 [0.24, 4.95]-1 study145,223not evaluable ROB-
Minor congenital malformations0.56 [0.10, 3.14]-1 study697not evaluable ROB-
Mitral valve anomalies1.10 [0.05, 23.00]-1 study25,223not evaluable ROB-
Multicystic renal dysplasia0.92 [0.11, 7.60]-1 study95,223not evaluable ROB-
Oesophageal atresia with or without tracheo-oesophageal fistula0.37 [0.02, 6.44]-1 study75,223not evaluable ROB-
Omphalocele1.19 [0.21, 6.82]-1 study75,223not evaluable ROB-
Oro-facial clefts2.00 [0.97, 4.13]-1 study405,223not evaluable ROB-
Patau syndrome / Trisomy 1316.56 [0.67, 406.64]-1 study15,223not evaluable ROB-
Patent ductus arterious0.61 [0.03, 11.39]-1 study45,223not evaluable ROB-
Polydactyly1.02 [0.30, 3.48]-1 study225,223not evaluable ROB-
Posterior urethral valve and/or prune belly0.61 [0.03, 11.39]-1 study45,223not evaluable ROB-
Pulmonary valve atresia0.61 [0.03, 11.39]-1 study45,223not evaluable ROB-
Pulmonary valve stenosis0.99 [0.12, 8.18]-1 study85,223not evaluable ROB-
Respiratory system anomalies2.58 [0.26, 25.43]-1 study45,223not evaluable ROB-
Situs inversus1.84 [0.07, 45.17]-1 study15,223not evaluable ROB-
Skeletal dysplasias3.83 [0.32, 45.92]-1 study35,223not evaluable ROB-
Spina bifida1.77 [0.32, 9.82]-1 study75,223not evaluable ROB-
Syndactyly1.58 [0.16, 15.59]-1 study45,223not evaluable ROB-
Tetralogy of Fallot0.26 [0.02, 4.48]-1 study105,223not evaluable ROB-
Total anomalous pulm venous return0.79 [0.04, 15.27]-1 study35,223not evaluable ROB-
Tricuspid atresia and stenosis5.52 [0.11, 278.22]-1 study5,223not evaluable ROB-
Turner syndrome16.56 [0.67, 406.64]-1 study15,223not evaluable ROB-
Ventricular septal defect1.09 [0.65, 1.83]-1 study1115,223not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.80 [1.60, 2.02]3%18 studies2,8934,943low ROB2.99 [2.57; .]
Low birth weight (< 2500g)1.51 [1.04, 2.19]34%13 studies16,3821,096low ROB2.39 [1.25; .]
Small for gestational age (weight)0.86 [0.61, 1.20]49%9 studies48,7874,541not evaluable ROB-
Large for gestational age (weight)0.95 [0.42, 2.16]81%3 studies70,4084,060not evaluable ROB-
Very preterm (28 to 32 weeks)1.89 [1.40, 2.54]0%3 studies2953,692not evaluable ROB3.18 [2.15; .]
Macrosomia (> 4000g)0.59 [0.32, 1.10]-1 study46,060467not evaluable ROB-

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.20 [1.03, 1.40]17%6 studies6,1844,030not evaluable ROB1.69 [1.20; .]
Maternal liver disorder / failure during pregnancy or Intrahepatic cholestasis of pregnancy5.90 [3.69, 9.43]32%4 studies2282,572not evaluable ROB11.27 [6.84; .]
Preeclampsia1.26 [0.75, 2.11]0%2 studies69322not evaluable ROB-
Assisted deliveries (forceps, vacuum, ...)0.42 [0.16, 1.14]-1 study3087not evaluable ROB-
Gestational diabetes0.58 [0.19, 1.75]-1 study20240not evaluable ROB-
Placenta previa--0 study-
Polyhydramnios--0 study-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal infections1.52 [0.62, 3.72]62%3 studies43,517not evaluable ROB-
Neonatal medical care1.07 [0.22, 5.15]34%3 studies2059not evaluable ROB-
Neonatal anemia1.03 [0.19, 5.51]37%2 studies1942not evaluable ROB-
Low Apgar score (< 7) (at 5 min)0.88 [0.07, 10.71]0%2 studies1132not evaluable ROB-
Hearing loss / Auditory deficit12.13 [0.46, 317.61]-1 study113not evaluable ROB-
Jaundice / Icterus3.75 [0.39, 36.44]-1 study621not evaluable ROB-
Neonatal death (< 28 days of life)--0 study-

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant infections (> 1 year)1.19 [0.79, 1.80]53%4 studies1453,734not evaluable ROB-
Cancer (all kind) in children or adults2.65 [0.16, 43.99]0%2 studies29not evaluable ROB-
Child/Infant growth abnormalities (> 1 year)0.78 [0.21, 2.91]-1 study12240not evaluable ROB-
Childhood asthma--0 study-
Infant allergies1.72 [0.67, 4.40]-1 study2083not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.12 [0.71, 1.76]0%5 studies112306not evaluable ROB-
Intrauterine deaths (as a whole or unspecified)0.58 [0.17, 2.03]4%5 studies9459serious ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths2.36 [1.40, 3.97]0%4 studies1493,891not evaluable ROB4.14 [2.14; .]
Therapeutic terminations of pregnancy1.46 [0.70, 3.05]0%3 studies30313not evaluable ROB-
Ectopic pregnancy3.01 [0.31, 29.53]0%2 studies2139not evaluable ROB-
Elective/induced termination of pregnancy2.00 [0.88, 4.55]0%2 studies52128not evaluable ROB-
Perinatal death3.20 [0.19, 53.97]-1 study210not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neuro-developmental disorders (as a whole)2.03 [0.49, 8.43]66%4 studies52130not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk2.15 [0.34, 13.70]27%3 studies8127not evaluable ROB-
Learning disorders 0.65 [0.17, 2.46]0%3 studies15127not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis4.88 [0.76, 31.47]0%2 studies540not evaluable ROB-
Language disorders/delay3.93 [0.75, 20.56]34%2 studies1440not evaluable ROB-
Psychomotor developmental disorders/delay3.08 [0.21, 44.32]26%2 studies240not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk0.32 [0.02, 6.22]-1 study387not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)1.27 [0.41, 3.90]-1 study1487not evaluable ROB-

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