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

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)1.33 [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-
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-
Atrial septal defect1.75 [1.00, 3.06]-1 study834,160not evaluable ROB2.90 [1.02; .]
Cleft lip with or without cleft palate2.59 [1.08, 6.21]-1 study274,160not evaluable ROB4.62 [1.38; .]
63 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)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; .]
1 non statistically significant endpoints reported in only one study

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-
Placenta previa--0 study-
Polyhydramnios--0 study-
2 non statistically significant endpoints reported in only one 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-
Neonatal death (< 28 days of life)--0 study-
2 non statistically significant endpoints reported in only one 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-
Childhood asthma--0 study-
2 non statistically significant endpoints reported in only one study

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-
1 non statistically significant endpoints reported in only one study

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-
2 non statistically significant endpoints reported in only one study

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