Proton Pump Inhibitors updated on 01-14-2026

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)1.07 [1.02, 1.12]0%12 studies122,16359,423low ROB1.34 [1.18; .]
Major congenital malformations1.07 [1.03, 1.12]0%9 studies121,39458,383not evaluable ROB1.35 [1.19; .]
Congenital heart defects1.09 [1.01, 1.17]0%4 studies50,79643,701not evaluable ROB1.39 [1.12; .]
Cleft palate1.17 [0.75, 1.83]11%4 studies2,84544,348not evaluable ROB-
Hypospadias1.37 [0.67, 2.79]61%5 studies2,48124,977not evaluable ROB-
Club foot / Talipes equinovarus1.30 [0.75, 2.25]0%3 studies5733,816not evaluable ROB-
Congenital hydronephrosis0.60 [0.27, 1.32]0%3 studies34,065not evaluable ROB-
Atrial septal defect1.28 [0.90, 1.81]0%3 studies7635,085not evaluable ROB-
Cardiac septal defects2.33 [0.36, 14.99]78%2 studies33,91140,679not evaluable ROB-
Cleft lip with or without cleft palate0.70 [0.07, 7.28]50%2 studies13,790not evaluable ROB-
Down syndrom / Trisomy 214.12 [0.34, 49.29]0%2 studies1414not evaluable ROB-
Eye defects0.97 [0.67, 1.40]0%2 studies2,09440,679not evaluable ROB-
Hydrocephaly1.47 [0.60, 3.60]78%2 studies1,27248,302not evaluable ROB-
Limb defects1.07 [0.93, 1.22]0%2 studies13,71540,679not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.52 [0.42, 5.56]36%2 studies138166not evaluable ROB-
Nervous system anomalies1.24 [1.00, 1.55]0%2 studies4,79040,679not evaluable ROB-
Polydactyly0.97 [0.27, 3.48]0%2 studies43,790not evaluable ROB-
Syndactyly1.28 [0.04, 37.41]59%2 studies3,790not evaluable ROB-
Ventricular septal defect1.09 [0.76, 1.56]0%3 studies1,1885,085not evaluable ROB-
Patent ductus arterious3.47 [2.25, 5.36]0%2 studies1,885356not evaluable ROB6.40 [3.92; .]
Abdominal wall defects2.74 [1.14, 6.58]-1 study23640,540not evaluable ROB4.92 [1.54; .]
Respiratory system anomalies1.77 [1.12, 2.79]-1 study89140,540not evaluable ROB2.94 [1.49; .]
16 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)1.25 [0.97, 1.62]58%8 studies8,3521,400not evaluable ROB-
Low birth weight (< 2500g)1.02 [0.78, 1.33]47%7 studies116,24742,505not evaluable ROB-
Small for gestational age (weight)1.17 [0.91, 1.50]14%3 studies2139not evaluable ROB-
Very preterm (28 to 32 weeks)0.64 [0.29, 1.40]0%2 studies29391not evaluable ROB-
2 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preeclampsia1.08 [0.81, 1.44]85%3 studies18,71630,188not evaluable ROB-
Maternal infections--0 study-
3 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low Apgar score (< 7) (at 5 min)0.81 [0.64, 1.04]2%2 studies1,060not evaluable ROB-
Bone fractures / bone mineralisation anomalies0.73 [0.59, 0.90]-1 study4,47210,547not evaluable ROB2.08 [.; 1.47]
Neonatal infections0.53 [0.08, 3.51]72%2 studies92,010466,982not evaluable ROB-
2 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Childhood asthma1.23 [1.01, 1.49]91%7 studies30,15642,401not evaluable ROB1.75 [1.08; .]
Infant allergies1.21 [0.91, 1.61]94%3 studies38,03139,764not evaluable ROB-
1 non statistically significant endpoints reported in only one study

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Late intrauterine deaths (> 22 weeks) / Stillbirths1.66 [0.58, 4.75]0%5 studies77738not evaluable ROB-
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.28 [0.89, 1.84]0%3 studies199630not evaluable ROB-
Elective/induced termination of pregnancy3.05 [1.90, 4.91]0%2 studies81517not evaluable ROB5.55 [3.20; .]
Perinatal death0.80 [0.16, 3.98]74%2 studies1,3501,529not evaluable ROB-
Ectopic pregnancy--0 study-
2 non statistically significant endpoints reported in only one study

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.31 [1.24, 1.38]-1 study93,89429,378not evaluable ROB1.95 [1.79; .]
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.31 [1.24, 1.38]-1 study93,89429,378not evaluable ROB1.95 [1.79; .]
ASD (Autism spectrum disorder): Diagnosis1.34 [1.23, 1.46]-1 study30,44029,378not evaluable ROB2.01 [1.76; .]
ASD (Autism spectrum disorder): Diagnosis/Risk1.34 [1.23, 1.46]-1 study30,44029,378not evaluable ROB2.01 [1.76; .]
Cognitive developmental disorders/delay (> 6 years old)1.24 [1.12, 1.38]-1 study24,46129,378not evaluable ROB1.79 [1.48; .]
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.24 [1.12, 1.38]-1 study24,46129,378not evaluable ROB1.79 [1.48; .]
1 non statistically significant endpoints reported in only one study

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