Olanzapine updated on 06-10-2025

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)1.17 [0.98, 1.39]0%7 studies30,8583,534not evaluable ROB-
Major congenital malformations1.17 [0.98, 1.39]0%7 studies30,8583,534not evaluable ROB-
Congenital heart defects1.09 [0.78, 1.52]0%2 studies1372,442not evaluable ROB-
Ano-rectal atresia and stenosis2.44 [0.85, 6.96]0%2 studies5743,111not evaluable ROB-
Microcephaly / Small head circumference for gestational age0.77 [0.26, 2.28]0%2 studies474956not evaluable ROB-
Digestive system anomalies4.33 [0.63, 29.68]-1 study47413not evaluable ROB-
Hip dislocation and/or dysplasia0.36 [0.05, 2.57]-1 study2,341not evaluable ROB-
Hydrocephaly0.30 [0.04, 2.19]-1 study2,341not evaluable ROB-
Limb defects3.71 [1.36, 10.15]-1 study242413not evaluable ROB6.88 [2.05; .]
Limb reduction defects (LRD)2.26 [0.32, 16.00]-1 study2,341not evaluable ROB-
Nervous system anomalies1.00 [0.08, 12.55]-1 study49413not evaluable ROB-
Oro-facial clefts2.56 [1.22, 5.38]-1 study2,341not evaluable ROB4.56 [1.74; .]
Respiratory system anomalies1.43 [0.04, 48.60]-1 study21413not evaluable ROB-
Atrial septal defect1.40 [0.28, 7.00]-1 study3,584770not evaluable ROB-
Bilateral renal agenesis including Potter syndrome16.25 [1.01, 262.42]-1 study75770not evaluable ROB31.99 [1.08; .]
Bladder exstrophy and/or epispadia14.87 [0.92, 239.97]-1 study82770not evaluable ROB-
Cleft lip with or without cleft palate2.90 [0.56, 15.00]-1 study1,677770not evaluable ROB-
Cleft palate1.00 [0.06, 16.07]-1 study1,221770not evaluable ROB-
Club foot / Talipes equinovarus2.90 [0.56, 14.93]-1 study1,696770not evaluable ROB-
Coarctation of aorta1.49 [0.09, 23.79]-1 study825770not evaluable ROB-
Craniosynostosis1.58 [0.10, 25.23]-1 study778770not evaluable ROB-
Diaphragmatic hernia3.11 [0.19, 49.84]-1 study394770not evaluable ROB-
Ebstein's anomaly23.37 [1.44, 378.91]-1 study52770not evaluable ROB46.23 [2.24; .]
Gastroschisis4.98 [0.31, 79.86]-1 study246770not evaluable ROB-
Hypoplastic left heart (HLH/HLHS)5.17 [0.32, 82.90]-1 study237770not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)16.92 [1.05, 273.39]-1 study72770not evaluable ROB33.34 [1.27; .]
Hypospadias0.72 [0.10, 5.12]-1 study3,405770not evaluable ROB-
Multicystic renal dysplasia1.77 [0.11, 28.33]-1 study693770not evaluable ROB-
Oesophageal atresia with or without tracheo-oesophageal fistula2.93 [0.18, 46.98]-1 study418770not evaluable ROB-
Omphalocele4.33 [0.27, 69.41]-1 study283770not evaluable ROB-
Polydactyly3.16 [0.20, 50.62]-1 study388770not evaluable ROB-
Pulmonary artery atresia7.64 [0.48, 122.84]-1 study160770not evaluable ROB-
Spina bifida3.90 [0.26, 57.98]-1 study625770not evaluable ROB-
Tetralogy of Fallot1.90 [0.12, 30.48]-1 study644770not evaluable ROB-
Transposition of the great vessels2.24 [0.14, 35.83]-1 study548770not evaluable ROB-
Ventricular septal defect1.00 [0.17, 6.00]-1 study5,011770not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.28 [0.77, 2.11]27%4 studies179354not evaluable ROB-
Small for gestational age (weight)1.71 [1.07, 2.72]0%2 studies64353not evaluable ROB2.80 [1.35; .]
Large for gestational age (length)1.94 [0.87, 4.33]-1 study186not evaluable ROB-
Large for gestational age (weight)0.55 [0.14, 2.14]-1 study187not evaluable ROB-
Large head circumference for gestational age3.02 [1.60, 5.71]-1 study186not evaluable ROB5.49 [2.58; .]
Small for gestational age (length)1.17 [0.54, 2.54]-1 study186not evaluable ROB-
Low birth weight (< 2500g)11.84 [0.57, 247.85]-1 study414not evaluable ROB-
Macrosomia (> 4000g)0.92 [0.05, 16.46]-1 study214not evaluable ROB-

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Gestational diabetes1.53 [1.17, 2.00]0%5 studies6,147719not evaluable ROB2.42 [1.61; .]
Preeclampsia1.03 [0.45, 2.32]-1 study49166not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal disorders (as a whole)4.02 [2.07, 7.81]-1 study5686not evaluable ROB7.51 [3.56; .]
Infant health status 1.01 [0.91, 1.12]-1 studynot evaluable ROB-
Neonatal death (< 28 days of life)1.19 [0.77, 1.84]-1 study101not evaluable ROB-
Neonatal medical care11.84 [0.57, 247.85]-1 study414not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.00 [0.80, 1.25]0%3 studies158,486403not evaluable ROB-
Elective/induced termination of pregnancy2.00 [0.10, 38.88]-1 study145not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Cognitive developmental disorders/delay (> 6 years old)0.80 [0.35, 1.85]27%2 studies8762,727not evaluable ROB-
Language disorders/delay0.92 [0.73, 1.16]0%2 studies78,5242,676not evaluable ROB-
Learning disorders 0.70 [0.38, 1.29]0%2 studies1,3101,181not evaluable ROB-
Neuro-developmental disorders (as a whole)0.93 [0.80, 1.09]0%2 studies160,3702,895not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)0.80 [0.35, 1.85]27%2 studies8762,727not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis0.98 [0.78, 1.24]-1 study62,4551,495not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk0.98 [0.78, 1.24]-1 study62,4551,495not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.00 [0.60, 1.68]-1 study9,6171,327not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.00 [0.60, 1.68]-1 study9,6171,327not evaluable ROB-
Psychomotor developmental disorders/delay0.89 [0.40, 2.00]-1 study1,327not evaluable ROB-

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