Aripiprazole 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)1.40 [0.91, 2.17]53%5 studies30,5664,929serious ROB-
Major congenital malformations1.36 [0.88, 2.11]49%5 studies30,5574,929not evaluable ROB-
Ano-rectal atresia and stenosis0.72 [0.14, 3.54]0%2 studies5744,651not evaluable ROB-
Gastroschisis1.82 [0.10, 34.19]67%2 studies2474,651not evaluable ROB-
Oesophageal atresia with or without tracheo-oesophageal fistula1.37 [0.28, 6.75]0%2 studies4184,651not evaluable ROB-
Congenital heart defects1.10 [0.84, 1.45]-1 study3,861not evaluable ROB-
Digestive system anomalies1.96 [0.04, 95.27]-1 study46220not evaluable ROB-
Hip dislocation and/or dysplasia0.64 [0.21, 1.97]-1 study3,861not evaluable ROB-
Hydrocephaly0.64 [0.16, 2.57]-1 study3,861not evaluable ROB-
Limb defects1.21 [0.19, 7.74]-1 study237220not evaluable ROB-
Limb reduction defects (LRD)2.04 [0.51, 8.15]-1 study3,861not evaluable ROB-
Nervous system anomalies1.08 [0.07, 17.55]-1 study47220not evaluable ROB-
Oro-facial clefts0.66 [0.27, 1.60]-1 study3,861not evaluable ROB-
Respiratory system anomalies2.50 [0.15, 41.51]-1 study20220not evaluable ROB-
Atrial septal defect1.40 [0.28, 6.93]-1 study3,584790not evaluable ROB-
Bilateral renal agenesis including Potter syndrome15.84 [0.98, 255.77]-1 study75790not evaluable ROB-
Bladder exstrophy and/or epispadia14.49 [0.90, 233.88]-1 study82790not evaluable ROB-
Cleft lip with or without cleft palate1.43 [0.20, 10.15]-1 study1,676790not evaluable ROB-
Cleft palate2.00 [0.19, 21.07]-1 study1,222790not evaluable ROB-
Club foot / Talipes equinovarus2.90 [0.49, 17.07]-1 study1,696790not evaluable ROB-
Coarctation of aorta1.45 [0.09, 23.19]-1 study825790not evaluable ROB-
Craniosynostosis3.10 [0.24, 40.89]-1 study779790not evaluable ROB-
Diaphragmatic hernia3.03 [0.19, 48.58]-1 study394790not evaluable ROB-
Ebstein's anomaly22.78 [1.40, 369.30]-1 study52790not evaluable ROB45.05 [2.16; .]
Hypoplastic left heart (HLH/HLHS)5.03 [0.31, 80.79]-1 study237790not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)16.49 [1.02, 266.45]-1 study72790not evaluable ROB32.48 [1.17; .]
Hypospadias1.40 [0.28, 7.07]-1 study3,406790not evaluable ROB-
Microcephaly / Small head circumference for gestational age2.52 [0.16, 40.38]-1 study474790not evaluable ROB-
Multicystic renal dysplasia1.72 [0.11, 27.61]-1 study693790not evaluable ROB-
Omphalocele4.22 [0.26, 67.65]-1 study283790not evaluable ROB-
Polydactyly3.08 [0.19, 49.33]-1 study388790not evaluable ROB-
Pulmonary artery atresia7.45 [0.46, 119.73]-1 study160790not evaluable ROB-
Spina bifida3.80 [0.26, 55.72]-1 study625790not evaluable ROB-
Tetralogy of Fallot1.85 [0.12, 29.71]-1 study644790not evaluable ROB-
Transposition of the great vessels2.18 [0.14, 34.92]-1 study548790not evaluable ROB-
Ventricular septal defect1.90 [0.60, 6.01]-1 study5,013790not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)2.57 [1.06, 6.25]-1 study2267not evaluable ROB4.58 [1.30; .]
Small for gestational age (weight)2.97 [1.23, 7.17]-1 study2363not evaluable ROB5.39 [1.76; .]

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Gestational diabetes1.24 [0.53, 2.92]48%3 studies99505not evaluable ROB-
Preeclampsia0.66 [0.07, 6.35]-1 study486not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal disorders (as a whole)6.95 [2.17, 22.20]-1 study4717not evaluable ROB13.38 [3.77; .]

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.47 [0.82, 2.63]78%4 studies158,485593not evaluable ROB-
Elective/induced termination of pregnancy6.65 [2.83, 15.61]0%2 studies27154not evaluable ROB12.78 [5.11; .]
Therapeutic terminations of pregnancy6.05 [0.24, 151.25]-1 study186not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Cognitive developmental disorders/delay (> 6 years old)1.53 [0.86, 2.73]0%2 studies523not evaluable ROB-
Language disorders/delay1.36 [0.77, 2.43]43%2 studies76,7572,201not evaluable ROB-
Learning disorders 0.69 [0.29, 1.66]0%2 studies463not evaluable ROB-
Neuro-developmental disorders (as a whole)1.33 [1.12, 1.58]0%2 studies160,3272,261not evaluable ROB1.99 [1.49; .]
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.53 [0.86, 2.73]0%2 studies523not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.36 [0.98, 1.89]-1 study62,4081,738not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.36 [0.98, 1.89]-1 study62,4081,738not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.49 [0.90, 2.45]-1 study13,4481,738not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.49 [0.90, 2.45]-1 study13,4481,738not evaluable ROB-
Psychomotor developmental disorders/delay1.05 [0.55, 2.01]-1 study11,8771,738not evaluable ROB-

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