Risperidone Paliperidone 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)1.34 [1.13, 1.59]0%6 studies61,5302,999not evaluable ROB2.02 [1.52; .]
Major congenital malformations1.34 [1.13, 1.59]0%6 studies61,5302,999not evaluable ROB2.02 [1.52; .]
Congenital heart defects0.99 [0.67, 1.47]0%2 studies1362,319not evaluable ROB-
Ano-rectal atresia and stenosis1.82 [0.52, 6.29]0%2 studies5742,777not evaluable ROB-
Gastroschisis2.32 [0.67, 8.04]0%2 studies2462,777not evaluable ROB-
Digestive system anomalies1.19 [0.08, 17.85]-1 study46242not evaluable ROB-
Hip dislocation and/or dysplasia1.21 [0.39, 3.75]-1 study2,270not evaluable ROB-
Hydrocephaly2.16 [0.81, 5.75]-1 study2,270not evaluable ROB-
Limb defects2.77 [0.92, 8.32]-1 study238242not evaluable ROB-
Limb reduction defects (LRD)4.01 [1.00, 16.06]-1 study2,270not evaluable ROB7.48 [1.04; .]
Nervous system anomalies1.00 [0.06, 16.18]-1 study48242not evaluable ROB-
Neural Tube Defects1.86 [0.26, 13.26]-1 study2,270not evaluable ROB-
Oro-facial clefts0.85 [0.27, 2.65]-1 study2,270not evaluable ROB-
Respiratory system anomalies2.27 [0.14, 37.71]-1 study20242not evaluable ROB-
Atrial septal defect5.50 [2.43, 12.45]-1 study3,588507not evaluable ROB10.47 [4.29; .]
Bilateral renal agenesis including Potter syndrome24.69 [1.53, 398.87]-1 study75507not evaluable ROB48.87 [2.43; .]
Bladder exstrophy and/or epispadia22.59 [1.40, 364.74]-1 study82507not evaluable ROB44.68 [2.15; .]
Cleft lip with or without cleft palate1.11 [0.07, 17.80]-1 study1,675507not evaluable ROB-
Cleft palate3.10 [0.24, 40.77]-1 study1,222507not evaluable ROB-
Club foot / Talipes equinovarus4.40 [0.77, 25.05]-1 study1,696507not evaluable ROB-
Coarctation of aorta2.26 [0.14, 36.16]-1 study825507not evaluable ROB-
Craniosynostosis2.39 [0.15, 38.35]-1 study778507not evaluable ROB-
Diaphragmatic hernia4.72 [0.29, 75.76]-1 study394507not evaluable ROB-
Ebstein's anomaly35.50 [2.19, 575.92]-1 study52507not evaluable ROB70.50 [3.80; .]
Hypoplastic left heart (HLH/HLHS)7.85 [0.49, 126.00]-1 study237507not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)25.71 [1.59, 415.53]-1 study72507not evaluable ROB50.91 [2.56; .]
Hypospadias2.20 [0.43, 11.29]-1 study3,406507not evaluable ROB-
Microcephaly / Small head circumference for gestational age7.80 [0.53, 115.56]-1 study475507not evaluable ROB-
Multicystic renal dysplasia2.69 [0.17, 43.06]-1 study693507not evaluable ROB-
Oesophageal atresia with or without tracheo-oesophageal fistula4.45 [0.28, 71.41]-1 study418507not evaluable ROB-
Omphalocele6.57 [0.41, 105.50]-1 study283507not evaluable ROB-
Polydactyly4.80 [0.30, 76.93]-1 study388507not evaluable ROB-
Pulmonary artery atresia11.61 [0.72, 186.72]-1 study160507not evaluable ROB-
Spina bifida2.98 [0.19, 47.82]-1 study624507not evaluable ROB-
Tetralogy of Fallot2.89 [0.18, 46.34]-1 study644507not evaluable ROB-
Transposition of the great vessels3.40 [0.21, 54.46]-1 study548507not evaluable ROB-
Ventricular septal defect0.74 [0.10, 5.29]-1 study5,010507not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.02 [0.57, 1.83]1%3 studies169120not evaluable ROB-
Low birth weight (< 2500g)8.33 [0.28, 244.06]-1 study16not evaluable ROB-
Macrosomia (> 4000g)0.70 [0.02, 20.03]-1 study16not evaluable ROB-

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Gestational diabetes1.03 [0.70, 1.51]0%3 studies152471not evaluable ROB-
Preeclampsia1.55 [0.68, 3.55]-1 study49112not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal medical care2.27 [0.04, 129.96]-1 study6not evaluable ROB-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation1.68 [0.48, 5.90]-1 study1271not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.31 [0.72, 2.38]57%4 studies158,481232not evaluable ROB-
Elective/induced termination of pregnancy4.57 [1.41, 14.77]0%2 studies24108not evaluable ROB8.61 [2.18; .]

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Cognitive developmental disorders/delay (> 6 years old)1.45 [0.71, 3.00]0%2 studies1,603not evaluable ROB-
Language disorders/delay0.87 [0.66, 1.15]0%2 studies58,2021,603not evaluable ROB-
Learning disorders 0.88 [0.27, 2.91]58%2 studies294not evaluable ROB-
Neuro-developmental disorders (as a whole)0.95 [0.69, 1.31]29%2 studies160,3321,698not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.45 [0.71, 3.00]0%2 studies1,603not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.01 [0.78, 1.30]-1 study62,4371,404not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.01 [0.78, 1.30]-1 study62,4371,404not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis0.62 [0.31, 1.24]-1 study1,309not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk0.62 [0.31, 1.24]-1 study1,309not evaluable ROB-
Psychomotor developmental disorders/delay1.44 [0.77, 2.69]-1 study8,2411,309not evaluable ROB-

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