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-
Limb reduction defects (LRD)4.01 [1.00, 16.06]-1 study2,270not evaluable ROB7.48 [1.04; .]
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; .]
Ebstein's anomaly35.50 [2.19, 575.92]-1 study52507not evaluable ROB70.50 [3.80; .]
Hypoplastic right heart (HRH/HRHS)25.71 [1.59, 415.53]-1 study72507not evaluable ROB50.91 [2.56; .]
26 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)1.02 [0.57, 1.83]1%3 studies169120not evaluable ROB-
2 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Gestational diabetes1.03 [0.70, 1.51]0%3 studies152471not evaluable ROB-
1 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
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 abortions1.31 [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-
5 non statistically significant endpoints reported in only one study

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