Atypical antipsychotics (Second generation) 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)1.46 [1.18, 1.81]44%14 studies89,05122,922critical ROB2.29 [1.65; .]
Major congenital malformations1.47 [1.17, 1.86]46%13 studies88,96922,029critical ROB2.31 [1.61; .]
Congenital heart defects1.50 [0.94, 2.40]56%4 studies11,98517,891not evaluable ROB-
Limb defects1.08 [0.69, 1.69]0%3 studies3694,271not evaluable ROB-
Nervous system anomalies1.24 [0.23, 6.68]44%3 studies1084,271not evaluable ROB-
Respiratory system anomalies0.27 [0.03, 2.09]0%2 studies463,841not evaluable ROB-
Urinary malformations1.11 [0.30, 4.18]0%2 studies75793not evaluable ROB-
Ano-rectal atresia and stenosis1.25 [0.65, 2.39]10%3 studies1,60519,369not evaluable ROB-
Digestive system anomalies0.55 [0.19, 1.58]0%2 studies593,908not evaluable ROB-
Gastroschisis1.58 [0.90, 2.74]0%3 studies1,64819,369not evaluable ROB-
Oesophageal atresia with or without tracheo-oesophageal fistula0.49 [0.14, 1.71]0%2 studies41819,354not evaluable ROB-
Oro-facial clefts1.25 [0.90, 1.75]0%2 studies4,58117,087not evaluable ROB-
Atrial septal defect2.03 [1.18, 3.52]0%2 studies6,5102,302not evaluable ROB3.48 [1.63; .]
Cleft lip with or without cleft palate1.17 [0.51, 2.67]0%2 studies4,7162,301not evaluable ROB-
Cleft palate1.96 [0.82, 4.70]0%2 studies2,7662,302not evaluable ROB-
Craniosynostosis1.54 [0.53, 4.50]0%2 studies2,3492,301not evaluable ROB-
Hypospadias1.07 [0.51, 2.23]0%2 studies5,9222,298not evaluable ROB-
Microcephaly / Small head circumference for gestational age0.82 [0.30, 2.24]0%2 studies4752,472not evaluable ROB-
Club foot / Talipes equinovarus3.91 [1.95, 7.84]-1 study1,7022,286not evaluable ROB7.28 [3.31; .]
25 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)1.24 [1.06, 1.45]30%17 studies38,0097,938low ROB1.78 [1.31; .]
Small for gestational age (weight)1.09 [0.91, 1.32]48%10 studies10,8998,878low ROB-
Large for gestational age (weight)1.29 [1.05, 1.59]40%8 studies3,5578,616not evaluable ROB1.91 [1.29; .]
Low birth weight (< 2500g)2.78 [1.44, 5.35]0%5 studies79284not evaluable ROB5.00 [2.24; .]
Very preterm (28 to 32 weeks)0.82 [0.57, 1.17]0%2 studies3035,246not evaluable ROB-
Extremely preterm (< 28 weeks)0.48 [0.25, 0.93]-1 study541,021not evaluable ROB3.59 [.; 1.37]
Large head circumference for gestational age3.02 [1.60, 5.71]-1 study186not evaluable ROB5.49 [2.58; .]
3 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.21 [1.04, 1.41]49%7 studies5,9446,812not evaluable ROB1.72 [1.24; .]
Gestational diabetes1.22 [1.01, 1.47]23%10 studies1,0565,895low ROB1.73 [1.08; .]
Preeclampsia1.38 [1.08, 1.76]0%5 studies2932,176not evaluable ROB2.11 [1.39; .]
Postpartum hemorrhage1.14 [0.70, 1.84]61%3 studies7,0591,248not evaluable ROB-
Assisted deliveries (forceps, vacuum, ...)0.65 [0.37, 1.15]0%2 studies2,448265not evaluable ROB-
2 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal medical care1.29 [1.11, 1.51]53%11 studies14,0168,192low ROB1.91 [1.46; .]
Low Apgar score (< 7) (at 5 min)1.43 [0.92, 2.21]44%3 studies2,2444,431not evaluable ROB-
Neonatal disorders (as a whole)2.78 [0.53, 14.70]89%2 studies98440not evaluable ROB-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation1.19 [0.92, 1.55]34%5 studies5372,615not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.38 [1.14, 1.67]0%2 studies1,5954,279not evaluable ROB2.11 [1.54; .]
Neonatal death (< 28 days of life)1.38 [0.61, 3.10]0%3 studies675,377not evaluable ROB-
5 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 abortions1.03 [0.91, 1.17]0%11 studies159,1582,473low ROB-
Elective/induced termination of pregnancy7.17 [5.12, 10.04]0%6 studies186914not evaluable ROB13.81 [9.71; .]
Late intrauterine deaths (> 22 weeks) / Stillbirths0.65 [0.39, 1.10]0%5 studies2236,110not evaluable ROB-
Therapeutic terminations of pregnancy1.65 [0.35, 7.88]83%4 studies2374,119not evaluable ROB-
Intrauterine deaths (as a whole or unspecified)0.96 [0.15, 5.97]0%2 studies693not evaluable ROB-
1 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): Diagnosis1.07 [0.97, 1.17]0%4 studies147,82317,309not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.07 [0.97, 1.17]0%4 studies147,82317,309not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.16 [1.00, 1.35]0%4 studies60,75617,386not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.16 [1.00, 1.35]0%4 studies60,75617,386not evaluable ROB-
Language disorders/delay1.10 [0.99, 1.22]0%3 studies78,94413,360not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)0.83 [0.53, 1.29]0%2 studies4,24212,192not evaluable ROB-
Learning disorders 1.12 [0.85, 1.47]0%2 studies7,78513,284not evaluable ROB-
Neuro-developmental disorders (as a whole)1.09 [1.01, 1.17]0%2 studies161,15113,882not evaluable ROB1.40 [1.13; .]
Psychomotor developmental disorders/delay1.11 [0.83, 1.47]0%2 studies11,9239,466not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)0.83 [0.53, 1.29]0%2 studies4,24212,192not evaluable ROB-
1 non statistically significant endpoints reported in only one study

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