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-
Congenital skin disorders2.36 [0.05, 119.12]-1 study430not evaluable ROB-
Craniosynostosis1.54 [0.53, 4.50]0%2 studies2,3492,301not evaluable ROB-
Ear, face and neck anomalies4.73 [0.43, 52.34]-1 study3430not evaluable ROB-
Genetic syndromes and microdeletions0.91 [0.57, 1.45]-1 study1633,478not evaluable ROB-
Genital anomalies0.79 [0.03, 19.33]-1 study1430not evaluable ROB-
Hip dislocation and/or dysplasia0.71 [0.41, 1.22]-1 study17,068not evaluable ROB-
Hydrocephaly1.01 [0.57, 1.77]-1 study17,068not evaluable ROB-
Hypospadias1.07 [0.51, 2.23]0%2 studies5,9222,298not evaluable ROB-
Limb reduction defects (LRD)1.16 [0.48, 2.79]-1 study17,068not evaluable ROB-
Microcephaly / Small head circumference for gestational age0.82 [0.30, 2.24]0%2 studies4752,472not evaluable ROB-
Minor congenital malformations1.20 [0.66, 2.18]-1 study49453not evaluable ROB-
Neural Tube Defects0.65 [0.21, 2.02]-1 study17,068not evaluable ROB-
Bilateral renal agenesis including Potter syndrome5.47 [0.34, 88.30]-1 study752,286not evaluable ROB-
Bladder exstrophy and/or epispadia5.01 [0.31, 80.75]-1 study822,286not evaluable ROB-
Cardiac septal defects0.80 [0.27, 2.36]-1 study16not evaluable ROB-
Club foot / Talipes equinovarus3.91 [1.95, 7.84]-1 study1,7022,286not evaluable ROB7.28 [3.31; .]
Coarctation of aorta0.50 [0.03, 8.01]-1 study8252,286not evaluable ROB-
Diaphragmatic hernia2.10 [0.29, 14.93]-1 study3952,286not evaluable ROB-
Ebstein's anomaly7.87 [0.49, 127.50]-1 study522,286not evaluable ROB-
Hypoplastic left heart (HLH/HLHS)1.74 [0.11, 27.89]-1 study2372,286not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)5.70 [0.35, 91.99]-1 study722,286not evaluable ROB-
Multicystic renal dysplasia0.60 [0.04, 9.53]-1 study6932,286not evaluable ROB-
Omphalocele1.46 [0.09, 23.36]-1 study2832,286not evaluable ROB-
Polydactyly2.13 [0.30, 15.16]-1 study3892,286not evaluable ROB-
Pulmonary artery atresia2.57 [0.16, 41.33]-1 study1602,286not evaluable ROB-
Spina bifida2.65 [0.66, 10.62]-1 study6262,286not evaluable ROB-
Tetralogy of Fallot0.64 [0.04, 10.26]-1 study6442,286not evaluable ROB-
Transposition of the great vessels0.75 [0.05, 12.06]-1 study5482,286not evaluable ROB-
Ventricular septal defect1.15 [0.55, 2.43]-1 study5,0162,286not evaluable ROB-

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 for gestational age (length)1.94 [0.87, 4.33]-1 study186not evaluable ROB-
Large head circumference for gestational age3.02 [1.60, 5.71]-1 study186not evaluable ROB5.49 [2.58; .]
Macrosomia (> 4000g)0.30 [0.02, 5.17]-1 study241not evaluable ROB-
Small for gestational age (length)1.17 [0.54, 2.54]-1 study186not evaluable ROB-

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-
Abruptio placentae (retroplacental hematoma)2.06 [0.99, 4.31]-1 study441,021not evaluable ROB-
Maternal hypothyroidism3.64 [0.74, 17.85]-1 study9133not evaluable ROB-

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-
Low Apgar score (< 7) (NOS)0.29 [0.00, 18.96]-1 study9not evaluable ROB-
Fetal distress1.45 [0.70, 2.99]-1 study35113not evaluable ROB-
Infant health status 1.00 [0.95, 1.05]-1 studynot evaluable ROB-
Neonatal infections0.70 [0.27, 1.83]-1 study171,021not evaluable ROB-
Neonatal intracranial hemorrhage1.33 [0.46, 3.84]-1 study141,021not evaluable ROB-

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-
Perinatal death1.40 [0.66, 2.94]-1 study281,016not evaluable ROB-

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-
Cognitive developmental disorders/delay (< 3 years old)1.33 [0.44, 4.04]-1 study1478not evaluable ROB-

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