Quetiapine 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)1.04 [0.94, 1.15]0%8 studies61,8359,196serious ROB-
Major congenital malformations1.04 [0.94, 1.15]0%8 studies61,8359,196serious ROB-
Congenital heart defects1.09 [0.92, 1.29]0%2 studies1428,519not evaluable ROB-
Ano-rectal atresia and stenosis1.76 [0.28, 10.90]46%2 studies5748,569not evaluable ROB-
Gastroschisis3.72 [0.44, 31.72]59%2 studies2468,569not evaluable ROB-
Oesophageal atresia with or without tracheo-oesophageal fistula1.80 [0.08, 39.91]70%2 studies4188,569not evaluable ROB-
Bilateral renal agenesis including Potter syndrome57.23 [3.54, 926.28]-1 study75219not evaluable ROB113.95 [6.53; .]
Bladder exstrophy and/or epispadia52.37 [3.24, 847.02]-1 study82219not evaluable ROB104.24 [5.93; .]
Club foot / Talipes equinovarus10.40 [1.85, 58.45]-1 study1,696219not evaluable ROB20.29 [3.11; .]
Diaphragmatic hernia22.20 [1.53, 321.20]-1 study395219not evaluable ROB43.89 [2.44; .]
Ebstein's anomaly82.30 [5.06, 1337.43]-1 study52219not evaluable ROB164.09 [9.60; .]
Hypoplastic left heart (HLH/HLHS)18.19 [1.13, 292.60]-1 study237219not evaluable ROB35.87 [1.52; .]
Hypoplastic right heart (HRH/HRHS)59.59 [3.68, 964.97]-1 study72219not evaluable ROB118.68 [6.82; .]
Polydactyly22.50 [1.54, 328.12]-1 study389219not evaluable ROB44.49 [2.46; .]
Pulmonary artery atresia26.92 [1.67, 433.60]-1 study160219not evaluable ROB53.33 [2.73; .]
22 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)1.17 [0.91, 1.50]0%4 studies2,413734not evaluable ROB-
Large for gestational age (weight)1.36 [0.68, 2.72]41%2 studies1,009708not evaluable ROB-
Small for gestational age (weight)1.09 [0.73, 1.64]0%2 studies967708not 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 diabetes1.30 [1.06, 1.58]0%5 studies4422,145not evaluable ROB1.91 [1.32; .]
Caesarean--0 study-
Postpartum hemorrhage1.65 [1.13, 2.41]-1 study6,930152not evaluable ROB2.69 [1.51; .]
2 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal medical care1.15 [0.80, 1.65]0%2 studies5,511173not evaluable ROB-
Neonatal death (< 28 days of life)2.00 [1.45, 2.75]0%2 studies29209not evaluable ROB3.41 [2.26; .]
Neonatal disorders (as a whole)7.85 [4.12, 14.98]-1 study5962not evaluable ROB15.19 [7.70; .]
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 abortions1.32 [0.79, 2.22]64%4 studies158,498372not evaluable ROB-
Elective/induced termination of pregnancy11.19 [2.42, 51.61]-1 study178not evaluable ROB21.86 [4.28; .]
2 non statistically significant endpoints reported in only one study

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Cognitive developmental disorders/delay (> 6 years old)0.94 [0.56, 1.57]1%2 studies8797,821not evaluable ROB-
Language disorders/delay1.10 [0.96, 1.25]0%2 studies78,7218,351not evaluable ROB-
Learning disorders 1.16 [0.85, 1.58]0%2 studies6,8417,821not evaluable ROB-
Neuro-developmental disorders (as a whole)1.09 [0.99, 1.19]0%2 studies160,7018,949not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)0.94 [0.56, 1.57]1%2 studies8797,821not evaluable ROB-
5 non statistically significant endpoints reported in only one study

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