Fluoxetine updated on 10-20-2025

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Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
All congenital malformations (majors, minors, majors and minors, or unspecified)1.17 [1.04, 1.32]23%15 studies133,06713,595low ROB1.62 [1.23; .]
Major congenital malformations1.16 [1.03, 1.31]18%15 studies132,29613,595low ROB1.59 [1.22; .]
Congenital heart defects1.24 [1.07, 1.44]28%14 studies54,77321,744low ROB1.79 [1.34; .]
Limb defects0.93 [0.69, 1.27]20%7 studies2086,482not evaluable ROB-
Digestive system anomalies1.33 [0.86, 2.06]1%6 studies3,2816,449not evaluable ROB-
Ventricular septal defect1.06 [0.77, 1.46]39%5 studies12,46211,459not evaluable ROB-
Genital anomalies0.45 [0.21, 0.92]0%4 studies3194,373not evaluable ROB3.92 [.; 1.38]
Hypospadias1.00 [0.70, 1.42]9%5 studies8,0827,865not evaluable ROB-
Respiratory system anomalies1.39 [0.78, 2.50]0%6 studies1,0676,445not evaluable ROB-
Atrial septal defect1.27 [0.88, 1.83]0%4 studies3,9902,779not evaluable ROB-
Cardiac septal defects1.32 [1.09, 1.58]0%5 studies26,8696,555serious ROB1.96 [1.41; .]
Cleft lip with or without cleft palate1.19 [0.79, 1.81]4%3 studies7041,890not evaluable ROB-
Cleft palate1.04 [0.64, 1.71]0%3 studies3771,882not evaluable ROB-
Craniosynostosis1.89 [1.24, 2.87]0%5 studies4222,099not evaluable ROB3.18 [1.78; .]
Nervous system anomalies1.27 [0.79, 2.05]0%5 studies2896,417not evaluable ROB-
Neural Tube Defects1.22 [0.79, 1.89]0%5 studies1,6422,837not evaluable ROB-
Oro-facial clefts1.16 [0.82, 1.65]0%3 studies4,117not evaluable ROB-
Urinary malformations0.99 [0.61, 1.59]0%4 studies2,9774,374not evaluable ROB-
Club foot / Talipes equinovarus1.19 [0.76, 1.84]0%4 studies6,2136,362not evaluable ROB-
Eye defects1.19 [0.53, 2.69]0%4 studies8284,436not evaluable ROB-
Ano-rectal atresia and stenosis1.29 [0.69, 2.41]0%3 studies60792not evaluable ROB-
Chromosomal abnormalities0.53 [0.20, 1.43]0%3 studies2164,408not evaluable ROB-
Diaphragmatic hernia1.42 [0.73, 2.73]0%2 studies19264not evaluable ROB-
Ear, face and neck anomalies1.93 [0.53, 7.07]34%3 studies8293,508not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.67 [0.74, 3.79]0%3 studies61221not evaluable ROB-
Omphalocele0.70 [0.14, 3.56]0%2 studies1271,879not evaluable ROB-
Transposition of the great vessels1.46 [0.76, 2.82]0%3 studies8531,845not evaluable ROB-
Atrioventricular septal defect2.29 [0.85, 6.14]25%2 studies29029not evaluable ROB-
Coarctation of aorta1.75 [1.01, 3.02]0%2 studies57027not evaluable ROB2.89 [1.12; .]
Gastroschisis1.65 [0.53, 5.16]70%2 studies104not evaluable ROB-
Hypoplastic left heart (HLH/HLHS)1.79 [0.90, 3.58]0%2 studies39828not evaluable ROB-
Limb reduction defects (LRD)1.66 [0.66, 4.21]0%2 studies97793not evaluable ROB-
Pulmonary valve stenosis1.89 [1.18, 3.01]0%2 studies77230not evaluable ROB3.18 [1.64; .]
Tetralogy of Fallot2.57 [0.83, 8.01]71%2 studies42831not evaluable ROB-
Aortic valve atresia/stenosis--0 study-
Congenital hydronephrosis--0 study-
Encephalocele--0 study-
Hip dislocation and/or dysplasia--0 study-
Hirschsprung's disease--0 study-
Hydrocephaly--0 study-
Minor congenital malformations2.62 [1.12, 6.09]-1 study2597not evaluable ROB4.67 [1.50; .]
Multicystic renal dysplasia5.76 [2.54, 13.07]-1 study61835not evaluable ROB11.00 [4.51; .]
Oesophageal atresia with or without tracheo-oesophageal fistula2.19 [1.19, 4.04]-1 studynot evaluable ROB3.80 [1.66; .]
Patent ductus arterious--0 study-
Polydactyly--0 study-
Pulmonary valve atresia--0 study-
Syndactyly--0 study-
6 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)1.16 [1.06, 1.26]3%10 studies157,63215,157low ROB1.59 [1.33; .]
Small for gestational age (weight)1.24 [0.92, 1.66]33%4 studies237,40311,412not evaluable ROB-
Low birth weight (< 2500g)1.16 [0.78, 1.72]60%3 studies38,1981,141not evaluable ROB-
Large for gestational age (weight)0.79 [0.50, 1.26]0%2 studies9,760770not evaluable ROB-
4 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.30 [0.98, 1.72]63%5 studies141,8781,218not evaluable ROB-
Assisted deliveries (forceps, vacuum, ...)0.99 [0.76, 1.29]0%2 studies46,095770not evaluable ROB-
Postpartum hemorrhage1.36 [1.08, 1.72]61%3 studies30,3504,405not evaluable ROB2.07 [1.38; .]
Preeclampsia0.97 [0.87, 1.09]0%2 studies4,7305,650not 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 care2.05 [1.32, 3.17]77%7 studies8,8942,439not evaluable ROB3.52 [1.98; .]
Low Apgar score (< 7) (at 5 min)1.62 [1.43, 1.84]0%5 studies34,2519,743not evaluable ROB2.63 [2.20; .]
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation6.30 [2.06, 19.21]82%4 studies6833,748not evaluable ROB12.07 [3.55; .]
Low Apgar score (< 7) (at 1 min)1.59 [0.93, 2.71]42%2 studies14,919770not evaluable ROB-
Neonatal disorders (as a whole)1.55 [1.33, 1.80]0%2 studies161,792751not evaluable ROB2.47 [1.98; .]
Persistent pulmonary hypertension1.99 [1.09, 3.61]0%3 studies2,3233,901not evaluable ROB3.39 [1.41; .]
Neonatal tachypnea1.77 [1.17, 2.69]-1 study118579not evaluable ROB2.95 [1.61; .]
3 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)1.51 [0.70, 3.28]0%2 studies1,194719not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.24 [1.07, 1.43]13%8 studies23,4334,951serious ROB1.77 [1.34; .]
Elective/induced termination of pregnancy2.37 [1.53, 3.65]0%3 studies103484not evaluable ROB4.16 [2.43; .]
Late intrauterine deaths (> 22 weeks) / Stillbirths0.85 [0.30, 2.40]0%3 studies12791not evaluable ROB-
Ectopic pregnancy1.28 [0.49, 3.31]0%2 studies1,489548not evaluable ROB-
Intrauterine deaths (as a whole or unspecified)1.83 [1.37, 2.45]30%3 studies24,788766not evaluable ROB3.07 [2.09; .]
Therapeutic terminations of pregnancy5.88 [2.45, 14.13]-1 study29154not evaluable ROB11.24 [4.33; .]

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis1.28 [1.01, 1.63]20%6 studies1,62532,313not evaluable ROB1.88 [1.10; .]
ASD (Autism spectrum disorder): Diagnosis/Risk1.28 [1.01, 1.63]20%6 studies1,62532,313not evaluable ROB1.88 [1.10; .]
Cognitive developmental disorders/delay (3-6 years old)1.39 [0.29, 6.70]63%2 studies6018,363not evaluable ROB-
Language disorders/delay1.21 [1.01, 1.45]0%2 studies1,25726,632not evaluable ROB1.71 [1.08; .]
Psychomotor developmental disorders/delay1.28 [0.76, 2.14]0%2 studies20126,628not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.11 [0.95, 1.29]0%2 studies1,28431,362not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.11 [0.95, 1.29]0%2 studies1,28431,362not evaluable ROB-
Neuro-developmental disorders (as a whole)1.14 [1.00, 1.29]0%2 studies2,81626,606not evaluable ROB1.54 [1.06; .]
5 non statistically significant endpoints reported in only one study

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