Paroxetine updated on 10-20-2025

Table   Graphic     exposition period:

Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Congenital heart defects1.29 [1.14, 1.46]0%17 studies56,56519,308probable ROB1.90 [1.53; .]
All congenital malformations (majors, minors, majors and minors, or unspecified)1.18 [1.04, 1.34]25%14 studies139,7549,542low ROB1.64 [1.25; .]
Major congenital malformations1.21 [1.06, 1.38]23%13 studies132,1569,360probable ROB1.72 [1.32; .]
Limb defects1.00 [0.79, 1.25]0%7 studies2054,621not evaluable ROB-
Digestive system anomalies0.99 [0.65, 1.51]0%7 studies3,1944,656not evaluable ROB-
Respiratory system anomalies1.17 [0.65, 2.09]0%7 studies1,2404,649not evaluable ROB-
Ventricular septal defect1.11 [0.66, 1.87]69%5 studies12,43210,341not evaluable ROB-
Cardiac septal defects1.42 [1.17, 1.73]0%6 studies27,5144,279not evaluable ROB2.20 [1.61; .]
Genital anomalies0.90 [0.46, 1.76]39%4 studies1,1763,082not evaluable ROB-
Nervous system anomalies1.03 [0.62, 1.73]0%6 studies9624,621serious ROB-
Urinary malformations0.65 [0.36, 1.16]0%5 studies3,4473,116not evaluable ROB-
Atrial septal defect1.46 [0.95, 2.26]0%4 studies3,9851,568not evaluable ROB-
Craniosynostosis1.63 [1.02, 2.61]0%5 studies4222,159not evaluable ROB2.65 [1.16; .]
Ear, face and neck anomalies1.55 [0.49, 4.91]15%5 studies1,2642,549not evaluable ROB-
Hypospadias1.46 [0.95, 2.24]9%4 studies3,5381,275not evaluable ROB-
Chromosomal abnormalities2.31 [1.14, 4.70]6%4 studies922,522not evaluable ROB4.06 [1.54; .]
Cleft lip with or without cleft palate1.01 [0.59, 1.72]0%3 studies7041,002not evaluable ROB-
Cleft palate1.54 [0.88, 2.70]0%3 studies3771,001not evaluable ROB-
Eye defects1.87 [1.08, 3.26]0%4 studies1,5511,984not evaluable ROB3.16 [1.36; .]
Oro-facial clefts1.04 [0.62, 1.75]0%3 studies5311,382not evaluable ROB-
Club foot / Talipes equinovarus4.14 [2.43, 7.04]0%3 studies3,02781not evaluable ROB7.74 [4.30; .]
Diaphragmatic hernia1.24 [0.50, 3.06]0%2 studies19231not evaluable ROB-
Neural Tube Defects1.61 [0.63, 4.10]44%3 studies1,64261not evaluable ROB-
Omphalocele1.36 [0.27, 6.87]0%2 studies127998not evaluable ROB-
Spina bifida1.14 [0.21, 6.20]36%2 studies29182not evaluable ROB-
Transposition of the great vessels1.28 [0.54, 3.04]0%3 studies853996not evaluable ROB-
Ano-rectal atresia and stenosis2.05 [0.61, 6.86]0%2 studies60760not evaluable ROB-
Coarctation of aorta1.26 [0.55, 2.89]0%2 studies57029not evaluable ROB-
Gastroschisis2.73 [1.48, 5.02]0%2 studies41327not evaluable ROB4.90 [2.33; .]
Limb reduction defects (LRD)1.61 [0.56, 4.63]0%2 studies97760not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.09 [0.30, 3.93]0%2 studies5746not evaluable ROB-
Pulmonary valve stenosis1.92 [1.04, 3.56]0%2 studies77228not evaluable ROB3.25 [1.23; .]
Tetralogy of Fallot1.40 [0.62, 3.18]0%2 studies42827not 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-
Patent ductus arterious--0 study-
Polydactyly--0 study-
Pulmonary valve atresia--0 study-
Syndactyly--0 study-
Total anomalous pulm venous return4.00 [1.42, 11.28]-1 studynot evaluable ROB7.46 [2.19; .]
8 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 [1.00, 1.55]31%8 studies156,7014,058not evaluable ROB-
Low birth weight (< 2500g)1.00 [0.51, 1.98]54%3 studies38,164794not evaluable ROB-
Small for gestational age (weight)1.19 [1.04, 1.36]0%3 studies236,3292,246not evaluable ROB1.66 [1.24; .]
Large for gestational age (weight)0.92 [0.30, 2.81]0%2 studies9,744109not evaluable ROB-
3 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.17 [1.00, 1.38]3%3 studies141,707785not evaluable ROB-
Postpartum hemorrhage1.27 [1.08, 1.50]0%3 studies30,2672,808not evaluable ROB1.86 [1.38; .]
Assisted deliveries (forceps, vacuum, ...)0.83 [0.42, 1.66]0%2 studies46,043109not evaluable ROB-
Preeclampsia1.25 [0.70, 2.23]75%2 studies4,6143,517not 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 care2.07 [1.29, 3.32]4%6 studies8,697294not evaluable ROB3.56 [1.91; .]
Low Apgar score (< 7) (at 5 min)1.55 [1.19, 2.03]0%5 studies33,9722,455not evaluable ROB2.48 [1.66; .]
Neonatal disorders (as a whole)1.12 [0.63, 2.00]20%3 studies161,472190not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.57 [0.76, 3.27]0%2 studies14,888109not evaluable ROB-
Persistent pulmonary hypertension3.39 [1.51, 7.61]0%3 studies2,3171,340not evaluable ROB6.24 [2.39; .]
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation6.26 [0.96, 40.75]32%2 studies647not evaluable ROB-
4 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)4.09 [0.29, 57.17]73%2 studies1,19977not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.46 [1.15, 1.86]65%7 studies23,4684,129not evaluable ROB2.28 [1.56; .]
Elective/induced termination of pregnancy2.32 [1.45, 3.74]31%3 studies1621,160not evaluable ROB4.08 [2.25; .]
Late intrauterine deaths (> 22 weeks) / Stillbirths1.13 [0.53, 2.42]0%2 studies121,148not evaluable ROB-
Intrauterine deaths (as a whole or unspecified)1.43 [1.14, 1.80]0%2 studies24,7241,226not evaluable ROB2.22 [1.54; .]
2 non statistically significant endpoints reported in only one study

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis1.33 [0.80, 2.21]50%5 studies1,3732,098not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.33 [0.80, 2.21]50%5 studies1,3732,098not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)3.40 [1.37, 8.43]-1 study27not evaluable ROB6.26 [2.09; .]
Cognitive developmental disorders/delay (3-6 years old)--0 study-
Psychomotor developmental disorders/delay2.58 [1.05, 6.33]-1 study27not evaluable ROB4.60 [1.28; .]
4 non statistically significant endpoints reported in only one study