Mirtazapine updated on 10-20-2025

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)1.02 [0.72, 1.43]20%8 studies53,4962,003not evaluable ROB-
Major congenital malformations1.02 [0.72, 1.43]20%8 studies53,4962,003not evaluable ROB-
Congenital heart defects1.14 [0.56, 2.32]0%2 studies8,109661not evaluable ROB-
Cardiac septal defects1.22 [0.50, 2.96]-1 study585not evaluable ROB-
Cleft lip with or without cleft palate--0 study-
Cleft palate--0 study-
Oro-facial clefts--0 study-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.48 [1.29, 1.69]0%6 studies148,8133,111not evaluable ROB2.32 [1.91; .]
Low birth weight (< 2500g)1.47 [0.48, 4.46]28%2 studies31,36393not evaluable ROB-
Macrosomia (> 4000g)1.45 [0.03, 77.15]-1 study16not evaluable ROB-
Small for gestational age (weight)1.56 [0.87, 2.79]45%2 studies236,4382,427not evaluable ROB-
Large for gestational age (weight)0.62 [0.09, 4.37]-1 study9,74577not evaluable ROB-

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.01 [0.64, 1.58]0%2 studies111,69293not evaluable ROB-
Postpartum hemorrhage0.71 [0.30, 1.70]0%2 studies19,757206not evaluable ROB-
Assisted deliveries (forceps, vacuum, ...)0.69 [0.28, 1.71]-1 study46,04177not evaluable ROB-
Maternal consequences (as a whole)0.85 [0.51, 1.41]-1 study311,14977not evaluable ROB-
Preeclampsia0.81 [0.49, 1.33]-1 study3,229253not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal medical care0.96 [0.31, 2.99]0%2 studies8,57393not evaluable ROB-
Jaundice / Icterus0.25 [0.06, 1.13]-1 study1416not evaluable ROB-
Low Apgar score (< 7) (at 5 min)1.11 [0.81, 1.52]0%2 studies32,7612,309not evaluable ROB-
Neonatal death (< 28 days of life)2.08 [0.14, 30.02]81%2 studies651974not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.82 [0.73, 4.54]-1 study14,88877not evaluable ROB-
Neonatal disorders (as a whole)1.56 [1.00, 2.44]-1 study161,44577not evaluable ROB-

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)23.20 [1.43, 376.35]-1 study13077not evaluable ROB45.90 [2.22; .]

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.53 [0.83, 2.85]46%4 studies1,2252,016not evaluable ROB-
Therapeutic terminations of pregnancy2.13 [1.17, 3.87]0%3 studies16461not evaluable ROB3.68 [1.62; .]
Elective/induced termination of pregnancy2.29 [1.25, 4.21]57%3 studies64364not evaluable ROB4.01 [1.81; .]
Late intrauterine deaths (> 22 weeks) / Stillbirths0.97 [0.39, 2.43]0%2 studies342,049not evaluable ROB-
Intrauterine deaths (as a whole or unspecified)1.34 [0.81, 2.21]-1 study70323not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ADHD (Attention deficit hyperactivity disorder): Diagnosis2.03 [0.99, 4.16]-1 study552not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk2.03 [0.99, 4.16]-1 study552not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.45 [0.67, 3.14]-1 study552not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.45 [0.67, 3.14]-1 study552not evaluable ROB-

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