Tricyclic antidepressants 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)1.05 [0.93, 1.18]0%13 studies41,7627,205low ROB-
Major congenital malformations1.06 [0.93, 1.20]0%12 studies34,3807,035low ROB-
Congenital heart defects1.02 [0.80, 1.30]23%7 studies2,98110,192not evaluable ROB-
Urinary malformations1.12 [0.66, 1.91]0%5 studies5754,766not evaluable ROB-
Limb defects1.02 [0.70, 1.49]0%3 studies1562,991not evaluable ROB-
Nervous system anomalies1.31 [0.66, 2.61]8%4 studies724,599not evaluable ROB-
Respiratory system anomalies1.69 [0.70, 4.07]9%4 studies2813,158not evaluable ROB-
Cardiac septal defects1.31 [1.00, 1.73]3%5 studies7585,297not evaluable ROB-
Genital anomalies0.70 [0.45, 1.08]0%4 studies1,3114,585not evaluable ROB-
Ventricular septal defect0.85 [0.59, 1.22]0%4 studies3,5025,953not evaluable ROB-
Atrial septal defect1.34 [0.74, 2.45]0%3 studies1,1992,647not evaluable ROB-
Digestive system anomalies2.33 [1.38, 3.94]0%3 studies1532,977not evaluable ROB4.09 [2.10; .]
Chromosomal abnormalities0.89 [0.33, 2.38]0%2 studies1232,595not evaluable ROB-
Ear, face and neck anomalies0.51 [0.07, 3.77]0%2 studies2182,595not evaluable ROB-
Eye defects1.05 [0.11, 9.88]58%2 studies6622,595not evaluable ROB-
Oro-facial clefts0.67 [0.18, 2.41]0%2 studies1162,595not evaluable ROB-
Eye, ear, face and neck malformations1.48 [0.44, 4.93]57%2 studies141,990not evaluable ROB-
Spina bifida12.43 [1.70, 90.77]-1 study29167not evaluable ROB24.35 [2.80; .]
7 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)1.53 [1.23, 1.89]73%9 studies212,5617,181not evaluable ROB2.42 [1.76; .]
Low birth weight (< 2500g)1.20 [0.99, 1.47]0%4 studies68,5781,643not evaluable ROB-
Small for gestational age (weight)0.99 [0.90, 1.10]0%3 studies261,3165,256not evaluable ROB-
Large for gestational age (weight)0.83 [0.42, 1.66]75%2 studies78,6261,397not evaluable ROB-
Macrosomia (> 4000g)0.62 [0.40, 0.96]-1 study46,071784not evaluable ROB2.61 [.; 1.27]

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preeclampsia1.80 [1.24, 2.63]45%9 studies8,9021,137not evaluable ROB3.01 [1.78; .]
Caesarean1.00 [0.84, 1.19]0%2 studies111,874618not evaluable ROB-
Postpartum hemorrhage1.19 [0.88, 1.60]27%3 studies19,7791,182not evaluable ROB-
Gestational diabetes1.47 [1.22, 1.77]-1 study20,905971not evaluable ROB2.30 [1.74; .]
2 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal medical care2.03 [1.32, 3.11]75%4 studies71,5971,570not evaluable ROB3.47 [1.97; .]
Low Apgar score (< 7) (at 5 min)1.36 [0.87, 2.14]62%4 studies32,7914,115not evaluable ROB-
Neonatal disorders (as a whole)1.58 [1.18, 2.13]76%2 studies161,7331,007not evaluable ROB2.54 [1.63; .]
Jaundice / Icterus1.39 [1.03, 1.88]-1 study52,050784not evaluable ROB2.13 [1.20; .]
Low Apgar score (< 7) (NOS)2.75 [1.91, 3.96]-1 study15,570784not evaluable ROB4.94 [3.23; .]
Neonatal hypoglycemia1.83 [1.38, 2.43]-1 study34,844784not evaluable ROB3.06 [2.10; .]
Metabolic disorders in neonate/infant2.15 [1.04, 4.44]-1 study1,805136not evaluable ROB3.72 [1.25; .]
6 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Childhood asthma1.28 [1.06, 1.55]-1 study409not evaluable ROB1.88 [1.30; .]
1 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 abortions1.38 [1.17, 1.62]11%8 studies24,0714,689not evaluable ROB2.10 [1.62; .]
Elective/induced termination of pregnancy1.40 [1.19, 1.64]0%4 studies214,427not evaluable ROB2.14 [1.66; .]
Ectopic pregnancy1.44 [1.00, 2.07]-1 study2,2891,037not evaluable ROB2.24 [1.06; .]
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): Diagnosis1.42 [1.20, 1.68]0%6 studies7,09412,417not evaluable ROB2.19 [1.68; .]
ASD (Autism spectrum disorder): Diagnosis/Risk1.42 [1.20, 1.68]0%6 studies7,09412,417not evaluable ROB2.19 [1.68; .]
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.19 [0.98, 1.45]0%5 studies4,7987,398not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.19 [0.98, 1.45]0%5 studies4,7987,398not evaluable ROB-
Psychomotor developmental disorders/delay1.05 [0.56, 1.97]23%4 studies494,544not evaluable ROB-
Language disorders/delay0.90 [0.71, 1.14]0%3 studies3614,561not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)1.03 [0.44, 2.41]0%2 studies3,512not evaluable ROB-
7 non statistically significant endpoints reported in only one study

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