Trazodone updated on 07-01-2025

Major congenital malformations

R analysis
id Study   Lib. in paper Exposition period    Study type 
 Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S18172
R76410		 Chan (Controls exposed to SSRIs), 2024 Any major malformations 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.77 [0.18;3.26] C
excluded (control group) 		2/35   70/956 72 35
ref
S18153
R76309		 Chan (Controls unexposed, pop general), 2024 Any major malformations 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.19 [0.29;4.97] 2/35   22,628/462,377 22,630 35
ref
S11772
R43276		 Anderson, 2020 Major birth defects 1st trimester case control unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 3.37 [0.78;14.54] C 18/20   30,612/42,088 30,630 20
ref
S11790
R43379		 Ozturk, 2016 Major congenital defects at least 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 69.29 [1.20;4014.93] C 0/1   3/246 3 1
ref
S11752
R43196		 Einarson, 2009 Major malformations 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 1.07 [0.06;18.37] C 0/17   25/928 25 17
ref
Total 4 studies 2.39 [0.74;7.73] 53,288 73
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Chan (Controls unexposed, pop general), 2024Chan, 2024 1 1.19[0.29; 4.97]22,6303540%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Anderson, 2020Anderson, 2020 3.37[0.78; 14.54]30,6302038%ROB confusion: criticalROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Ozturk, 2016Ozturk, 2016 69.29[1.20; 4014.93]318%ROB confusion: criticalROB selection: unclearROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Einarson, 2009Einarson, 2009 1.07[0.06; 18.37]251714%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: moderate Total (4 studies) I2 = 26% 2.39[0.74; 7.73]53,288730.5500.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, pop general;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 2.39[0.33; 17.15]22,6585344%NAChan (Controls unexposed, pop general), 2024 Ozturk, 2016 Einarson, 2009 3 case control studiescase control studies 3.37[0.78; 14.54]30,63020 -NAAnderson, 2020 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.39[0.74; 7.73]53,2887326%NAChan (Controls unexposed, pop general), 2024 Anderson, 2020 Ozturk, 2016 Einarson, 2009 4 Tags Adjustment   - No  - No 3.89[0.73; 20.68]30,6583827%NAAnderson, 2020 Ozturk, 2016 Einarson, 2009 3   - Yes  - Yes 1.19[0.29; 4.93]22,63035 -NAChan (Controls unexposed, pop general), 2024 1 Monotherapy   - no or not specified  - no or not specified 6.63[0.12; 381.41]281863%NAOzturk, 2016 Einarson, 2009 2   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.97[0.71; 5.48]53,260550%NAChan (Controls unexposed, pop general), 2024 Anderson, 2020 2 All studiesAll studies 2.39[0.74; 7.73]53,2887326%NAChan (Controls unexposed, pop general), 2024 Anderson, 2020 Ozturk, 2016 Einarson, 2009 40.51000.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-5.15.72.4850.000Chan (Controls unexposed, pop general), 2024Anderson, 2020Ozturk, 2016Einarson, 2009

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 18172

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.39[0.74; 7.73]53,2887326%NAChan (Controls unexposed, pop general), 2024 Anderson, 2020 Ozturk, 2016 Einarson, 2009 4 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.77[0.18; 3.26]7235 -NAChan (Controls exposed to SSRIs), 2024 10.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Einarson - Nefazodone/trazodone (Major struct ...Einarson - Nefazodone/trazodone (Major structural or functional malformations) 0.54[0.10; 2.90]NA-Wwhatever (meta-analysis)T11st trimesterstudies TTT1 metaPregmetaPreg 2.39[0.74; 7.73]26%73----Chan (Controls unexposed, pop general), 2024 Anderson, 2020 Ozturk, 2016 Einarson, 2009 40.510.01.0