Fluconazole (all routes except local only) - Cumulative dose ≤ 150 mg updated on 01-29-2025

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.
S17647
R74531
Berard (150 mg), 2019 Major congenital malformation (according ICD-9 and 10) 1st trimester nested case control unexposed (general population or NOS) Adjustment: Yes 1.08 [0.87;1.34] 92/913   19,396/225,686 19,488 913
ref
S17642
R74416
Molgaard-Nielsen (150 mg), 2013 Major birth defects 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 0.99 [0.82;1.20] 107/4,082   25,159/968,236 25,266 4,082
ref
S17653
R74568
Jick (92% received the single 150-mg dose preparation), 1999 Congenital anomaly 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.07 [0.37;3.10] C 4/234   26/1,629 30 234
ref
Total 3 studies 1.03 [0.89;1.19] 44,784 5,229
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 Berard (150 mg), 2019Berard, 2019 1 1.08[0.87; 1.34]19,48891343%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: lowROB mesure: criticalROB reporting: moderate Molgaard-Nielsen (150 mg), 2013Molgaard-Nielsen, 2013 2 0.99[0.82; 1.20]25,2664,08255%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Jick (92% received the single 150-mg dose preparation), 1999Jick, 1999 3 1.07[0.37; 3.10]302342%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: criticalROB reporting: moderate Total (3 studies) I2 = 0% 1.03[0.89; 1.19]44,7845,2290.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: 150 mg; 2: 150 mg; 3: 92% received the single 150-mg dose preparation;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.99[0.82; 1.20]25,2964,3160%NAMolgaard-Nielsen (150 mg), 2013 Jick (92% received the single 150-mg dose preparation), 1999 2 case control studiescase control studies 1.08[0.87; 1.34]19,488913 -NABerard (150 mg), 2019 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.03[0.89; 1.19]44,7845,2290%NABerard (150 mg), 2019 Molgaard-Nielsen (150 mg), 2013 Jick (92% received the single 150-mg dose preparation), 1999 3 Tags Adjustment   - No  - No 1.07[0.37; 3.10]30234 -NAJick (92% received the single 150-mg dose preparation), 1999 1   - Yes  - Yes 1.03[0.89; 1.19]44,7544,9950%NABerard (150 mg), 2019 Molgaard-Nielsen (150 mg), 2013 2 All studiesAll studies 1.03[0.89; 1.19]44,7845,2290%NABerard (150 mg), 2019 Molgaard-Nielsen (150 mg), 2013 Jick (92% received the single 150-mg dose preparation), 1999 30.25.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

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

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.03[0.89; 1.19]44,7845,2290%NABerard (150 mg), 2019 Molgaard-Nielsen (150 mg), 2013 Jick (92% received the single 150-mg dose preparation), 1999 30.510.01.0