Meta Information
ID:testosterone-replacement-therapy
Name:Testosterone Replacement Therapy
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-05-25T18:50:05.062584+00:00
Model
claude-sonnet-4.6-wave15-stub-rebuild
Interactions
Target id:
/class/anticoagulants
Target name:
Anticoagulants (Warfarin)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Testosterone can potentiate the anticoagulant effect of warfarin; monitor INR closely.
Actionable advice:
This is best used with caution, and it is a good idea to monitor for clinical effect; dose adjustment or monitoring may be required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Changes in anticoagulant activity may be seen with androgens.
Label source:
FDA label: Testosterone
Action type:
adjust_with_prescriber
Target id:
/intervention/insulin
Target name:
Insulin / Oral Hypoglycemics
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Testosterone may improve insulin sensitivity; monitor glucose in diabetics.
Actionable advice:
This is best used with caution, and it is a good idea to monitor for clinical effect; dose adjustment or monitoring may be required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
7.1 Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Label source:
FDA label: Testosterone
Action type:
adjust_with_prescriber
Target id:
/class/corticosteroids
Target name:
Corticosteroids (Fluid Retention)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Combination with corticosteroids may increase fluid retention; use with caution.
Actionable advice:
This is best used with caution, and it is a good idea to monitor for clinical effect; dose adjustment or monitoring may be required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Use of testosterone with Adrenocorticotropic Hormone (ACTH) or corticosteroids may result in increased fluid retention.
Label source:
FDA label: Testosterone
Action type:
adjust_with_prescriber
Target id:
/condition/breast-cancer-male
Target name:
Male Breast Cancer (CONTRAINDICATED)
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Contraindicated in men with known or suspected carcinoma of the breast.
Actionable advice:
This combination should be avoided; if unavoidable, it should be managed under specialist supervision with intensive monitoring.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Warnings and Precautions ( 5.6 ) 03/2025 4 CONTRAINDICATIONS Men with carcinoma of the breast or known or suspected carcinoma of the prostate ( 4 , 5.1 ) Pregnant or breastfeeding women.
Label source:
FDA label: Testosterone
Action type:
avoid
Target id:
/condition/prostate-cancer
Target name:
Prostate Cancer / High Risk
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Contraindicated in known or suspected prostate cancer; evaluate prostate before initiating.
Actionable advice:
This combination should be avoided; if unavoidable, it should be managed under specialist supervision with intensive monitoring.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Sleep apnea may occur in those with risk factors ( 5.13 ) Monitor serum testosterone, prostate
Label source:
FDA label: Testosterone
Action type:
avoid
Target id:
/condition/pregnancy
Target name:
Pregnancy (CONTRAINDICATED)
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Contraindicated in pregnancy due to virilization risk to female fetuses.
Actionable advice:
Use should be avoided during pregnancy unless the benefit clearly outweighs the risk, and it is worth discussing with a prescriber.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Testosterone topical solution may cause fetal harm when administered to a pregnant woman.
Label source:
FDA label: Testosterone
Action type:
avoid
Target id:
/condition/lactation
Target name:
Lactation (CONTRAINDICATED)
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Contraindicated during breastfeeding.
Actionable advice:
Not recommended while breastfeeding. If you are nursing, do not start testosterone without your prescriber arranging an alternative or advising you to stop nursing.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Testosterone and other androgens may adversely affect lactation.
Label source:
FDA label: Testosterone
Action type:
avoid
Target id:
/condition/secondary-exposure
Target name:
Secondary Exposure (Topicals, Women/Children)
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Topical testosterone can transfer to women and children via skin contact; serious virilization reported.
Actionable advice:
This combination should be avoided; if unavoidable, it should be managed under specialist supervision with intensive monitoring.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Secondary exposure to testosterone can produce signs of virilization.
Label source:
FDA label: Testosterone
Action type:
avoid
Target id:
/condition/cardiovascular-disease
Target name:
Cardiovascular Events (MI/Stroke Signal)
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Some studies suggest increased MI/stroke risk with testosterone replacement.
Actionable advice:
This combination should be avoided; if unavoidable, it should be managed under specialist supervision with intensive monitoring.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Blood pressure increases can increase cardiovascular (CV) risk over time.
Label source:
FDA label: Testosterone
Action type:
avoid
Target id:
/condition/erythrocytosis
Target name:
Polycythemia / Erythrocytosis
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Testosterone can cause polycythemia/erythrocytosis; monitor hematocrit.
Actionable advice:
This is best used with caution, and it is a good idea to monitor for clinical effect; dose adjustment or monitoring may be required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
5.3 Polycythemia Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone.
Label source:
FDA label: Testosterone
Action type:
adjust_with_prescriber
Target id:
/condition/sleep-apnea
Target name:
Sleep Apnea Worsening
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Testosterone may worsen sleep apnea, particularly in obese patients or those with COPD.
Actionable advice:
This is best used with caution, and it is a good idea to monitor for clinical effect; dose adjustment or monitoring may be required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
5.13 Sleep Apnea The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity and chronic lung disease.
Label source:
FDA label: Testosterone
Action type:
adjust_with_prescriber
Target id:
/condition/hepatic-impairment
Target name:
Hepatic Impairment
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Use with caution in hepatic impairment; risk of cholestasis with oral 17-alpha alkylated forms.
Actionable advice:
This is best used with caution in hepatic impairment, and it is a good idea to monitor liver function.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
out congestive heart failure, may be a complication in patients with preexisting cardiac, renal, or hepatic disease ( 5.11 ).
Label source:
FDA label: Testosterone
Action type:
monitor
Target id:
/adverse/hepatotoxicity
Target name:
Hepatotoxicity (17-Alpha Alkylated Oral Forms)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
17-alpha alkylated oral testosterone derivatives can cause serious hepatotoxicity, peliosis hepatis, and hepatic tumors.
Actionable advice:
This combination should be avoided; if unavoidable, it should be managed under specialist supervision with intensive monitoring.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas.
Label source:
FDA label: Testosterone
Action type:
avoid
Target id:
/class/cns-depressants
Target name:
CNS Depressants
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
null
Description:
General caution when combined with other active therapeutic agents.
Actionable advice:
It is important to talk to a physician before combining this with other medications.
Validation status:
unvalidatable
Evidence tier:
tier_e
Evidence basis:
unvalidatable
Evidence anchors:
Source url:
Scientific literature support not found
Exact phrase from label:
Label source:
Generic placeholder row: the text is non-specific ('general caution') and there is no established CNS-depressant interaction for this agent. No validatable interaction claim - marked unvalidatable (candidate for removal).
Action type:
informational_none
Derived From
testosterone_systemic_disease
Provenance Note
Interactions duplicated from 'testosterone_systemic_disease'. TRT = systemic testosterone.