Meta Information
ID:methylene-blue
Name:
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/ssris-snris
Target name:
Serotonergic Drugs (CONTRAINDICATED — Serotonin Syndrome)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Methylene blue is a potent MAO-A inhibitor; concomitant use with serotonergic agents can precipitate serotonin syndrome.
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:
Opioids and dextromethorphan may increase the risk of developing serotonin syndrome.
Label source:
FDA label: Methylene Blue (PROVAYBLUE)
Action type:
avoid
Target id:
/class/maois
Target name:
MAO Inhibitors / Methylene Blue is an MAOI
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Methylene blue itself has MAO-inhibitor activity; do not combine with other MAOIs.
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:
understood, literature reports suggest methylene blue injection is a potent reversible inhibitor of monoamine oxidase.
Label source:
FDA label: Methylene Blue (PROVAYBLUE)
Action type:
avoid
Target id:
/condition/g6pd-deficiency
Target name:
G6PD Deficiency (Hemolytic Anemia Risk)
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Methylene blue can cause severe hemolytic anemia in G6PD-deficient patients.
Actionable advice:
Screen for G6PD deficiency in at-risk populations before high-dose IV vitamin C or methylene blue.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
• Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD
Label source:
FDA label: Methylene Blue (PROVAYBLUE)
Action type:
informational_none
Target id:
/condition/pregnancy
Target name:
Pregnancy
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
May cause fetal harm when administered to pregnant women.
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:
7 ) 8.1 Pregnancy Risk Summary Methylene blue injection may cause fetal harm when administered to a pregnant woman.
Label source:
FDA label: Methylene Blue (PROVAYBLUE)
Action type:
avoid
Target id:
/condition/lactation
Target name:
Lactation
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Avoid breastfeeding for at least 8 days after methylene blue administration.
Actionable advice:
It is important to talk to a prescriber about risk/benefit before nursing; alternatives or temporary cessation may be warranted.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
( 8.1 ) • Lactation: Discontinue breast-feeding for up to 8 days after treatment.
Label source:
FDA label: Methylene Blue (PROVAYBLUE)
Action type:
informational_none
Target id:
/adverse/methemoglobinemia-paradoxical
Target name:
Paradoxical Methemoglobinemia (Excessive Doses)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
At high doses (>7 mg/kg) methylene blue paradoxically induces methemoglobinemia.
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:
Monitor response to therapy with methylene blue injection through resolution of methemoglobinemia.
Label source:
FDA label: Methylene Blue (PROVAYBLUE)
Action type:
avoid
Target id:
/condition/renal-impairment
Target name:
Renal Impairment
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Limited data in renal impairment; monitor closely.
Actionable advice:
Adjust dose per renal function; monitor SCr/eGFR.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
the kidney, so the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
Label source:
FDA label: Methylene Blue (PROVAYBLUE)
Action type:
adjust_with_prescriber
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