Meta Information
ID:low-dose-colchicine
Name:
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-05-25T10:30:00Z
Model
wave14_quickwin_colchicine_mitigare_pdf
Interactions
Target id:
/class/p-glycoprotein-inhibitors
Target name:
Dual P-glycoprotein and CYP3A4 Inhibitors
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
In patients with renal or hepatic impairment, combining low-dose colchicine with drugs that inhibit BOTH P-glycoprotein and CYP3A4 has resulted in life-threatening or fatal colchicine toxicity. This is an absolute contraindication.
Actionable advice:
Low-dose colchicine should not be combined with drugs that inhibit both P-gp and CYP3A4 (e.g., clarithromycin, ritonavir, ketoconazole, itraconazole, cyclosporine) with any degree of renal or hepatic impairment.
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 renal or hepatic impairment should not be given MITIGARE with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
avoid
Target id:
/condition/renal-and-hepatic-impairment
Target name:
Combined Renal and Hepatic Impairment
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Patients with both renal and hepatic impairment should not be given low-dose colchicine. This combination of organ impairment dramatically increases the risk of fatal colchicine accumulation.
Actionable advice:
Low-dose colchicine is contraindicated when both renal and hepatic impairment are present.
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 both renal and hepatic impairment should not be given MITIGARE
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
avoid
Target id:
/class/cyp3a4-inhibitors
Target name:
CYP3A4 Inhibitors
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
CYP3A4 is one of two pathways that clear colchicine from the body. Blocking CYP3A4 with drugs like clarithromycin, ketoconazole, itraconazole, or ritonavir can produce dangerously high colchicine blood levels and life-threatening toxicity.
Actionable advice:
Low-dose colchicine should not be combined with strong CYP3A4 inhibitors. If unavoidable, the colchicine dose must be reduced and close monitoring provided.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
concomitant use of MITIGARE and inhibitors of CYP3A4 or P-glycoprotein should be avoided
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
avoid
Target id:
/class/statins
Target name:
HMG-CoA Reductase Inhibitors (Statins)
Severity:
moderate
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Statins (and fibrates) can cause muscle toxicity on their own. Combining them with colchicine increases the risk of myopathy, including rhabdomyolysis.
Actionable advice:
If you take a statin or fibrate together with low-dose colchicine, watch for muscle pain, weakness, or dark urine and report it promptly.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
HMG-CoA Reductase Inhibitors and Fibrates
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
monitor
Target id:
/dietary/grapefruit-pomelo
Target name:
Grapefruit or Grapefruit Juice
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Grapefruit juice inhibits intestinal CYP3A4 and can raise colchicine blood levels, increasing the risk of toxicity.
Actionable advice:
Grapefruit and grapefruit juice are best avoided while on low-dose colchicine.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
grapefruit juice, erythromycin, verapamil
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
avoid
Target id:
/adverse/gastrointestinal
Target name:
Gastrointestinal Symptoms
Severity:
moderate
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
The most common adverse reactions with colchicine are gastrointestinal: diarrhea, nausea, vomiting, and abdominal pain.
Actionable advice:
If GI symptoms develop on low-dose colchicine, report them — they may indicate early toxicity.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
diarrhea, nausea, vomiting, and abdominal pain
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
monitor
Target id:
/adverse/blood-dyscrasias
Target name:
Blood Dyscrasias
Severity:
major
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Therapeutic colchicine doses have caused myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia.
Actionable advice:
If you develop unusual bruising, bleeding, fatigue, or recurrent infections, contact your prescriber and obtain blood counts.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
informational_none
Target id:
/adverse/neuromuscular-toxicity
Target name:
Neuromuscular Toxicity (Rhabdomyolysis)
Severity:
major
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Neuromuscular toxicity, including rhabdomyolysis, has been reported with colchicine — especially in combination with other drugs known to cause muscle toxicity.
Actionable advice:
Muscle pain, tenderness, weakness, or dark urine should be reported promptly.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Neuromuscular toxicity
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
monitor
Target id:
/condition/pregnancy
Target name:
Pregnancy
Severity:
moderate
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Colchicine should be used in pregnancy only when the potential benefit justifies the potential risk to the fetus.
Actionable advice:
It is important to talk to a prescriber about benefit/risk when pregnant or planning pregnancy.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Use only if the potential benefit justifies the potential risk
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
informational_none
Target id:
/condition/lactation
Target name:
Lactation / Breastfeeding
Severity:
moderate
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for colchicine and any potential adverse effects on the breastfed child.
Actionable advice:
It is important to talk to a prescriber about continued breastfeeding before starting low-dose colchicine.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
breastfeeding should be considered along with the mother's clinical need for MITIGARE and any potential adverse effects on the breastfed child from MITIGARE or from the underlying maternal condition
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
informational_none
Target id:
/condition/male-fertility
Target name:
Male Fertility
Severity:
minor
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Low-dose colchicine may rarely and transiently impair male fertility.
Actionable advice:
If you are trying to conceive, discuss timing with your prescriber.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
MITIGARE may rarely and transiently impair fertility
Label source:
FDA label: Colchicine (MITIGARE)
Action type:
informational_none
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