Ketoconazole Topical and Colchicine: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Ketoconazole Topical
Colchicine
How we grade severity & evidence
Severity levels
- Contraindicated: These should generally not be used together.
- Major: Potentially serious — often needs a change or close monitoring.
- Moderate: Can be significant — usually manageable with monitoring.
- Minor: Usually limited clinical impact.
Evidence grades
- Established: Well documented — supported by controlled studies or strong clinical data.
- Probable: Good supporting evidence, though not definitively proven.
- Suspected: Some evidence suggests this interaction, but it is not well established.
- Possible: Limited or conflicting evidence; the interaction may occur.
- Theoretical: Predicted from the drugs' pharmacology; not yet confirmed in people.
Ratings come from the documented interaction literature and are reviewed by a pharmacist. They describe the documented risk of the combination, not what will necessarily happen to you — your dose, timing, and health picture all matter.
What happens
Increased colchicine exposure and an increased risk of colchicine toxicity
Interaction Deep Dive
Colchicine is a substrate of both CYP3A4 and P-gp. Concomitant use of colchicine with dual strong CYP3A4 and P-gp inhibitors is contraindicated because life-threatening and fatal colchicine toxicity has been reported in these patients with colchicine taken in therapeutic doses1. Also, use of colchicine with a dual CYP3A4 and P-gp inhibitor, such as ketoconazole, is contraindicated in patients with renal or hepatic impairment 2. A colchicine dose adjustment is required in patients with normal renal and hepatic function who are receiving concurrently or have received ketoconazole within the last 14 days. For the treatment of gout flare, reduce the colchicine dose to one 0.6 mg tablet for one dose followed by 0.3 mg (half tablet) 1 hour later, with the repeat dose to be given no earlier than 3 days. For the prophylaxis of gout flare, reduce the colchicine dose from an original dose of 0.6 mg twice daily to 0.3 mg once daily or from an original dose of 0.6 mg once daily to 0.3 mg once every other day. For the treatment of familial Mediterranean fever, the maximum daily colchicine dose should be no more than 0.6 mg (may be given as 0.3 mg twice daily) 3.
Why it happens (mechanism)
Inhibition of CYP3A4-mediated metabolism of colchicine; and P-gp-mediated efflux transport of colchicine
Literature reports
2 reports — tap to read
a) Concomitant use of a 0.6 mg dose of colchicine and ketoconazole 200 mg twice daily for 5 days resulted in 101.7% and 212.2% increases in colchicine Cmax and AUC, respectively, from baseline in a study of 24 patients 3.
b) Concomitant use of a 0.6 mg dose of colchicine and clarithromycin 250 mg twice daily for 7 days resulted in 227.2% and 281.5% increases in colchicine Cmax and AUC, respectively, from baseline in a study of 23 patients 3.
Common questions
Can I take Ketoconazole Topical and Colchicine together?
Increased colchicine exposure and an increased risk of colchicine toxicity Always confirm with your pharmacist or prescriber before making any change.
How serious is the Ketoconazole Topical and Colchicine interaction?
It is rated contraindicated. These should generally not be used together.
How quickly could this interaction happen?
The documented onset is "unspecified". The timing of this interaction is not well characterized.
How strong is the evidence for this interaction?
The evidence is graded "established". Well documented — supported by controlled studies or strong clinical data.
Questions for your pharmacist
- Does my dose of Ketoconazole Topical or Colchicine need adjusting while I take them together?
- What symptoms should prompt me to call you or my prescriber right away?
- Does the timing of my doses matter for this combination?
- Is there a safer alternative to one of these medications for me?
References (3)
- Product Information: LODOCO(R) oral tablets, colchicine oral tablets. AGEPHA Pharma USA, LLC (per FDA), Parsippany, NJ, 2023. DailyMed
- Product Information: GLOPERBA(R) oral solution, colchicine oral solution. SCILEX Pharmaceuticals Inc. (per FDA), Palo Alto, CA, 2024. DailyMed
- Product Information: COLCRYS oral tablets, colchicine oral tablets. Takeda Pharmaceuticals America Inc (per FDA), Deerfield, IL, 2020. DailyMed
Keep reading about Ketoconazole Topical
Keep reading about Colchicine
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