Omaveloxolone and Colchicine: Interaction Details
AI-assisted, pharmacist-reviewed · AI content regenerated Jul 11, 2026 · Source data updated Jul 2, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Omaveloxolone
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.
You've been prescribed Skyclarys (omaveloxolone) along with colchicine. Here's what's going on: omaveloxolone can gently speed up the liver system (called CYP3A4) that breaks down colchicine. When colchicine gets cleared a little faster, there may be less of it in your body, so it might not work quite as well for your gout or other condition.
The good news is this concern is mostly theoretical, based on how the drugs behave rather than lots of real-world reports. Your care team can watch to make sure your colchicine is still doing its job, and they can adjust things if needed. Please don't change either medicine on your own. Just keep taking both as prescribed and mention any return of symptoms to your pharmacist or doctor.
Direction: Omaveloxolone is a weak CYP3A4 inducer; colchicine is a CYP3A4 substrate (also a P-gp substrate). Induction is expected to increase colchicine metabolism, lowering its systemic exposure and potentially reducing efficacy. Neither is a prodrug, so the effect is a straightforward loss of therapeutic effect.
- Magnitude: Omaveloxolone reduced midazolam AUC by ~45% in a DDI study; the effect on colchicine is not directly quantified.
- Onset: Unspecified.
- Evidence: Theoretical.
- Management: Monitor for lack of colchicine efficacy (e.g., inadequate gout flare control). Dose may be individualized and adjusted by the care team as needed.
What happens
Reduced CYP3A4 substrate exposure and reduced efficacy of CYP3A4 substrate
Interaction Deep Dive
When omaveloxolone, which acts as a weak CYP3A4 inducer, is taken alongside CYP3A4 substrates, the exposure of those substrates may decline, potentially diminishing their effectiveness. For patients receiving a CYP3A4 substrate at the same time, watch for signs that the co-administered therapy is not working as intended. A drug interaction study demonstrated that giving omaveloxolone together with midazolam (a CYP3A4 substrate) lowered midazolam's AUC by roughly 45%1.
Why it happens (mechanism)
Induction of CYP3A4 substrate metabolism by omaveloxolone
How to manage this interaction
Your care team can manage this combination. The main step is watching to be sure your colchicine keeps working as expected.
- Keep taking both exactly as prescribed unless your prescriber tells you otherwise.
- Your team may monitor you more closely for signs that colchicine is not controlling your symptoms as well as before.
- Your colchicine dose may need to be adjusted and individualized by your care team if reduced effect is seen.
- Tell your pharmacist or doctor if gout flares, pain, or other symptoms return or worsen.
Management is individual — confirm any change with your pharmacist or prescriber.
Literature reports
1 report — tap to read
a) In a study evaluating drug interactions, coadministration of omaveloxolone with midazolam reduced the AUC of midazolam (a CYP3A4 substrate) by roughly 45% 1.
Common questions
Can I take Omaveloxolone and Colchicine together?
Omaveloxolone may lower colchicine levels and make it less effective, so watch for returning symptoms and let your care team adjust and monitor as needed. Keep taking both as prescribed. Always confirm with your pharmacist or prescriber before making any change.
How serious is the Omaveloxolone and Colchicine interaction?
It is rated major. Potentially serious — often needs a change or close monitoring.
How quickly could this interaction happen?
The documented onset is "unspecified". The timing of this interaction is not well characterized.
How is the Omaveloxolone and Colchicine interaction managed?
Your care team can manage this combination. The main step is watching to be sure your colchicine keeps working as expected. Keep taking both exactly as prescribed unless your prescriber tells you otherwise. Your team may monitor you more closely for signs that colchicine is not controlling your symptoms as well as before. Your colchicine dose may need to be adjusted and individualized by your care… Management is individual — always follow your own care team's guidance.
How strong is the evidence for this interaction?
The evidence is graded "theoretical". Predicted from the drugs' pharmacology; not yet confirmed in people.
Questions for your pharmacist
- Does my dose of Omaveloxolone 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 (1)
- Product Information: Skyclarys® oral capsules, omaveloxolone oral capsules. Biogen U.S. Corporation, Cambridge, MA, 2026. DailyMed
Keep reading about Omaveloxolone
Keep reading about Colchicine
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