Colchicine and Dronedarone: 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
Dronedarone
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.
Taking these two together needs a close look from your care team. Colchicine (for gout or familial Mediterranean fever) is broken down and pushed out of your body by two systems in your gut and liver. Dronedarone (Multaq, for heart rhythm) slows both of those systems down. That means colchicine can build up to higher levels than intended.
Too much colchicine can cause serious problems like severe diarrhea, muscle weakness, and effects on your blood cells, and in rare cases it can be life-threatening. Please do not stop or change either medicine on your own. Talk with your pharmacist or doctor, because this combination often needs to be avoided or the colchicine dose carefully lowered and watched.
Interaction: Dronedarone is a dual CYP3A4 and P-gp inhibitor. Colchicine is a substrate of both. Inhibition reduces colchicine metabolism and efflux, increasing colchicine exposure and risk of toxicity (myelosuppression, neuromyopathy, GI toxicity, multi-organ failure). Neither is a prodrug; the effect is a straightforward increase in colchicine levels.
- Direction: increased colchicine exposure
- Evidence: theoretical, but analogous to fatal cases with clarithromycin
- Severity: contraindicated, especially with renal or hepatic impairment
Management: Avoid combination. If required with normal renal/hepatic function, reduce colchicine dose or frequency per labeling (e.g., gout flare 0.6 mg x1, repeat no sooner than 3 days) and monitor closely; discontinue colchicine if toxicity suspected.
What happens
Increased colchicine exposure and an increased risk of colchicine toxicity
Interaction Deep Dive
CYP3A4 and P-gp both metabolize and transport colchicine, which is a substrate of each. Giving colchicine together with P-glycoprotein (P-gp) inhibitors such as dronedarone is contraindicated1. When colchicine has been combined with clarithromycin, an agent that inhibits both CYP3A4 and P-gp, fatal interactions and serious toxicities have been documented. Similar toxicities have also been seen with colchicine plus CYP3A4 inhibitors and with colchicine plus P-gp inhibitors. Furthermore, in patients who have renal or hepatic impairment, using colchicine alongside a dual CYP3A4 and P-gp inhibitor like dronedarone is contraindicated. When such combined use is necessary in individuals whose hepatic and renal function is normal, the colchicine dose must be modified, either by lowering the daily amount or by reducing how often it is given, and the patient must be monitored closely for colchicine toxicity3. Where the two are used together or where the inhibitor has been taken within the previous 14 days, the colchicine dose for treating a gout flare should be reduced to a single 0.6 mg dose, and any repeat dose should not be administered any sooner than 3 days. For prophylaxis against gout flares, cut the colchicine dose from an original 0.6 mg twice daily down to 0.3 mg once daily, or from an original 0.6 mg once daily down to 0.3 mg every other day. In patients with familial Mediterranean fever, the colchicine dose should not exceed a maximum of 0.6 mg per day (this may be administered as 0.3 mg twice daily). Watch for colchicine toxicity and stop colchicine right away if it is suspected2.
Why it happens (mechanism)
Inhibition of CYP3A-mediated metabolism of colchicine; inhibition of P-gp-mediated efflux transport of colchicine
How to manage this interaction
This combination is generally avoided. Your care team will decide the safest path, and there are clear steps they can follow.
- Do not start, stop, or change either drug on your own. Keep taking what you were prescribed until you speak with your team.
- If you have kidney or liver problems, this pairing is not used, so your team may choose a different option.
- If both are needed and your kidneys and liver are normal, your colchicine dose may be lowered or spaced out further and you will be monitored more closely.
- Watch for signs of colchicine toxicity (severe diarrhea, vomiting, muscle weakness or pain, numbness, unusual bruising or infection) and report them right away.
Management is individual — confirm any change with your pharmacist or prescriber.
Literature reports
2 reports — tap to read
a) In a pharmacokinetic study, taking a single 0.6 mg dose of colchicine together with ketoconazole 200 mg twice daily for 5 days (a potent CYP3A4 inhibitor) raised the colchicine Cmax by 101.7% and the AUC by 212.2% relative to baseline values (N=24) 2.
b) When a 0.6 mg dose of colchicine was administered alongside clarithromycin 250 mg twice daily for 7 days, colchicine Cmax and AUC rose by 227.2% and 281.5%, respectively, from baseline in a study involving 23 patients 2.
Common questions
Can I take Colchicine and Dronedarone together?
Dronedarone raises colchicine levels and this pairing is contraindicated, especially with kidney or liver impairment; do not combine without your care team specifically adjusting the colchicine dose and monitoring you closely. Always confirm with your pharmacist or prescriber before making any change.
How serious is the Colchicine and Dronedarone 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 is the Colchicine and Dronedarone interaction managed?
This combination is generally avoided. Your care team will decide the safest path, and there are clear steps they can follow. Do not start, stop, or change either drug on your own. Keep taking what you were prescribed until you speak with your team. If you have kidney or liver problems, this pairing is not used, so your team may choose a different option. If both are needed and your kidneys and li… 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 Colchicine or Dronedarone 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: COLCRYS oral tablets, colchicine oral tablets. Takeda Pharmaceuticals America Inc (per FDA), Deerfield, IL, 2020. DailyMed
- Product Information: GLOPERBA(R) oral solution, colchicine oral solution. Romeg Therapeutics LLC (per FDA), Woburn, MA, 2019. DailyMed
Keep reading about Dronedarone
Keep reading about Colchicine
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