Colchicine and Osimertinib: 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
Osimertinib
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.
Here is what is going on. Colchicine (Colcrys, Mitigare) is normally pumped out of your body by a transporter called P-gp. Osimertinib (Tagrisso) can slow that pump down. When the pump slows, colchicine can build up to higher levels than expected, and that raises the risk of serious colchicine toxicity, which can show up as bad diarrhea, vomiting, muscle weakness, or worse.
This is considered a very serious pairing, so please do not adjust either medicine on your own. The good news is your care team can manage this safely, often by adjusting your colchicine or watching you closely. Call your pharmacist or doctor and let them know you take both.
Effect: Osimertinib inhibits P-gp mediated efflux of colchicine, increasing colchicine exposure and risk of toxicity. Colchicine is a P-gp (and CYP3A4) substrate; neither drug is a prodrug, so this is a straightforward exposure increase.
- Direction: increased colchicine AUC/Cmax, increased toxicity risk.
- Severity/labeling: contraindicated per colchicine labeling with P-gp inhibitors.
- Evidence: theoretical (extrapolated from documented P-gp/CYP3A4 inhibitor cases); onset unspecified.
- Management: avoid in renal or hepatic impairment. If unavoidable with normal organ function, reduce colchicine daily dose or dosing frequency and monitor closely for toxicity (GI, myopathy, cytopenias, neuromuscular symptoms).
What happens
Increased colchicine exposure and an increased risk of colchicine toxicity
Interaction Deep Dive
Colchicine serves as a substrate for both CYP3A4 and P-gp. Reports of toxicity have emerged when colchicine was given together with clarithromycin, which inhibits both CYP3A4 and P-gp. Toxicity has likewise been observed when colchicine was combined with a CYP3A4 inhibitor and when it was combined with a P-gp inhibitor3. Because life-threatening and fatal colchicine toxicity has been documented in patients taking colchicine at therapeutic doses along with P-gp inhibitors, the concurrent use of colchicine with P-gp inhibitors is contraindicated 1. This combination is similarly contraindicated in individuals with renal or hepatic impairment, given that life-threatening and fatal drug interactions have been reported. For patients whose renal and hepatic function is normal 2, when colchicine must be coadministered with a P-gp inhibitor, adjust the colchicine dose either by lowering the daily amount or by reducing how often it is dosed. Watch closely for signs of colchicine toxicity 3.
Why it happens (mechanism)
Inhibition of P-gp-mediated colchicine efflux transport
How to manage this interaction
What your care team may do:
- Because this combination is labeled as contraindicated, your team may choose an alternative or, if both are truly needed and your kidneys and liver work normally, reduce your colchicine dose or how often you take it.
- They may monitor you more closely for signs of colchicine toxicity.
What you should do:
- Keep taking both exactly as prescribed for now, and do not change anything on your own.
- Tell your pharmacist or prescriber right away that you take both drugs, and mention any kidney or liver problems.
- Report diarrhea, vomiting, muscle pain or weakness, numbness, or unusual bruising promptly.
Management is individual — confirm any change with your pharmacist or prescriber.
Common questions
Can I take Colchicine and Osimertinib together?
Osimertinib can raise colchicine to dangerous levels by blocking its P-gp transporter, and this pairing is labeled contraindicated, so contact your pharmacist or doctor before taking them together and never adjust doses yourself. Always confirm with your pharmacist or prescriber before making any change.
How serious is the Colchicine and Osimertinib 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 Osimertinib interaction managed?
What your care team may do: Because this combination is labeled as contraindicated, your team may choose an alternative or, if both are truly needed and your kidneys and liver work normally, reduce your colchicine dose or how often you take it. They may monitor you more closely for signs of colchicine toxicity. What you should do: Keep taking both exactly as prescribed for now, and do not change a… 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 Osimertinib 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 Osimertinib
Keep reading about Colchicine
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