Ketoconazole Topical and Nilotinib: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Nilotinib
No brand names on recordKetoconazole Topical
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 nilotinib exposure, an increased risk of nilotinib-related adverse reactions, an increased ketoconazole exposure and an increased risk for QT interval prolongation
Interaction Deep Dive
Concomitant use of ketoconazole and nilotinib (strong CYP3A4 substrate that prolong QT interval) is contraindicated as it may increase the exposure of nilotinib and may prolong QT interval. Coadministration of ketoconazole (strong CYP3A4 substrate) and nilotinib (moderate CYP3A4 inhibitor), may also increase ketoconazole exposure1. If ketoconazole therapy is needed, consider interrupting nilotinib therapy. However, if coadministration is required, consider reducing nilotinib (Tasigna(R)) dose to 200 mg/day in patients with newly diagnosed, Ph+ CML-chronic phase, or to 300 mg/day in patients with resistant or intolerant Ph+ CML-chronic or accelerated phase 2. Reduce nilotinib (Danziten(R)) dosage to 142 mg once daily in patients with resistant or intolerant Ph+ CML or to 95 mg once daily in patients with newly diagnosed Ph+ CML in chronic phase. If ketoconazole is discontinued, allow a washout period of 5 half-lives before adjusting nilotinib dose upward. Obtain ECGs periodically to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and adjust the dose accordingly 3.
Why it happens (mechanism)
Inhibition of CYP3A4-mediated metabolism of ketoconazole; inhibition of CYP3A4 mediated metabolism of nilotinib; additive QT interval prolongation
Literature reports
3 reports — tap to read
a) Although not specifically studied with the CYP3A4 substrate ketoconazole, multiple doses of nilotinib (a moderate CYP3A4 inhibitor) increased the systemic exposure of midazolam (a CYP3A4 substrate) by 2.6-fold in patients with chronic myeloid leukemia 2.
b) In a drug interaction study, coadministration of ketoconazole, a strong CYP3A4 inhibitor, at a dose of 400 mg/day for 6 days increased nilotinib AUC by approximately 3-fold in healthy subjects 23.
c) In a pharmacokinetic study in 25 healthy volunteers, coadministration of nilotinib with ketoconazole increased the Cmax and AUC of nilotinib by approximately 1.8- and 3-fold, respectively, compared with nilotinib given alone 4.
Common questions
Can I take Ketoconazole Topical and Nilotinib together?
Increased nilotinib exposure, an increased risk of nilotinib-related adverse reactions, an increased ketoconazole exposure and an increased risk for QT interval prolongation Always confirm with your pharmacist or prescriber before making any change.
How serious is the Ketoconazole Topical and Nilotinib 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 Nilotinib 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 (4)
- Product Information: Ketoconazole oral tablet, ketoconazole oral tablet. Taro Pharmaceuticals U.S.A. Inc. (per DailyMed), Hawthorne, NY, 2024. DailyMed
- Product Information: TASIGNA(R) oral capsules, nilotinib oral capsules. Novartis Pharmaceuticals Corporation (per FDA), East Hanover, NJ, 2024. DailyMed
- Product Information: DANZITEN oral tablets, nilotinib oral tablets. Azurity Pharmaceuticals, Inc. (per FDA), Woburn, MA, 2024. DailyMed
- Tanaka C, Yin OQ, Smith T, et al: Effects of rifampin and ketoconazole on the pharmacokinetics of nilotinib in healthy participants. J Clin Pharmacol 2011; 51(1):75-83. PubMed
Keep reading about Nilotinib
Keep reading about Ketoconazole Topical
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