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Does Tofacitinib Interact with Ketoconazole?

CDI records a moderate classification for Tofacitinib and Ketoconazole. The stored summary is: Table 7: Clinically Significant Interactions Affecting XELJANZ/XELJANZ XR When Concomitantly Used with Other Drugs Strong CYP3A4 Inhibitors (e.g., ketoconazole) Clinical Impact Increased exposure to tofacitinib Intervention Dosage modification of XELJANZ/XELJANZ XR is recommended [see Dosage and Administration (2) , Clinical Pharmacology, Figure 3 (12.3) ] Moderate CYP3A4 Inhibitors Concomitantly Used with Strong CYP2C19 Inhibitors (e.g., fluconazole) Clinical Impact Increased exposure to tofacitinib Intervention Dosage modification of XELJANZ/XELJANZ XR is recommended [see Dosage and Administration (2) , Clinical Pharmacology, Figure 3 (12.3) ] Strong CYP3A4 Inducers (e.g., rifampin) Clinical Impact Decreased exposure to tofacitinib and may result in loss of or reduced clinical response Intervention Concomitant use with XELJANZ/XELJANZ XR is not recommended [see Clinical Pharmacology, Figure 3 (12.3) ] Immunosuppressive Drugs (e.g., azathioprine, tacrolimus, cyclosporine) Clinical Impact Risk of added immunosuppression; concomitant use of XELJANZ/XELJANZ XR with biologic DMARDs or potent immunosuppressants has not been studied in patients with RA, PsA, AS, UC, or pcJIA. Patients taking both medications should consult their healthcare provider before starting, stopping, or changing the dosage of either drug. This record was extracted from drug labeling through openFDA. NIH/NLM RxNorm is used for drug identities. The summary and severity classification are CDI's processed information, not a verbatim source quotation. Product, route, and patient circumstances matter.

Severity
Moderate
Ketoconazole Class
Azole Antifungal
Management
Monitor for effects
Data Source
U.S. FDA via OpenFDA

What To Tell Your Doctor or Pharmacist

If you are taking Tofacitinib and your doctor is considering prescribing Ketoconazole (or vice versa), make sure to:

  • Inform your doctor and pharmacist of all current medications, including over-the-counter drugs and supplements
  • Ask whether the benefits of combining these medications outweigh the risks for your specific situation
  • Ask what symptoms to watch for that would indicate the interaction is causing problems
  • Ask whether any dosage adjustments are needed
  • Never stop or change either medication without first consulting your healthcare provider
💊 Tofacitinib(Xeljanz)+💊 Ketoconazole(T8 Keto Flush)

Severity & Interaction Details

🟡
moderate
Be aware — moderate interaction
Documented interaction with manageable risk. May require dose adjustment or monitoring.
Severity scale
MinorContra
On record
Yes
Drug A class
—
Drug B class
Azole Antifungal
Source
FDA drug label - tofacitinib

What this means in plain English

Table 7: Clinically Significant Interactions Affecting XELJANZ/XELJANZ XR When Concomitantly Used with Other Drugs Strong CYP3A4 Inhibitors (e.g., ketoconazole) Clinical Impact Increased exposure to tofacitinib Intervention Dosage modification of XELJANZ/XELJANZ XR is recommended [see Dosage and Administration (2) , Clinical Pharmacology, Figure 3 (12.3) ] Moderate CYP3A4 Inhibitors Concomitantly Used with Strong CYP2C19 Inhibitors (e.g., fluconazole) Clinical Impact Increased exposure to tofacitinib Intervention Dosage modification of XELJANZ/XELJANZ XR is recommended [see Dosage and Administration (2) , Clinical Pharmacology, Figure 3 (12.3) ] Strong CYP3A4 Inducers (e.g., rifampin) Clinical Impact Decreased exposure to tofacitinib and may result in loss of or reduced clinical response Intervention Concomitant use with XELJANZ/XELJANZ XR is not recommended [see Clinical Pharmacology, Figure 3 (12.3) ] Immunosuppressive Drugs (e.g., azathioprine, tacrolimus, cyclosporine) Clinical Impact Risk of added immunosuppression; concomitant use of XELJANZ/XELJANZ XR with biologic DMARDs or potent immunosuppressants has not been studied in patients with RA, PsA, AS, UC, or pcJIA.

About Tofacitinib and Ketoconazole

Ketoconazole is an Azole Antifungal. You may recognize them by the brand names Xeljanz and Ketodan. Both Tofacitinib and Ketoconazole carry an FDA boxed warning — the agency's most serious safety designation.

Source and Limitations

This record was produced by automated extraction from drug-label information, including AI processing. The summary and mechanism are not verbatim FDA quotations. The drug profiles below may describe different formulations from the source label. Confirm the exact product and route with your pharmacist. This page does not establish independent clinical review.

📖 Source: FDA drug label - tofacitinib

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How this information is prepared: CDI uses automated extraction, including AI, to summarize drug labeling from openFDA and includes separately identified curated-reference records. RxNorm helps identify medications; it does not verify interaction claims. Extracted summaries and CDI severity classifications can contain errors and are not verbatim FDA statements or independent clinical review. Maintained by CheckDrugInteractions.com. See our methodology or report a correction at support@checkdruginteractions.com.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.

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