What the FDA labels say about taking them together
Itraconazole and tacrolimus
Itraconazole's FDA label of July 13, 2026 names tacrolimus in its drug interactions section, and tacrolimus's label names itraconazole too. The tacrolimus label: “Reduce PROGRAF dose and adjust dose based on tacrolimus whole blood trough concentrations. Early and frequent monitoring of tacrolimus whole blood trough levels should start within 1-3 days and continue monitoring as …”
Check it at the source: the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.); the tacrolimus FDA label on DailyMed (effective July 17, 2026, Stellon Biotech Inc.).
What does the itraconazole label say about tacrolimus?
Itraconazole label, drug interactionsExamples of Concomitant Drugs Within Class: Budesonide (inhalation) Budesonide (non-inhalation) Ciclesonide (inhalation) Cyclosporine (IV) Cyclosporine (non-IV) Dexamethasone; Prevention or Management: Fluticasone (inhalation) Fluticasone (nasal) Methylprednisolone Tacrolimus (IV) Tacrolimus (oral); Monitor for adverse reactions. Concomitant drug dose reduction may be necessary.
Source: FDA drug label (Tolsura, NDA208901), Mayne Pharma Commercial LLC, effective April 23, 2025 (SPL set 306352d1-9d5a-49ad-b72d-893b99546861), via openFDA
Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed
What does the tacrolimus label say about itraconazole?
Tacrolimus label, drug interactionsDrug/Substance Class or Name: Strong CYP3A Inhibitors 3: Protease inhibitors (e.g, nelfinavir, telaprevir, boceprevir, ritonavir), azole antifungals (e.g., voriconazole, posaconazole, itraconazole, ketoconazole), antibiotics (e.g., clarithromycin, troleandomycin, chloramphenicol), nefazodone, letermovir, Schisandra sphenanthera extracts; Drug Interaction Effect: May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation). A rapid, sharp rise in tacrolimus levels may occur early, despite an immediate reduction of tacrolimus dose [see,,)].; …
Tacrolimus label, warnings and precautionsInhibitors and Inducers When co-administering tacrolimus with strong CYP3A4 inhibitors (e.g., telaprevir, boceprevir, ritonavir, ketoconazole, itraconazole, voriconazole, clarithromycin) and strong inducers (e.g., rifampin, rifabutin), adjustments in the dosing regimen of tacrolimus and subsequent frequent monitoring of tacrolimus whole blood trough concentrations and tacrolimus-associated adverse reactions are recommended.
Astagraf Xl label (Astellas Pharma US, Inc., January 14, 2026), warnings and precautionsTherefore, adjust ASTAGRAF XL dose and monitor tacrolimus whole blood trough concentrations when co-administering ASTAGRAF XL with strong CYP3A inhibitors (e.g., including, but not limited to, telaprevir, boceprevir, ritonavir, ketoconazole, itraconazole, voriconazole, clarithromycin) or strong CYP3A inducers (e.g., including, but not limited to, rifampin, rifabutin) [see Dosage and Administration ( 2.4 ) and Drug Interactions ( 7.2 )].
Source: FDA drug label (Prograf, NDA050708), Astellas Pharma US, Inc., effective August 25, 2023 (SPL set 7f667de1-9dfa-4bd6-8ba0-15ee2d78873b), via openFDA
Source: FDA drug label (Tacrolimus), Stellon Biotech Inc., effective July 17, 2026 (SPL set 6b89e8a4-9f11-42e3-8e79-fe617e7c461f), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Itraconazole | Tacrolimus | |
|---|---|---|
| Labeled for | Fungal infections | Organ transplant rejection, Eczema (atopic dermatitis) |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $0.910 per capsule 100 mg capsule | $0.970 per gram 0.1% ointment |
| Shortage now | A presentation being discontinued | No current entry |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once