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What the FDA labels say about taking them together

Amiodarone and tacrolimus

Tacrolimus's FDA label of July 17, 2026 names amiodarone in its drug interactions section; the amiodarone labels PlainMeds reads (2) do not name tacrolimus. The tacrolimus label: “Monitor tacrolimus whole blood trough concentrations and reduce ASTAGRAF XL dose if needed.”

Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the tacrolimus FDA label on DailyMed (effective July 17, 2026, Stellon Biotech Inc.).

What does the amiodarone label say about tacrolimus?

Amiodarone's label (effective December 9, 2025) and its 1 other brand-application label do not name tacrolimus in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Amiodarone Hydrochloride), Chartwell RX, LLC, effective December 9, 2025 (SPL set 5520f11d-968d-4f4f-bf57-d14369c0d746), via openFDA; the full label on DailyMed

What does the tacrolimus label say about amiodarone?

Tacrolimus label, drug interactions

Drug/Substance Class or Name: Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., erythromycin, fluconazole), calcium channel blockers (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole; Drug Interaction Effect: May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see,,)].; Recommendations: Monitor tacrolimus whole blood trough concentrations and reduce tacrolimus dose if needed [ see,) and ].

Tacrolimus label, warnings and precautions

Use of tacrolimus with amiodarone has been reported to result in increased tacrolimus whole blood concentrations with or without concurrent QT prolongation [see Drug Interactions ( 7.2 )].

Envarsus Xr label (Veloxis Pharmaceuticals, Inc, February 26, 2025), drug interactions

Drug/Substance Class or Name: Mild or Moderate CYP3A Inhibitors, such as: antibiotics (e.g., erythromycin), calcium channel blockers (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole, azole antifungals (e.g., clotrimazole, fluconazole, isavuconazole), imatinib, nilotinib, letermovir; Drug Interaction Effect: May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see,, ].; Recommendations: Monitor tacrolimus whole blood trough concentrations and reduce ENVARSUS XR dose if needed [see and ].

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 (Astagraf Xl, NDA204096), Astellas Pharma US, Inc., effective January 14, 2026 (SPL set 550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e), 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

32Amiodarone generic labelers
33Tacrolimus generic labelers
AmiodaroneTacrolimus
Labeled forn/aOrgan transplant rejection, Eczema (atopic dermatitis)
Boxed warningYesYes
Pharmacy cost (NADAC)$0.122 per tablet 200 mg tablet$0.970 per gram 0.1% ointment
Shortage nowNo current entryNo 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?