Skip to main content

What the FDA labels say about taking them together

Rifabutin and tacrolimus

Tacrolimus's FDA label of July 17, 2026 names rifabutin in its drug interactions section; the rifabutin label PlainMeds reads does not name tacrolimus. The tacrolimus label: “Increase PROGRAF dose and monitor tacrolimus whole blood trough concentrations.”

Check it at the source: the rifabutin FDA label on DailyMed (effective September 1, 2026, REMEDYREPACK INC.); the tacrolimus FDA label on DailyMed (effective July 17, 2026, Stellon Biotech Inc.).

What does the rifabutin label say about tacrolimus?

Rifabutin's label (effective September 1, 2026) does 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 (Rifabutin), NDA050689 (Pfizer), as published by REMEDYREPACK INC., effective September 1, 2026 (SPL set 25a60937-cbbe-4a50-994f-2ce15203f589), via openFDA; the full label on DailyMed

What does the tacrolimus label say about rifabutin?

Tacrolimus label, drug interactions

Drug/Substance Class or Name: Strong CYP3A Inducers 3: Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John's wort; Drug Interaction Effect: May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see)].; Recommendations: Increase tacrolimus dose and monitor tacrolimus whole blood trough concentrations [ see,) and ].

Tacrolimus label, warnings and precautions

Inhibitors 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.

Prograf label (Astellas Pharma US, Inc., August 25, 2023), drug interactions

Drug/Substance Class or Name: Strong CYP3A Inducers Strong CYP3A inhibitor/inducer, based on reported effect on exposures to tacrolimus along with supporting in vitro CYP3A inhibitor/inducer data, or based on drug-drug interaction studies with midazolam (sensitive CYP3A probe substrate).: Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort; Drug Interaction Effect: May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see ()].; Recommendations: Increase PROGRAF dose and monitor tacrolimus whole blood trough concentrations [see (,) and ()].

Astagraf Xl label (Astellas Pharma US, Inc., January 14, 2026), warnings and precautions

Therefore, 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

4Rifabutin generic labelers
33Tacrolimus generic labelers
RifabutinTacrolimus
Labeled forn/aOrgan transplant rejection, Eczema (atopic dermatitis)
Boxed warningNoYes
Pharmacy cost (NADAC)$8.14 per capsule 150 mg capsule$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?