Skip to main content

What the FDA labels say about taking them together

Mifepristone and tacrolimus

Mifepristone's FDA label of September 25, 2025 names tacrolimus in its contraindications section; the tacrolimus labels PlainMeds reads (4) do not name mifepristone. The mifepristone label: “… dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, may be increased by concomitant administration with mifepristone.”

Check it at the source: the mifepristone FDA label on DailyMed (effective September 25, 2025, Corcept Therapeutics Incorporated); the tacrolimus FDA label on DailyMed (effective July 17, 2026, Stellon Biotech Inc.).

What does the mifepristone label say about tacrolimus?

Mifepristone label, contraindications

CONTRAINDICATIONS Mifepristone is contraindicated in: Pregnancy [See Dosage and Administration ( 2.1 ), Use in Specific Populations ( 8.1 , 8.3 )] Patients taking drugs metabolized by CYP3A such as simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events. [See Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] Patients receiving systemic corticosteroids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because mifepristone antagonizes the effect of glucocorticoids.

Mifepristone label, drug interactions

Concomitant use of simvastatin or lovastatin is contraindicated because of the increased risk of myopathy and rhabdomyolysis. [See Contraindications (4.2), Clinical Pharmacology 12.3 ] The exposure of other substrates of CYP3A with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, may be increased by concomitant administration with mifepristone.

Source: FDA drug label (Mifepristone), Corcept Therapeutics Incorporated, effective September 25, 2025 (SPL set 63c068cd-9370-460f-829b-70e8c7ebe91e), via openFDA; the full label on DailyMed

What does the tacrolimus label say about mifepristone?

Tacrolimus's label (effective July 17, 2026) and its 3 other brand-application labels do not name mifepristone in these sections. A label lists what its studies and reports found; it is not a complete list.

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

3Mifepristone generic labelers
33Tacrolimus generic labelers
MifepristoneTacrolimus
Labeled forn/aOrgan transplant rejection, Eczema (atopic dermatitis)
Boxed warningYesYes
Pharmacy cost (NADAC)n/a$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?