Prescription medicine
Mifepristone Brand names: Korlym; first approved as Mifeprex
Mifepristone (Mifeprex) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the mifepristone FDA label on DailyMed (effective September 25, 2025, Corcept Therapeutics Incorporated); the NDA 20687 record on Drugs@FDA; every mifepristone label on DailyMed.
Highlights of the record
FDA label of September 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
TERMINATION OF PREGNANCY.
Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with mifepristone and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential. WARNING: TERMINATION OF PREGNANCY See full prescribing information for complete boxed warning. Mifepristone has potent antiprogestational effects and will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with mifepristone, or if treatment is interrupted for more than 14 days in females of reproductive potential.
Used for
From the label: indications and usageMifepristone is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.
Forms and strengths
- 200 mg
- 300 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- September 28, 2000 Mifeprex, Danco Labs Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first April 11, 2019; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 22, 2038 Korlym tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,696 through July 30, 2026
What is mifepristone used for?
From the label: indications and usageMifepristone is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. LIMITATIONS OF USE: Mifepristone should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing's syndrome. […]
FDA pharmacologic class: Progestin Antagonist.
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 patient leaflet for mifepristone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about mifepristone?Mifepristone can cause serious side effects, including: Loss of a pregnancy. Women who can become pregnant must: have a negative pregnancy test before starting mifepristone have a negative pregnancy test before restarting mifepristone if you stop taking it for more than 14 days use a non-hormonal form of birth control while taking mifepristone and for 1 month after stopping mifepristone. Talk to your doctor about how to prevent pregnancy. Tell your doctor right away if you think you may be pregnant.
From the patient leaflet: What should I avoid while taking mifepristone?You should not drink grapefruit juice while you take mifepristone. Grapefruit juice may increase the amount of mifepristone in your blood and increase your chance of having side effects.
From the patient leaflet: How should I store mifepristone?Store mifepristone at room temperature, between 68°F to 77°F (20°C to 25°C). Keep mifepristone and all medicines out of the reach of children.
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
Is there a generic for mifepristone (Mifeprex)?
The FDA approved the first generic mifepristone on April 11, 2019. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists mifepristone from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Mifeprex tablets; a patent listed only for Korlym tablets runs to August 22, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2000 earliest approval on file
- 2019 first generic approved
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the mifepristone label say about other medicines?
The mifepristone label names 32 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name mifepristone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | Ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir /ritonavir, posaconazole, saquinavir, telithromycin, or voriconazole may increase exposure to mifepristone. |
| Bupropion | drug interactions | Drugs metabolized by CYP2B6: Use of mifepristone should be done with caution with bupropion and efavirenz ( 7.5 ). |
| Carbamazepine | drug interactions | Avoid co-administration of mifepristone and CYP3A inducers such as rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamazepine, and St. John's wort. |
| Clarithromycin | drug interactions | Ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir /ritonavir, posaconazole, saquinavir, telithromycin, or voriconazole may increase exposure to mifepristone. |
| Cyclosporine | contraindications | … 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. … |
| Dihydroergotamine | contraindications | … 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. … |
| Efavirenz | drug interactions | Drugs metabolized by CYP2B6: Use of mifepristone should be done with caution with bupropion and efavirenz ( 7.5 ). |
| Ergotamine | contraindications | … 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. … |
| Fentanyl | contraindications | … 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. … |
| Fluvastatin | drug interactions | Mifepristone significantly increased exposure of fluvastatin, a typical CYP2C8/2C9 substrate, in healthy subjects. |
| Fosamprenavir | drug interactions | Ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir /ritonavir, posaconazole, saquinavir, telithromycin, or voriconazole may increase exposure to mifepristone. |
| Itraconazole | drug interactions | Ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir /ritonavir, posaconazole, saquinavir, telithromycin, or voriconazole may increase exposure to mifepristone. |
| Ketoconazole | drug interactions | Ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir /ritonavir, posaconazole, saquinavir, telithromycin, or voriconazole may increase exposure to mifepristone. |
| Lopinavir and ritonavir | drug interactions | Ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir /ritonavir, posaconazole, saquinavir, telithromycin, or voriconazole may increase exposure to mifepristone. |
Every other medicine the mifepristone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Lovastatin | contraindications | … )] Patients taking drugs metabolized by CYP3A such as simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl … |
| Nefazodone | drug interactions | Ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir … |
| Nelfinavir | drug interactions | Ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir … |
| Phenobarbital | drug interactions | Avoid co-administration of mifepristone and CYP3A inducers such as rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamazepine, and St. John's wort. |
| Phenytoin | drug interactions | Avoid co-administration of mifepristone and CYP3A inducers such as rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamazepine, and St. John's wort. |
| Pimozide | contraindications | … ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events. … |
| Posaconazole | drug interactions | … and fosamprenavir, clarithromycin, conivaptan, lopinavir /ritonavir, posaconazole, saquinavir, telithromycin, or voriconazole may increase exposure to mifepristone. |
| Progesterone | boxed warning | TERMINATION OF PREGNANCY Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. |
| Quinidine | contraindications | … as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events. … |
| Repaglinide | drug interactions | When given concomitantly with mifepristone, drugs that are substrates of CYP2C8/2C9 (including non-steroidal anti-inflammatory drugs, warfarin, and repaglinide) should be used at the smallest … |
| Rifabutin | drug interactions | Avoid co-administration of mifepristone and CYP3A inducers such as rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamazepine, and St. John's wort. |
| Rifampin | drug interactions | Avoid co-administration of mifepristone and CYP3A inducers such as rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamazepine, and St. John's wort. |
| Ritonavir | drug interactions | Ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir … |
| Simvastatin | contraindications | … ( 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 … |
| Sirolimus | contraindications | … cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events. … |
| Tacrolimus | contraindications | … dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events. … |
| Voriconazole | drug interactions | … lopinavir /ritonavir, posaconazole, saquinavir, telithromycin, or voriconazole may increase exposure to mifepristone. |
| Warfarin | drug interactions | When given concomitantly with mifepristone, drugs that are substrates of CYP2C8/2C9 (including non-steroidal anti-inflammatory drugs, warfarin, and repaglinide) should be used at the smallest … |
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 do FAERS reports show for mifepristone?
The FDA Adverse Event Reporting System holds 4,696 reports that list mifepristone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 346 are coded as a death and 1,387 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Mifepristone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other