Your first 90 days
Your first 90 days on Korlym for Cushing syndrome
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Korlym works differently from the other Cushing syndrome medicines on this site. It does not lower cortisol, and it blocks the receptor that cortisol acts on instead. That changes how the first 3 months are watched, because the label says a cortisol blood test cannot show adrenal insufficiency during treatment. The endocrinologist follows blood sugar, potassium and how you feel instead of a cortisol number. This page lays out those weeks from the FDA label, Corcept's own Korlym pages and one insurer's written rules.
What has to happen before the first bottle ships
Korlym has no REMS, and the first fill waits on a pregnancy test where it applies, a potassium check, a medicine review and insurance approval. These are the 8 things in the way, in order.
Confirming the label fits
The label covers adults with endogenous Cushing syndrome who have type 2 diabetes or glucose intolerance from high cortisol.
- Surgery must have failed or not be an option for them.
- The label says Korlym is not for type 2 diabetes unrelated to Cushing syndrome.FDA label
A negative pregnancy test
Korlym carries a boxed warning because it causes the loss of a pregnancy.
- The label requires a negative pregnancy test before the first dose for anyone who can become pregnant.
- Pregnancy is one of the label's contraindications, meaning Korlym must not be taken.FDA label
Non-hormonal birth control
The label says Korlym interferes with hormonal birth control, such as the pill.
- It requires a non-hormonal method during treatment and for 1 month after the last dose.
- The boxed warning says no added method is needed after a surgical sterilization.FDA label
A potassium blood test
The label says low potassium is corrected before Korlym starts.
- In the main trial, low potassium was seen in 44% of people during treatment.
- The Medication Guide says the doctor should check potassium before starting and during treatment.FDA label
A full medicine review
The label says Korlym must not be taken with simvastatin, lovastatin, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus or tacrolimus.
- It also rules out Korlym for people who need corticosteroid medicines for lifesaving purposes, such as after an organ transplant.
- The endocrinologist and pharmacist review every prescription, nonprescription medicine, vitamin and herbal supplement.FDA label
Uterus and bleeding history
The label rules out Korlym for women with a history of unexplained vaginal bleeding.
- It also rules it out with endometrial hyperplasia with atypia or endometrial cancer, which are changes in the lining of the uterus.
- The Medication Guide says to tell your doctor if you have had a bleeding problem or take medicines to thin your blood.
- A known allergy to mifepristone or any ingredient in the tablet is the last contraindication.FDA label
The SPARK enrollment form
Corcept says Korlym is not available at a local retail pharmacy.
- The endocrinologist's office fills out an enrollment form and faxes it to a Patient Access Coordinator, and that form serves as the prescription.
- The coordinator then verifies your insurance benefits and reviews other coverage options if needed.Getting Korlym
The insurance approval
Plans such as the Blue Cross Blue Shield Federal Employee Program require prior approval before they pay for Korlym.
- That plan asks for the same diagnosis and surgery history that the label describes.
- It also asks the prescriber to agree that pregnancy will be ruled out first.FEP policy
The days that matter
Counted from the first dose, with the potassium checks, the earliest dose steps, the signs the label says to watch and the refill. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Pregnancy test, potassium and medicine review
A negative pregnancy test for anyone who can become pregnant, a potassium check and a review of every medicine.
- The label does not set an exact number of days ahead.
Enrollment form faxed to SPARK
The office faxes the SPARK Patient Enrollment Form, which Corcept says serves as the Korlym prescription.
- A Patient Access Coordinator then helps with insurance coverage and financial aid options.
The coordinator calls, then the pharmacist
Once coverage is set, Corcept says the Patient Access Coordinator calls to schedule the first delivery.
- On that call you are transferred to a Specialty Pharmacist, who reviews your other medicines for interactions.
First dose, 300mg once a day
One 300mg tablet once a day with a meal is the label's starting dose.
- The label says the tablet is swallowed whole and never split, crushed or chewed.
Potassium blood test
The label asks for a potassium blood test 1 to 2 weeks after starting Korlym.
- The same check follows every dose increase, and the label says low potassium can happen at any time.
Earliest dose change
The label lets the dose rise by 300mg, no more often than once every 2 to 4 weeks.
- The endocrinologist decides from side effects and from how much the Cushing syndrome signs have improved.
Refill call and delivery
Corcept says the Patient Access Coordinator calls every month to schedule the next delivery.
- Korlym cannot be shipped unless that delivery is confirmed with you each month, so answer the call.
Early signs of response
The label says changes in blood sugar control and diabetes medicine needs may give an early read on response within 6 weeks.
- Insulin levels and psychiatric symptoms are on the label's list too.
Refill call and delivery, number 2
Refill call and delivery, number 3
Three months in
After the first 2 months, the label says slower changes help guide the dose, alongside blood sugar measures.
- Those changes include appearance, acne, extra hair growth, stretch marks and body weight.
- The label says it is uncertain whether such changes in the trial were caused by Korlym.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Korlym label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated September 25, 2025, read from the FDA's label database today. FDA label
- September 2024
The current prescribing information and Medication Guide both carry a September 2024 revision date. The FDA records we read do not say what changed in that version.Corcept prescribing information
- August 2020
The FDA approved Teva's generic mifepristone 300mg tablet on August 3, 2020, and its record lists the equivalence code AB.Drugs@FDA generic record
- November 2019
The FDA approved a label update on November 5, 2019, adding results of a study with itraconazole, a strong CYP3A blocker. The pregnancy and breastfeeding sections were rewritten in the FDA's newer format, and the Medication Guide was revised to match.FDA letter
- May 2017
The FDA approved a safety update on May 16, 2017, about higher mifepristone levels when Korlym is taken with CYP3A blockers. The FDA had asked for the change in a February 3, 2017 letter.FDA letter
- February 2012
Korlym was first approved on February 17, 2012, for the same use the label carries today. The FDA decided a REMS was not necessary and asked Corcept to study long-term safety.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Once a day, with a meal, swallowed whole
The label says Korlym is taken as a single daily dose and always with a meal.
- Food raises the amount of medicine in the blood, so taking it with meals keeps levels steady.
- The Medication Guide says to tell your doctor if you cannot swallow the tablets whole.FDA label
- How the dose climbs
The label raises the dose by 300mg at a time, no more often than once every 2 to 4 weeks.
- The highest dose is 1200mg once a day, and never more than 20mg per kilogram of body weight a day.
- That limit works out to about 9mg per pound of body weight.FDA label
- If you miss a dose
The label and Medication Guide do not say what to do about a missed dose.
- The prescriber or the SPARK pharmacist can answer that question for your dose.FDA label
- After a break in treatment
The label says treatment that was interrupted restarts at the lowest dose, 300mg a day.
- A break longer than 14 days means a new negative pregnancy test before restarting for anyone who can become pregnant.
- When a side effect caused the break, the label aims for a lower dose than before.FDA label
- Birth control that does not use hormones
The label says hormonal birth control is not used with Korlym, because Korlym interferes with how well it works.
- A non-hormonal method is required during treatment and for 1 month after the last dose.
- The Medication Guide says to talk with your doctor about how to prevent pregnancy.FDA label
- Grapefruit juice
The Medication Guide says you should not drink grapefruit juice while you take Korlym.
- It says grapefruit juice may raise the amount of Korlym in your blood and the chance of side effects.FDA label
- Medicines that change the dose or are avoided
Strong CYP3A blockers, such as ketoconazole, itraconazole, clarithromycin and ritonavir, cap the Korlym dose at 900mg a day.
- The label says those medicines are combined with Korlym only when necessary.
- The label says to avoid rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine and St. John's wort.
- It asks for the smallest recommended doses of warfarin, repaglinide and nonsteroidal anti-inflammatory drugs, known as NSAIDs.
- The label asks for the lowest dose of other medicines that the CYP3A enzyme breaks down.
- It asks for caution with bupropion and efavirenz, which Korlym may raise in the blood.FDA label
- Korlym lingers after the last dose
The label gives mifepristone a half-life of 85 hours, the time for half of it to leave the body.
- It says at least 2 weeks should pass after stopping Korlym before an interacting medicine is started or raised.FDA label
- Steroid medicines
Korlym blocks the effect of corticosteroids such as prednisone, dexamethasone and cortisone.
- The label warns that conditions treated with those medicines, such as autoimmune disorders, may get worse.
- The Medication Guide asks you to tell your doctor if you have been taking them or have had an organ transplant.FDA label
- Why cortisol blood tests do not track it
The label says Korlym does not reduce cortisol, and blood cortisol stays high or even rises during treatment.
- It says cortisol levels therefore cannot show whether the adrenal effect has gone too far.
- Doctors watch symptoms, blood sugar and potassium during treatment instead of a cortisol level.FDA label
- Kidney and liver conditions
The label caps the dose at 600mg a day with kidney impairment and with mild to moderate liver impairment.
- It says Korlym should not be used with severe liver impairment.FDA label
- Heart conditions
The label says Korlym lengthens the heart's QT interval more as the dose rises, so the lowest effective dose is used.
- It says to avoid medicines that also lengthen the QT interval.
- It also says to avoid Korlym in people with potassium channel variants that cause a long QT interval.
- It asks for caution with heart failure and coronary vascular disease, because cortisol stays high.FDA label
- Breastfeeding
The label says mifepristone passes into breast milk, and the effect on a breastfed child is not known.
- It says women may consider pumping and discarding milk during treatment and for 18 to 21 days after the last dose, before breastfeeding.FDA label
- Generic mifepristone 300mg
FDA records show Teva's generic mifepristone 300mg tablet was approved on August 3, 2020.
- The FDA record lists it with the equivalence code AB.
- A separate FDA record for Korlym marks Korlym as the reference drug.Drugs@FDA generic record
- What the generic label says
Teva's generic, labeled under the Actavis name, carries the same use, boxed warning and dose steps as Korlym.
- Its label describes a dark yellow to light brown oval tablet marked A33 on one side.Generic label
- Bottles and storage
The label lists bottles of 28 and 280 tablets, and a bottle of 28 lasts 28 days at one tablet a day.
- The Medication Guide says to store Korlym at room temperature, between 68 and 77 degrees Fahrenheit (20 to 25 degrees Celsius).
- The guide also says to keep Korlym and all medicines out of the reach of children.FDA label
- Side effect reports
The label lists Corcept Therapeutics at 1-855-844-3270 for reporting side effects.
- Reports can also go straight to the FDA at 1-800-FDA-1088.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Any chance of pregnancy
The Medication Guide says to tell your doctor right away if you think you may be pregnant.
- Korlym causes the loss of a pregnancy, which is the subject of its boxed warning.FDA label
Signs of adrenal insufficiency
Unusual tiredness or weakness, nausea, fatigue, low blood pressure or low blood sugar.
- The Medication Guide says to tell your doctor right away about any of these.
- In the main trial, adrenal insufficiency was reported in 2 of 50 people, or 4%.FDA label
Vaginal bleeding that is not normal for you
The Medication Guide says to tell your doctor right away about this bleeding.
- Korlym can thicken the lining of the uterus, and the label refers women with bleeding to a gynecologist.
- In the main trial, vaginal bleeding occurred in 5 of 35 women, or 14%.FDA label
Signs of low potassium
Muscle weakness, aches or cramps, or abnormal or irregular heartbeats, also called palpitations.
- The Medication Guide says to tell your doctor if you have any of these signs.FDA label
Heart rhythm changes
The Medication Guide lists problems with the heart's electrical system, called QT interval prolongation, as a serious side effect.
- It asks you to tell your doctor if you have or have had heart problems.FDA label
Trouble breathing soon after starting
The label says people with Cushing syndrome are at risk of a lung infection called Pneumocystis pneumonia during treatment.
- It says breathing distress can appear shortly after Korlym starts, and it tells doctors to test for the infection.FDA label
Other serious side effects in the Medication Guide
The Medication Guide lists worsening symptoms of medical problems that are treated with corticosteroids.
- It also lists disruption of the menstrual cycle among the serious side effects.
- The label also lists angioedema among side effects reported after Korlym was approved.FDA label
Side effects that bother you or do not go away
The most common ones are nausea, fatigue, headache, low potassium, joint pain, vomiting, and swelling of the arms and legs.
- High blood pressure, dizziness, decreased appetite and thickening of the lining of the uterus are also on the list.
- The Medication Guide says to tell your doctor about any that bother you or do not go away.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- The prescription went to a local pharmacyCorcept says Korlym is only commercially available through its SPARK specialty pharmacy partners. The office completes the SPARK Patient Enrollment Form, which serves as the prescription, and faxes it to 1-855-288-0601. A SPARK representative answers the phone at 1-855-456-7596, also written 1-855-4KORLYM.Corcept Cares and SPARK
- Prior approval pending or deniedThe Federal Employee Program policy asks for age 18 or older and endogenous Cushing syndrome. It also requires type 2 diabetes or glucose intolerance, and failed surgery or no option of surgery. The endocrinologist's office sends the records that show each point.FEP policy
- The prior authorization is missing recordsCorcept's enrollment form says most payers require prior authorization, and that SPARK can help prepare it. It lists the cortisol test reports that diagnosed Cushing syndrome and an HbA1c or other glucose test. It also lists chart notes on surgery, the medicine list and a negative pregnancy test where it applies.SPARK enrollment form
- The plan wants pregnancy ruled outFor women who can become pregnant, the same policy asks the prescriber to agree that pregnancy will be excluded before treatment starts. The label requires that test anyway, so the office can confirm it on the request.FEP policy
- A current medicine cannot be combined with KorlymThe label rules out simvastatin, lovastatin and 8 other named medicines, and it limits or avoids several more. Any change to another medicine is a decision for the prescribers involved.FDA label
- The monthly shipment did not comeCorcept says Korlym cannot be shipped unless the Patient Access Coordinator confirms the delivery with you each month. The coordinator also asks about medicine and insurance changes on that call. The coordinator's number is 1-855-456-7596, the same one used for the Specialty Pharmacist.Getting Korlym
- A copay you cannot pay, or no coverageCorcept lists a Co-Pay Assistance Program and a Patient Assistance Program for qualifying patients. It also lists medication at no cost for eligible patients who are seeking reimbursement approval, have no insurance or were denied coverage. Corcept's pages do not publish the full terms, so the Patient Access Coordinator at 1-855-456-7596 is the one to ask.Getting Korlym
Blue Cross Blue Shield Federal Employee Program prior authorization policy, July 1, 2026
- Age 18 or older
- A diagnosis of endogenous Cushing syndrome
- Type 2 diabetes mellitus or glucose intolerance
- The patient has failed surgery or is not a candidate for surgery
- For females of childbearing potential, the prescriber agrees that pregnancy will be excluded before treatment starts
- No severe liver impairment (Child-Pugh Class C)
Approval length. Approved for 12 months. Renewal, also for 12 months, asks for age, the diagnosis, type 2 diabetes or glucose intolerance, and no severe liver impairment.
Policy 5.30.025 was last reviewed on June 11, 2026 and took effect July 1, 2026. It cites the September 2024 Korlym package insert, which is the current one. Other plans set their own criteria and their own approval lengths. It is here as an example of what a plan asks for, not as a rule. FEP policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- A Patient Access Coordinator who reviews insurance benefits, assists with prior authorization, explains affordability options and coordinates delivery to your door
- A Specialty Pharmacist on call 24/7 who reviews your medication list and answers questions about drug interactions and side effects
- A Co-Pay Assistance Program and a Patient Assistance Program for qualifying patients
- Medication at no cost for eligible patients who are seeking reimbursement approval, have no insurance, or have been denied coverage
- Referral to independent organizations that may provide alternate funding, if needed
- A Corcept Cares Patient Advocate, reached at 1-855-295-9969, who calls to check in if you consent to one-on-one support
- Patient Advocates explain how Korlym works and what to expect, review the resources sent with shipments, and offer emotional support, but cannot give medical advice Korlym one-on-one support
- For prescribers, the SPARK Patient Enrollment Form is faxed to 1-855-288-0601 Corcept Cares and SPARK
Details as the drugmaker publishes them. Getting Korlym
Five questions for the pharmacist or the support line
- I take these medicines and supplements. Are any of them on the list that cannot be combined with Korlym?
- How many tablets come in each shipment at my dose, and when will the monthly call come?
- If my dose changes, does SPARK need a new prescription before the next shipment?
- My plan may prefer generic mifepristone 300mg. Which product will you send, and does anything else change?
- Who do I call at night if I feel very weak, sick or lightheaded?
Questions people ask in the first weeks
Who is Korlym approved for?
The label covers adults with endogenous Cushing syndrome who have type 2 diabetes or glucose intolerance caused by high cortisol. Surgery must have failed, or the person must not be a candidate for surgery. The label says it is not for type 2 diabetes unrelated to Cushing syndrome.
Why is a pregnancy test needed before Korlym?
Korlym blocks progesterone as well as cortisol, and its boxed warning says it will end a pregnancy. The label requires a negative test before starting and before restarting after any break longer than 14 days. It also requires non-hormonal birth control during treatment and for 1 month after.
How does the Korlym dose change over time?
The label starts at 300mg once a day with a meal. The dose can rise by 300mg, no more often than once every 2 to 4 weeks. The maximum is 1200mg once a day, and no more than 20mg per kilogram of body weight a day.
How often is potassium checked on Korlym?
The label asks for low potassium to be corrected before starting. Potassium is then measured 1 to 2 weeks after starting or raising the dose, and from time to time afterward. Low potassium was seen in 44% of people in the main trial.
Why can a cortisol blood test not be used with Korlym?
Korlym blocks the cortisol receptor and does not lower cortisol. The label says blood cortisol stays high and may even rise, so it cannot show adrenal insufficiency. Doctors watch for symptoms such as weakness, nausea, fatigue, low blood pressure and low blood sugar.
Does Korlym have a REMS?
No, the FDA's 2012 approval letter says a REMS was not necessary, and the current label describes none. Korlym does carry a boxed warning about the loss of a pregnancy, and Corcept ships it only through its own pharmacy program.
Is there a generic for Korlym?
Yes, FDA records show a generic mifepristone 300mg tablet from Teva was approved on August 3, 2020. Corcept also lists its own unbranded mifepristone 300mg tablet under the Korlym approval. Both labels carry the same use and the same boxed warning as Korlym.
Where does Korlym come from?
Corcept says Korlym is not available at a local retail pharmacy. The doctor's office faxes an enrollment form that serves as the prescription. A Patient Access Coordinator then calls every month to schedule delivery to your door.
Free email alert
Hear when the Korlym label changes
One email the day the FDA revises the Korlym label, with what changed in plain words. No trial alerts, no newsletter.
Label changes for Korlym only, usually a few a year and some years none. Stop anytime. We never share your email. Privacy policy
Want the whole condition instead? Follow Cushing syndrome, including Cushing disease for new trials, FDA decisions and label changes for every treatment.
Sources
- KORLYM (mifepristone) 300mg tablets: prescribing information and Medication Guide, revised 09/2024, SPL version 26, Corcept Therapeutics Incorporated, via the openFDA drug label API, September 25, 2025.
- KORLYM (mifepristone) 300 mg Tablets, Highlights of Prescribing Information and Medication Guide, Revised: 09/2024, Corcept Therapeutics Incorporated, September 1, 2024.
- How to Get Korlym, Getting your medicine, Corcept Therapeutics Incorporated, November 12, 2026.
- One-on-One Support for Korlym, Corcept Therapeutics Incorporated, November 12, 2026.
- Corcept Cares and SPARK - Korlym (mifepristone) HCP, Corcept Therapeutics Incorporated, November 12, 2026.
- 5.30.025 Korlym, Prescription Drugs, Endocrine and Metabolic Drugs, Blue Cross Blue Shield Association, Federal Employee Program, July 1, 2026.
- Patient Enrollment and Prescription Form for Korlym (mifepristone), US-KOR-25-0043 5-26, Corcept Therapeutics Incorporated, May 1, 2026.
- NDA 202107 approval letter, Korlym (mifepristone) tablets, 300 mg, FDA, February 17, 2012.
- NDA 202107/S-007 supplement approval letter, safety labeling on CYP3A inhibitors, FDA, May 16, 2017.
- NDA 202107/S-008 supplement approval letter, itraconazole interaction study and Pregnancy Lactation Labeling Rule revisions, FDA, November 5, 2019.
- Drugs@FDA record for NDA 202107, Korlym, via openFDA, FDA, November 12, 2026.
- Drugs@FDA record for ANDA 211436, mifepristone 300mg tablets, Teva Pharmaceuticals USA, via openFDA, FDA, November 12, 2026.
- Mifepristone tablets 300mg (Actavis Pharma, Teva): prescribing information and Medication Guide, issued 2/2022, Actavis Pharma, Inc., via the openFDA drug label API, February 1, 2022.
- Mifepristone 300mg tablets (Corcept, under NDA 202107): prescribing information and Medication Guide, revised 09/2024, Corcept Therapeutics Incorporated, via the openFDA drug label API, September 25, 2025.
- NDC directory listings for mifepristone 300mg tablets, via openFDA, FDA, November 12, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing endocrinologist. Found an error? Use the report link in the footer and it will be checked against the source.