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This safety information provides essential warnings and guidelines for the use of mifepristone. Please read carefully and consult with your healthcare provider if you have any questions or concerns.

• Pregnancy Risks: Mifepristone can lead to pregnancy loss. Women of childbearing age must have a negative pregnancy test before starting the medication and if they stop and plan to restart it after a 14-day period. It is crucial to avoid becoming pregnant while on this medication and for one month after discontinuation. Use reliable non-hormonal birth control methods, such as condoms or a copper IUD, because mifepristone may reduce the effectiveness of hormonal contraceptives. Contact your doctor immediately if you become pregnant or suspect pregnancy.

• Adrenal Insufficiency: There is a risk of developing low adrenal hormone levels (adrenal insufficiency) as mifepristone inhibits cortisol function. Monitor for symptoms and consult your healthcare provider if you have concerns.

• Vaginal Bleeding and Uterine Changes: Mifepristone may cause vaginal bleeding and thickening of the uterine lining, due to its action as a progesterone receptor blocker. This is particularly important for those taking blood thinners, as it may exacerbate bleeding issues.

• Electrolyte Imbalance: The medication can lower potassium levels, so your healthcare provider will monitor your potassium before and during treatment, particularly if your dose changes.

• Heart Rhythm Concerns (QT Prolongation): Mifepristone may affect heart rhythm, potentially leading to a life-threatening condition known as QT prolongation. Those with a personal or family history of QT prolongation, heart failure, or electrolyte imbalances are at increased risk. Discuss any heart-related issues with your doctor.

• Drug Interactions: Mifepristone can interact with various other medications, potentially increasing its blood levels or interfering with steroid function. Be sure to inform your healthcare provider about any other medications you are taking.

Contraindications include:

• Allergy to mifepristone.
• Current pregnancy.
• Unexplained vaginal bleeding.
• Suspected endometrial cancer.
• Use of life-saving corticosteroids.
• Concurrent use of medications like simvastatin, dihydroergotamine, fentanyl, cyclosporine, or tacrolimus, which may increase side effects.

Always consult your healthcare provider with any concerns or questions regarding mifepristone use.

When taking this medication, you may experience some common side effects such as nausea, fatigue, headaches, low appetite, dry mouth, dizziness, and joint or muscle pain. While these are often mild, if they persist or worsen, it is advisable to consult your healthcare provider. Additionally, some individuals may experience vomiting, swelling in the hands, ankles, or feet, or low potassium levels, which might manifest as muscle cramps or weakness.

Less commonly reported side effects include shortness of breath, diarrhea, constipation, sleepiness, back pain, and general pain. Some people may also experience symptoms resembling a common cold, anxiety, or changes in thyroid function test results. While these are generally less serious, it is still important to inform your healthcare provider if you experience any discomfort.

Serious side effects, though rare, require immediate medical attention. These include severe allergic reactions characterized by trouble breathing, hives, or swelling of the face, lips, tongue, or throat. Low potassium levels can also lead to serious issues such as an irregular heartbeat, fatigue, or high blood pressure. Another rare but serious condition is abnormal heart rhythm, which may cause chest pain, shortness of breath, or fainting. If any of these symptoms occur, seek urgent medical care promptly.

Mifepristone, marketed as Korlym, can interact with a variety of medications, potentially altering the way these drugs work or are eliminated from your body. It's crucial to inform your doctor and pharmacist about all the medications and supplements you're taking, including prescription, over-the-counter, vitamins, and herbal supplements.

The following medications should generally not be used with mifepristone: bepridil, cisapride, cyclosporine, dihydroergotamine, dronedarone, ergotamine, fentanyl, fluconazole, ketoconazole, lovastatin, mesoridazine, pimozide, piperaquine, posaconazole, quinidine, saquinavir, simvastatin, sirolimus, sparfloxacin, tacrolimus, terfenadine, and thioridazine. Your doctor may choose to avoid prescribing mifepristone or may adjust your other medications if these are part of your treatment plan.

Additionally, mifepristone can reduce the effectiveness of hormonal birth control methods, such as pills, patches, or rings, potentially leading to pregnancy. It is important to discuss non-hormonal birth control options with your healthcare provider while using this medication.

Certain medications, like azole antifungals (e.g., itraconazole), macrolide antibiotics (e.g., clarithromycin), nefazodone, HIV protease inhibitors, and rifamycins, can affect how mifepristone is removed from the body, impacting its effectiveness. If these are prescribed together, dosage adjustments may be necessary.

There is also a risk of altered blood sugar levels when taking mifepristone with beta-blockers, which can mask symptoms of low blood sugar, such as a rapid heartbeat. Monitoring your blood sugar levels regularly and communicating with your healthcare provider about any changes is essential to maintain effective diabetes management.