Indications for Mifepristone 25 mg
Mifepristone 25 mg is not a standard clinical dose—the established indications use either low doses (5-50 mg daily for uterine fibroids) or higher doses (200-600 mg for pregnancy termination, 300-1200 mg daily for Cushing's syndrome). 1, 2, 3
FDA-Approved Indication
- Mifepristone 300-1200 mg daily is FDA-approved specifically for hyperglycemia associated with Cushing's syndrome, not at the 25 mg dose you're asking about. 1
Off-Label Indications at Different Doses
Pregnancy Termination (200-600 mg single dose)
- Mifepristone 200-600 mg (not 25 mg) combined with prostaglandin is the established regimen for first-trimester pregnancy termination up to 7 weeks gestation, as recommended by the American College of Obstetricians and Gynecologists. 2, 4
- The combination achieves approximately 95% complete abortion rates when mifepristone is followed 36-48 hours later by misoprostol. 3, 4
- Avoid misoprostol in women with previous cesarean delivery due to uterine rupture risk. 2, 5
Uterine Fibroid Management (5-50 mg daily)
- Mifepristone 5-50 mg daily (not 25 mg specifically) has been noted by the American College of Obstetricians and Gynecologists to relieve symptoms, reduce fibroid volume, and achieve amenorrhea, despite not being formally FDA-indicated for this use. 2
- This dose range is used off-label for preoperative fibroid management. 2
Cushing's Syndrome (300-1200 mg daily)
- Mifepristone 300-1200 mg daily is used for glucocorticoid receptor blockade in Cushing's syndrome with hyperglycemia, showing significant improvement in glycemia (approximately 60%) and blood pressure. 1
- This requires specialized clinical practice with close monitoring for hypokalemia and adrenal insufficiency. 1
Clinical Considerations for the 25 mg Dose
The 25 mg dose falls within the range used for uterine fibroids (5-50 mg daily) but is not a standard starting or maintenance dose for any established indication. 2
- If considering 25 mg for fibroid management, this would be off-label use requiring careful patient selection and monitoring. 2
- The dose is far too low for pregnancy termination (requires 200-600 mg) or Cushing's syndrome management (requires 300-1200 mg). 1, 2, 4
Important Safety Warnings
- No laboratory markers exist to monitor efficacy when using mifepristone for Cushing's syndrome, making clinical assessment essential. 1
- Careful review of other medications for potential drug-drug interactions is essential, as mifepristone is metabolized by CYP3A4. 1, 6
- High-risk patients should be managed in experienced centers with emergency support services available. 5, 7