Mifepristone
KORLYM
What it isProgesterone- and glucocorticoid-receptor antagonist; pregnancy termination and Cushing-syndrome hyperglycemia.
Why this oneThe same receptor pharmacology enables medical abortion with misoprostol and cortisol blockade without lowering cortisol levels.
What limits itAbortion use can cause severe bleeding or infection; Cushing treatment can cause adrenal insufficiency, hypokalemia, and QT prolongation.
FDA-approved for
- pregnancy termination (2000)
- Cushing hyperglycemia (2012)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Medical termination of intrauterine pregnancy ≤70 days gestation | Adult | 200 mg PO once (Day 1) | 200 mg once + misoprostol 800 mcg buccal 24–48 h later | 200 mg single dose |
Renal Undefined
Hepatic Undefined
Misoprostol must be taken within 24–48 h of mifepristone (efficacy lower outside window)
Instructions
- One 200 mg tablet as a single oral dose on Day 1
- Misoprostol 800 mcg buccally 24–48 h after mifepristone (place 2 tablets in each cheek pouch 30 min, then swallow remnants)
- Remove any IUD before treatment
- Post-treatment follow-up at Day 7–14 to confirm complete termination
- Provide Rh immunization prophylaxis as for surgical abortion
Contraindications
- Confirmed/suspected ectopic pregnancy or undiagnosed adnexal mass
- Chronic adrenal failure
- Concurrent long-term corticosteroid therapy
- Allergy to mifepristone, misoprostol, or other prostaglandins
- Hemorrhagic disorders or concurrent anticoagulant therapy
- Inherited porphyrias
- IUD in place (remove before use)
Cautions
- Infection and sepsis (may present atypically without fever)
- Prolonged/heavy uterine bleeding — may need surgical intervention
- Undiagnosed ectopic pregnancy
- Rhesus immunization prevention needed
- Restricted distribution via REMS
Adverse reactions
- Nausea
- Weakness
- Fever/chills
- Vomiting
- Headache
- Diarrhea
- Dizziness
- Uterine bleeding/cramping (expected)
Pregnancy Indicated to terminate pregnancy; failed termination followed by continued pregnancy risks fetal malformation (misoprostol embryopathy/skull deformities in animals)
Lactation Present in human milk at undetectable-to-low levels (relative infant dose ≤0.5%)
⚠ BOXED WARNING
- Serious and sometimes fatal infection and bleeding
Cost, est. cash$300–$2,500/month
Generic entry2019
Classes and tags
Clinical profile
Legacy pregnancy categoryX
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Mifepristone ballicule
