Europe — EMA
Mifegyne (Mifepristone)
GNH USA supplies Mifegyne (Mifepristone), a progesterone receptor antagonist for pregnancy termination and off‑label Cushing’s syndrome. Request a quote.
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What is Mifepristone?
Mifepristone, the active ingredient in Mifegyne, is a progesterone receptor antagonist presented as an oral tablet for oral use. It is employed in the medical termination of intra‑uterine pregnancy up to 10 weeks gestation and, in some jurisdictions, for the off‑label management of Cushing’s syndrome.
GNH USA supplies Mifegyne as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with established distribution networks and regulatory expertise across EU and other markets. Our quality‑assured batches meet EU pharmacopeial standards and are shipped under controlled conditions.
What is Mifepristone used for?
Mifepristone acts on progesterone‑dependent pathways to achieve therapeutic outcomes in the following conditions:
- Medical termination of intrauterine pregnancy (≤10 weeks gestation): induces uterine expulsion of the gestational sac when used with a prostaglandin analogue. - Cushing's syndrome (off‑label): blocks glucocorticoid receptors to reduce cortisol‑mediated effects in selected patients.
What are the side effects of Mifepristone?
Mifepristone may cause a range of adverse reactions, which are grouped by frequency.
Common Side Effects: - Nausea: mild to moderate upset stomach. - Vomiting: occasional emesis after dosing. - Abdominal pain: cramping or discomfort in the lower abdomen. - Vaginal bleeding: spotting or heavier flow during the abortion process. - Diarrhea: loose stools occurring within days of administration. - Fatigue: transient tiredness or weakness.
Serious or Rare Side Effects: - Heavy bleeding: excessive hemorrhage requiring medical attention. - Infection: signs of uterine or systemic infection such as fever. - Incomplete abortion: retained tissue necessitating further intervention. - Allergic reaction: rash, itching, or anaphylaxis in rare cases. - Liver enzyme elevation: abnormal hepatic function tests observed in isolated reports.
What precautions apply to Mifepristone?
Before prescribing Mifegyne, clinicians should consider several safety measures:
- Assess gestational age: confirm pregnancy is ≤10 weeks. - Confirm contraindications: exclude ectopic pregnancy, chronic adrenal insufficiency, or severe bleeding disorders. - Obtain informed consent: discuss expected outcomes and potential risks with the patient. - Monitor vital signs: watch for signs of hemorrhage or hemodynamic instability after dosing. - Avoid concomitant CYP3A4 inducers: drugs like rifampin may reduce efficacy. - Store at ambient temperature: keep in the original pack, protect from moisture and light.
What does Mifepristone interact with?
Mifepristone can interact with other medicines, altering its effectiveness or safety profile.
Major Interactions (Avoid): - Rifampin: strong CYP3A4 inducer that markedly lowers plasma concentrations of mifepristone. - Carbamazepine: enzyme inducer that may reduce therapeutic levels and compromise efficacy.
Moderate Interactions (Monitor Closely): - Azole antifungals (e.g., ketoconazole, fluconazole): CYP3A4 inhibitors that can increase mifepristone exposure. - SSRIs: may enhance bleeding risk when combined with prostaglandin agents used in the regimen. - Hormonal contraceptives: could diminish the effectiveness of the mifepristone‑misoprostol protocol.



