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Active Pharma Ingredients / 01 Sep 2026

ASOPRISNIL

Generic Name: ASOPRISNIL

ABSTRACT -

Asoprisnil is a synthetic selective progesterone receptor modulator investigated for gynecologic disorders such as uterine fibroids and heavy menstrual bleeding. It exhibits mixed progesterone agonist/antagonist activity. Development was limited by concerns about endometrial changes and long-term safety, so it is not a routine approved therapy.

DOSAGE -

No approved standard dosage is available. Clinical studies evaluated oral daily dosing under protocol conditions. It should not be used outside specialist research or regulatory-authorized settings.

SIDE EFFECTS–

  • Possible or reported side effects may include:
  • Hot flushes
  • Headache
  • Abdominal or pelvic pain
  • Breast tenderness
  • Nausea
  • Changes in uterine bleeding pattern or amenorrhea
  • Endometrial changes
  • Liver enzyme abnormalities are a class concern

ALLERGIC REACTIONS -

Hypersensitivity may include rash, hives, swelling, or breathing difficulty.

DRUG INTERACTIONS-

Use caution with:

  • Hormonal contraceptives and other sex-hormone therapies
  • CYP3A inhibitors or inducers if relevant
  • Anticoagulants when abnormal uterine bleeding occurs
  • Hepatotoxic medicines
  • Patients should inform healthcare providers about all prescription medicines, over-the-counter medicines, herbal products, and supplements they are using.

PREAUTIONS–

  • Exclude pregnancy before use.
  • Assess liver function, gynecologic diagnosis, endometrial status, and bleeding pattern.
  • Use contraception as directed by protocol.

WARNINGS –

  • Not approved for routine treatment of fibroids or endometriosis.
  • Report severe abdominal pain, jaundice, heavy bleeding, or allergic symptoms immediately.
  • Keep out of reach of children.
  • In case of overdose, severe reaction, or clinical deterioration, seek immediate medical attention.

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