Ethanolamine oleate is a sclerosing (skler-OS-ing) agent that is used to treat esophageal varices (dilated blood vessels inside the tissues lining the esophagus or upper part of the stomach). Esophageal varices is a life-threatening condition that causes severe bleeding from the esophagus into the throat or intestines.

Esophageal varices is common in people with severe liver disease. Ethanolamine oleate will not treat any underlying liver disease.

Ethanolamine oleate is only for treating esophageal varices that have recently bled. ethanolamine oleate is not for treating varicose veins in the legs.

Ethanolamine oleate may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Ethanolamine oleate is injected into a vein by a healthcare provider in an emergency setting.

Ethanolamine oleate is usually given during a bleeding episode and again at 1 week, 6 weeks, 3 months, and 6 months afterward.

Your doctor will need to check your progress on a regular basis.

Usual Adult Dose for Esophageal Varices:

Initial dose: 1.5 to 5.0 mL IV per varix up to a maximum of 20 mL per treatment session

You should not use ethanolamine oleate if you are allergic to ethanolamine oleate or oleic acid (oleo).

If possible during an emergency, tell your medical caregivers if you've ever had:

• kidney disease;

• heart disease; or

• lung disease.

If possible during an emergency, tell your medical caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

In a medical setting you are not likely to miss a dose.

In a medical setting an overdose would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your medical caregivers right away if you have:

• fever, chills, cough with yellow or green mucus;

• chest pain, feeling short of breath;

• severe pain or burning in your upper stomach; or

• fluid build-up in or around the lungs--pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold and clammy skin, anxiety, rapid heartbeats.

Common side effects of ethanolamine oleate may include:

• low fever; or

• trouble swallowing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.