Quick answers
- What is Ethanolamine oleate used for?
- The FDA-approved label (Ethamolin, QOL Medical, LLC., December 10, 2025) says: “ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding. ETHAMOLIN is not indicated for the treatment of patients with esophageal varices that have not bled. There is no evidence that treatment of this population decreases the likelihood of bleeding. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ethanolamine oleate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ethanolamine oleate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ethanolamine oleate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ethanolamine oleate?
- 1 company lists prescription products of Ethanolamine oleate in the FDA NDC Directory, including QOL Medical, LLC.
What Ethanolamine oleate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding. ETHAMOLIN is not indicated for the treatment of patients with esophageal varices that have not bled. There is no evidence that treatment of this population decreases the likelihood of bleeding. …
— FDA label: Ethamolin, QOL Medical, LLC., effective December 10, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Ethamolin |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- QOL Medical, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019357 ETHAMOLIN | Qol Medcl | December 22, 1988 | 16, latest February 7, 2014 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 106675, 205745 |
|---|---|
| SPL set ID of the quoted label | a9c1d8c5-443e-400e-a42c-16a25fb47231 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA019357 |
| Active ingredients (FDA) | ETHANOLAMINE OLEATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ethamolin, QOL Medical, LLC., effective December 10, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →