Prescription medicine
Ethanolamine oleate Brand names: Ethamolin
Ethanolamine oleate (Ethamolin) is a prescription medicine with an FDA approval on record since 1988. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ethanolamine oleate FDA label on DailyMed (effective December 10, 2025, QOL Medical, LLC.); the NDA 19357 record on Drugs@FDA; every ethanolamine oleate label on DailyMed.
Highlights of the record
FDA label of December 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding.
Forms and strengths
- 50 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- December 22, 1988 Ethamolin, Qol Medcl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 18 through July 30, 2026
What is ethanolamine oleate used for?
From the label: indications and usageETHAMOLIN 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. Sclerotherapy with ETHAMOLIN has no beneficial effect upon portal hypertension, the cause of esophageal varices, so that recanalization and collateralization may occur, necessitating reinjection.
FDA pharmacologic class: Sclerosing Agent.
Source: FDA drug label (Ethamolin), NDA019357 (Qol Medcl), as published by QOL Medical, LLC., effective December 10, 2025 (SPL set a9c1d8c5-443e-400e-a42c-16a25fb47231), via openFDA; the full label on DailyMed
Is there a generic for ethanolamine oleate (Ethamolin)?
No generic ethanolamine oleate is approved (Drugs@FDA, October 8, 2026).
- 1988 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for ethanolamine oleate?
The FDA Adverse Event Reporting System holds 18 reports that list ethanolamine oleate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other sclerosing agents
- the pharmacologic class, with prices and generics
- Ethanolamine oleate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other