Quick answers
- What is Amifostine used for?
- The FDA-approved label (Ethyol, Legacy Pharma USA Inc., March 3, 2026) says: “ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amifostine 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 Amifostine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amifostine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Amifostine?
- 1 company lists prescription products of Amifostine in the FDA NDC Directory, including Legacy Pharma USA Inc..
What Amifostine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. …
— FDA label: Ethyol, Legacy Pharma USA Inc., effective March 3, 2026. 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Ethyol |
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.
- Legacy Pharma USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020221 ETHYOL | Legacy | December 8, 1995 | 22, latest July 25, 2019 2019: Labeling · 2017: Labeling · 2016: Labeling |
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) | 308096, 1803018 |
|---|---|
| SPL set ID of the quoted label | a17563f2-d231-4385-bc94-0217be78b89d |
| FDA labels (SPL) | 1 |
| FDA applications | NDA020221 |
| Active ingredients (FDA) | AMIFOSTINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ethyol, Legacy Pharma USA Inc., effective March 3, 2026; 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 →