Prescription medicine
Amifostine Brand names: Ethyol
Amifostine (Ethyol) is a prescription medicine with an FDA approval on record since 1995. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the amifostine FDA label on DailyMed (effective March 3, 2026, Legacy Pharma USA Inc.); the NDA 20221 record on Drugs@FDA; every amifostine label on DailyMed.
Highlights of the record
FDA label of March 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
Forms and strengths
- 500 mg/10ml
Injection.
On the market
- Earliest approval on file
- December 8, 1995 Ethyol, Legacy; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first March 14, 2008; 0 with a marketed status in Drugs@FDA
- 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
- 807 through July 30, 2026
What is amifostine used for?
From the label: indications and usageETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. ( 1.1 ) – 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. ( 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. […]
FDA pharmacologic class: Cytoprotective Agent.
Source: FDA drug label (Ethyol), Legacy Pharma USA Inc., effective March 3, 2026 (SPL set a17563f2-d231-4385-bc94-0217be78b89d), via openFDA; the full label on DailyMed
Is there a generic for amifostine (Ethyol)?
The FDA approved the first generic amifostine on March 14, 2008. 2 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
- 1995 earliest approval on file
- 2008 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the amifostine label say about other medicines?
The amifostine label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name amifostine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cisplatin | warnings and precautions | Limited data are currently available regarding interference with antitumor efficacy when ETHYOL is administered prior to cisplatin therapy in settings other than advanced ovarian cancer. |
| Epinephrine | warnings and precautions | Epinephrine and other appropriate measures should be available for treatment of serious infusion-related reactions when administering ETHYOL. |
Source: FDA drug label (Ethyol), Legacy Pharma USA Inc., effective March 3, 2026 (SPL set a17563f2-d231-4385-bc94-0217be78b89d), via openFDA; the full label on DailyMed
What do FAERS reports show for amifostine?
The FDA Adverse Event Reporting System holds 807 reports that list amifostine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 86 are coded as a death and 440 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cytoprotective agents
- the pharmacologic class, with prices and generics
- Amifostine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other