Prescription medicine
Ferumoxytol Brand names: Ferabright, Feraheme
Ferumoxytol (Feraheme) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the ferumoxytol FDA label on DailyMed (effective October 14, 2025, Azurity Pharmaceuticals, Inc.); the NDA 22180 record on Drugs@FDA; every ferumoxytol label on DailyMed.
Highlights of the record
FDA label of October 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS.
Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as FERABRIGHT. Initial signs may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred even in patients who previously tolerated ferumoxytol. Only administer FERABRIGHT as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following FERABRIGHT infusion including monitoring of blood pressure and pulse during and after FERABRIGHT administration [see Warnings and Precautions ( 5.1 )]. WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as FERABRIGHT. Initial signs may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred even in patients who previously tolerated ferumoxytol. […]
Used for
From the label: indications and usageFERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.
Forms and strengths
- 30 mg/ml
- 510 mg/17ml
Injection.
On the market
- Earliest approval on file
- June 30, 2009 Feraheme, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first January 15, 2021; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 2 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
- 1,902 through July 30, 2026
What is ferumoxytol used for?
From the label: indications and usageFERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. FERABRIGHT is an iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.
Conditions named in the indications of ferumoxytol's FDA labels, with every medicine labeled for each:
From other ferumoxytol labelsAnemia: Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:
FDA pharmacologic class: Parenteral Iron Replacement.
Source: FDA drug label (FeraBright), Azurity Pharmaceuticals, Inc., effective October 14, 2025 (SPL set ac666008-a14f-43b4-9d06-ec70f45a4234), via openFDA; the full label on DailyMed
What does the patient leaflet for ferumoxytol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about FERABRIGHT?FERABRIGHT can cause serious side effects, including: Serious allergic reactions that can lead to death. Serious allergic reactions have happened in people receiving ferumoxytol products such as FERABRIGHT. Even if you have received ferumoxytol before without any problems, you could still develop an allergic reaction with a future dose. If you have a history of allergies to many different medicines, you may have an increased risk of serious allergic reactions to FERABRIGHT. Immediately tell your healthcare provider or get medical help right away if you get any of these signs or symptoms: rash itching dizziness or lightheadedness low blood pressure swelling of the tongue or throat wheezing or trouble breathing feeling faint or fainting (syncope) See “What are the possible side effects of FERABRIGHT?” for more information about side effects.
Source: FDA drug label (FeraBright), Azurity Pharmaceuticals, Inc., effective October 14, 2025 (SPL set ac666008-a14f-43b4-9d06-ec70f45a4234), via openFDA; the full label on DailyMed
Is there a generic for ferumoxytol (Feraheme)?
The FDA approved the first generic ferumoxytol on January 15, 2021. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ferumoxytol from 1 labeler under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2009 earliest approval on file
- 2021 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for ferumoxytol?
The FDA Adverse Event Reporting System holds 1,902 reports that list ferumoxytol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 131 are coded as a death and 461 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 else is labeled for the same conditions as ferumoxytol?
8 other medicines are given the same way (intravenous) and in the same FDA class as ferumoxytol or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Iron sucrose | Anemia | 3 labelers | n/a | A presentation being discontinued |
| Sodium ferric gluconate complex | Anemia | 1 labeler | n/a | No current entry |
| Epoetin | Anemia | none listed | $32.27 per mL 2,000 units/mL vial | No current entry |
| Darbepoetin alfa | Anemia | none listed | $446.58 per mL 25 mcg/0.42 mL syring | No current entry |
| Methoxy polyethylene glycol-epoetin beta | Anemia | none listed | n/a | No current entry |
| Ferric derisomaltose | Anemia | none listed | n/a | No current entry |
| Imetelstat | Anemia | none listed | n/a | No current entry |
| Nipocalimab | Anemia | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as ferumoxytol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ferumoxytol
- 8 medicines for the same use
- Other parenteral iron replacements
- the pharmacologic class, with prices and generics
- Ferumoxytol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other