FDA-filed SPL labeling · retrieved through openFDA

Ferumoxytol Injection

Ferumoxytol is an intravenous iron replacement used to treat iron deficiency anemia, and FeraBright is also used as an MRI contrast agent for brain imaging.

Brand names FerahemeFeraBright
Drug class Parenteral Iron Replacement
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMay 31, 2026
Clinical labels in scope 3
AvailabilityRx
Earliest approval/marketing year 2009
FDA-listed product records 10
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Ferumoxytol Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ferumoxytol is an IV iron treatment for adults with iron deficiency anemia, especially those who cannot use or haven't responded to oral iron or who have chronic kidney disease. FeraBright, a ferumoxytol product, is also used to enhance brain MRI imaging. Because of a real risk of serious allergic reactions — including fatal anaphylaxis — it is given only in medical settings with close monitoring before, during, and after each infusion.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Ferumoxytol carries a serious boxed warning about the risk of fatal and life-threatening allergic reactions (anaphylaxis). These reactions have caused cardiac arrest, extremely low blood pressure, fainting, and unresponsiveness. They can happen even in people who received ferumoxytol before with no problems. Because of this, ferumoxytol must only be given as a slow IV infusion (over at least 15 minutes) in a setting where emergency care is immediately available. Healthcare providers will monitor your blood pressure and pulse during the infusion and for at least 30 minutes after. If you feel faint, have trouble breathing, or become unresponsive during or after the infusion, emergency help must be called immediately.

Read the full warning on DailyMed →

📖 Ferumoxytol Injection: Patient Information Guide

A plain-language walkthrough of Ferumoxytol Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Ferumoxytol injection is used to treat iron deficiency anemia and, in one specific product, as an imaging aid for brain MRI scans.

  • Iron deficiency anemia (IDA): Treats adults whose iron levels are too low — particularly those who cannot tolerate oral iron supplements or have not improved with them
  • Iron deficiency anemia with chronic kidney disease (CKD): Also approved for adults with CKD who have iron deficiency anemia
  • Brain MRI contrast agent (FeraBright only): FeraBright is used to enhance T1-weighted MRI images of the brain, helping healthcare providers better see lesions such as tumors — this use is specific to FeraBright and is not shared by all ferumoxytol products
⚙️How it works

Ferumoxytol is an iron oxide compound coated with a carbohydrate shell. When used to treat iron deficiency anemia, it delivers iron directly into the bloodstream, replenishing the body's iron stores so it can produce healthy red blood cells. When used as an MRI contrast agent (FeraBright), it has superparamagnetic properties — meaning it reacts to magnetic fields and alters how water molecules in nearby tissues appear on MRI scans, making certain brain lesions appear brighter and easier to identify. Because the large ferumoxytol molecules move out of blood vessels slowly, the clearest MRI images of brain tissue are seen in a delayed phase, roughly 24 hours after FeraBright is given.

💊How it's taken

Ferumoxytol is given exclusively by a healthcare provider through an intravenous (IV) infusion — it is never taken by mouth or given at home. The infusion must be administered slowly, over at least 15 minutes, with the patient lying down or partially reclined. The number of doses and timing depend on which product is being used and why.

  • For iron deficiency anemia treatment, dosing is typically given in a course directed by your provider
  • For FeraBright brain MRI imaging, the infusion is given approximately 24 hours before the MRI scan is performed
  • You will be observed during the infusion and for at least 30 minutes after each dose
🤒Side effects — in detail

The most common side effects reported in clinical trials include:

  • Headache
  • Nausea
  • Dizziness
  • Diarrhea
  • Low blood pressure (hypotension)
  • Constipation
  • Swelling in the legs or feet (peripheral edema)
  • Fatigue and back pain

More serious reactions — including severe allergic reactions (anaphylaxis), cardiac arrest, severe hypotension, fainting, and loss of consciousness — have been reported and require immediate emergency medical attention. Skin irritation or lasting brown discoloration at the injection site has also been reported.

⚠️Warnings & precautions
  • Anaphylaxis (severe allergic reaction): The most critical risk. Fatal reactions have occurred, even in people who previously tolerated ferumoxytol. Emergency staff and treatments must be available during every infusion. Monitor during and for 30 minutes after.
  • Low blood pressure (hypotension): Can occur independently of an allergic reaction. Blood pressure and pulse are monitored throughout the infusion and afterward.
  • Iron overload: Excess iron can accumulate in body tissues (hemosiderosis). Ferumoxytol should not be used in patients who already have iron overload.
  • MRI interference: FeraBright can interfere with unrelated MRI scans for up to 3 months after it is given. T2-weighted MRI should not be done within 4 weeks of a FeraBright dose. Always tell your imaging team you received FeraBright.
  • MRI appearance differences: FeraBright produces different patterns of lesion contrast compared to gadolinium-based contrast agents, which may affect how images are interpreted if prior scans used a different agent.
🔀What it interacts with

Ferumoxytol has limited formally studied drug interactions, but two important points apply:

  • Oral iron supplements: Ferumoxytol may reduce how much iron the gut absorbs from oral iron taken at the same time — your provider may adjust your oral iron schedule
  • Medications that cause allergic reactions or low blood pressure (such as certain chemotherapy drugs or monoclonal antibodies): These should not be given until at least 30 minutes after your ferumoxytol infusion ends, to reduce the risk of compounding serious reactions

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Known allergy to ferumoxytol or any IV iron product: This is a contraindication — you must not receive it
  • Multiple drug allergies: You may be at greater risk for a severe allergic reaction; discuss this with your provider
  • Pregnancy: Limited safety data; severe reactions during infusion can cause fetal heart rate changes, especially in the second and third trimester — weigh risks and benefits with your doctor
  • Breastfeeding: It is unknown whether ferumoxytol passes into human breast milk; discuss with your provider
  • Children under 18: Safety and effectiveness have not been established in pediatric patients
  • Older adults: Elderly patients with multiple serious health conditions are at higher risk for severe outcomes from reactions or low blood pressure and should be monitored with extra care
  • Iron overload or hemosiderosis: Ferumoxytol should be avoided if you already have excess iron stored in your body
  • Planned MRI scans: Tell all imaging providers if you have received FeraBright, as it can affect MRI results for up to 3 months
🚑If you take too much

Too much ferumoxytol can lead to a buildup of iron in body tissues, a condition called hemosiderosis, which can damage organs over time. Ferumoxytol is not removed by hemodialysis, so standard dialysis cannot help clear it from the body. If an overdose is suspected, contact the Poison Help line at 1-800-222-1222 or seek immediate medical care.

📡Pharmacodynamics — effects in the body

Ferumoxytol's exact exposure-response relationship — meaning precisely how much drug produces how much effect — is not fully characterized. Studies in healthy volunteers showed that ferumoxytol does not meaningfully affect the heart's electrical activity (QT interval) or heart rate, which is reassuring from a cardiac safety standpoint.

🔬Pharmacokinetics — how your body processes it

After IV infusion, ferumoxytol distributes into a relatively small volume in the body (about 3.4 liters), suggesting it stays mostly within the blood and certain tissues rather than spreading widely. It is eliminated from the blood in a dose-dependent way — higher doses take longer to clear — with a half-life of roughly 21 hours after a standard dose. The rate of infusion does not significantly change how the drug behaves in the body. Age, sex, race, and kidney function do not meaningfully affect ferumoxytol's pharmacokinetics, though clearance is somewhat faster in people with higher body weight.

📦How to store it

Store at 20°C to 25°C (68°F to 77°F). Store in the original package to protect from light. Protect from freezing.

📄 Written from Ferumoxytol Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Ferumoxytol Injection — the kind of thing our pharmacy team would talk through with you at the counter.

Why am I getting an IV iron infusion instead of just taking iron pills?
Some people can't absorb enough iron from pills, or the pills cause stomach problems like cramping or nausea. If you have chronic kidney disease, oral iron often just doesn't work well enough. In those cases, getting iron directly into your bloodstream through an IV is much more reliable and gets your iron levels up faster.
What should I expect during and after my ferumoxytol infusion?
The infusion is given slowly over at least 15 minutes while you're lying back in a reclined position. After it's done, you'll be observed for at least 30 minutes. The most common things people notice are headache, mild nausea, or dizziness — those usually pass. Your blood pressure and pulse will be checked throughout, so you're in good hands.
What symptoms should make me speak up or call for help right away?
If during or shortly after the infusion you feel faint, have trouble breathing, your heart races or feels like it's stopping, or you feel like you're going to pass out — say something immediately. These can be signs of a serious allergic reaction called anaphylaxis, and the staff will act right away. This is why you're monitored closely and never given this at home.
I've had ferumoxytol before without any problems. Do I still need to worry?
Yes, unfortunately. Serious allergic reactions have happened in people who received ferumoxytol before with no issues at all. Every infusion carries this risk, which is why monitoring and having emergency staff ready is required every single time — not just the first dose.
I have an MRI coming up — does receiving ferumoxytol affect that?
It can, yes. Ferumoxytol — especially FeraBright — can interfere with how MRI images look for up to 3 months after your infusion. Make sure you tell the imaging team you received it. If you have an unrelated MRI planned, it's best to get it done before your ferumoxytol infusion if possible. Your care team can help coordinate the timing.
Can I take my regular oral iron supplements along with ferumoxytol?
Ferumoxytol can reduce how much iron your body absorbs from oral iron taken at the same time. Let your provider know about all supplements and medications you're taking so they can adjust your schedule if needed. Don't stop any supplement on your own without checking first.
Is Ferumoxytol Injection available over the counter?
Ferumoxytol Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Ferumoxytol Injection first available?
Ferumoxytol Injection has been available in the United States since at least 2009, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Ferumoxytol Injection?
Ferumoxytol Injection is supplied by 5 manufacturers listed in the FDA NDC Directory, including Sandoz Inc, AMAG Pharmaceuticals, Inc., Azurity Pharmaceuticals, Inc..

💬 Answers drafted from Ferumoxytol Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Ferumoxytol Injection comes

Ferumoxytol Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Into a vein
Brands FeraBright Feraheme
How this form is used
What it may be used for
  • Feraheme is used to treat iron deficiency anemia in adults who cannot tolerate oral iron, have not responded to oral iron, or who have chronic kidney disease
  • FeraBright is used as an MRI contrast agent to improve visibility of brain lesions on T1-weighted MRI scans in adults
  • FeraBright is administered approximately 24 hours before MRI imaging is performed
Important instructions
  • FeraBright must be diluted before administration and given as a slow intravenous infusion over at least 15 minutes while the patient is in a reclined or semi-reclined position
  • FeraBright post-contrast MRI images should be obtained approximately 24 hours after the infusion
  • All ferumoxytol products must be given only in settings where emergency treatment for severe allergic reactions is immediately available
  • Patients must be monitored during the infusion and for at least 30 minutes afterward for signs of allergic reaction or low blood pressure
Available strengths 2 strengths
10 FDA-listed product records

📊 Ferumoxytol Injection across the U.S. market

How Ferumoxytol Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
5
Manufacturers
3
Brand names
10
FDA-listed product records
2009
First marketed
Sandoz Inc40%
AMAG Pharmaceuticals, Inc.20%
Azurity Pharmaceuticals, Inc.20%
AMAG Pharmaceuticals, Inc10%
Patheon Manufacturing Services LLC10%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Ferumoxytol Injection is used

A general measure of how commonly Ferumoxytol Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ferumoxytol Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

36,883
Medicaid prescriptions filled (Q1–Q4 2025)
$12.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ferumoxytol Injection prescribed? Of the 1,596 medications we measure, Ferumoxytol Injection ranks #691 by Medicaid prescriptions — more than 57% of them.

Where Ferumoxytol Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Ferumoxytol Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

17 ML ferumoxytol 30 MG/ML Injection

36,883 Medicaid prescriptions (Q1–Q4 2025) 100% of Ferumoxytol Injection prescriptions shown $12.6M gross reimbursement (before rebates) ≈ $342 per prescription (gross)

Summed across the 3 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860605

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ferumoxytol Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 4 listed Ferumoxytol Injection NDCs with Medicaid activity.

🔍 Compare Ferumoxytol Injection products

A representative set of FDA-listed product records for Ferumoxytol Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Injection
510 mg/17 mL Intravenous AMAG Pharmaceuticals, Inc NDA View NDC →
510 mg/17 mL Intravenous AMAG Pharmaceuticals, Inc. × 2 listings NDA View NDC →
30 mg/mL Intravenous Azurity Pharmaceuticals, Inc. × 2 listings NDA View NDC →
510 mg/17 mL Patheon Manufacturing Services LLC DRUG FOR FURTHER PROCESSING View NDC →
510 mg/17 mL Intravenous Sandoz Inc × 4 listings ANDA View NDC →

Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Ferumoxytol Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ferumoxytol Injection RxCUI 473387 1 dose form · 1 strength
  1. Dose form (SCDF) Injection RxCUI 1741130 In current FDA listings
    Clinical drug / strength (SCD) 17 ML ferumoxytol 30 MG/ML RxCUI 860605

Look up RxCUI 473387 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Feraheme FeraBright

🏭 Manufacturers & labelers

Sandoz Inc 4 AMAG Pharmaceuticals, Inc. 2 Azurity Pharmaceuticals, Inc. 2 AMAG Pharmaceuticals, Inc 1 Patheon Manufacturing Services LLC 1

RxNorm drug class

Ferumoxytol Injection belongs to the Parenteral Iron Replacement class.

Pharmacologic class Parenteral Iron Replacement

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 31, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ferumoxytol Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ferumoxytol Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
NDC products indexed
10
Distinct labelers/manufacturers represented
5
Linked representative label
AMAG Pharmaceuticals, Inc.
Linked label effective
May 31, 2026
Composite sections available
23
Linked SPL Set ID
32b0e320-a739-11dc-a704-0002a5d5c51b
Linked SPL Document ID
a13ebd7b-ac6b-47c7-8c39-ba4702b66f5a
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. AMAG Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.