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Ferumoxytol (Feraheme): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
510 mg/17 mL
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Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Ferumoxytol

What is the most important information I should know about ferumoxytol injection?

Ferumoxytol injection may cause serious side effects, including:

  • Serious allergic reactions that may lead to death. Serious allergic reactions have happened in people after receiving the first dose of ferumoxytol injection or after receiving additional doses in people who did not previously have an allergic reaction. If you have a history of allergies to many different medicines, you may have an increased risk of serious allergic reactions to ferumoxytol injection. Tell your healthcare provider or get medical help right away if you get any of these signs or symptoms:

    • rash
    • itching
    • dizziness or lightheadedness
    • swelling of the tongue or throat
    • wheezing or trouble breathing

See “What are the possible side effects of ferumoxytol injection?” for more information about side effects.

What is ferumoxytol injection?

Ferumoxytol injection is a prescription medicine used to treat iron deficiency anemia in adults who have:

  • intolerance to oral iron or who have not responded well to treatment with oral iron or
  • chronic kidney disease (CKD)

It is not known if ferumoxytol injection is safe and effective in children less than 18 years of age.

Who should not receive ferumoxytol injection?

Do not receive ferumoxytol injection if you:

  • are allergic to ferumoxytol injection or any of the ingredients in ferumoxytol injection. See the end of this leaflet for a complete list of ingredients in ferumoxytol injection.
  • have had an allergic reaction to any iron medicine given into your vein by intravenous (IV) infusion.

Before receiving ferumoxytol injection, tell your healthcare provider about all of your medical conditions, including if you:

  • have allergies to many different medicines.
  • have low blood pressure (hypotension).
  • have iron overload.

  • are pregnant or plan to become pregnant. It is not known if ferumoxytol injection will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if ferumoxytol passes into your breast milk. You and your healthcare provider should decide if you will receive ferumoxytol injection or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive ferumoxytol injection?

  • Ferumoxytol injection will be given to you into your vein by intravenous (IV) infusion over at least 15 minutes by your healthcare provider. You will receive ferumoxytol injection in 2 doses 3 to 8 days apart.
  • Your healthcare provider will watch you during and for at least 30 minutes after you receive ferumoxytol injection.
  • Ferumoxytol can cause discoloration or staining of your skin if leaking happens at your infusion site. Tell your healthcare provider if you notice any leaking from the infusion site during your infusion.

What are the possible side effects of ferumoxytol injection?

Ferumoxytol injection may cause serious side effects, including:

  • See “What is the most important information I should know about ferumoxytol injection?”
  • Low blood pressure (hypotension). Your healthcare provider will check you for signs and symptoms of hypotension after each ferumoxytol infusion.
  • Iron overload. Your healthcare provider will do blood tests to check your iron levels during treatment with ferumoxytol injection.
  • Magnetic resonance imaging (MRI) test interference. Ferumoxytol may alter the test results of MRIs. You should have any planned MRI test before starting treatment with Ferumoxytol. Ferumoxytol may alter MRI test results during and for up to 3 months after your last dose of Ferumoxytol.

The most common side effects of ferumoxytol injection include:

  • diarrhea
  • headache
  • nausea
  • dizziness
  • low blood pressure
  • constipation
  • swelling of your legs, feet, arms, or hands

These are not all of the possible side effects of ferumoxytol injection.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

General information about the safe and effective use of ferumoxytol injection.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about ferumoxytol injection that is written for health professionals.

What are the ingredients in ferumoxytol injection?

Active ingredient: ferumoxytol

Inactive ingredient: mannitol

Manufactured by Lek d.d., Slovenia for

Sandoz Inc., Plainsboro, NJ 08536

For more information, call 1-800-525-8747.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 07/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 206604 · View the label on DailyMed

Revision date stated in the text: July 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Ferumoxytol

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Parenteral Iron Replacement
Active ingredient Ferumoxytol non-stoichiometric magnetite 510 mg/17 mL
Dosage form Injection
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) SANDOZ
FDA approval ANDA 206604Abbreviated New Drug Application (ANDA) – generic drug Approved January 15, 2021
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Feraheme with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
510 mg/17 mL – 17 ml in 1 vial, single-dose / 1 in 1 carton NDC 0781-3154-01
510 mg/17 mL – 17 ml in 1 vial, single-dose / 10 in 1 carton NDC 0781-3154-95

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.