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Feraheme: Uses, Side Effects and Dosage

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

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

What is the most important information I should know about Feraheme?

Feraheme 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 Feraheme 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 Feraheme. Tell your healthcare provider or get medical help right away if you get any of these signs or symptoms:
  • rash • swelling of the tongue or throat
  • itching • wheezing or trouble breathing
  • dizziness or lightheadedness

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

What is Feraheme?

Feraheme 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 Feraheme is safe and effective in children less than 18 years of age.

Who should not receive Feraheme?

Do not receive Feraheme if you:

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

Before receiving Feraheme, 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 Feraheme will harm your unborn baby.

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

  • Feraheme will be given to you into your vein by intravenous (IV) infusion over at least 15 minutes by your healthcare provider. You will receive Feraheme in 2 doses 3 to 8 days apart.
  • Your healthcare provider will watch you during and for at least 30 minutes after you receive Feraheme.
  • Feraheme 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 Feraheme?

Feraheme may cause serious side effects, including:

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

The most common side effects of Feraheme include:

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

These are not all of the possible side effects of Feraheme. 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 Feraheme.

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 Feraheme that is written for health professionals.

What are the ingredients in Feraheme?

Active ingredient: ferumoxytol

Inactive ingredient: mannitol

Distributed by: AMAG Pharmaceuticals, Inc. Waltham, MA 02451

For more information, go to www.feraheme.com or call 1-877-411-2510.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 05/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 022180 · View the label on DailyMed

Revision date stated in the text: May 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 Feraheme

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) AZURITY
FDA approval NDA 022180New Drug Application (NDA) Approved June 30, 2009
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Ferumoxytol 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-use / 1 in 1 carton NDC 59338-775-01
510 mg/17 mL – 17 ml in 1 vial, single-use / 10 in 1 carton NDC 59338-775-10

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.