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FeraBright: Uses, Side Effects and Dosage

Status:
Prescription (Rx) Boxed warning Facts
Strength:
30 mg/mL
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

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

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.

What is FERABRIGHT?

FERABRIGHT is an iron-based dye for brain magnetic resonance imaging (MRI) scans in adults who have or may have brain cancer. It helps healthcare providers see malignant tumors that have disrupted the protective barrier around the brain (blood-brain barrier).

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

Who should not receive FERABRIGHT?

Do not receive FERABRIGHT if you:

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

Before receiving FERABRIGHT, 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 too much iron stored in your body (iron overload)

  • are pregnant or plan to become pregnant. Your unborn baby may be harmed if you experience a severe allergic reaction to FERABRIGHT.

  • are breastfeeding or plan to breastfeed. It is not known if FERABRIGHT passes into breast milk.

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 FERABRIGHT?

  • Your healthcare provider will advise you when you need to be administered the dose of FERABRIGHT and when your MRI scan will occur.
  • FERABRIGHT will be given to you into your vein by intravenous (IV) infusion over at least 15 minutes by your healthcare provider about 24 hours before your MRI scan. You may also have an MRI scan before the FERABRIGHT infusion.
  • You will be positioned partially or completely laying back with your back supported while receiving FERABRIGHT.
  • Your healthcare provider will watch you during and for at least 30 minutes after you receive FERABRIGHT.
  • Wait at least 30 minutes after FERABRIGHT infusion before receiving other medicines that may cause allergic reactions or low blood pressure such as chemotherapy or antibody treatment.

What are the possible side effects of FERABRIGHT?

FERABRIGHT can cause serious side effects, including:

  • See “What is the most important information I should know about FERABRIGHT?”

  • Low blood pressure (hypotension) is a side effect of FERABRIGHT that can sometimes be serious. Your healthcare provider will check you for signs and symptoms of hypotension after each FERABRIGHT infusion. Report the following symptoms immediately to your healthcare provider:

    • feeling dizzy or lightheaded
    • feeling faint or fainting (syncope)
    • blurred vision
    • trouble concentrating or confused
    • feeling weak, tired, or sleepy
    • upset stomach or vomiting
  • Iron overload. FERABRIGHT can cause too much iron storage in your body.
  • MRI Test Interference. Tell your healthcare provider if you have any MRIs, other than your brain scan, scheduled in the next 3 months after you receive FERABRIGHT, because it may affect the test results.

The most common side effects of FERABRIGHT include:

  • nausea
  • itchy skin (pruritus)
  • constipation
  • headache
  • diarrhea
  • high blood pressure
  • bleeding
  • skin darkening (hyperpigmentation)
  • blood vessel injury
  • change in taste
  • burning or tingling with injection
  • red eyes (red sclera)
  • stuffy or runny nose
  • back pain
  • vomiting
  • increase in blood liver enzymes

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

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 FERABRIGHT that is written for healthcare professionals.

What are the ingredients in FERABRIGHT?

Active ingredient: ferumoxytol

Inactive ingredient: mannitol

Manufactured for:

Azurity Pharmaceuticals, Inc.,

Woburn, MA 01801 USA

For more information, go to www.ferabright.com or call 1-800-461-7449.

This Patient Information has been approved by the U.S. Food and Drug Administration. Approved: 10/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 219868 · View the label on DailyMed

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

Drug information for FeraBright

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 30 mg/mL
Dosage form Injection
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) AZURITY
FDA approval NDA 219868New Drug Application (NDA) Approved October 16, 2025
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
30 mg/mL – 10 ml in 1 vial, single-dose / 1 in 1 carton NDC 24338-310-10
30 mg/mL – 17 ml in 1 vial, single-dose / 1 in 1 carton NDC 24338-510-17

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.