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Ferric Carboxymaltose: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
50 mg/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 - Ferric Carboxymaltose

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

Ferric carboxymaltose injection can cause serious side effects, including:

Low blood phosphate levels (hypophosphatemia). Hypophosphatemia has happened after one or more doses of ferric carboxymaltose injection and can be severe or serious, and lead to hospitalization, softening of your bones (osteomalacia), and broken bones (fractures). Hypophosphatemia can happen even if your blood phosphate levels were normal before treatment and you do not have any risk factors for hypophosphatemia. Your healthcare provider will check your blood phosphate levels before a repeat treatment with ferric carboxymaltose injection if you are at risk for hypophosphatemia. If a repeat treatment is needed within 3 months of your last treatment, your healthcare provider will check your blood phosphate levels.

Tell your healthcare provider if you develop any of the following signs or symptoms of hypophosphatemia during treatment with ferric carboxymaltose injection:

  • tiredness
  • muscle weakness or pain
  • bone or joint pain
  • broken bones

Your healthcare provider may permanently stop treatment with ferric carboxymaltose injection if you develop severe hypophosphatemia with symptoms or if your blood phosphate levels remain low during treatment with ferric carboxymaltose injection.

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

What is ferric carboxymaltose injection?

Ferric carboxymaltose injection is a prescription iron replacement medicine used for the treatment of:

  • iron deficiency anemia (IDA) in:

    • adults and children 1 year of age and older who cannot tolerate iron taken by mouth (oral) or who have not responded well to oral iron.
    • adults who have chronic kidney disease who are not on dialysis (non-dialysis dependent chronic kidney disease).
  • iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity).

It is not known if ferric carboxymaltose injection is safe and effective in children with IDA who are under 1 year of age.

It is not known if ferric carboxymaltose injection is safe and effective in children with iron deficiency and mild to moderate heart failure to improve exercise capacity.

Who should not receive ferric carboxymaltose injection?

Do not receive ferric carboxymaltose injection if you are allergic to ferric carboxymaltose or any of the ingredients in ferric carboxymaltose injection. See the end of this Patient Information leaflet for a complete list of ingredients in ferric carboxymaltose injection.

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

  • have a history of trouble absorbing certain vitamins or phosphate in your body
  • have inflammatory bowel disease
  • have hyperparathyroidism
  • have low vitamin D levels
  • have hereditary hemorrhagic telangiectasia (HHT) or Osler-Weber-Rendu syndrome
  • have had an allergic reaction to iron given into your vein
  • have previously received ferric carboxymaltose injection
  • have high blood pressure (hypertension)

  • are pregnant or plan to become pregnant. Ferric carboxymaltose injection may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ferric carboxymaltose injection.

  • are breastfeeding or plan to breastfeed. Ferric carboxymaltose passes into your breast milk. It is not known if ferric carboxymaltose injection will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ferric carboxymaltose injection.

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 ferric carboxymaltose injection?

  • Ferric carboxymaltose injection is given into your vein by intravenous (IV) infusion by your healthcare provider.
  • Ferric carboxymaltose injection is usually given in 2 doses at least 7 days apart for IDA, or 6 weeks apart for iron deficiency with mild to moderate heart failure to improve exercise capacity.
  • If your healthcare provider decides it is right for you, ferric carboxymaltose injection may be given intravenously by your healthcare provider as a single-dose treatment.
  • Ferric carboxymaltose injection treatment may be repeated if your healthcare provider decides it is needed.
  • Ferric carboxymaltose injection 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 ferric carboxymaltose injection?

Ferric carboxymaltose injection may cause serious side effects, including:

  • See “What is the most important information I should know about ferric carboxymaltose injection?”
  • Allergic reactions. Serious life-threatening allergic reactions that can lead to death have happened in people who receive ferric carboxymaltose injection. Your healthcare provider will watch you during and for at least 30 minutes after you receive ferric carboxymaltose injection. Tell your healthcare provider right away if you develop any of the following signs or symptoms of allergic reactions during or after treatment with ferric carboxymaltose injection:
  • low blood pressure
  • feeling dizzy or lightheaded
  • loss of consciousness
  • trouble breathing
  • swelling
  • fast heartbeat
  • cold or clammy skin
  • feet or hands turn blue
  • itching
  • rash
  • hives
  • wheezing
  • High blood pressure. High blood pressure, sometimes with redness and warmth of the face (facial flushing), dizziness, or nausea, has happened during treatment with ferric carboxymaltose injection. Your healthcare provider will check your blood pressure and check for any signs and symptoms of high blood pressure after you receive ferric carboxymaltose injection.

The most common side effects of ferric carboxymaltose injection in adults include:

  • nausea
  • high blood pressure
  • flushing
  • injection site reactions
  • skin redness
  • low blood phosphate levels
  • dizziness

The most common side effects of ferric carboxymaltose injection in children include:

  • low blood phosphate levels
  • injection site reactions
  • rash
  • headache
  • vomiting

These are not all the possible side effects of ferric carboxymaltose 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 ferric carboxymaltose injection.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about ferric carboxymaltose injection that is written for health professionals.

What are the ingredients in ferric carboxymaltose injection?

Active ingredient: ferric carboxymaltose.

Inactive ingredients: water for injection. Sodium hydroxide or hydrochloric acid may be added to adjust pH to 5.0-7.0.

For more information contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX).

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributed by:

Mylan Institutional LLC, a Viatris Company

Morgantown, WV 26505 U.S.A.

Manufactured by:

Mylan Laboratories Limited

Bangalore, India

Revised: 8/2026

MI:FECAIJ750:R2

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 212572 · View the label on DailyMed

Revision date stated in the text: August 2026

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

Drug information for Ferric Carboxymaltose

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, Phosphate Binder
Active ingredient Ferric carboxymaltose 50 mg/mL
Dosage form Injection, solution
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) MYLAN LABS LTD
FDA approval ANDA 212572Abbreviated New Drug Application (ANDA) – generic drug Approved June 25, 2026
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Injectafer, Venofer with the same TE code
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
50 mg/mL – 15 ml in 1 vial, single-dose / 1 in 1 carton NDC 67457-797-00
50 mg/mL – 15 ml in 1 vial, single-dose / 2 in 1 carton NDC 67457-797-99

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.