Ferric Carboxymaltose: uses, dosing, side effects & brands
Ferric Carboxymaltose is a parenteral iron replacement sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Parenteral Iron Replacement
- Available as
- Injectable
- Sold as
- Injectafer
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How ferric carboxymaltose is dosed
From the FDA label for Injectafer (application NDA203565). Other ferric carboxymaltose products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For patients weighing 50 kg or more, the recommended dosage is Injectafer 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. For adult patients weighing 50 kg or more, an alternative dose of Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. ( 2.1 ) For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. ( 2.1 ) See Section 2.1, Table 1 for dosage in patients with iron deficiency and heart failure. ( 2.1 ) Injectafer treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. ( 2.3 ) 2.1 Recommended Dosage Recommended Dosage for Treatment of Iron Deficiency Anemia For patients weighing 50 kg or more, the recommended dosage is: Injectafer 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. In adult patients, Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. Recommended Dosage in Patients with Iron Deficiency…
Ferric Carboxymaltose side effects
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypophosphatemia [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Laboratory Test Alterations [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness. ( 6.1 ) The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. Adults In two randomized clinical studies [Studies 1 and 2, see Clinical Studies ( 14 ) ], a total of 1,775 patients were exposed to Injectafer 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a cumulative dose of 1,500 mg of iron. Adverse reactions…
Who shouldn’t take ferric carboxymaltose
Injectafer is contraindicated in patients with a history of hypersensitivity to Injectafer or any of its components [see Warnings and Precautions ( 5.1 ) ]. Hypersensitivity to Injectafer or any of its inactive components.
Every ferric carboxymaltose product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Injectafer.
How long ferric carboxymaltose keeps
The date on a sealed pack is not the only one: some ferric carboxymaltose labels start a second clock once the product is opened or mixed, as short as 72 hours.
Does ferric carboxymaltose expire? The in-use limits and storage rules from its labelsFerric Carboxymaltose and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for ferric carboxymaltose: levels in milk, effects in breastfed infants, and the drugs it would consider insteadIntravenous iron carboxymaltose increases breastmilk iron in mothers with iron deficiency anemia. Breastfed neonates of these mothers appear to have no serious adverse reactions. Ferric carboxymaltose appears to be acceptable to use in nursing mothers with no special precautions required. For additional information on iron use during breastfeeding, see the monograph on Iron Salts.
National Institute of Child Health and Human Development, record revised January 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about ferric carboxymaltose
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,614 reports naming ferric carboxymaltose, and the FDA flagged 71% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- hypophosphataemia545 reports
- anxiety200 reports
- emotional distress198 reports
- anhedonia197 reports
- arthralgia166 reports
- asthenia150 reports
- headache147 reports
- nausea141 reports
Read these as a signal, not a rate. A report does not mean ferric carboxymaltose caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is ferric carboxymaltose?
Injectafer (Ferric Carboxymaltose) is a parenteral iron replacement.
What kind of drug is ferric carboxymaltose?
The FDA classifies ferric carboxymaltose as a parenteral iron replacement. Given by injection or IV, these supply iron directly into the bloodstream wrapped in a protective carbohydrate shell. The iron is gradually released, picked up by the protein transferrin, and delivered to the bone marrow, where it is used to build hemoglobin and treat iron-deficiency anemia. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take ferric carboxymaltose with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ferric carboxymaltose against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does ferric carboxymaltose come in?
Across the brands we track, ferric carboxymaltose is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ferric carboxymaltose?
We do not currently list a generic-labelled ferric carboxymaltose product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ferric Carboxymaltose: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ferric-carboxymaltose
- MLA
- “Ferric Carboxymaltose: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ferric-carboxymaltose.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ferric carboxymaltose on DailyMed (NIH) ↗.