Ferric Carboxymaltose Injection
Ferric carboxymaltose injection is an intravenous iron replacement used to treat iron deficiency anemia and iron deficiency in adults with heart failure.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Ferric carboxymaltose injection can cause severely low blood phosphate levels (hypophosphatemia) — a serious risk that can lead to hospitalization, bone softening, and fractures. This can happen even in people who had normal phosphate levels before treatment and had no obvious risk factors. It is most common after repeated courses of the medication.
Watch for warning signs of low phosphate: unusual fatigue, muscle weakness or pain, bone or joint pain, or unexplained bone fractures. Report any of these to your doctor right away. If you need a repeat course of treatment — especially within three months — your doctor should check your phosphate levels first and correct any deficiency before proceeding.
📖 Ferric Carboxymaltose Injection: Patient Information Guide
A plain-language walkthrough of Ferric Carboxymaltose Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ferric carboxymaltose injection is an intravenous iron replacement approved for the following conditions:
- Iron deficiency anemia (IDA) in adults and children aged 1 year and older who cannot tolerate oral iron or have not had a satisfactory response to it
- Iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease
- Iron deficiency in adults with heart failure (New York Heart Association class II or III) to improve exercise capacity
⚙️How it works▾
Ferric carboxymaltose is iron bound to a carbohydrate molecule called carboxymaltose, which acts as a protective carrier. When infused into the bloodstream, the complex releases iron in a controlled way. That iron is then taken up by red blood cells and stored in the body — restoring iron levels and supporting the production of healthy, oxygen-carrying red blood cells.
💊How it's taken▾
Ferric carboxymaltose injection is given intravenously (into a vein) by a healthcare professional. It is not taken by mouth. The number of doses and timing depend on your weight, hemoglobin level, and the condition being treated.
- For iron deficiency anemia, it is generally given in two doses at least 7 days apart
- For iron deficiency with heart failure, the schedule is more individualized — your doctor will determine timing based on your hemoglobin and iron levels
- Treatment can be repeated if your condition returns
- Always follow the schedule your prescriber gives you; do not adjust doses on your own
🤒Side effects — in detail▾
The most common side effects in adults include:
- Nausea
- High blood pressure (hypertension) — usually a temporary spike right after dosing
- Flushing or feeling hot
- Injection site reactions (pain, redness, swelling, or brown skin discoloration)
- Dizziness
- Low blood phosphate (hypophosphatemia) — can be serious; see warnings
- Headache
- Vomiting
In children, the most commonly reported side effects include low phosphate, injection site reactions, rash, headache, and vomiting. Seek immediate medical help if you notice signs of a severe allergic reaction — difficulty breathing, swelling, sudden drop in blood pressure, or loss of consciousness.
⚠️Warnings & precautions▾
- Low phosphate levels (hypophosphatemia): This is the most serious risk flagged by the FDA with a boxed warning. Phosphate can drop to dangerous levels — causing bone softening (osteomalacia) and fractures — even in people who started with normal levels. Watch for fatigue, muscle weakness, bone or joint pain, or fractures, and report these immediately.
- Severe allergic reactions (anaphylaxis): Life-threatening reactions have occurred. You must receive this medication in a setting where emergency treatment is immediately available, and you'll be monitored for at least 30 minutes after each dose.
- High blood pressure: Temporary blood pressure spikes — sometimes with flushing, dizziness, or nausea — occur in some patients shortly after dosing and usually resolve within 30 minutes.
- Lab test interference: In the 24 hours after infusion, blood iron tests may read falsely high. Make sure any lab drawing blood during that window knows you received this medication.
- Pregnancy: Serious allergic reactions during infusion can cause fetal heart rate drops (bradycardia), especially in the second and third trimester. Discuss risks carefully with your doctor.
🔀What it interacts with▾
The FDA label for ferric carboxymaltose injection does not describe specific drug, food, or supplement interactions. However, inform your doctor and pharmacist about all medications you take, especially:
- Any medications that affect kidney tubule function — these may increase the risk of low phosphate levels
- Any other iron supplements or IV iron products — your doctor needs the full picture to dose safely
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy history: Do not use if you have had a serious allergic reaction to ferric carboxymaltose or any of its components — this is a contraindication
- Low phosphate: Pre-existing hypophosphatemia must be corrected before starting treatment
- Risk factors for low phosphate: Tell your doctor if you have gastrointestinal malabsorption, inflammatory bowel disease, vitamin D deficiency, hyperparathyroidism, malnutrition, hereditary hemorrhagic telangiectasia (HHT), or take medications that affect kidney tubule function
- Pregnancy: There is a risk of serious allergic reactions that could affect the fetus; discuss risks and benefits with your doctor. Untreated iron deficiency anemia in pregnancy also carries risks
- Breastfeeding: Iron can pass into breast milk; discuss with your doctor whether to continue breastfeeding
- Children: Approved for IDA in children aged 1 year and older; safety and effectiveness have not been established in children under 1 year or for heart failure in children
- Older adults: Clinical studies included many patients 65 and over with no overall safety differences found, though individual sensitivity cannot be ruled out
🚑If you take too much▾
Too much ferric carboxymaltose can cause iron to build up in the body's storage organs — a condition called hemosiderosis — which can affect joints and mobility. There are also reports of bone problems (hypophosphatemic osteomalacia) with repeated high-dose courses. If overdose is suspected, contact the Poison Help line at 1-800-222-1222 or seek immediate medical attention.
📡Pharmacodynamics — effects in the body▾
After infusion, iron from ferric carboxymaltose is taken up by red blood cells to support oxygen transport. In people with iron deficiency, studies using imaging technology showed that 91% to 99% of the infused iron was incorporated into red blood cells within 24 days. In people with kidney-related anemia, red blood cell uptake ranged from 61% to 84% over the same period — still a meaningful correction of iron status.
🔬Pharmacokinetics — how your body processes it▾
After an intravenous dose, iron levels in the blood peak quickly — within about 15 minutes to just over an hour in adults. The iron is then rapidly cleared from the bloodstream, with a half-life (the time for blood levels to drop by half) of roughly 7 to 12 hours in adults and about 9.7 hours in children. Very little iron is eliminated through the kidneys; instead, it is redistributed and stored in the body's tissues. In children aged 1 to 17, peak blood levels are reached in about 7 minutes after the dose.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze.
📄 Written from Ferric Carboxymaltose Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ferric Carboxymaltose Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is ferric carboxymaltose injection used for? ▾
What side effects should I expect after my infusion? ▾
I've heard this can cause problems with phosphate levels. Should I be worried? ▾
How is this medication given — do I have to stay at the clinic? ▾
Is it safe to receive this if I'm pregnant? ▾
Can this medication affect my blood test results? ▾
Is Ferric Carboxymaltose Injection available over the counter? ▾
When was Ferric Carboxymaltose Injection first available? ▾
Who makes Ferric Carboxymaltose Injection? ▾
💬 Answers drafted from Ferric Carboxymaltose Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Ferric Carboxymaltose Injection comes
Ferric Carboxymaltose Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Treats iron deficiency anemia in adults and children aged 1 year and older who cannot tolerate or have not responded to oral iron
- Treats iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease
- Treats iron deficiency in adults with heart failure (NYHA class II/III) to improve exercise capacity
- Given intravenously by a healthcare professional as a slow IV push or diluted infusion; never self-administered
- Typically given in two doses separated by at least 7 days — exact schedule depends on your weight, hemoglobin, and condition
- Patients are monitored for at least 30 minutes after each infusion for signs of allergic reaction or blood pressure changes
- Avoid extravasation (iron leaking outside the vein) — it can cause long-lasting brown skin discoloration at the injection site
📊 Ferric Carboxymaltose Injection across the U.S. market
How Ferric Carboxymaltose Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Ferric Carboxymaltose Injection is used
A general measure of how commonly Ferric Carboxymaltose Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ferric Carboxymaltose Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ferric Carboxymaltose Injection prescribed? Of the 1,596 medications we measure, Ferric Carboxymaltose Injection ranks #686 by Medicaid prescriptions — more than 57% of them.
Utilization by Ferric Carboxymaltose Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
15 ML ferric carboxymaltose 50 MG/ML Injection Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1435169
2 ML ferric carboxymaltose 50 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2602296
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ferric Carboxymaltose Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 2 listed Ferric Carboxymaltose Injection NDCs with Medicaid activity.
🔍 Compare Ferric Carboxymaltose Injection products
A representative set of FDA-listed product records for Ferric Carboxymaltose Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 50 mg/mL | Intravenous | American Regent, Inc. × 12 listings | NDA | View NDC → |
| 50 mg/mL | Intravenous | Mylan Institutional LLC × 8 listings | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Sandoz, Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
Showing 22 of 22 products — FDA National Drug Code Directory. See every product, package size and price: browse all 22 Ferric Carboxymaltose Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ferric Carboxymaltose Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ferric Carboxymaltose Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ferric Carboxymaltose Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1433693 1 dose form · 3 strengths
-
Dose form (SCDF) Injection RxCUI 1741059In current FDA listingsClinical drug / strength (SCD) 2 ML ferric carboxymaltose 50 MG/MLRxCUI 260229615 ML ferric carboxymaltose 50 MG/MLRxCUI 143516920 ML ferric carboxymaltose 50 MG/MLRxCUI 2552400
Look up RxCUI 1433693 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Ferric Carboxymaltose Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 5 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Sandoz, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.