Iron Dextran Injection
Iron dextran injection is an injectable iron replacement used to treat iron deficiency in adults and children when oral iron cannot be tolerated or has not worked.
🧬 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 3 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 ▾
INFeD carries a serious boxed warning about life-threatening allergic reactions. Severe and sometimes fatal allergic-type reactions (anaphylaxis) have been reported after injection of iron dextran — including after the very first small test dose. These reactions can cause sudden breathing difficulty and cardiovascular collapse. Fatal reactions have occurred even in patients who tolerated the test dose without any problem.
Because of this risk, INFeD should only be used when iron deficiency has been confirmed by lab tests and oral iron has failed or cannot be tolerated. It must be administered only where emergency equipment and trained personnel are immediately available. People with a history of drug allergies or multiple medication allergies may face a higher risk and should be monitored especially closely.
📖 Iron Dextran Injection: Patient Information Guide
A plain-language walkthrough of Iron Dextran 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▾
Iron dextran injection is used to treat iron deficiency when injected iron is necessary. Here are the supported uses:
- INFeD is indicated for documented iron deficiency in adults and children 4 months of age and older who have intolerance to oral iron or have not responded adequately to oral iron therapy
- INFeD is used for iron replacement in patients who experience significant or recurring blood loss — for example, those with bleeding disorders (such as hemophilia or hereditary telangiectasia) or patients on regular kidney hemodialysis
⚙️How it works▾
After injection, iron dextran is taken up by the body's reticuloendothelial system (the network of cells that handles immune defense and recycling). These cells split the compound into its two parts — iron and dextran (a type of sugar). The released iron then attaches to proteins in the blood and is used to rebuild hemoglobin (the oxygen-carrying protein in red blood cells) and to refill iron stores throughout the body. The body regulates how much of the released iron it uses, which helps prevent immediate overload.
💊How it's taken▾
INFeD is given only by a healthcare professional as an injection — either into a vein (intravenously) or into a muscle (intramuscularly). A small test dose is always given first; if no reaction occurs after at least an hour of observation, the therapeutic dose is administered. The total amount needed is calculated based on body weight, current hemoglobin level, and the reason for treatment (iron deficiency anemia vs. blood loss replacement).
- Oral iron supplements must be stopped before starting INFeD
- The full course may be spread over multiple visits, with daily doses given until the calculated total is reached
- Your care team will monitor your blood counts and iron levels throughout treatment
🤒Side effects — in detail▾
The most commonly reported side effects with INFeD include:
- Nausea, vomiting, or abdominal pain
- Headache or dizziness
- Flushing and low blood pressure (especially with too-rapid IV injection)
- Chest pain or tightness
- Joint pain, back pain, or muscle aches
- Itching, rash, or hives
- Shortness of breath or wheezing
- Pain, swelling, or skin staining at the injection site (especially with intramuscular use)
Seek emergency help immediately if you develop sudden difficulty breathing, throat tightening, a rapid drop in blood pressure, loss of consciousness, or seizures — these can be signs of a life-threatening allergic reaction.
⚠️Warnings & precautions▾
- Anaphylaxis (severe allergic reaction): The most critical risk — life-threatening and sometimes fatal reactions have occurred, even after a tolerated test dose. INFeD must only be given where emergency resuscitation is available, and patients must be monitored throughout every infusion.
- Delayed reactions: Large IV doses can trigger fever, chills, joint pain, back pain, headache, nausea, and fatigue starting 1–2 days after the dose. These generally resolve within 3–4 days.
- Iron overload (hemosiderosis): Too much iron from excessive dosing can accumulate in organs and tissues. Regular monitoring of hemoglobin, hematocrit, and iron levels is required.
- Underlying conditions: Use with extra caution in patients with significant liver disease, active infectious kidney disease, cardiovascular disease, rheumatoid arthritis, or asthma — INFeD can worsen these conditions.
- Possible cancer risk with intramuscular injections: There are reports of tumors developing at intramuscular injection sites in humans who received iron-carbohydrate complexes; animal studies show sarcoma formation under some conditions.
🔀What it interacts with▾
INFeD has a few important interactions and interferences to be aware of:
- ACE inhibitors (blood pressure medications like lisinopril or enalapril) — using these alongside INFeD may increase the risk of a serious anaphylactic-type reaction
- Lab tests — INFeD can falsely elevate serum bilirubin levels and falsely lower serum calcium; iron level tests may be unreliable for up to 3 weeks after dosing; always tell lab staff you have received this medication
- Bone marrow iron tests — residual iron dextran in tissues can make bone marrow iron assessments unreliable for an extended period after treatment
- Bone scans — certain nuclear medicine scans using radioactive tracers may show abnormal results in the days following INFeD injections
- Other medications or IV solutions — INFeD must never be mixed in the same syringe or IV bag with other drugs or parenteral nutrition
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▾
- Do not use INFeD if you have ever had a hypersensitivity reaction (allergic reaction) to iron dextran — this is a contraindication
- Tell your prescriber about all drug allergies, especially if you've had reactions to multiple medications — this raises your risk of a serious reaction to INFeD
- Tell your prescriber if you have liver disease, active kidney infection, heart disease, rheumatoid arthritis, asthma, or a history of significant allergies
- Tell your prescriber if you have iron overload — INFeD must not be given to patients with excess iron stores
- Pregnancy: Serious allergic reactions to INFeD can cause fetal bradycardia (slowed fetal heart rate) and other complications. Animal studies show potential harm at high doses. Discuss the benefits and risks carefully with your doctor.
- Breastfeeding: Trace amounts of iron dextran may pass into breast milk. Discuss with your prescriber.
- Children under 4 months: INFeD is not recommended for infants younger than 4 months of age
- Stop taking oral iron supplements before starting INFeD treatment
🚑If you take too much▾
An accidental overdose of iron dextran is unlikely to cause immediate obvious symptoms. However, receiving more iron than the body needs can lead to excess iron accumulating in organs and tissues over time — a condition called hemosiderosis — which can be harmful. Monitoring serum ferritin (an iron storage marker) levels regularly helps detect this buildup early, particularly in people with chronic kidney disease, Hodgkin's disease, or rheumatoid arthritis.
📡Pharmacodynamics — effects in the body▾
After INFeD is administered, the body's response can be measured in the blood. One of the first signs that treatment is working is a rise in the reticulocyte count — an increase in young, newly produced red blood cells. Serum ferritin levels (a measure of iron stored in body tissues) also rise, reflecting the replenishment of iron stores. These lab changes provide a practical window into how effectively the body is using the delivered iron.
🔬Pharmacokinetics — how your body processes it▾
After an intramuscular injection of INFeD, most of the iron is absorbed within 72 hours, with the remainder absorbed gradually over the following 3 to 4 weeks. With intravenous dosing, serum ferritin (a marker of iron stores) peaks about 7 to 9 days after the dose and returns toward baseline within about 3 weeks. The body does not excrete meaningful amounts of iron in urine or stool after iron dextran administration — the iron stays in the body and is redistributed rather than cleared. The dextran portion is either broken down (metabolized) or excreted separately. Importantly, dialysis does not meaningfully remove iron dextran from the blood.
📦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).
📄 Written from Iron Dextran 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 Iron Dextran Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I need an injection instead of just taking iron pills? ▾
What is the test dose, and why do I need it? ▾
What side effects should I expect, and which ones mean I should get help right away? ▾
Is it normal to feel achy and feverish a day or two after my infusion? ▾
I'm pregnant — is it safe for me to receive INFeD? ▾
Will INFeD affect my blood test results or other scans? ▾
Is Iron Dextran Injection available over the counter? ▾
When was Iron Dextran Injection first available? ▾
Who makes Iron Dextran Injection? ▾
💬 Answers drafted from Iron Dextran 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 Iron Dextran Injection comes
Iron Dextran 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
- INFeD treats documented iron deficiency in adults and children 4 months and older who cannot tolerate or have not responded to oral iron
- INFeD is used to replace iron lost from significant or recurring blood loss, such as in bleeding disorders or during regular hemodialysis
- INFeD must always be preceded by a small test dose before the first full treatment dose, regardless of whether it is given intravenously or intramuscularly
- When given intravenously, INFeD is injected slowly and undiluted; patients must be observed for at least one hour after the test dose before the full dose is given
- When given intramuscularly, INFeD is injected deeply into the upper outer buttock using a Z-track technique (skin pulled aside before injecting) to prevent leakage and skin staining — never injected into the arm or other exposed areas
- INFeD must not be mixed with other medications or added to IV nutrition solutions
📊 Iron Dextran Injection across the U.S. market
How Iron Dextran 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 Iron Dextran Injection is used
A general measure of how commonly Iron Dextran 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 Iron Dextran 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 Iron Dextran Injection prescribed? Of the 1,596 medications we measure, Iron Dextran Injection ranks #708 by Medicaid prescriptions — more than 56% of them.
Utilization by Iron Dextran 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.
2 ML iron-dextran complex 50 MG/ML Injection
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311144
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 Iron Dextran 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 1 of 3 listed Iron Dextran Injection NDCs with Medicaid activity.
🔍 Compare Iron Dextran Injection products
A representative set of FDA-listed product records for Iron Dextran 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 | Intramuscular, Intravenous | Allergan, Inc. | NDA | View NDC → |
| 50 mg/mL | Intramuscular; Intravenous | Allergan, Inc. × 2 listings | NDA | View NDC → |
| 50 mg/mL | Intramuscular; Intravenous | General Injectables & Vaccines, Inc. × 2 listings | NDA | View NDC → |
| 50 mg/mL | Intramuscular, Intravenous | Henry Schein, Inc. | NDA | View NDC → |
| 50 mg/mL | Intramuscular; Intravenous | Henry Schein, Inc. × 2 listings | NDA | View NDC → |
| 50 mg/mL | Intramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | NDA | View NDC → |
| 50 mg/mL | Intramuscular; Intravenous | HF Acquisition Co LLC, DBA HealthFirst | NDA | View NDC → |
Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Iron Dextran 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 Iron Dextran 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 Iron Dextran 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 Iron Dextran 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 5992 2 dose forms · 3 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 370706In current FDA listingsClinical drug / strength (SCD) 100 MG/MLRxCUI 311143200 MG/MLRxCUI 2464305 -
Dose form (SCDF) Injection RxCUI 1865657In current FDA listingsClinical drug / strength (SCD) 2 ML iron-dextran complex 50 MG/MLRxCUI 311144
Look up RxCUI 5992 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 Iron Dextran 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 3 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. Allergan, 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.