FDA-filed SPL labeling · retrieved through openFDA

Iron Sucrose Injection

Iron sucrose injection is an intravenous iron replacement used to treat iron deficiency anemia in adults and children with chronic kidney disease.

Brand name Venofer
Drug class ⓘ Parenteral Iron Replacement
Rx Form 1 Routes Intravenous · Intravitreal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 6 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 →

At a glance
Linked label effectiveMar 1, 2026
Clinical labels in scope ⓘ6
AvailabilityRx
Earliest approval/marketing year ⓘ2000
FDA-listed product records ⓘ31
Boxed warningNone found in compared labels
How we combine label and product data →
⭐ Iron Sucrose Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Iron sucrose injection is an effective IV iron replacement for treating iron deficiency anemia in people with chronic kidney disease. It is given by a healthcare professional in a clinical setting, and you'll be monitored closely during and after each dose for allergic reactions and low blood pressure. Regular blood and iron level checks are part of safe treatment.
How we write & review this content — our editorial policy →

📖 Iron Sucrose Injection: Patient Information Guide

A plain-language walkthrough of Iron Sucrose 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 sucrose injection is an IV iron replacement approved to treat iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). It covers several specific patient groups:

  • Adults on hemodialysis (hemodialysis-dependent CKD, or HDD-CKD): used to replace iron and correct anemia
  • Adults not on dialysis (non-dialysis-dependent CKD, or NDD-CKD): used to replace iron and correct anemia
  • Adults on peritoneal dialysis (peritoneal dialysis-dependent CKD, or PDD-CKD): used to replace iron and correct anemia
  • Children 2 years and older with HDD-CKD, NDD-CKD, or PDD-CKD who are on erythropoietin therapy: used for iron maintenance treatment (keeping iron at a stable level, not initial replacement)
⚙️How it works▾

Iron sucrose injection delivers iron directly into the bloodstream. Once infused, it breaks apart into iron and sucrose (a type of sugar). The iron binds to a blood protein called transferrin, which acts like a transport vehicle, carrying iron to the bone marrow and other target cells. There, the iron is incorporated into hemoglobin — the oxygen-carrying protein in red blood cells — as those cells mature. This process raises iron levels in the blood and helps the body produce more healthy red blood cells, easing anemia.

💊How it's taken▾

Iron sucrose injection is given only intravenously (into a vein) — never by mouth. It is always administered by a healthcare professional. The number of doses and how often they are given depends on your type of kidney disease and your age:

  • Adults on hemodialysis typically receive doses during each consecutive dialysis session
  • Adults not on dialysis typically receive doses spread over a two-week period
  • Adults on peritoneal dialysis typically receive doses spread over about a four-week period
  • Children 2 years and older on erythropoietin therapy receive doses every two or four weeks over 12 weeks, depending on their dialysis status

Always follow your prescriber's specific instructions. Treatment can be repeated if iron deficiency comes back. There is no food or drink restriction specific to this medication.

🤒Side effects — in detail▾

Like any medication, iron sucrose injection can cause side effects. The most commonly reported ones include:

  • Muscle cramps
  • Nausea, vomiting, or diarrhea
  • Headache
  • Dizziness
  • Low blood pressure (hypotension)
  • Swelling in the legs or feet (peripheral edema)
  • Itching (pruritus)
  • Chest pain or back pain
  • Injection site reactions (pain, burning, or discoloration at the IV site)

More serious reactions — including severe allergic reactions (anaphylaxis), a sudden dangerous drop in blood pressure, or signs of iron overload — require immediate medical attention. You will be monitored for at least 30 minutes after every infusion for this reason.

⚠️Warnings & precautions▾
  • Serious allergic reactions (including anaphylaxis): Life-threatening and fatal reactions have occurred. Signs include sudden low blood pressure, trouble breathing, swelling, loss of consciousness, or collapse. Emergency treatment must be immediately available during every infusion.
  • Low blood pressure (hypotension): Can happen during or after infusion, especially if iron is given too quickly. Your blood pressure will be monitored throughout your treatment.
  • Iron overload (hemosiderosis): Too much iron given over time can accumulate in organs and cause damage. Regular blood tests — checking hemoglobin, iron levels, and a protein called ferritin — are required throughout therapy. Do not receive iron sucrose if you already have high iron levels.
🔀What it interacts with▾

Iron sucrose injection has a known interaction with one category of medications:

  • Oral iron supplements: Venofer (iron sucrose injection) can reduce how well oral iron pills or liquids are absorbed. If you are taking an oral iron supplement, let your doctor or pharmacist know so they can plan your treatment accordingly.

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 to iron sucrose: Do not receive this medication if you have ever had a hypersensitivity reaction to iron sucrose injection — this is a contraindication.
  • Iron overload: Do not receive this medication if you already have too much iron stored in your body.
  • Pregnancy: Published data suggest iron sucrose is generally safe after the first trimester. However, severe allergic reactions during infusion can slow the baby's heart rate. Discuss the risks and benefits with your doctor.
  • Breastfeeding: Iron sucrose does pass into breast milk. No harmful effects in breastfed infants have been reported, but monitor your baby for stomach or bowel issues (constipation or diarrhea).
  • Children under 2 years: Iron sucrose has not been studied in children younger than 2 years and should not be used in this age group.
  • Older adults: No major safety differences have been found in adults 65 and older, but caution is advised because older patients often have other health conditions or take multiple medications.
🚑If you take too much▾

Too much iron sucrose can cause iron to build up in body tissues — a condition called hemosiderosis — which can damage organs over time. There is no specific antidote, and iron sucrose cannot be removed by standard dialysis membranes. Your doctor will watch your iron levels regularly to prevent this from happening.

📡Pharmacodynamics — effects in the body▾

After an IV infusion, iron sucrose raises the amount of iron circulating in the blood (serum iron) and increases ferritin — a protein that reflects how much iron is stored in the body. At the same time, it lowers total iron binding capacity (TIBC), a measure of how much more iron the blood could still carry. Together, these changes show the body is being replenished with iron. These measurable effects were seen within four weeks of starting treatment in clinical studies.

🔬Pharmacokinetics — how your body processes it▾

After IV administration, iron sucrose splits into iron and sucrose in the bloodstream. The iron is cleared from the blood with a half-life of about 6 hours in adults — meaning it takes roughly 6 hours for half the iron to leave the bloodstream. It distributes mainly in the blood but also travels to the liver, spleen, and bone marrow, where it can be stored or used. The sucrose portion is cleared quickly through the urine — about 75% is gone within 24 hours. In adolescents (ages 12–16), iron levels after a dose are somewhat higher than in adults, with a slightly longer half-life of about 8 hours.

📦How to store it▾

Contains no preservatives. Store in original carton at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Do not freeze.

📄 Written from Iron Sucrose 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 Sucrose Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is iron sucrose injection and why do I need it? ▾
Iron sucrose injection is a way to get iron directly into your bloodstream through an IV. It's used when you have iron deficiency anemia — meaning your body doesn't have enough iron to make healthy red blood cells — and you have chronic kidney disease. Kidneys play a role in managing iron and red blood cell production, so people with CKD often develop this type of anemia. Oral iron pills don't always work well enough in this situation, so the IV route is used instead.
What will happen during my infusion? How long does it take? ▾
A nurse or healthcare professional will place an IV and slowly administer the medication — the infusion itself can take anywhere from a few minutes to a couple of hours depending on your dose and which CKD group you're in. After the infusion is done, you'll be monitored for at least 30 minutes before you're cleared to leave. This is a safety step to watch for any allergic reactions, which most often happen within that 30-minute window.
What side effects should I expect, and which ones mean I should get help right away? ▾
The most common side effects are muscle cramps, nausea, headache, dizziness, and low blood pressure — these are generally manageable and often improve on their own. However, if you suddenly feel like you can't breathe, your face or throat swells, you feel faint or collapse, or your heart is racing, that's a serious allergic reaction and you need emergency help immediately. Because of this risk, you're always monitored right after your infusion.
Can I keep taking my oral iron supplement while getting these infusions? ▾
You should tell your doctor or pharmacist about any oral iron supplements you're taking. Iron sucrose injection can reduce how well oral iron is absorbed, so your care team may adjust your plan. Don't stop or start any iron supplement on your own — let them guide you based on your blood test results.
Is it safe to receive this medication if I'm pregnant or breastfeeding? ▾
Studies in pregnant women suggest iron sucrose is generally considered safer after the first trimester, and untreated iron deficiency anemia in pregnancy carries its own risks too. That said, a severe allergic reaction during an infusion can affect the baby's heart rate, so you'll be carefully monitored. If you're breastfeeding, a small amount of iron does pass into breast milk, but no harmful effects in infants have been reported — just watch your baby for any constipation or diarrhea and mention it to your doctor.
How will my doctor know if the treatment is working — or if I'm getting too much iron? ▾
Your doctor will do regular blood tests to check your hemoglobin, hematocrit (the percentage of red blood cells in your blood), ferritin, and transferrin saturation. These tests show whether your iron levels and red blood cell counts are going in the right direction. It's also how they make sure iron isn't building up to unsafe levels — getting too much iron over time can cause a condition called iron overload, where iron accumulates in organs. That's why it's important not to miss these follow-up lab appointments.
Is Iron Sucrose Injection available over the counter? ▾
Iron Sucrose Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Iron Sucrose Injection first available? ▾
Iron Sucrose Injection has been available in the United States since at least 2000, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Iron Sucrose Injection? ▾
Iron Sucrose Injection is supplied by 6 manufacturers listed in the FDA NDC Directory, including American Regent, Inc., Fresenius Medical Care Holdings, Inc., Mylan Institutional LLC.

💬 Answers drafted from Iron Sucrose 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

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💊 How Iron Sucrose Injection comes

Iron Sucrose 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

In the eye · Into a vein
Brands Venofer
How this form is used
What it may be used for
  • Venofer is used intravenously to treat iron deficiency anemia in adults with hemodialysis-dependent chronic kidney disease
  • Venofer is used intravenously to treat iron deficiency anemia in adults with non-dialysis-dependent chronic kidney disease
  • Venofer is used intravenously to treat iron deficiency anemia in adults with peritoneal dialysis-dependent chronic kidney disease
  • Venofer is used intravenously for iron maintenance treatment in children 2 years and older with chronic kidney disease who are on erythropoietin therapy
Important instructions
  • Venofer is given only by slow intravenous injection or IV infusion — never by mouth or any other route
  • Venofer must be given by a trained healthcare professional, who will monitor you for at least 30 minutes after each dose
  • Venofer may interact with oral iron supplements taken at the same time, potentially reducing how much oral iron your body absorbs
  • Venofer treatment may be repeated if iron deficiency returns, based on your doctor's assessment
Available strengths 4 strengths
20 mg/mL 50 mg/2.5 mL 100 mg/5 mL 200 mg/10 mL
31 FDA-listed product records ⓘ

📊 Iron Sucrose Injection across the U.S. market

How Iron Sucrose 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.

1
Dose forms ⓘ
6
Manufacturers
2
Brand names
31
FDA-listed product records ⓘ
2000
First marketed ⓘ
American Regent, Inc.39%
Fresenius Medical Care Holdings, Inc.19%
Mylan Institutional LLC19%
International Medication Systems, Limited10%
Sandoz Inc10%
A-S Medication Solutions3%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Iron Sucrose Injection is used

A general measure of how commonly Iron Sucrose 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 Sucrose 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.

913,265
Medicaid prescriptions filled (Q1–Q4 2025)
$76.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Iron Sucrose Injection prescribed? Of the 1,596 medications we measure, Iron Sucrose Injection ranks #186 by Medicaid prescriptions — more than 88% of them.

Where Iron Sucrose Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #186 of 1,596
#181 Naloxone Nasal Spray 970,105 Rx #182 Budesonide 967,284 Rx #183 Ciprofloxacin 959,810 Rx #184 Erythromycin 942,102 Rx #185 Linaclotide 914,996 Rx #186 Iron Sucrose Injection 913,265 Rx #187 Allopurinol 901,974 Rx #188 Ondansetron Injection 901,061 Rx #189 Budesonide Oral Inhala... 893,664 Rx #190 Latanoprost Ophthalmic 879,118 Rx #191 Ceftriaxone Injection 875,273 Rx

Utilization by Iron Sucrose 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.

The 5 mL / 20 mg/mL injection is the most-dispensed Iron Sucrose Injection product — about 49% of these Medicaid prescriptions.

5 ML iron sucrose 20 MG/ML Injection Most dispensed

449,229 Medicaid prescriptions (Q1–Q4 2025) 49% of Iron Sucrose Injection prescriptions shown $43.2M gross reimbursement (before rebates) ≈ $96 per prescription (gross)

Summed across the 10 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1741267

2.5 ML iron sucrose 20 MG/ML Injection

405,857 Medicaid prescriptions (Q1–Q4 2025) 44% of Iron Sucrose Injection prescriptions shown $28.3M gross reimbursement (before rebates) ≈ $70 per prescription (gross)

Summed across the 3 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1741270

10 ML iron sucrose 20 MG/ML Injection

58,179 Medicaid prescriptions (Q1–Q4 2025) 6% of Iron Sucrose Injection prescriptions shown $5.2M gross reimbursement (before rebates) ≈ $89 per prescription (gross)

Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1741261

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 Sucrose 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 17 of 40 listed Iron Sucrose Injection NDCs with Medicaid activity.

🔍 Compare Iron Sucrose Injection products

A representative set of FDA-listed product records for Iron Sucrose 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
20 mg/mL Intravenous A-S Medication Solutions NDA Find on DailyMed ↗
20 mg/mL Intravenous American Regent, Inc. × 12 listings NDA View NDC →
20 mg/mL Intravenous Fresenius Medical Care Holdings, Inc. × 6 listings NDA View NDC →
20 mg/mL Intravenous International Medication Systems, Limited × 3 listings ANDA View NDC →
50 mg/2.5 mL Intravenous Mylan Institutional LLC × 2 listings ANDA View NDC →
100 mg/5 mL Intravenous Mylan Institutional LLC × 2 listings ANDA View NDC →
200 mg/10 mL Intravenous Mylan Institutional LLC × 2 listings ANDA View NDC →
50 mg/2.5 mL Intravenous Sandoz Inc ANDA View NDC →
100 mg/5 mL Intravenous Sandoz Inc ANDA View NDC →
200 mg/10 mL Intravitreal Sandoz Inc ANDA View NDC →

Showing 31 of 31 products — FDA National Drug Code Directory. See every product, package size and price: browse all 31 Iron Sucrose Injection NDCs →

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.

Ingredient (IN) Iron Sucrose Injection RxCUI 24909 1 dose form · 3 strengths

Look up RxCUI 24909 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.

🏷️ Sold under these brand names

Venofer

🏭 Manufacturers & labelers

American Regent, Inc. 12 Fresenius Medical Care Holdings, Inc. 6 Mylan Institutional LLC 6 International Medication Systems, Limited 3 Sandoz Inc 3 A-S Medication Solutions 1

RxNorm drug class

Iron Sucrose Injection belongs to the Parenteral Iron Replacement class.

Pharmacologic class Parenteral Iron Replacement
Drug family (ATC) Iron trivalent, oral preparations

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 1, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Iron Sucrose Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Iron Sucrose Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
6
NDC products indexed
31
Distinct labelers/manufacturers represented
6
Linked representative label ⓘ
American Regent, Inc.
Linked label effective
Mar 1, 2026
Composite sections available
23
Linked SPL Set ID
626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a
Linked SPL Document ID
500b09f8-36f1-4842-8d07-246fea7bdfd0
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 6 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. American Regent, 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.