Sodium Ferric Gluconate Injection
Sodium ferric gluconate injection is an intravenous iron replacement used to treat iron deficiency anemia in adults and children aged 6 and older with chronic kidney disease who are on hemodialysis.
🧬 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 4 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 →
📖 Sodium Ferric Gluconate Injection: Patient Information Guide
A plain-language walkthrough of Sodium Ferric Gluconate 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▾
Sodium ferric gluconate injection is an IV iron replacement approved to treat iron deficiency anemia in specific patients with chronic kidney disease.
- Sodium Ferric Gluconate Complex in Sucrose injection is approved for adults with chronic kidney disease who are on hemodialysis and are also receiving epoetin (a red blood cell-stimulating medication)
- Sodium Ferric Gluconate Complex in Sucrose injection is approved for children aged 6 years and older with chronic kidney disease who are on hemodialysis and are also receiving epoetin therapy
- It is not approved for children under age 6, or for patients who are not on hemodialysis or epoetin therapy
⚙️How it works▾
Your body needs iron to make hemoglobin — the molecule inside red blood cells that carries oxygen to every tissue. In people with chronic kidney disease on dialysis, iron levels often run low, making it hard to build enough healthy red blood cells. Sodium ferric gluconate injection delivers iron directly into the bloodstream. From there, about 80% of the iron is transferred to transferrin (a transport protein in the blood) within 24 hours, which then carries it to where it's needed. Iron also supports normal metabolism and many enzyme-driven processes throughout the body.
💊How it's taken▾
Sodium ferric gluconate injection is given intravenously (directly into a vein) by a trained healthcare provider — it is never taken by mouth. It is administered during or alongside hemodialysis sessions. Adults may receive it as a diluted infusion over about 1 hour or as a slow injection, once per session. Children aged 6 and older receive a weight-based diluted infusion over 1 hour per session, with a maximum amount per dose. A full course of treatment for adults is typically spread over 8 dialysis sessions; treatment may be repeated if iron deficiency returns. Always follow your care team's instructions for your specific regimen.
🤒Side effects — in detail▾
The most common side effects include:
- Nausea, vomiting, or diarrhea
- Low blood pressure (hypotension), which may cause dizziness or lightheadedness
- High blood pressure (hypertension)
- Muscle or leg cramps
- Injection site reactions
- Shortness of breath
- Chest pain or other body pain
- In children: headache and fast heart rate (tachycardia) were also common
Seek emergency care immediately for signs of a serious allergic reaction — such as difficulty breathing, collapse, loss of consciousness, or severe low blood pressure — as these can be life-threatening.
⚠️Warnings & precautions▾
- Severe allergic reactions (including anaphylaxis): Life-threatening reactions, including shock and loss of consciousness, have occurred. You must be monitored for at least 30 minutes after each dose in a setting where emergency care is available.
- Low blood pressure (hypotension): This medication can cause a significant drop in blood pressure, sometimes with severe pain or weakness. Risk may be higher if you're also taking an ACE inhibitor blood pressure medication.
- Iron overload (hemosiderosis): Too much iron can build up in the body if this medication is given excessively. Regular blood and iron level monitoring is required throughout treatment.
- Benzyl alcohol risk in infants: This medication is not approved for neonates or infants. It contains benzyl alcohol, which can cause a potentially fatal condition called "gasping syndrome" in newborns and low-birth-weight babies.
- Pregnancy: Serious allergic reactions could harm the fetus. Use only when clearly necessary, and note the medication contains benzyl alcohol.
🔀What it interacts with▾
Formal drug interaction studies have not been conducted for sodium ferric gluconate injection, but the label identifies the following important points:
- Oral iron supplements: This injection may reduce absorption of iron taken by mouth — tell your doctor or pharmacist about any iron pills or liquids you take
- ACE inhibitors (e.g., blood pressure medicines ending in "-pril"): Patients taking these medicines alongside this injection had a slightly higher rate of drug intolerance and allergic-type reactions
- Other IV medications or parenteral nutrition: Do not mix this injection with any other medication or add it to IV nutritional solutions — compatibility has only been established with 0.9% sodium chloride (normal saline)
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 this medication if you have a known allergy to sodium ferric gluconate or any of its components — allergic reactions can be life-threatening
- Tell your doctor if you already have iron overload or high iron levels — this medication should not be given in that case
- Tell your doctor if you are pregnant — this medication carries a risk of serious allergic reactions that could affect the fetus, and it contains benzyl alcohol
- This medication is not recommended if you are breastfeeding
- This medication is not approved for neonates or infants due to the benzyl alcohol content, which can cause fatal reactions in this age group
- Safety and effectiveness have not been established in children younger than 6 years old
- You will need regular blood tests (hemoglobin, hematocrit, ferritin, and transferrin levels) throughout treatment to make sure iron is at safe levels
🚑If you take too much▾
Receiving too much sodium ferric gluconate injection can cause iron to build up in the body — a condition called hemosiderosis — which can damage organs. Doses higher than the recommended maximum per session have been linked to a higher rate and severity of side effects, including low blood pressure, nausea, vomiting, dizziness, and shortness of breath. This medication cannot be removed from the body by dialysis, so prevention through careful dosing is critical — contact a healthcare provider or poison control immediately if overdose is suspected.
📡Pharmacodynamics — effects in the body▾
Sodium ferric gluconate injection replenishes the body's iron stores, which are essential for producing hemoglobin — the oxygen-carrying protein in red blood cells. By restoring iron levels, it supports the body's ability to make healthy red blood cells and helps correct anemia. Iron supplied by this medication is also required for normal metabolism and enzyme activity throughout the body.
🔬Pharmacokinetics — how your body processes it▾
After IV administration, sodium ferric gluconate delivers iron to transferrin (a blood transport protein), with about 80% transferred within 24 hours. The drug is cleared from the bloodstream relatively quickly — the elimination half-life (the time for half the drug to leave the blood) is approximately 1 hour in adults, and around 2 to 2.5 hours in pediatric hemodialysis patients. Very little iron from this medication is removed by dialysis, and urinary excretion is not considered a meaningful route of elimination. Iron levels in the blood return toward baseline roughly 40 hours after a dose.
📦How to store it▾
Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F). Do not freeze. Keep out of the reach of children.
📄 Written from Sodium Ferric Gluconate 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 Sodium Ferric Gluconate Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I need an iron IV instead of just taking iron pills? ▾
What should I watch out for during or after my infusion? ▾
How many treatments will I need? ▾
Is it safe to take my iron pills on the same days I get this IV iron? ▾
I'm pregnant. Can I still get this medication? ▾
Can my child receive this medication? ▾
Is Sodium Ferric Gluconate Injection available over the counter? ▾
When was Sodium Ferric Gluconate Injection first available? ▾
Who makes Sodium Ferric Gluconate Injection? ▾
💬 Answers drafted from Sodium Ferric Gluconate 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 Sodium Ferric Gluconate Injection comes
Sodium Ferric Gluconate 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
- Sodium Ferric Gluconate Complex in Sucrose injection is used to treat iron deficiency anemia in adults with chronic kidney disease on hemodialysis who are also receiving epoetin therapy
- Sodium Ferric Gluconate Complex in Sucrose injection is used to treat iron deficiency anemia in children aged 6 and older with chronic kidney disease on hemodialysis who are also receiving epoetin therapy
- Sodium Ferric Gluconate Complex in Sucrose injection is given intravenously (into a vein) by a healthcare provider — it must not be mixed with other medications or added to IV nutrition solutions
- For adults, Sodium Ferric Gluconate Complex in Sucrose injection may be given as a diluted IV infusion over 1 hour or as a slow IV injection, once per dialysis session
- For children aged 6 and older, Sodium Ferric Gluconate Complex in Sucrose injection is given as a diluted IV infusion over 1 hour, once per dialysis session — the dose is weight-based and must not exceed 125 mg per dose
- If diluted, Sodium Ferric Gluconate Complex in Sucrose injection should be used immediately; inspect the solution for particles or discoloration before administration
📊 Sodium Ferric Gluconate Injection across the U.S. market
How Sodium Ferric Gluconate 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 Sodium Ferric Gluconate Injection is used
A general measure of how commonly Sodium Ferric Gluconate 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 Sodium Ferric Gluconate 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 Sodium Ferric Gluconate Injection prescribed? Of the 1,596 medications we measure, Sodium Ferric Gluconate Injection ranks #687 by Medicaid prescriptions — more than 57% of them.
Utilization by Sodium Ferric Gluconate 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.
5 ML sodium ferric gluconate complex 12.5 MG/ML Injection
Summed across the 4 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 242761
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 Sodium Ferric Gluconate 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 4 of 8 listed Sodium Ferric Gluconate Injection NDCs with Medicaid activity.
🔍 Compare Sodium Ferric Gluconate Injection products
A representative set of FDA-listed product records for Sodium Ferric Gluconate 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 | ||||
| 12.5 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 4 listings | ANDA | View NDC → |
| 12.5 mg/mL | Intravenous | sanofi-aventis U.S. LLC × 4 listings | NDA | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Sodium Ferric Gluconate 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 Sodium Ferric Gluconate 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 Sodium Ferric Gluconate 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 Sodium Ferric Gluconate 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.
📦 Supply & shortage status
Whether Sodium Ferric Gluconate 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 4 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. sanofi-aventis U.S. LLC 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.