Iron Sucrose: uses, dosing, side effects & brands

Iron Sucrose is a parenteral iron replacement sold in the U.S. under one brand, for hematologic pregnancy complications and iron-deficiency anemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Parenteral Iron Replacement
Treats: Hematologic Pregnancy Complications and Iron-Deficiency Anemia
Available as: Injectable
Sold as: Venofer
Prescription?: Prescription only
Generic available?: Not in our catalog

How iron sucrose is dosed

From the FDA label for Venofer (application NDA021135). Other iron sucrose products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Venofer must only be administered intravenously either by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron. Population Dose Adult patients Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) ( 2.2 ) 100 mg slow intravenous injection or infusion Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) ( 2.3 ) 200 mg slow intravenous injection or infusion Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) ( 2.4 ) 300 mg or 400 mg intravenous infusion Pediatric patients HDD-CKD ( 2.5 ), PDD-CKD or NDD-CKD ( 2.6 ) 0.5 mg/kg slow intravenous injection or infusion 2.1 Mode of Administration Administer Venofer only intravenously by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron. 2.2 Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) Administer Venofer 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session [see How Supplied/Storage and Handling ( 16.2 ).] Administer Venofer early during the dialysis session (generally within the first hour). The usual total treatment course of Venofer is 1000 mg. Venofer treatment may be…

Iron Sucrose side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypotension [see Warnings and Precautions ( 5.2 )] Iron Overload [see Warnings and Precautions ( 5.3 )] Adult patients: The most common adverse reactions (≥2%) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema. ( 6.1 ) Pediatric patients: The most common adverse reactions (≥2%) are headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice. Adverse Reactions in Adults Patients with CKD The frequency of adverse reactions associated with the use of Venofer has been documented in six clinical trials involving 231 patients with HDD-CKD, 139 patients with NDD-CKD and 75 patients with PDD-CKD. Adverse reactions…

Who shouldn’t take iron sucrose

Known hypersensitivity to Venofer. Known hypersensitivity to Venofer ( 4 )

Iron Sucrose drug interactions

Venofer may reduce the absorption of concomitantly administered oral iron preparations.

Every iron sucrose 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: Venofer.

Iron Sucrose recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long iron sucrose keeps

The date on a sealed pack is not the only one: some iron sucrose labels start a second clock once the product is opened or mixed, as short as 7 days.

Does iron sucrose expire? The in-use limits and storage rules from its labels

Iron Sucrose and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Limited data indicate that breastmilk iron is not increased after intravenous infusion of iron sucrose. Amounts of iron ingested by the infant would be normal and are not expected to cause any adverse effects in breastfed infants. The oral form of the drug, called sucroferric oxyhydroxide and used as a phosphate binder, is not orally absorbed and it is unlikely to reach the breastmilk or adversely affect the breastfed infant. No special precautions are required. For additional information on iron use during breastfeeding, see the monograph on Iron Salts.

Full LactMed record for iron sucrose: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised August 15, 2024. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about iron sucrose

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,565 reports naming iron sucrose, and the FDA flagged 93% 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:

nausea238 reports
arthralgia216 reports
dyspnoea206 reports
rash206 reports
diarrhoea196 reports
hypertension179 reports
drug hypersensitivity178 reports
headache159 reports

Read these as a signal, not a rate. A report does not mean iron sucrose 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.

Related calculators

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Frequently asked questions

What is iron sucrose?

Venofer (Iron Sucrose) is a parenteral iron replacement used to treat Hematologic Pregnancy Complications, Iron-Deficiency Anemia.

What kind of drug is iron sucrose?

The FDA classifies iron sucrose 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 iron sucrose 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 iron sucrose 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 iron sucrose come in?

Across the brands we track, iron sucrose 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 iron sucrose?

We do not currently list a generic-labelled iron sucrose 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.

Has iron sucrose been recalled?

The FDA's Enforcement database lists 3 recall records whose product description mentions iron sucrose. The most recent: Venofer (iron sucrose) Injection (Nov 11, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Cite this page

APA: pharmaranks. (2026, July 24). Iron Sucrose: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/iron-sucrose
MLA: “Iron Sucrose: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/iron-sucrose.

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 iron sucrose on DailyMed (NIH) ↗.