Iron Sucrose

Iron sucrose is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, iron sucrose is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells.

• Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).ICD-10: D64.9, E61.1, N18.9

• • Known hypersensitivity to iron sucrose. • Known hypersensitivity to iron sucrose.contraindicated

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 iron sucrose injection only intravenously by slow injection or by infusion. The dosage of iron sucrose injection 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 iron sucrose injection 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 iron sucrose injection early during the dialysis session (generally within the first hour). The usual total treatment course of iron sucrose injection is 1000 mg. Iron sucrose injection treatment may be repeated if iron deficiency reoccurs.

• Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after iron sucrose administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer iron sucrose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. ( 5.1 ) • Hypotension: May cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration. ( 5.2 ) • Iron Overload: Regularly monitor hematologic responses during therapy. Do not administer to patients with iron overload. ( 5.3 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving iron sucrose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop iron sucrose immediately. Monitor patients for signs and symptoms of hypersensitivity during and after iron sucrose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer iron sucrose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion [see Adverse Reactions ( 6.1 and 6.2 )] .

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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 Adult Patients with CKD The frequency of adverse reactions associated with the use of iron sucrose 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 reported by ≥ 2% of treated patients in the six clinical trials for which the rate for iron sucrose exceeds the rate for comparator are listed by indication in Table 1.

8.1 Pregnancy Risk Summary Published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes ( see Data ). Available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see Clinical Considerations ). Animal reproduction studies of iron sucrose administered to rats and rabbits during the period of organogenesis at elemental iron doses equivalent to the maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Iron deficiency anemia during pregnancy should be treated.

Metabolism

In healthy adults administered intravenous doses of iron sucrose, its iron component exhibited first order kinetics with an elimination half-life of 6 h, total clearance of 1.2 L/h, and steady state apparent volume of distribution of 7.9 L. The iron component appeared to distribute mainly in blood and to some extent in extravascular fluid.

No data are available regarding overdosage of iron sucrose in humans. Excessive dosages of iron sucrose may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer iron sucrose to patients with iron overload [see Warnings and Precautions (5.3) ] . Iron sucrose is not dialyzable through CA210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. Toxicities in single-dose studies in mice and rats, at intravenous iron sucrose doses up to 8 times the maximum recommended human dose based on body surface area, included sedation, hypoactivity, pale eyes, bleeding in the gastrointestinal tract and lungs, and mortality.

• Nov 6, 2000NDANDA021135Am Regent
• Aug 8, 2025ANDAANDA212340Sandoz
• Aug 8, 2025ANDAANDA208977Intl Medication Sys
• Aug 8, 2025ANDAANDA212559Mylan Labs Ltd

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Iron Sucrose, Injection, 50 mg/2.5 mL (NDC 67457-957-99)To be discontinued
  Sponsor: Mylan Institutional, a Viatris Company
  Updated May 21, 2026

1. 1Drug Hypersensitivity1,15412%
2. 2Nausea99211%
3. 3Dyspnoea96910%
4. 4Off Label Use6236.7%
5. 5Pruritus6146.6%
6. 6Vomiting6096.6%
7. 7Diarrhoea5355.8%
8. 8Rash5255.7%
9. 9Hypotension4975.4%
10. 10Dizziness4885.3%
11. 11Headache4574.9%
12. 12Malaise4474.8%
13. 13Arthralgia4424.8%
14. 14Pain4314.7%
15. 15Urticaria4274.6%

Recent PubMed references pinned to Iron Sucrose as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• The effect of intravenous sodium ferric gluconate complex (Ferrlecit) on outcomes of patients undergoing transcatheter aortic valve implantation: a prospective randomized controlled trial.
  Journal of cardiovascular medicine (Hagerstown, Md.) · 2026 · Bar O, Zukermann R, Halhal B, et al.
  PMID 41870899DOI 10.2459/JCM.0000000000001867
• Comparative Study between Intravenous Ferric Carboxymaltose versus Iron Sucrose in the Treatment of Iron Deficiency Anemia in Postpartum Patients.
  Mymensingh medical journal : MMJ · 2026 · Hossain S, Siddiqui H, Munira S, et al.
  PMID 41474901
• Comparing iron sucrose and ferric carboxymaltose interactions with murine and human macrophages: Focus on the lysosomal compartment.
  European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2026 · Sousa de Almeida M, Bazzoni A, Balog S, et al.
  PMID 41319923DOI 10.1016/j.ejps.2025.107390
• Postpartum IV iron sucrappenose, and rates of RBC transfusion: A quality improvement initiative.
  Transfusion medicine (Oxford, England) · 2026 · Futterman ID, Azhar E, Geller NF, et al.
  PMID 41102891DOI 10.1111/tme.70028
• Understanding the kinetics of macrophage uptake and the metabolic fate of iron-carbohydrate complexes used for iron deficiency anemia treatment.
  Journal of controlled release : official journal of the Controlled Release Society · 2025 · Eitner S, Kissling VM, Rippl A, et al.
  PMID 40915361DOI 10.1016/j.jconrel.2025.114186
• Safety and effectiveness of iron sucrose therapy in paediatric patients with iron deficiency anaemia: a single-institution retrospective study.
  BMC pediatrics · 2025 · Zhao S, Cheng J, Zhang L, et al.
  PMID 40764563DOI 10.1186/s12887-025-05894-0
• Iron supplementation protects against renal ischemia-reperfusion injury by enhancing mitochondrial respiratory complex assembly.
  Biochemical pharmacology · 2025 · Qi Y, Wang Z, Zhang Z, et al.
  PMID 40744231DOI 10.1016/j.bcp.2025.117197
• Real-world use of intravenous iron sucrose in children with cardiac disease.
  Cardiology in the young · 2025 · Stack KO, Shulman SB, Blume ED, et al.
  PMID 40739898DOI 10.1017/S1047951125101133

The 10 most recently updated of 145 ClinicalTrials.gov registrations naming Iron Sucrose as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion
  Recruiting · Interventional · 400 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT06012760updated 2026-06-02
• Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
  Recruiting · Phase 2 · Interventional · 34 enrolled · Fox Chase Cancer Center
  NCT05800600updated 2026-05-22
• Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients
  Completed · Interventional · 128 enrolled · Sindh Institute of Urology and Transplantation
  NCT06994065updated 2026-04-22
• A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
  Recruiting · Phase 3 · Interventional · 75 enrolled · AMAG Pharmaceuticals, Inc.
  NCT03893045updated 2026-04-17
• A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)
  Recruiting · Phase 3 · Interventional · 129 enrolled · AMAG Pharmaceuticals, Inc.
  NCT03619850updated 2026-04-17
• Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy
  Recruiting · Interventional · 400 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT06968936updated 2026-04-13
• Iron and Immune Response to Vaccine (IRONMUM)
  Completed · Interventional · 171 enrolled · University of Oxford
  NCT05385042updated 2026-03-24
• Comparison of the Mean Change in Hemoglobin With Ferric Carboxymaltose and IV Iron Sucrose in Anemic Antenatal Patients
  Completed · Interventional · 40 enrolled · Muhammad Aamir Latif
  NCT07115121updated 2025-09-05
• Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery
  Recruiting · Early phase 1 · Interventional · 40 enrolled · Englewood Hospital and Medical Center
  NCT06970925updated 2025-08-07
• Pharmacokinetic of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
  Completed · Phase 2 · Interventional · 10 enrolled · American Regent, Inc.
  NCT00239616updated 2025-05-18

Frequently asked questions

How does Iron Sucrose work?

Iron sucrose is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, iron sucrose is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells.

What is Iron Sucrose used for?

According to FDA labeling, Iron Sucrose carries indications including: Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Iron Sucrose?

Iron Sucrose is classified as Iron trivalent, oral preparations, Parenteral Iron Replacement, Electrolyte Activity, Increased Erythroid Cell Production.

What are the brand names for Iron Sucrose?

Iron Sucrose is marketed under brand names including Venofer.

What are the contraindications for Iron Sucrose?

Iron Sucrose labeling lists contraindications including: • Known hypersensitivity to iron sucrose. • Known hypersensitivity to iron sucrose.. Always consult the full prescribing information and a clinician.