# Iron Sucrose

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DRUG INFORMATION

  ADULT
    - 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 ) ] .
      Source: US FDA label for iron (Iron Sucrose), section 'dosage and administration',
      retrieved 2026-08-29
    - Iron Sucrose Injection treatment may be repeated if iron deficiency reoccurs. 2.3
      Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD)
      Administer Iron Sucrose Injection 200 mg undiluted as a slow intravenous injection
      over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0.9%
      NaCl over a period of 15 minutes.
      Source: US FDA label for iron (Iron Sucrose), section 'dosage and administration',
      retrieved 2026-08-29
    - There is limited experience with administration of an infusion of 500 mg of Iron
      Sucrose Injection, diluted in a maximum of 250 mL of 0.9% NaCl, over a period of
      3.5 to 4 hours on Day 1 and Day 14 [ see How Supplied/Storage and Handling ( 16.2
      ) ] .
      Source: US FDA label for iron (Iron Sucrose), section 'dosage and administration',
      retrieved 2026-08-29

  CHILD
    - Safety and effectiveness of Iron Sucrose Injection for iron replacement treatment
      in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have
      not been established. Safety and effectiveness of Iron Sucrose Injection for iron
      maintenance treatment in pediatric patients 2 years of age and older with
      dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy
      were studied.
      Source: US FDA label for iron (Iron Sucrose), section 'pediatric use', retrieved
      2026-08-29
    - 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.
      Source: US FDA label for iron (Iron Sucrose), section 'use in specific
      populations', retrieved 2026-08-29
    - Iron Sucrose Injection at doses of 0.5 mg/kg, 1 mg/kg, and 2 mg/kg was
      administered.
      Source: US FDA label for iron (Iron Sucrose), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - 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 ) ] .
      Source: US FDA label for iron (Iron Sucrose), section 'dosage and administration',
      retrieved 2026-08-29
    - Administer Iron Sucrose Injection early during the dialysis session (generally
      within the first hour).
      Source: US FDA label for iron (Iron Sucrose), section 'dosage and administration',
      retrieved 2026-08-29
    - Iron Sucrose Injection treatment may be repeated if iron deficiency reoccurs. 2.3
      Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD)
      Administer Iron Sucrose Injection 200 mg undiluted as a slow intravenous injection
      over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0.9%
      NaCl over a period of 15 minutes.
      Source: US FDA label for iron (Iron Sucrose), section 'dosage and administration',
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for iron (Iron Sucrose), retrieved
      2026-08-29

  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 ).
      Source: US FDA label for iron (Iron Sucrose), section 'pregnancy', retrieved
      2026-08-29
    - 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.
      Source: US FDA label for iron (Iron Sucrose), section 'pregnancy', retrieved
      2026-08-29
    - There are risks to the mother and fetus associated with untreated IDA in pregnancy
      as well as risk to the fetus associated with maternal severe hypersensitivity
      reactions ( see Clinical Considerations ).
      Source: US FDA label for iron (Iron Sucrose), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary Iron Sucrose is present in human milk, and available published
      reports following exposure to 100-300 mg intravenous iron sucrose have not
      reported adverse reactions in breastfed infants ( see Data ).
      Source: US FDA label for iron (Iron Sucrose), section 'nursing mothers', retrieved
      2026-08-29
    - There are no data on the effects on milk production.
      Source: US FDA label for iron (Iron Sucrose), section 'nursing mothers', retrieved
      2026-08-29
    - The developmental and health benefits of breastfeeding should be considered, along
      with the mother’s clinical need for Iron Sucrose Injection and any potential
      adverse effects on the breastfed child from Iron Sucrose Injection or from the
      underlying maternal condition.
      Source: US FDA label for iron (Iron Sucrose), section 'nursing mothers', retrieved
      2026-08-29
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