{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "iron sucrose",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/iron.json",
        "verbatim": true
      }
    ]
  }
}