Baby Safety / Compounds / Iron dextran

Is Iron dextran safe for babies and kids?

Moderate risk for kids

Infants are more vulnerable to Iron dextran than children or adults due to immature hepatic/renal clearance, higher intake-to-body-weight ratio, rapid organ development, and increased gastrointestinal absorption.

What is iron dextran?

Also known as: Armidexan, Cosmofer, Ferran 100, Ferrum.

CAS number
9004-66-4

Risk for babies

Moderate risk

Infants are more vulnerable to Iron dextran than children or adults due to immature hepatic/renal clearance, higher intake-to-body-weight ratio, rapid organ development, and increased gastrointestinal absorption.

Neonates and infants up to 12 months have incomplete blood-brain barrier development, immature Phase I/II metabolic enzymes (particularly CYP3A4, UGT1A1), and higher gastrointestinal permeability. Equivalent doses produce higher internal concentrations and longer residence times.

What to do: Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

Risk for pregnant and nursing people

Context-dependent

Pregnancy alters the metabolism and distribution of Iron dextran, potentially increasing fetal exposure. The developing embryo/fetus is vulnerable during organogenesis (weeks 3-8) and neurological development. Placental transfer should be assumed.

No specific reproductive toxicity data identified, but pregnancy-specific safety data is limited for most chemicals. Precautionary minimization of exposure is recommended.

What to do: Minimize exposure during pregnancy and lactation. Consult healthcare provider regarding specific risks. Consider alternative products with lower hazard profiles.

Regulatory consensus

4 regulatory and scientific bodies have classified Iron dextran. The classifications differ — that's the data.

AgencyYearClassificationNotes
IARC1973Group 2B — Iron dextran is possibly carcinogenic to humans (IARC Monograph Volume 2, 1973); carcinogenicity classification based on injection-site sarcomas (primarily fibrosarcomas) observed in rodents following repeated intramuscular injection; the mechanism is proposed to involve chronic inflammation and iron-catalyzed oxidative damage at the depot site; no human carcinogenicity evidence; widely used clinically as parenteral iron supplementation
EPA CTX / NTP RoC—Reasonably Anticipated to be a Human Carcinogen
EPA CTX / IARC—Group 2B - Possibly carcinogenic to humans
EPA CTX / CalEPA—Known human carcinogen

Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.

Where kids encounter iron dextran

  • Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
  • Occupational Environments — Factories, Warehouses, Transportation vehicles
  • Consumer Products — dietary supplements, fortified foods, energy drinks

Safer alternatives

Lower-risk approaches that achieve a similar outcome to Iron dextran:

  • Food-based nutrient sources; Whole food diet
    Trade-offs: Alternative approach; specific tradeoffs depend on application context, scale, and regulatory requirements. Full hazard assessment of alternative recommended before adoption to avoid regrettable substitution.
    Relative cost: 1.2-2×

Frequently asked questions

Is iron dextran safe for kids?

Infants are more vulnerable to Iron dextran than children or adults due to immature hepatic/renal clearance, higher intake-to-body-weight ratio, rapid organ development, and increased gastrointestinal absorption.

What products contain iron dextran?

Iron dextran appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments); dietary supplements (Consumer products).

What should I do if my child is exposed to iron dextran?

Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

Why do regulators disagree about iron dextran?

Iron dextran has been classified by 4 agencies including IARC, EPA CTX / NTP RoC, EPA CTX / IARC, EPA CTX / CalEPA, with differing conclusions. Regulators apply different standards of evidence (animal data weighting, exposure-pattern assumptions, epidemiological power thresholds), which is why two scientific bodies can review the same data and reach different conclusions. See the regulatory consensus table on this page for the full picture.

See Iron dextran in the baby app

Look up products containing iron dextran, compare to alternatives, and explore the full data record.

Open in baby View raw API data

Sources (1)
  1. IARC Group 2B Iron Dextran Vol 2 1973; Injection-Site Sarcoma Rodent IM SC Solid-State Carcinogenesis; HMWID LMWID InFeD DexFerrum CosmoFer; Anaphylaxis Test Dose 0.1-0.7%; CKD IBD Bariatric Surgery Parenteral Iron; Ferric Carboxymaltose Ferumoxytol Iron Sucrose Newer Formulations; Fenton Chemistry Fe2+/Fe3+ ROS Injection Depot; No Human Sarcoma Evidence; FDA EU Approved Hypersensitivity Label (1973) — regulatory

Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →