Baby Safety / Compounds / Hydroxyurea

Is Hydroxyurea safe for babies and kids?

Moderate risk for kids

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Hydroxyurea poses heightened risk.

What is hydroxyurea?

Also known as: Hydroxycarbamide, N-Hydroxyurea, Hydrea, Oxyurea.

CAS number
127-07-1
Molecular formula
CH4N2O2
Molecular weight
76.055 g/mol
SMILES
C(=O)(N)NO
PubChem CID
3657

Risk for babies

Moderate risk

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Hydroxyurea poses heightened risk.

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

High risk

Hydroxyurea poses pregnancy risk through potential teratogenicity, altered pharmacokinetics (increased blood volume, changed CYP activity), and placental transfer. FDA pregnancy category should be evaluated.

Known reproductive toxicant (GHS H360) or confirmed endocrine disruptor. Placental transfer is presumed. Fetal exposure during critical developmental windows may cause structural malformations, growth restriction, or functional deficits.

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

Regulatory consensus

1 regulatory bodyhas classified Hydroxyurea.

AgencyYearClassificationNotes
Regulatory Framework—Regulated as pharmaceutical (FDA/EMA); not typically classified under industrial chemical regulations

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 hydroxyurea

  • Consumer Products — various

Safer alternatives

Lower-risk approaches that achieve a similar outcome to Hydroxyurea:

  • Alternative drug class
    Trade-offs: Direct chemical substitution requires verification that the replacement does not introduce new hazards (regrettable substitution). Conduct full hazard assessment of proposed alternative before adoption.
    Relative cost: 1.2-2×

Frequently asked questions

Is hydroxyurea safe for kids?

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Hydroxyurea poses heightened risk.

What products contain hydroxyurea?

Hydroxyurea appears in: various (Consumer products).

What should I do if my child is exposed to hydroxyurea?

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.

See Hydroxyurea in the baby app

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

Open in baby View raw API data

Sources (1)
  1. PubChem (2026) — database

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 →