Baby Safety / Compounds / Cyclophosphamide

Is Cyclophosphamide safe for babies and kids?

Severe 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 Cyclophosphamide poses heightened risk.

What is cyclophosphamide?

The IUPAC name is N,N-bis(2-chloroethyl)-2-oxo-1,3,2lambda5-oxazaphosphinan-2-amine.

Also known as: N,N-bis(2-chloroethyl)-2-oxo-1,3,2lambda5-oxazaphosphinan-2-amine, Cytoxan, Cyclophosphamid, Cyclophosphane.

IUPAC name
N,N-bis(2-chloroethyl)-2-oxo-1,3,2lambda5-oxazaphosphinan-2-amine
CAS number
50-18-0
Molecular formula
C7H15Cl2N2O2P
Molecular weight
261.08 g/mol
SMILES
C1CNP(=O)(OC1)N(CCCl)CCCl
PubChem CID
2907

Risk for babies

Severe risk

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

Very high risk

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

Suspected reproductive toxicant (GHS H361) or suspected endocrine disruptor. Precautionary approach warranted. Animal studies or limited human data suggest developmental toxicity potential.

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

Regulatory consensus

6 regulatory and scientific bodies have classified Cyclophosphamide. The classifications differ — that's the data.

AgencyYearClassificationNotes
IARC2012Group 1IARC Group 1 classification for cyclophosphamide based on sufficient evidence of carcinogenicity in humans — specifically, increased incidence of bladder cancer, myelodysplastic syndrome (MDS), and acute myeloid leukemia (AML) in patients treated with cyclophosphamide as part of cancer chemotherapy or immunosuppressive therapy. Acrolein, a reactive metabolite of cyclophosphamide, is the primary causative agent for bladder urothelial toxicity and carcinogenicity. Mesna (sodium 2-mercaptoethane sulfonate) co-administration is used clinically to inactivate acrolein in the bladder and reduce hemorrhagic cystitis and bladder cancer risk.
EPA CTX / NTP RoC—Known Human Carcinogen
EPA CTX / IARC—Group 1 - Carcinogenic to humans
EPA CTX / CalEPA—Known human carcinogen
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 50 positive / 1 negative reports)
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 50 positive / 1 negative reports)

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 cyclophosphamide

  • Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
  • Occupational Environments — Factories, Warehouses, Transportation vehicles

Safer alternatives

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

  • Alternative drug class; Non-pharmacological therapy; Lowest effective dose
    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 cyclophosphamide 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 Cyclophosphamide poses heightened risk.

What products contain cyclophosphamide?

Cyclophosphamide appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments).

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

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 cyclophosphamide?

Cyclophosphamide has been classified by 6 agencies including IARC, EPA CTX / NTP RoC, EPA CTX / IARC, EPA CTX / CalEPA, EPA CTX / Genetox, 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 Cyclophosphamide in the baby app

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

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Sources (5)
  1. IARC Monographs Volume 100A: Pharmaceuticals — Cyclophosphamide, Group 1 Classification (Bladder Cancer, AML/MDS; Acrolein Mechanism) (2012) — regulatory
  2. US FDA: Cyclophosphamide Prescribing Information — Indications, Dosing, Myelosuppression, Hemorrhagic Cystitis, Teratogenicity, and Secondary Malignancy Warnings (2021) — regulatory
  3. ASPCA Animal Poison Control Center: Cyclophosphamide and Alkylating Agent Toxicosis in Dogs and Cats — Emergency Management (2023) — veterinary
  4. Plumb's Veterinary Drug Handbook (10th ed.) — Cyclophosphamide: Veterinary Oncology Use, CHOP Protocol, Hemorrhagic Cystitis Prevention, and Toxicity Management (2023) — veterinary
  5. NIOSH: Safe Handling of Hazardous Drugs — Antineoplastic Agents, PPE Requirements, Engineering Controls, and Pharmaceutical Waste Disposal (2016) — 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 →