Baby Safety / Compounds / Doxylamine

Is Doxylamine 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 Doxylamine poses heightened risk.

What is doxylamine?

The IUPAC name is N,N-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine.

Also known as: N,N-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine, Dossilamina, Doxylaminum, Doxilminio.

IUPAC name
N,N-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine
CAS number
469-21-6
Molecular formula
C17H22N2O
Molecular weight
270.37 g/mol
SMILES
CC(C1=CC=CC=C1)(C2=CC=CC=N2)OCCN(C)C
PubChem CID
3162

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 Doxylamine 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

Elevated risk

Doxylamine 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

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

AgencyYearClassificationNotes
IARC—Not classifiedIARC has not classified doxylamine
FDA—ApprovedFDA-approved for nausea and vomiting of pregnancy (Diclegis/Bonjesta combination product)
American Geriatrics Society—Potentially inappropriate for older adultsIncluded in Beers Criteria due to high anticholinergic burden and disproportionate risk of delirium, falls, urinary retention, and cognitive impairment in elderly patients

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 doxylamine

  • 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 Doxylamine:

  • 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 doxylamine 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 Doxylamine poses heightened risk.

What products contain doxylamine?

Doxylamine 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 doxylamine?

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 doxylamine?

Doxylamine has been classified by 3 agencies including IARC, FDA, American Geriatrics Society, 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 Doxylamine in the baby app

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

Open in baby View raw API data

Sources (2)
  1. FDA Drug Approval: Doxylamine/Pyridoxine (Bonjesta/Diclegis) — Pregnancy Category A nausea/vomiting; Bendectin withdrawal/reapproval history; Unisom OTC sleep aid; not <12 years; anticholinergic ACB score 3; Beers Criteria elderly; NyQuil combination risks (2016) (2016) — regulatory
  2. American Association of Poison Control Centers (AAPCC): National Poison Data System Annual Report — Pediatric cocaine/stimulant exposures; body packing emergencies; levamisole agranulocytosis; accidental child ingestion outcomes (2022) (2022) — 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 →