Baby Safety / Compounds / Phenobarbital

Is Phenobarbital safe for babies and kids?

Elevated 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 Phenobarbital poses heightened risk.

What is phenobarbital?

Also known as: Phenobarbitone, Luminal, Phenobarbitol, Fenobarbital.

CAS number
50-06-6
Molecular formula
C12H12N2O3
Molecular weight
232.23 g/mol
SMILES
CCC1(C(=O)NC(=O)NC1=O)C2=CC=CC=C2
PubChem CID
4763

Risk for babies

Elevated risk

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

Phenobarbital 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

1 regulatory bodyhas classified Phenobarbital.

AgencyYearClassificationNotes
DEASchedule IVControlled substance classification

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 phenobarbital

  • Industrial FacilitiesManufacturing plants, Chemical storage areas, Waste treatment sites
  • Occupational EnvironmentsFactories, Warehouses, Transportation vehicles

Safer alternatives

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

  • 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 phenobarbital 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 Phenobarbital poses heightened risk.

What products contain phenobarbital?

Phenobarbital 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 phenobarbital?

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 Phenobarbital in the baby app

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

Open in baby View raw API data

Sources (3)

  1. US FDA: Phenobarbital Prescribing Information — Indications, Adverse Effects, Dependence, Drug Interactions, and Controlled Substance Status (Schedule IV) (2019) — regulatory
  2. ASPCA Animal Poison Control Center: Phenobarbital Toxicosis in Dogs and Cats — Accidental Overdose, CNS Depression, and Management (2023) — veterinary
  3. Plumb's Veterinary Drug Handbook (10th ed.) — Phenobarbital: Anticonvulsant Use in Dogs and Cats, Hepatotoxicity Monitoring, and Dosing (2023) — veterinary

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 →