Baby Safety / Compounds / Cyclobenzaprine

Is Cyclobenzaprine 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 Cyclobenzaprine poses heightened risk.

What is cyclobenzaprine?

The IUPAC name is N,N-dimethyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)propan-1-amine.

Also known as: N,N-dimethyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)propan-1-amine, Proheptatriene, Proheptatrien, Ciclobenzaprina.

IUPAC name
N,N-dimethyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)propan-1-amine
CAS number
303-53-7
Molecular formula
C20H21N
Molecular weight
275.4 g/mol
SMILES
CN(C)CCC=C1C2=CC=CC=C2C=CC3=CC=CC=C31
PubChem CID
2895

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 Cyclobenzaprine 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

Cyclobenzaprine 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 Cyclobenzaprine.

AgencyYearClassificationNotes
US FDA (approved drug; non-scheduled)2020no carcinogenicity classification; FDA-approved muscle relaxant for short-term (≤2–3 weeks) relief of muscle spasm; tricyclic structure related to amitriptyline; not a DEA controlled substance; not classified for carcinogenicity by NTP, IARC, or EFSA

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 cyclobenzaprine

  • 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 Cyclobenzaprine:

  • Therapeutic alternatives (consult prescriber)
    Trade-offs: Drug-specific. Cannot substitute without medical guidance.
    Relative cost: 1.2-2×

Frequently asked questions

Is cyclobenzaprine 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 Cyclobenzaprine poses heightened risk.

What products contain cyclobenzaprine?

Cyclobenzaprine 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 cyclobenzaprine?

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 Cyclobenzaprine in the baby app

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

Open in baby View raw API data

Sources (1)
  1. FDA Cyclobenzaprine Flexeril Prescribing Information 2020: Not Controlled Substance; TCA Structure Amitriptyline; Anticholinergic Dry Mouth 21%; QTc Prolongation; Serotonin Syndrome SSRIs MAOIs; Beers Criteria Elderly; Pediatric <15 Not Approved (2020) — 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 →