Baby Safety / Compounds / Dantrolene

Is Dantrolene 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 Dantrolene poses heightened risk.

What is dantrolene?

The IUPAC name is 1-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]imidazolidine-2,4-dione.

Also known as: 1-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]imidazolidine-2,4-dione, Dantroleno, Dantrolenum, F-368.

IUPAC name
1-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]imidazolidine-2,4-dione
CAS number
7261-97-4
Molecular formula
C14H10N4O5
Molecular weight
314.25 g/mol
SMILES
C1C(=O)NC(=O)N1N=CC2=CC=C(O2)C3=CC=C(C=C3)[N+](=O)[O-]
PubChem CID
6914273

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 Dantrolene 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

Dantrolene 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 Dantrolene.

AgencyYearClassificationNotes
US FDA (approved drug; non-scheduled)2022no carcinogenicity classification; FDA-approved for malignant hyperthermia treatment and prevention (IV), chronic spasticity (oral), and neuroleptic malignant syndrome (off-label); FDA warning for hepatotoxicity with chronic oral use; 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 dantrolene

  • 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 Dantrolene:

  • 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 dantrolene 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 Dantrolene poses heightened risk.

What products contain dantrolene?

Dantrolene 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 dantrolene?

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 Dantrolene in the baby app

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

Open in baby View raw API data

Sources (1)
  1. FDA Dantrolene Dantrium Ryanodex Prescribing Information 2022: RyR1 Sarcoplasmic Reticulum Calcium Inhibitor; MH Treatment 2.5 mg/kg IV Mortality Reduced <10%; Oral Hepatotoxicity Warning Fatal Necrosis 0.1%; Spasticity Cerebral Palsy SCI; LFT Monitoring Required (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 →