Baby Safety / Compounds / Sarolaner (Simparica)

Is Sarolaner (Simparica) 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 Sarolaner (Simparica) poses heightened risk.

What is sarolaner (simparica)?

The IUPAC name is 1-[6-[(5S)-5-(3,5-dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4H-1,2-oxazol-3-yl]spiro[1H-2-benzofuran-3,3'-azetidine]-1'-yl]-2-methylsulfonylethanone.

Also known as: 1-[6-[(5S)-5-(3,5-dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4H-1,2-oxazol-3-yl]spiro[1H-2-benzofuran-3,3'-azetidine]-1'-yl]-2-methylsulfonylethanone, Sarolaner, Simparica, PF-6450567.

IUPAC name
1-[6-[(5S)-5-(3,5-dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4H-1,2-oxazol-3-yl]spiro[1H-2-benzofuran-3,3'-azetidine]-1'-yl]-2-methylsulfonylethanone
CAS number
1398609-39-6
Molecular formula
C23H18Cl2F4N2O5S
Molecular weight
581.4 g/mol
SMILES
CS(=O)(=O)CC(=O)N1CC2(C1)C3=C(CO2)C=C(C=C3)C4=NOC(C4)(C5=CC(=C(C(=C5)Cl)F)Cl)C(F)(F)F
PubChem CID
73169092

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 Sarolaner (Simparica) 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

Sarolaner (Simparica) 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 Sarolaner (Simparica).

AgencyYearClassificationNotes
IARC2022Not evaluated by IARC — sarolaner (Simparica, Simparica TRIO; Zoetis) is an FDA/CVM-approved isoxazoline ectoparasiticide for dogs; monthly oral tablet providing flea and tick protection; FDA 2018/2022 class-wide neurological adverse event warning; Simparica TRIO combines sarolaner with milbemycin oxime and pyrantel; no carcinogenicity 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 sarolaner (simparica)

  • 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 Sarolaner (Simparica):

  • 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 sarolaner (simparica) 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 Sarolaner (Simparica) poses heightened risk.

What products contain sarolaner (simparica)?

Sarolaner (Simparica) 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 sarolaner (simparica)?

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 Sarolaner (Simparica) in the baby app

Look up products containing sarolaner (simparica), compare to alternatives, and explore the full data record.

Open in baby View raw API data

Sources (1)
  1. Sarolaner Simparica Simparica TRIO Zoetis FDA CVM 2016; Isoxazoline GluCl GABA Channel Dog; Triple Combination Milbemycin Oxime Pyrantel Heartworm Flea Tick; FDA 2018 2022 Class Warning Neurological Tremors Ataxia Seizures; Half-Life 11-12 Days 99.9% Protein Binding; MDR1 Milbemycin Component TRIO; EMA VMP Environmental Risk Aquatic Arthropod; Simparica TRIO Comprehensive Monthly Prevention; IARC Not Evaluated (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 →