Sarolaner

Indications

SIMPARICA kills adult fleas, and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations [ Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing lxodes scapularis vector ticks.

Dosage and Administration

SIMPARICA is given orally once a month at the recommended minimum dosage of 0.91 mg/lb (2 mg/kg). Dosage Schedule: Body Weight SAROLANER per Tablet (mg) Number of Tablets Administered 2.8 to 5.5 lbs 5 One 5.6 to 11 lbs 10 One 11.1 to 22 lbs 20 One 22.1 to 44 lbs 40 One 44.1 to 88 lbs 80 One 88.1 to 132 lbs 120 One >132.1 lbs Administer the appropriate combination of tablets SIMPARICA can be offered by hand, in the food, or administered like other tablet medications. Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. If a dose is missed, administer SIMPARICA and resume a monthly dosing schedule. SIMPARICA should be administered at monthly intervals. Flea Treatment and Prevention: Treatment with SIMPARICA may begin at any time of the year. In areas where fleas are common year-round, monthly treatment with SIMPARICA can continue the entire year without interruption. To minimize the likelihood of flea re-infestation, it is important to treat all dogs and cats within a household with an approved flea control product. Tick Treatment and Control: Treatment with SIMPARICA can begin at any time of the year (see Effectiveness ).

Contraindications

There are no known contraindications for the use of SIMPARICA.

Warnings

Not for use in humans. Keep this and all drugs out of reach of children. For use in dogs only. Do not use SIMPARICA in cats. SIMPARICA should not be used in dogs less than 6 months of age (see Animal Safety ). Keep SIMPARICA in a secure location out of reach of dogs, cats and other animals to prevent accidental ingestion or overdose.

Precautions

Sarolaner is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. The safe use of SIMPARICA has not been evaluated in breeding, pregnant, or lactating dogs.

Adverse Reactions

SIMPARICA was administered in a well-controlled US field study, which included a total of 479 dogs (315 dogs treated with SIMPARICA and 164 dogs treated with active control once monthly for three treatments). Over the 90-day study period, all observations of potential adverse reactions were recorded. Table 1. Dogs with adverse reactions Adverse reaction sarolaner sarolaner active control active control N % (n = 315) N # (n =164) Vomiting 3 0.95% 9 5.50% Diarrhea 2 0.63% 2 1.20% Lethargy 1 0.32% 2 1.20% Inappetence 0 0% 3 1.80% Additionally, one female dog aged 8.6 years exhibited lethargy, ataxia while posturing to eliminate, elevated third eyelids, and inappetence one day after receiving SIMPARICA concurrently with a heartworm preventative (ivermectin/pyrantel pamoate). The signs resolved one day later. After the day 14 visit, the owner elected to withdraw the dog from the study. Abnormal neurologic signs such as tremors, decreased conscious proprioception, ataxia, decreased or absent menace, and/or seizures were reported in dogs receiving SIMPARICA (see Animal Safety ). Post Approval Experience (2019): The following adverse events are based on post-approval adverse drug experience reporting for SIMPARICA. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events reported for dogs are listed in decreasing order of reporting frequency: Vomiting, tremors, lethargy, seizure, diarrhea (with and without blood), anorexia, ataxia, pruritus, hypersalivation and hyperactivity.

Description

SIMPARICA is a flavored, chewable tablet for administration to dogs over 6 months of age according to their weight. Each tablet is formulated to provide a minimum sarolaner dosage of 0.91 mg/lb (2 mg/kg ) body weight. Sarolaner is a member of the isoxazoline class of parasiticides and the chemical name is 1-(5'-((5S)-5-(3,5-Dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3'-H-spiro(azetidine-3,1'-(2)benzofuran)-1-yl)-2-(methylsulfonyl)ethanone. SIMPARICA contains the S-enantiomer of sarolaner.

Storage

Store at or below 30°C (86°F) with excursions permitted up to 40°C (104°F).

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming sarolaner as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.