Fluralaner

Indications

Bravecto 1-Month kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations [ Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Rhipicephalus sanguineus (brown dog tick) and Haemaphysalis longicornis (Asian longhorned tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. Bravecto 1-Month is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for one month in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

Dosage and Administration

Bravecto 1-Month should be administered orally as a single dose monthly according to the Dosage Schedule below to provide a minimum dose of 4.5 mg/lb (10 mg/kg) fluralaner. Bravecto 1-Month should be administered with food. Dosage Schedule Body Weight Ranges (lb) Fluralaner content (mg) Chews Administered 4.4 – 9.9 45 One >9.9 – 22.0 100 One >22.0 – 44.0 200 One >44.0 – 88.0 400 One >88.0 – 123.0 Dogs over 123.0 lb should be administered the appropriate combination of chews 560 One Treatment with Bravecto 1-Month may begin at any time of the year and can continue year-round without interruption.

Contraindications

There are no known contraindications for the use of the product.

Warnings

Not for human use. Keep this and all drugs out of the reach of children. Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product. Do not eat, drink or smoke while handling the product. Wash hands thoroughly with soap and water immediately after use of the product. Keep Bravecto 1-Month in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Precautions

Fluralaner 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. Bravecto 1-Month is not effective against A. americanum in puppies less than 6 months of age (see

Adverse Reactions

In a well-controlled U.S. field study, which included 271 dogs (201 dogs were administered Bravecto 1-Month every 30 days and 70 dogs were administered an oral active control [an isoxazoline] every 30 days), there were no serious adverse reactions associated with treatment. Over the 90-day study period, all observations of potential adverse reactions were recorded. Dogs with Adverse Reactions in the Field Study Adverse Reaction (AR) Fluralaner Group: Percentage of Dogs with the AR during the 90-Day Study (n= 201 dogs) Active Control Group: Percentage of Dogs with the AR during the 90-Day Study (n= 70 dogs) Pruritus 7.0% 10.0% Diarrhea 3.0% 4.3% Vomiting 3.0% 4.3% Decreased Appetite 3.0% 0.0% Liver enzymes (serum ALT or ALP) greater than twice the upper reference range Alanine aminotransferase (ALT); alkaline phosphatase (ALP) 1.0% 1.4% Lethargy 1.0% 1.4% Weight loss (>15%) 0.5% 0.0% One dog in the Bravecto 1-Month group with a history of seizures managed with anticonvulsant medication had seizure activity 28 days after its first dose; the dog received its second dose later the same day. No additional seizures occurred during the study. One dog in the control group with no history of seizures had seizure activity 12 days after its second dose. The dog was started on anticonvulsant medication and no additional seizures occurred during the study. During the palatability assessment, four dogs coughed within 1 hour of dosing with Bravecto 1-Month. Palatability was not assessed in the control group. In well-controlled laboratory effectiveness studies, one dog and three puppies administered Bravecto 1-Month had diarrhea (with or without blood). Post-Approval Experience (2024): The following adverse events are based on post-approval adverse drug experience reporting for Bravecto 1-Month. 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, lethargy, diarrhea, anorexia, tremors, ataxia, seizure, pruritus, and allergic reactions (including hives, swelling, and erythema). The following reproductive adverse events have been reported following use of Bravecto (fluralaner) Chews: birth defects (including limb deformities and cleft palate), stillbirth, and abortion. To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Merck Animal Health at 1-800-224-5318. Additional information can be found at www.bravecto.com . For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.FDA.gov/reportanimalae .

Description

Bravecto 1-Month (fluralaner) is a flavored chew formulated to provide a minimum dose of 4.5 mg/lb (10 mg/kg) body weight of fluralaner. The chemical name of fluralaner is (±)-4-[5-(3,5-dichlorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl]-2-methyl- N -[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl]benzamide.

Storage

Do not store above 86°F (30°C).

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• BRAVECTO ® (fluralaner topical solution) for Cats, Merck Sharp & Dohme Corp.. Set id fed84d87-049a-4e22-8091-451cde091815.
• BRAVECTO ® (fluralaner topical solution) for Dogs, Merck Sharp & Dohme Corp.. Set id b4181fa7-e45f-4beb-a3f5-49c987d584ac.
• BRAVECTO ® (fluralaner) Chews, Merck Sharp & Dohme Corp.. Set id 1fcbf232-cfd4-481e-ba9b-6251b7b468d7.
• BRAVECTO ® QUANTUM (fluralaner for extended-release injectable suspension), Merck Sharp & Dohme Corp.. Set id 82f1fc7c-41f1-4a1d-8117-6d8eb9d0b54f.

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 fluralaner 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.