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Fluralaner

Detailed information about Fluralaner

Official label facts Owner quick guide first Marketing clearly labeled
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Reviewed / Updated / Sources

Reviewed: Not available

Updated: February 12, 2026, 10:44 PM UTC

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

For the prevention and treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) and treatment and control of cattle fever tick ( Rhipicephalus microplus ) in beef cattle 2 mont...

What to watch for:

  • Vomiting (1 reports)
  • wobbly/unsteady walking (1 reports)
  • Hyperglycaemia (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

What to ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
Safety & side effects

What to watch:

  • Vomiting
  • wobbly/unsteady walking
  • Hyperglycaemia

Most reported reactions:

  • Vomiting (1 reports)
  • Unsteady walking (ataxia) (1 reports)
  • Hyperglycaemia (1 reports)

When to call your vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:03 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:03 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 12, 2026, 10:42 PM UTC
Image coming soon
Fluralaner

Fluralaner

Drug type: Generic ingredient • Branded profile • FDA branded products available

Species: Both

Manufacturer: Intervet, Inc.

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Intervet, Inc.
Form: Chewable Tablets, Concentrated Solution, Powder for extended-release injectable suspension, Solution, Topical Solution
Identifiers:
NADA: 141426 NADA: 141459 NADA: 141518 NADA: 141532 NADA: 141599 NADA: 141607 NADA: 141617 NDC Package: 0061-1438-02 NDC Package: 0061-1440-01 NDC Package: 0061-1440-02 NDC Package: 0061-1442-01 NDC Package: 0061-1442-02 NDC Package: 0061-1442-03 NDC Package: 0061-4340-01 NDC Package: 0061-4341-01 NDC Package: 0061-4342-01 NDC Package: 0061-4343-01 NDC Package: 0061-4344-01 NDC Package: 0061-4366-01 NDC Package: 0061-4367-01
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
15
Species represented
2
Grouped by Body System
Digestive (1) · Vomiting Skin & allergy (3) · Hives, Application site hair loss, Allergic pruritus Neurologic (1) · Unsteady walking (ataxia) Other (27) · Injection site lump, Hyperglycaemia, Hypercalcaemia
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Neurologic 1 Dog 1
Other 1 Dog 1
Skin & allergy 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (23) Cat (9)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Serious - 1
Neurologic Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Skin & allergy Dog Serious - 1
Other Dog Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Skin & allergy Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Source metadata:

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (0)
  • No official label or package insert links yet.
SPL (7)
  • Exzolt™ Cattle-CA1 · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18127/Exzolt%E2%84%A2%20Cattle-CA1
  • BRAVECTO® PLUS · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/7989/BRAVECTO%C2%AE%20PLUS
  • BRAVECTO® QUANTUM · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17506/BRAVECTO%C2%AE%20QUANTUM
  • Exzolt™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17531/Exzolt%E2%84%A2
  • Bravecto® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2344/Bravecto%C2%AE
  • BRAVECTO® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2563/BRAVECTO%C2%AE
  • BRAVECTO® 1-MONTH · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/9370/BRAVECTO%C2%AE%201-MONTH
FOI (12)
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:03 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 12, 2026, 10:42 PM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: BRAVECTO® BRAVECTO® 1-MONTH BRAVECTO® PLUS BRAVECTO® QUANTUM Bravecto® Exzolt™ Exzolt™ Cattle-CA1
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Beef calves 2 months of age and older, Cat, Dog, Layers, Replacement dairy heifers under 20 months of age, Replacements
Rx/OTC: RX
Form/route: Chewable Tablets, Concentrated Solution, Powder for extended-release injectable suspension, Solution, Topical Solution • Oral, Subcutaneous, Topical
Applications: C 141-617 • NADA 141-518 • NADA 141-599 • NADA 141-607 • NADA 141-426 • NADA 141-459 • NADA 141-532
Documents: 12 (FOI: 12) • SPL: 7 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 30 • Cat 10 • View
Case summaries: 11 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: B74.8 ICD10_CM: B88.1
Other filariases

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Top reaction signals
Vomiting (1) Unsteady walking (ataxia) (1) Hyperglycaemia (1) Hives (1) Foaming at the mouth (1) Elevated creatinine (1) Disorientation (1) Disorder of red blood cell NOS (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
NADA: 141426 NADA: 141459 NADA: 141518 NADA: 141532 NADA: 141599 NADA: 141607 NADA: 141617 NDC Package: 0061-1438-02 NDC Package: 0061-1440-01 NDC Package: 0061-1440-02 NDC Package: 0061-1442-01 NDC Package: 0061-1442-02 NDC Package: 0061-1442-03 NDC Package: 0061-4340-01 NDC Package: 0061-4341-01 NDC Package: 0061-4342-01 NDC Package: 0061-4343-01 NDC Package: 0061-4344-01 NDC Package: 0061-4366-01 NDC Package: 0061-4367-01 NDC Package: 0061-4368-01 NDC Package: 0061-4370-01 NDC Package: 0061-5500-02 NDC Package: 0061-5501-02
Package NDC Product NDC Form / Route Status
0061-1438-02 0061 -
0061-1440-01 0061 -
0061-1440-02 0061 -
0061-1442-01 0061 -
0061-1442-02 0061 -
0061-1442-03 0061 -
0061-4340-01 0061 -
0061-4341-01 0061 -
0061-4342-01 0061 -
0061-4343-01 0061 -
0061-4344-01 0061 -
0061-4366-01 0061 -
0061-4367-01 0061 -
0061-4368-01 0061 -
0061-4370-01 0061 -
0061-5500-02 0061 -
0061-5501-02 0061 -
0061-5502-02 0061 -
0061-5503-02 0061 -
0061-5504-02 0061 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 14 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'… (Official, 2026-02-12)
  • usage: Bravecto® kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of … (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Exzolt™ Cattle-CA1
RX
Fluralaner
Topical Solution • Topical
Label highlights
Official documents
Intervet, Inc. C 141-617 Approved Feb 23, 2026
BRAVECTO® PLUS
RX
Fluralaner Moxidectin
Solution • Topical
Label highlights
Official documents
Intervet, Inc. NADA 141-518 Approved Feb 2, 2026
BRAVECTO® QUANTUM
RX
Fluralaner
Powder for extended-release injectable suspension • Subcutaneous
Label highlights
Official documents
Intervet, Inc. NADA 141-599 Approved Jul 31, 2025
Exzolt™
RX
Fluralaner
Concentrated Solution • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-607 Approved Jul 31, 2025
Bravecto®
RX
Fluralaner
Chewable Tablets • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-426 Approved Jan 13, 2025
BRAVECTO®
RX
Fluralaner
Solution • Topical
Label highlights
Official documents
Intervet, Inc. NADA 141-459 Approved Jan 13, 2025
BRAVECTO® 1-MONTH
RX
Fluralaner
Chewable Tablets • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-532 Approved Jan 13, 2025

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Replacement dairy heifers under 20 months of age • Beef calves 2 months of age and older
Composition / specifications
Each milliliter of solution contains 50 milligrams of fluralaner
Beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age
Indication

For the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) and treatment and control of cattle fever tick (Rhipicephalus microplus) in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age.

Dosage

2.5 milligrams per kilogram (1.13 milligram per one pound) body weight.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains 280 mg of fluralaner and 14 mg of moxidectin
Cats
Indication

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati; 4th stage larvae, immature adults and adults) and hookworm (Ancylostoma tubaeforme; 4th stage larvae, immature adults and adults). 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), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

Dosage

Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
Each mL of constituted suspension contains 150 mg fluralaner
Dogs
Indication

Kills adult fleas and for the treatment and prevention of flea infestations (Ctenocephalides felis); for the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 months in dogs and puppies 6 months of age and older; and for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 months in dogs and puppies 6 months of age and older.

Dosage

Administer as a single subcutaneous dose every 12 months or every 8 months in the case of potential exposure to Amblyomma americanum ticks. The subcutaneous dose volume is 0.1 mL of the constituted suspension/kg body weight (0.045 mL per pound (/lb)). This volume provides a dose of 15 mg fluralaner per kilogram body weight (6.8 mg/lb).

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Layers • Replacements
Composition / specifications
10 mg fluralaner/mL
Chickens, laying hens and replacement chickens
Indication

For the treatment and control of northern fowl mites (Ornithonyssus sylviarum).

Dosage

Administer orally to chickens via the drinking water as 2 single doses spaced 7 days apart, with each dose consumed over a period of 6 to 24 hours. Each dose is 0.5 mg fluralaner/kg (0.227 mg/lb) body weight, equivalent to 0.05 mL fluralaner oral solution/kg body weight (0.023 mL/lb).

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each chewable tablet contains 112.5, 250, 500, 1000, or 1400 mg fluralaner.
Dogs (Dogs and Puppies 6 Months and Older)
Indication

Bravecto® 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 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

Bravecto® is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

Dosage
May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains 280 mg fluralaner.
Cats
Indication

Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (black-legged tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater. It is also indicated for the treatment and control of Dermacentor variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater.

For the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for 12 weeks in cats and kittens 6 months of age, and older and weighing 2.6 pounds or greater.

Dosage

Administer topically as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 18.2 mg/lb (40 mg/ kg) body weight. May be administered every 8 weeks in case of potential exposure to Dermacentor variabilis ticks.

Limitations
Dogs
Indication

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),and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. It is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

Dosage

Administer topically as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 11.4 mg/lb (25 mg/ kg) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each chewable tablet (“chew”) contains 45, 100, 200, 400, or 560 mg of fluralaner
Dogs
Indication

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

Administer orally as a single dose monthly to provide a minimum dose of 4.5 mg/lb (10 mg/kg) fluralaner. Administer with food.

Limitations

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary

    For the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) and treatment and control of cattle fever tick (Rhipicephalus microplus) in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for the addition of the indication for the treatment and control of Amblyomma maculatum (Gulf Coast tick) infestations for 2 months in cats and kittens 6 months of age and older and weighing 2.6 pounds or greater.


  • Summary

    This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for 2 months in cats and kittens 6 months of age and older and weighing 2.6 pounds or greater.

  • Summary

    For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, immature adults, and adults); 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) and Dermacentor variabilis (American dog tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Kills adult fleas and for the treatment and prevention of flea infestations (Ctenocephalides felis); for the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 months in dogs and puppies 6 months of age and older; and for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 months in dogs and puppies 6 months of age and older.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

  • Summary

    BRAVECTO 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), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

    BRAVECTO is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 pounds or greater.

  • Summary
    BRAVECTO® 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), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater. BRAVECTO® is also indicated for the treatment and control of Ambloyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. BRAVECTO® kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of Ixodes scapularis (black-legged tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater. BRAVECTO® is also indicated for the treatment and control of Dermacentor variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater.

  • Summary

    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) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater.

    It 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.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

Bravecto® 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 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. Bravecto® is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (black-legged tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater. It is also indicated for the treatment and control of Dermacentor variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater. For the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for 12 weeks in cats and kittens 6 months of age, and older and weighing 2.6 pounds or greater. 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),and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. It is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

Source: FDA Animal Drugs @ FDA • Reference

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hives (1) • Dog Application site hair loss (1) • Cat Allergic pruritus (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

Other
Injection site lump (1) • Cat Hyperglycaemia (1) • Dog Hypercalcaemia (1) • Cat Hepatomegaly (1) • Dog Head tilt - ear disorder (1) • Cat
Show more (22)
Glucosuria (1) • Cat General illness (1) • Cat Foaming at the mouth (1) • Dog Fever (1) • Dog Falling (1) • Dog Eosinopenia (1) • Dog Elevated globulins (1) • Dog Elevated creatinine (1) • Dog Elevated blood urea nitrogen (1) • Cat Disorientation (1) • Dog Disorder of red blood cell NOS (1) • Dog Difficulty standing (1) • Dog Decreased red blood cell count (1) • Dog Decreased mean corpuscular haemoglobin concentration (1) • Dog Decreased haemoglobin (1) • Dog Decreased haematocrit (1) • Dog Decreased drinking (1) • Dog Death by euthanasia (1) • Dog Coprophagia (1) • Cat Anaemia NOS (1) • Cat Abrasion (1) • Dog Abnormal radiograph finding (1) • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Shepherd Dog - German, Male, 5.8 year, 40.82 kilogram • Drug: MSK, Tablet, Unknown • Reactions: Sneezing, Listless, Not eating, Reduced responses, Difficulty standing… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055636
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.80 Year
  • Weight: 40.820 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet
Reactions Reported:
Sneezing Listless Not eating Reduced responses Difficulty standing Falling Polyuria Decreased drinking Fever Tachycardia Tachypnoea Weight loss Stress leukogram Neutrophilia Monocytosis Eosinopenia Elevated globulins Abnormal radiograph finding Hepatomegaly Proprioception deficit Muscle atrophy Pain NOS
Outcomes: Ongoing

Dog, Corgi (unspecified), Female, 3 year, 11.793 kilogram • Drug: MSK, Unassigned, Subcutaneous • Reactions: Vomiting, Allergic pruritus, Swollen lip, Hives • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055192
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 3.00 Year
  • Weight: 11.793 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Unassigned
Reactions Reported:
Vomiting Allergic pruritus Swollen lip Hives
Outcomes: Ongoing

Dog, Retriever - Labrador, Male, 3 year, 36.832 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Itchy skin • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055024
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 36.832 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Itchy skin
Outcomes: Ongoing

Dog, Pointing Dog - Hungarian Short-haired (Vizsla), Female, 7 year, 25 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (bacteria) - Borrelia, Disorientation, Urination, Spondylosis, Foaming at the mouth… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055629
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.00 Year
  • Weight: 25.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (bacteria) - Borrelia Disorientation Urination Spondylosis Foaming at the mouth Seizure NOS
Outcomes: Outcome Unknown

Dog, Retriever - Labrador, Female, 6 year, 44.905 kilogram • Drug: MSK, Unknown • Reactions: Abrasion, Laceration, Death by euthanasia, Lack of efficacy (endoparasite) - heartworm • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-055794
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 6.00 Year
  • Weight: 44.905 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Abrasion Laceration Death by euthanasia Lack of efficacy (endoparasite) - heartworm
Outcomes: Euthanized

Dog, Dog (other), Male, 13.41 year, 16.33 kilogram • Drug: MSK, Unknown, Frequency: 1 per month • Reactions: Pale mucous membrane, Weakness, Unsteady walking (ataxia), Elevated creatinine, Tachycardia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-056007
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.41 Year
  • Weight: 16.330 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Frequency: 1 per month
Reactions Reported:
Pale mucous membrane Weakness Unsteady walking (ataxia) Elevated creatinine Tachycardia Decreased haematocrit Disorder of red blood cell NOS Decreased mean corpuscular haemoglobin concentration Lack of efficacy - NOS Shallow breathing Low platelet count Decreased haemoglobin Elevated blood urea nitrogen Lymphopenia Decreased red blood cell count Hyperglycaemia Abnormal radiograph finding Neutrophilia Vomiting bile Tiredness (lethargy)
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 10 year, 3.18 kilogram • Drug: MSK, Solution, Topical • Reactions: General illness, Intentional misuse • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-051529
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 10.00 Year
  • Weight: 3.180 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Solution
Reactions Reported:
General illness Intentional misuse
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 5 year, 4.536 kilogram • Drug: MSK, Topical, Dose: 1 dose per animal • Reactions: Tiredness (lethargy) • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-032290
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 4.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Dose: 1 dose per animal
Reactions Reported:
Tiredness (lethargy)
Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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