Meds A-Z
Fluralaner
Detailed information about Fluralaner
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
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 ( Ancylosto...
What it does:
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), De...
When it's needed:
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 ( Ancylosto...
Commonly reported reactions:
- (2 reports)
- (2 reports)
- (2 reports)
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?
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.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141518 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141617 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
No contraindication summary is linked yet.
No owner-focused warning rows are linked yet.
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.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 2 | Cat, Dog | 1 | |
| 2 | Cat, Dog | 1 | |
| 2 | Cat, Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 |
Species coverage: Dog (23) Cat (9)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-055636
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 19 • Secondary summaries: 0
- FOI Summary sN 141-518 Approved January 13, 2026.pdf · FOI
- FOI Summary sN 141-518 Approved August 9, 2022.pdf · FOI
- FOI Summary oN 141-518 Approved November 14, 2019_.pdf · FOI
- BRAVECTO® PLUS · SPL
- FOI Summary 141-617 Approved December 4, 2025.pdf · FOI
- Exzolt™ Cattle-CA1 · SPL
- FOI Summary oN 141-599 Approved July 10 2025. pdf.pdf · FOI
- BRAVECTO® QUANTUM · SPL
- FOI Summary oN 141-607 Approved July 17, 2025.pdf · FOI
- Exzolt™ · SPL
- FOI Summary sN 141-426 Approved January 12, 2023.pdf · FOI
- N-141426-Q-0022-OT-AA_foi.pdf · FOI
- Bravecto® · SPL
- FOI Summary sN 141-459 Approved August 9, 2022.pdf · FOI
- UCM514701.pdf · FOI
- BRAVECTO® · SPL
- FOI Summary sN 141-532 Approved November 25, 2024.pdf · FOI
- FOI Summary oN 141-532 Approved July 9, 2020.pdf · FOI
- BRAVECTO® 1-MONTH · SPL
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17871 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/12752 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/7947 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/7989/BRAVECTO%C2%AE%20PLUS · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17773 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18127/Exzolt%E2%84%A2%20Cattle-CA1 · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17185 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17506/BRAVECTO%C2%AE%20QUANTUM · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17210 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17531/Exzolt%E2%84%A2 · document · SPL
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 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 Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:03 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 12, 2026, 10:42 PM UTC
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| 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.
-
FOI Summary oN 141-518 Approved November 14, 2019_.pdf
• FOI summary • Official
• Feb. 2, 2026
FDA FOI summary for application 141518
-
FOI Summary sN 141-518 Approved August 9, 2022.pdf
• FOI summary • Official
• Feb. 2, 2026
FDA FOI summary for application 141518
-
FOI Summary sN 141-518 Approved January 13, 2026.pdf
• FOI summary • Official
• Feb. 2, 2026
FDA FOI summary for application 141518
-
FOI Summary 141-617 Approved December 4, 2025.pdf
• FOI summary • Official
• Jan. 27, 2026
FDA FOI summary for application 141617
-
FOI Summary oN 141-607 Approved July 17, 2025.pdf
• FOI summary • Official
• July 31, 2025
FDA FOI summary for application 141607
-
FOI Summary oN 141-599 Approved July 10 2025. pdf.pdf
• FOI summary • Official
• July 31, 2025
FDA FOI summary for application 141599
-
FOI Summary oN 141-532 Approved July 9, 2020.pdf
• FOI summary • Official
• Jan. 13, 2025
FDA FOI summary for application 141532
-
FOI Summary sN 141-532 Approved November 25, 2024.pdf
• FOI summary • Official
• Jan. 13, 2025
FDA FOI summary for application 141532
-
UCM514701.pdf
• FOI summary • Official
• Jan. 13, 2025
FDA FOI summary for application 141459
-
FOI Summary sN 141-459 Approved August 9, 2022.pdf
• FOI summary • Official
• Jan. 13, 2025
FDA FOI summary for application 141459
-
N-141426-Q-0022-OT-AA_foi.pdf
• FOI summary • Official
• Jan. 13, 2025
FDA FOI summary for application 141426
-
FOI Summary sN 141-426 Approved January 12, 2023.pdf
• FOI summary • Official
• Jan. 13, 2025
FDA FOI summary for application 141426
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- 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)
- 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 |
|---|---|---|---|---|
|
BRAVECTO® PLUS
RX
Fluralaner Moxidectin
Solution
• Topical
|
Intervet, Inc. | NADA 141-518 | Approved | Feb 2, 2026 |
|
Exzolt™ Cattle-CA1
RX
Fluralaner
Topical Solution
• Topical
|
Intervet, Inc. | C 141-617 | Approved | Jan 27, 2026 |
|
BRAVECTO® QUANTUM
RX
Fluralaner
Powder for extended-release injectable suspension
• Subcutaneous
|
Intervet, Inc. | NADA 141-599 | Approved | Jul 31, 2025 |
|
Exzolt™
RX
Fluralaner
Concentrated Solution
• Oral
|
Intervet, Inc. | NADA 141-607 | Approved | Jul 31, 2025 |
|
Bravecto®
RX
Fluralaner
Chewable Tablets
• Oral
|
Intervet, Inc. | NADA 141-426 | Approved | Jan 13, 2025 |
|
BRAVECTO®
RX
Fluralaner
Solution
• Topical
|
Intervet, Inc. | NADA 141-459 | Approved | Jan 13, 2025 |
|
BRAVECTO® 1-MONTH
RX
Fluralaner
Chewable Tablets
• Oral
|
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.
Composition / specifications
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.
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.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
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.
2.5 milligrams per kilogram (1.13 milligram per one pound) body weight.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
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.
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).
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the treatment and control of northern fowl mites (Ornithonyssus sylviarum).
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).
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
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.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
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.
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.
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.
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.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
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.
Administer orally as a single dose monthly to provide a minimum dose of 4.5 mg/lb (10 mg/kg) fluralaner. Administer with food.
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
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.
- BRAVECTO® PLUS (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
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.
- Exzolt™ Cattle-CA1 (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
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.
- BRAVECTO® QUANTUM (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the treatment and control of northern fowl mites (Ornithonyssus sylviarum).
- Exzolt™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
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.
- Bravecto® (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
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.
-
FOI UCM514701.pdf
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.
- BRAVECTO® (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
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.
- BRAVECTO® 1-MONTH (ZIP)
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
Contraindications
No approved contraindication text is linked yet. Review FDA label highlights and openFDA safety reports before making treatment decisions.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 56 and Cat 20 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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
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
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
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
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
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
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
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
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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