Roxee Meds Catalog

Fluralaner

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Chewable Tablets Intervet, Inc. Official label facts Owner quick guide first

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Data freshness

Storefront facts

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These are the storefront facts Roxee uses on browse cards and quick facts.

FDA applications

FDA application data refreshed

May 5, 2026, 10:00 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports

Safety data refreshed

May 5, 2026, 10:01 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details

Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
The storefront fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed May 5, 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.
openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 15, 2026

Updated: April 15, 2026, 10:04 AM UTC

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
Exzolt™ · official_label
openFDA case USA-USFDACVM-2025-US-055636 · adverse_reaction

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Fluralaner

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Chewable Tablets Rx required 100% storefront ready

Species: Both

Manufacturer: Intervet, Inc.

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Fluralaner

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. Species commonly shown: Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied.

Generic name

Fluralaner

Brand names

Bravecto®, BRAVECTO® 1-MONTH, BRAVECTO® QUANTUM, Exzolt™

Manufacturer

Intervet, Inc.

Species

Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied, Layers

Dosage forms

Chewable Tablets, Solution, Powder for extended-release injectable suspension, Concentrated Solution

Prescription

Prescription required

Completeness

100%

Validation

Complete

Brand names

Bravecto® BRAVECTO® 1-MONTH BRAVECTO® QUANTUM Exzolt™ Exzolt™ Cattle-CA1

Dosage forms

Chewable Tablets Solution Powder for extended-release injectable suspension Concentrated Solution Topical Solution

Indications / Uses

Side Effects

Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Other abnormal test result NOS, Seizure NOS.

FAQ

Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied, Layers, Replacements, Replacement dairy heifers under 20 months of age, Beef calves 2 months of age and older

Yes. Roxee shows this as prescription-only.

Chewable Tablets, Solution, Powder for extended-release injectable suspension, Concentrated Solution

Related Conditions

Fleas (Flea Infestation) Myiasis (fly strike) Pica Tick infestation

Source Transparency

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/12711
Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/945
Last refreshed: Apr 22, 2026, 10:07 a.m.
Last verified: Apr 15, 2026, 10:04 a.m.
Validation status: Complete

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Pet Owner Quick Guide

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Used for:

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 (A...

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

Vomiting (1 reports)
Elevated serum alkaline phosphatase (1 reports)
Elevated haematocrit (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 tell or 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?

Major cautions & emergency warning signs

Side effects to monitor:

Vomiting
Elevated serum alkaline phosphatase
Elevated haematocrit

Most reported reactions:

Vomiting (1 reports)
Elevated serum alkaline phosphatase (1 reports)
Elevated haematocrit (1 reports)

Emergency warning signs:

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

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:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141599 · 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

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

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (4) · Vomiting, Diarrhea, Decreased appetite Skin & allergy (2) · Application site hair loss, Allergic pruritus Neurologic (1) · Unsteady walking (ataxia) Behavior (2) · Behavioral disorder (unspecified), Anxiety Other (23) · Elevated serum alkaline phosphatase, Elevated haematocrit, Elevated globulins

Most Reported Reactions

Body system	Cases	Species	Serious cases
Digestive	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Cat	1
Other	1	Dog	1
Other	1	Dog	1

Species coverage: Dog (24) Cat (8)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Digestive	Dog	Serious	-	1
Neurologic	Cat	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Non-serious	-	1
Digestive	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
Digestive	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Digestive	Dog	Serious	-	1
Behavior	Dog	Non-serious	-	1
Skin & allergy	Cat	Non-serious	-	1
Behavior	Dog	Serious	-	1
Other	Cat	Non-serious	-	1
Skin & allergy	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-055636

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

No owner handouts linked yet.

Official label / PI

No official label or package insert links yet.

SPL

FOI

BRAVECTO® QUANTUM

SPL · SPL

Open original

FDA Structured Product Label

BRAVECTO® QUANTUM

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Intervet, Inc.
NADA: 141-599
Status: RX
Form: Powder for extended-release injectable suspension
Route: Subcutaneous

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).

Exzolt™ Cattle-CA1

SPL · SPL

Open original

FDA Structured Product Label

Exzolt™ Cattle-CA1

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Intervet, Inc.
C: 141-617
Status: RX
Form: Topical Solution
Route: Topical
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.

Exzolt™

SPL · SPL

Open original

FDA Structured Product Label

Exzolt™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Intervet, Inc.
NADA: 141-607
Status: RX
Form: Concentrated Solution
Route: Oral
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).

Bravecto®

SPL · SPL

Open original

FDA Structured Product Label

Bravecto®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Intervet, Inc.
NADA: 141-426
Status: RX
Form: Chewable Tablets
Route: Oral
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.

BRAVECTO®

SPL · SPL

Open original

FDA Structured Product Label

BRAVECTO®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Intervet, Inc.
NADA: 141-459
Status: RX
Form: Solution
Route: Topical
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.

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.

BRAVECTO® 1-MONTH

SPL · SPL

Open original

FDA Structured Product Label

BRAVECTO® 1-MONTH

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Intervet, Inc.
NADA: 141-532
Status: RX
Form: Chewable Tablets
Route: Oral
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.

FOI · FOI summary

Open original

Source metadata:

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/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/17210 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17531/Exzolt%E2%84%A2 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/13361 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1502 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2344/Bravecto%C2%AE · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/12711 · document · FOI

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

Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
The storefront fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed May 5, 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.
openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Official (FDA)

Identity: Generic ingredient • No FDA branded products linked

No official FDA brand rows linked yet for this ingredient.

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: NADA 141-599 • C 141-617 • NADA 141-607 • NADA 141-426 • NADA 141-459 • NADA 141-532

Documents: 9 (FOI: 9) • SPL: 6 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 49 • Cat 15 • View

Case summaries: 19 (showing 8) • View

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Fleas (Flea Infestation) Myiasis (fly strike) Pica Tick infestation

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) Elevated serum alkaline phosphatase (1) Elevated haematocrit (1) Elevated blood urea nitrogen (1) Elevated alanine aminotransferase (1) Dysphoria (1) Disorientation (1) Disorder of red blood cell NOS (1)

Identifiers & Packages

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

Identifiers

Package NDC	Product NDC	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 141-599 Approved July 10 2025. pdf.pdf • FOI summary • Official • April 1, 2026
FDA FOI summary for application 141599
FOI Summary 141-617 Approved December 4, 2025.pdf • FOI summary • Official • Feb. 23, 2026
FDA FOI summary for application 141617
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 oN 141-607 Approved July 17, 2025.pdf • FOI summary • Official • July 31, 2025
FDA FOI summary for application 141607
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 & Change Log

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

Official 29 Clinical 6 Manufacturer 0 Marketing 0

Current Field Facts

monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'… (Clinical, 2026-04-11)
usage: Bravecto® kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of … (Clinical, 2026-04-15)
usage: Bravecto® kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of … (Clinical, 2026-04-15)
usage: Bravecto® kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of … (Clinical, 2026-04-11)
indications: BRAVECTO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tic… (Official, 2026-05-05)
indications: BRAVECTO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tic… (Official, 2026-05-03)
indications: BRAVECTO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tic… (Official, 2026-05-02)
indications: BRAVECTO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tic… (Official, 2026-04-29)
indications: BRAVECTO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tic… (Official, 2026-04-28)
indications: BRAVECTO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tic… (Official, 2026-04-27)
indications: BRAVECTO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tic… (Official, 2026-04-26)
indications: BRAVECTO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tic… (Official, 2026-04-25)
indications: BRAVECTO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tic… (Official, 2026-04-22)
side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'… (Official, 2026-04-22)
side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'… (Official, 2026-04-15)
side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'… (Official, 2026-04-15)
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, 2026-04-22)

Recent Revisions

side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
monitoring updated 2026-04-16 13:28 by curated_loader • Clinical monitoring context for feline diabetes management.
usage updated 2026-04-16 13:28 by curated_loader • Usage statement from FDA warning letter and approved-product context.
drug_profile_type updated 2026-04-16 13:28 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
manufacturer_name updated 2026-04-16 13:28 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
brand_names updated 2026-04-16 13:28 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
approval_reference updated 2026-04-16 13:28 by curated_loader • Official FDA application reference for Senvelgo.
side_effects updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
monitoring updated 2026-04-15 10:07 by curated_loader • Clinical monitoring context for feline diabetes management.
usage updated 2026-04-15 10:07 by curated_loader • Usage statement from FDA warning letter and approved-product context.
drug_profile_type updated 2026-04-15 10:07 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
manufacturer_name updated 2026-04-15 10:07 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
brand_names updated 2026-04-15 10:07 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
approval_reference updated 2026-04-15 10:07 by curated_loader • Official FDA application reference for Senvelgo.
side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-11 10:05 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® QUANTUM RX Fluralaner Powder for extended-release injectable suspension • Subcutaneous Label highlights Official documents	Intervet, Inc.	NADA 141-599	Approved	Apr 1, 2026
Exzolt™ Cattle-CA1 RX Fluralaner Topical Solution • Topical Label highlights Official documents	Intervet, Inc.	C 141-617	Approved	Feb 23, 2026
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.

Composition / specifications

Each mL of constituted suspension contains 150 mg fluralaner

Dogs

Indication

Dosage

Limitations

FDA page: Open in Animal Drugs @ FDA

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

Dosage

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

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

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

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

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

Limitations

Dogs

Indication

Dosage

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

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

Usage

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 Diarrhea (1) • Dog Decreased appetite (1) • Cat Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy

Application site hair loss (1) • Cat Allergic pruritus (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic

Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior

Behavioral disorder (1) • Dog Anxiety (1) • Dog

Showing top 5 for Behavior.

Other

Elevated serum alkaline phosphatase (1) • Dog Elevated haematocrit (1) • Dog Elevated globulins (1) • Dog Elevated creatinine (1) • Cat Elevated blood urea nitrogen (1) • Dog

Show more (18)

Elevated alanine aminotransferase (1) • Dog Dysphoria (1) • Cat Disorientation (1) • Dog Disorder of red blood cell NOS (1) • Dog Dilated pupils (1) • Cat 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 Conjunctivitis (1) • Dog Bone and joint disorder NOS (1) • Dog 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, Dachshund (unspecified), Male, 1.5 year, 7.348 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Pale mucous membrane, Facial swelling (possible allergy), Periorbital oedema, Hives, Hypersensitivity NOS • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2025-US-075443
Serious AE: Yes
Treated For AE: Yes
Sex: Male
Age: 1.50 Year
Weight: 7.348 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Unassigned

Reactions Reported:

Pale mucous membrane Facial swelling (possible allergy) Periorbital oedema Hives Hypersensitivity NOS

Outcomes: Recovered/Normal

Dog, Poodle - Standard, Female, 9 year, 19.142 kilogram • Drug: MSK, Liquid, Unknown • Reactions: Itching, Elevated alanine aminotransferase, Elevated serum alkaline phosphatase, Neutrophilia, Eosinopenia • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-075342
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 9.00 Year
Weight: 19.142 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Liquid

Reactions Reported:

Itching Elevated alanine aminotransferase Elevated serum alkaline phosphatase Neutrophilia Eosinopenia

Outcomes: Ongoing

Dog, Shepherd Dog - German, Female, 11 year, 40.37 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Partial lack of efficacy, Swollen feet, Polyarthritis, Localised pain NOS, Swollen joint… • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-075140
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 11.00 Year
Weight: 40.370 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Unassigned

Reactions Reported:

Partial lack of efficacy Swollen feet Polyarthritis Localised pain NOS Swollen joint Joint pain

Outcomes: Ongoing

Dog, ['Terrier - Bull - American Pit', 'Dog (unknown)'], Male, 8 year, 20.638 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Polyuria, Polydipsia, Isosthenuria, Hyposthenuria, Weakness… • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-075356
Serious AE: Yes
Treated For AE: Yes
Sex: Male
Age: 8.00 Year
Weight: 20.638 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Unassigned

Reactions Reported:

Polyuria Polydipsia Isosthenuria Hyposthenuria Weakness Falling Muscle tremor Increased red blood cell count Lymphopenia Eosinopenia Anxiety

Outcomes: Ongoing

Dog, Shih Tzu, Female, 1 year, 4.445 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Diarrhea, Vomiting, Bloody diarrhoea, Elevated haematocrit, Lymphocytosis • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2025-US-074282
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 1.00 Year
Weight: 4.445 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Unassigned

Reactions Reported:

Diarrhea Vomiting Bloody diarrhoea Elevated haematocrit Lymphocytosis

Outcomes: Recovered/Normal

Dog, Cattle Dog (unspecified), Female, 3 year • Drug: MSK, Unknown • Reactions: Injection site swelling, Lack of efficacy (endoparasite) - heartworm • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-073617
Serious AE: No
Treated For AE: No
Sex: Female
Age: 3.00 Year

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown

Reactions Reported:

Injection site swelling Lack of efficacy (endoparasite) - heartworm

Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 7 year, 9.172 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Tiredness (lethargy), Decreased appetite, Injection site lump, Injection site bleeding, Wound… • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-073134
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 7.00 Year
Weight: 9.172 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Unassigned

Reactions Reported:

Tiredness (lethargy) Decreased appetite Injection site lump Injection site bleeding Wound Injection site complication NOS

Outcomes: Ongoing

Dog, ['Pit Bull', 'Dog (unknown)'], Female, 11.5 year, 37.376 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Joint swelling, Bone and joint disorder NOS, Sarcoma NOS • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-074653
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 11.50 Year
Weight: 37.376 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Unassigned

Reactions Reported:

Joint swelling Bone and joint disorder NOS Sarcoma NOS

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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This medication has not been reviewed by a veterinarian yet.

Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Fluralaner

Data freshness

Evidence

Fluralaner

Medication Snapshot

Fluralaner

Indications / Uses

Side Effects

FAQ

What species is this commonly shown for?

Does this usually require a prescription?

What dosage forms are listed?

Related Conditions

Source Transparency

Add to My Pet's Meds

Pet Owner Quick Guide

Quick Facts

Adverse Reactions

Grouped by Body System

Most Reported Reactions

Documents

Owner handouts

Official label / PI

SPL

FOI

BRAVECTO® QUANTUM

BRAVECTO® QUANTUM

Dogs

Exzolt™ Cattle-CA1

Exzolt™ Cattle-CA1

Beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age

Exzolt™

Exzolt™

Chickens, laying hens and replacement chickens

Bravecto®

Bravecto®

Dogs (Dogs and Puppies 6 Months and Older)

BRAVECTO®

BRAVECTO®

Cats

Dogs

BRAVECTO® 1-MONTH

BRAVECTO® 1-MONTH

Dogs

FOI Summary oN 141-599 Approved July 10 2025. pdf.pdf

FOI Summary 141-617 Approved December 4, 2025.pdf

FOI Summary oN 141-607 Approved July 17, 2025.pdf

FOI Summary sN 141-426 Approved January 12, 2023.pdf

N-141426-Q-0022-OT-AA_foi.pdf

FOI Summary sN 141-459 Approved August 9, 2022.pdf

UCM514701.pdf

FOI Summary sN 141-532 Approved November 25, 2024.pdf

FOI Summary oN 141-532 Approved July 9, 2020.pdf

FOI Summary oN 141-518 Approved November 14, 2019_.pdf

FOI Summary sN 141-518 Approved August 9, 2022.pdf

FOI Summary sN 141-518 Approved January 13, 2026.pdf

At a Glance

Counseling and Monitoring Highlights

Identifiers & Packages

Enriched Documents

Data Sources & Change Log

FDA Products & Applications (Animal Drugs @ FDA)

What It's For (FDA Label Highlights)

BRAVECTO® QUANTUM • Powder for extended-release injectable suspension • Subcutaneous

Exzolt™ Cattle-CA1 • Topical Solution • Topical

Exzolt™ • Concentrated Solution • Oral

Bravecto® • Chewable Tablets • Oral

BRAVECTO® • Solution • Topical

BRAVECTO® 1-MONTH • Chewable Tablets • Oral

Usage

Top Reported Reactions (openFDA)

Adverse Event Case Summaries (openFDA)

Dec 23, 2025 • Dog • Dachshund (unspecified) • Pale mucous membrane, Facial swelling (possible allergy) • Recovered/Normal

Dec 23, 2025 • Dog • Poodle - Standard • Itching, Elevated alanine aminotransferase • Ongoing

Dec 23, 2025 • Dog • Shepherd Dog - German • Partial lack of efficacy, Swollen feet • Ongoing

Dec 20, 2025 • Dog • ['Terrier - Bull - American Pit', 'Dog (unknown)'] • Polyuria, Polydipsia • Ongoing

Dec 18, 2025 • Dog • Shih Tzu • Diarrhea, Vomiting • Recovered/Normal

Dec 15, 2025 • Dog • Cattle Dog (unspecified) • Injection site swelling, Lack of efficacy (endoparasite) - heartworm • Outcome Unknown

Dec 10, 2025 • Cat • Domestic Shorthair • Tiredness (lethargy), Decreased appetite • Ongoing

Dec 9, 2025 • Dog • ['Pit Bull', 'Dog (unknown)'] • Joint swelling, Bone and joint disorder NOS • Ongoing