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Roxee Medication Guide

Fluralaner 13.64% Chew Tablets

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete Regulatory linkage incomplete Rx required Chewable tablet Merck Sharp & Dohme Corp. Official label facts Owner quick guide first

Veterinary professional?

Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Reference refreshed
Aug 6, 2026, 7:58 p.m.

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

FDA applications
No FDA application data linked
No refresh timestamp yet

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

Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.m.

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

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:58 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Fluralaner 13.64% Chew Tablets

Fluralaner 13.64% Chew Tablets

Drug type: Generic ingredient • Branded profile Regulatory linkage incomplete

Both Chewable tablet Rx required 100% reference complete

Species: Both

Approval status: Official document linked, regulatory match incomplete. An official source document is available, but Roxee has not linked this row to a confirmed FDA animal-drug application or product record yet.

Medication Snapshot

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

Fluralaner 13.64% Chew Tablets

Bravecto (fluralaner) Chews are approved for dogs and puppies to treat and prevent flea infestations and to treat and control labeled tick infestations for the labeled duration. Species commonly shown: Dogs.

Generic name
Fluralaner 13.64% Chew Tablets
Brand names
Bravecto
Medication class
branded
Manufacturer
Merck Sharp & Dohme Corp.
Species
Dog
Dosage forms
Chewable tablet
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
Bravecto
Dosage forms
Chewable tablet

Indications / Uses

Bravecto (fluralaner) Chews are approved for dogs and puppies to treat and prevent flea infestations and to treat and control labeled tick infestations for the labeled duration.

Administration / How To Give

Administer orally with food on the labeled interval and dose by the dog's body weight; owners should follow the veterinarian's prescription and label directions.

Warnings / Contraindications

The official Bravecto Chews label lists no known contraindications.

  • Keep Bravecto Chews in the original packaging and out of reach of children, dogs, cats, and other animals to reduce accidental ingestion or overdose risk.
  • Fluralaner is in the isoxazoline class, which has been associated with neurologic adverse reactions; use Bravecto Chews cautiously in dogs with a history of seizures or neurologic disorders.

Side Effects

Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea.

FAQ

Dogs

Yes. Roxee shows this as prescription-only.

Chewable tablet

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Roxee still has limited plain-language guidance for this medication. Use the official documents and your veterinarian's instructions for product-specific details.

Used for:

Your vet decides this. Here's what owners typically ask/watch for.

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)
  • Eosinopenia (1 reports)
  • Elevated serum alkaline phosphatase (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?

Next actions

Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Fluralaner 13.64% Chew Tablets; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2026-US-013484
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 18 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2026-US-013484
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2026-US-013484
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Vomiting (1 reports), Eosinopenia (1 reports), Elevated serum alkaline phosphatase (1 reports), Elevated haematocrit (1 reports), Elevated alanine aminotransferase (1 reports)

Body systems represented Signal grouping

Digestive (5), Neurologic (1), Behavior (2), Other (24)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (28 reports), Cat (4 reports)

Breed metadata in reports Metadata only

Retriever - Labrador (2), Domestic Shorthair (1), ['Beagle', 'Dog (unknown)'] (1), ['Retriever - Labrador', 'Poodle (unspecified)'] (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Fluralaner 13.64% Chew Tablets fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Vomiting, Eosinopenia, Elevated serum alkaline phosphatase

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Fluralaner 13.64% Chew Tablets brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2026-US-013484 · adverse_reaction · adverse reactions
  2. Handling and storage warning from the official Bravecto Chews label. · safety_warning · warnings contraindications
  3. Structured Product Label · document · documents
  4. Official label · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 22, 2026, 10:07 AM UTC

Safety & side effects

Side effects to monitor:

  • Vomiting
  • Eosinopenia
  • Elevated serum alkaline phosphatase

Most reported reactions:

  • Vomiting (1 reports)
  • Eosinopenia (1 reports)
  • Elevated serum alkaline phosphatase (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Not linked yet
Indication / use
Your vet decides this. Here's what owners typically ask/watch for.
Form / route / dose
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.

Quick Facts

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

Species: Both
Manufacturer: Merck Sharp & Dohme Corp.

Adverse Reactions

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

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
35
Matching reports
35
Active filters
0
Reset
Showing up to 50 matching reports.

USA-USFDACVM-2026-US-014504

Received 2026-03-26 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.117 Kilogram)
Age
Under 1 year (11 Month)
Sex
Male Neutered
Region
USA
Reactions
Suckling disorder NOSLickingSkin scabPeripheral vascular disorderPinnal erythemaCrustExpired drug administered
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-014201

Received 2026-03-24 · MSK · MSK

Non-serious
Species
Dog
Breed
['Beagle', 'Dog (unknown)']
Size / weight
25-49 lb (13.6 Kilogram)
Age
8+ years (16 Year)
Sex
Female Unknown
Region
USA
Reactions
Vomiting
Body systems
Digestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-013741

Received 2026-03-24 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Poodle (unspecified)']
Size / weight
10-24 lb (6.985 Kilogram)
Age
Under 1 year (6 Month)
Sex
Male Intact
Region
USA
Reactions
Emesis (multiple)Generalised itchingAnaphylaxis
Body systems
DigestiveSkin & allergyOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-013849

Received 2026-03-23 · MSK · MSK

Non-serious
Species
Dog
Breed
['Saint Bernard Dog', 'Dog (unknown)']
Age
Under 1 year (7 Month)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy (bacteria) - Borrelia
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013489

Received 2026-03-23 · MSK · MSK

Serious
Species
Dog
Breed
['Dachshund - Standard Long-haired', 'Terrier - Yorkshire']
Size / weight
10-24 lb (6.35 Kilogram)
Age
8+ years (14 Year)
Sex
Female Unknown
Region
USA
Reactions
Seizure NOS
Body systems
Neurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013484

Received 2026-03-20 · MSK · MSK

Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (28.576 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
LimpingLimb weaknessCoughNeurological signs NOSWobblinessCollapse NOS (see also Cardio-vascular and Neurological disorders)FeverJoint painJoint swellingGait abnormalityTense musclesElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)HyperglycaemiaNeutrophiliaAbnormal radiograph findingImmune-mediated polyarthritisBlood in faecesMedication error NOS
Body systems
OtherNeurologicSkin & allergy
Outcomes
Ongoing

USA-USFDACVM-2026-US-013156

Received 2026-03-20 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (28.576 Kilogram)
Age
1-3 years (3 Year)
Sex
Male Neutered
Region
USA
Reactions
Increased salivationDrowsiness - systemic disorder
Body systems
DigestiveOther
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013522

Received 2026-03-19 · MSK · MSK

Non-serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
25-49 lb (22.044 Kilogram)
Age
8+ years (8 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy (endoparasite) - hookworm
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013535

Received 2026-03-18 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Sex
Female Neutered
Region
USA
Reactions
Anaemia NOSLeukopenia NOSNeutropeniaLethargy (see also Central nervous system depression in Neurological)AnorexiaDiarrhoeaLymphadenopathyEnteritisAbnormal radiograph findingOther abnormal test result NOSUrinary tract infectionIncreased band neutrophiliaPain NOSWobblinessTiredness
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-012493

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Schnauzer - Miniature
Size / weight
10-24 lb (7.212 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
AtaxiaCollapse of legElevated blood urea nitrogen (BUN)Elevated cholesterol (total)WeaknessConfusionHyperphosphataemiaElevated symmetrical dimethylarginine (SDMA)
Body systems
NeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-012464

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Dog
Breed
['Chihuahua', 'Dog (unknown)']
Size / weight
Under 10 lb (4.354 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
ShakingHair shedding
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-012001

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.987 Kilogram)
Age
8+ years (14 Year)
Sex
Female Unknown
Region
USA
Reactions
Lack of efficacy (ectoparasite) - flea
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-010178

Received 2026-03-03 · MSK · MSK

Serious
Species
Dog
Breed
Chihuahua
Size / weight
10-24 lb (5.579 Kilogram)
Age
4-7 years (6 Year)
Sex
Female Unknown
Region
USA
Reactions
UrolithiasisUrinary tract infectionBlood in urine
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-003714

Received 2026-01-29 · MSK · MSK

Non-serious
Species
Dog
Breed
Schnauzer - Miniature
Size / weight
10-24 lb (7.212 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
AtaxiaCollapse of legElevated blood urea nitrogen (BUN)Elevated cholesterol (total)WeaknessConfusionHyperphosphataemiaElevated symmetrical dimethylarginine (SDMA)Discomfort NOS
Body systems
NeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-002967

Received 2026-01-20 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (7.031 Kilogram)
Age
8+ years (13 Year)
Sex
Female Unknown
Region
USA
Reactions
Hair loss NOSFlaking skin
Body systems
Skin & allergyOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-000213

Received 2026-01-06 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.488 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
Hind limb ataxia
Body systems
Neurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-075443

Received 2025-12-23 · MSK · MSK

Serious
Species
Dog
Breed
Dachshund (unspecified)
Size / weight
10-24 lb (7.348 Kilogram)
Age
1-3 years (1.5 Year)
Sex
Male Neutered
Region
USA
Reactions
Pale mucous membraneFacial swelling (see also Skin)Periorbital oedemaHives (see also Skin)Hypersensitivity NOS
Body systems
OtherSkin & allergy
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-075342

Received 2025-12-23 · MSK · MSK

Serious
Species
Dog
Breed
Poodle - Standard
Size / weight
25-49 lb (19.142 Kilogram)
Age
8+ years (9 Year)
Sex
Female Unknown
Region
USA
Reactions
PruritusElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)NeutrophiliaEosinopenia
Body systems
Skin & allergyOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-075140

Received 2025-12-23 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (40.37 Kilogram)
Age
8+ years (11 Year)
Sex
Female Unknown
Region
USA
Reactions
Partial lack of efficacySwollen feetPolyarthritisLocalised pain NOS (see other SOCs for specific pain)Swollen jointJoint pain
Body systems
EffectivenessOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-075356

Received 2025-12-20 · MSK · MSK

Serious
Species
Dog
Breed
['Terrier - Bull - American Pit', 'Dog (unknown)']
Size / weight
25-49 lb (20.638 Kilogram)
Age
8+ years (8 Year)
Sex
Male Neutered
Region
USA
Reactions
PolyuriaPolydipsiaIsosthenuriaHyposthenuriaWeaknessFallingMuscle tremorIncreased red blood cell countLymphopeniaEosinopeniaAnxiety
Body systems
OtherNeurologicBehavior
Outcomes
Ongoing

USA-USFDACVM-2025-US-074282

Received 2025-12-18 · MSK · MSK

Serious
Species
Dog
Breed
Shih Tzu
Size / weight
Under 10 lb (4.445 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
DiarrhoeaVomitingBloody diarrhoeaElevated haematocritLymphocytosis
Body systems
DigestiveOther
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-073617

Received 2025-12-15 · MSK · MSK

Non-serious
Species
Dog
Breed
Cattle Dog (unspecified)
Age
1-3 years (3 Year)
Sex
Female Neutered
Region
USA
Reactions
Injection site swellingLack of efficacy (endoparasite) - heartworm
Body systems
Skin & allergyEffectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-073134

Received 2025-12-10 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (9.172 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Decreased appetiteInjection site lumpInjection site bleedingWoundInjection site complication NOS
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-074653

Received 2025-12-09 · MSK · MSK

Serious
Species
Dog
Breed
['Pit Bull', 'Dog (unknown)']
Size / weight
50-99 lb (37.376 Kilogram)
Age
8+ years (11.5 Year)
Sex
Female Neutered
Region
USA
Reactions
Joint swellingBone and joint disorder NOSSarcoma NOS
Body systems
Skin & allergyOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-073504

Received 2025-12-04 · MSK · MSK

Non-serious
Species
Dog
Breed
Chihuahua
Size / weight
10-24 lb (5.897 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy (ectoparasite) - flea
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-073502

Received 2025-12-04 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier (unspecified)
Size / weight
10-24 lb (8.618 Kilogram)
Age
8+ years (9 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy (ectoparasite) - flea
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-072281

Received 2025-12-02 · MSK · MSK

Non-serious
Species
Dog
Breed
['Terrier - Teddy Roosevelt', 'Poodle (unspecified)']
Size / weight
25-49 lb (19.9 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Unknown
Region
USA
Reactions
DiarrhoeaPolydipsiaLethargy (see also Central nervous system depression in Neurological)AtaxiaWound
Body systems
DigestiveOtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2025-US-070900

Received 2025-12-01 · MSK · MSK

Non-serious
Species
Dog
Breed
['Retriever (unspecified)', 'Dog (unknown)']
Size / weight
50-99 lb (38.555 Kilogram)
Age
8+ years (13 Year)
Sex
Female Neutered
Region
USA
Reactions
Urinary incontinence
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-073723

Received 2025-11-25 · MSK · MSK

Serious
Species
Dog
Breed
['Shepherd (unspecified)', 'Dog (unknown)']
Age
Under 1 year (11 Month)
Sex
Female Unknown
Region
USA
Reactions
FractureThrombocytopeniaRespiratory tract infection NOSConjunctivitisUnclassifiable adverse eventOther abnormal test result NOSLack of efficacy (endoparasite) - tapeworm
Body systems
OtherEffectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-070795

Received 2025-11-25 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Longhair
Size / weight
Under 10 lb (4.5 Kilogram)
Age
1-3 years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Dilated pupilsDysphoriaTwitchingFeverGrand mal seizure
Body systems
OtherSkin & allergyNeurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-069160

Received 2025-11-20 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.629 Kilogram)
Age
8+ years (12 Year)
Sex
Female Unknown
Region
USA
Reactions
Excessive chewing, licking and/or groomingSkin lesion NOSHot spot (pyotraumatic dermatitis)
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-068774

Received 2025-11-19 · MSK · MSK

Serious
Species
Dog
Breed
['Shepherd (unspecified)', 'Dog (unknown)']
Age
Under 1 year (11 Month)
Sex
Female Intact
Region
USA
Reactions
FractureThrombocytopeniaRespiratory tract infection NOSConjunctivitisUnclassifiable adverse eventOther abnormal test result NOSLack of efficacy (endoparasite) - tapeworm
Body systems
OtherEffectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-068337

Received 2025-11-17 · MSK · MSK

Non-serious
Species
Dog
Breed
['Akita', 'Dog (unknown)']
Size / weight
50-99 lb (37.1 Kilogram)
Age
4-7 years (6.5 Year)
Sex
Female Neutered
Region
USA
Reactions
Behavioural disorder NOSLethargy (see also Central nervous system depression in Neurological)
Body systems
BehaviorNeurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-068009

Received 2025-11-17 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.21 Kilogram)
Age
1-3 years (3.58 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy (endoparasite) - tapeworm
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-067936

Received 2025-11-17 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.24 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy (endoparasite) - tapeworm
Body systems
Effectiveness
Outcomes
Outcome Unknown

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

Tracked signals
32
Reported cases
32
Serious reports
18
Species represented
2
Grouped by Body System
Digestive (5) · Vomiting, Loss of appetite, Diarrhea Neurologic (1) · Unsteady walking (ataxia) Behavior (2) · Behavioral disorder (unspecified), Anxiety Other (24) · Eosinopenia, Enteritis, Elevated symmetrical dimethylarginine
Most Reported Reactions
Reaction 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 Cat 1
Digestive 1 Cat 1

Species coverage: Dog (28) Cat (4)

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

Source Documents

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Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

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Owner handouts

0
No owner handouts linked yet.

Official label / PI

1

SPL

1

FOI

0
No FOI links yet.

Bravecto Chews Official Label (DailyMed)

Official label / PI · Official label

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Official Bravecto Chews label.

Bravecto Chews FDA SPL XML

SPL · Structured Product Label

This source does not expose a safe inline preview. Use the original source link for the full document.

FDA Structured Product Label XML for Bravecto Chews.

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
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:58 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
Curated brands: Bravecto from curated manufacturer/official sources
Manufacturer mapping: Merck Sharp & Dohme Corp.
Case-reported brands (openFDA): MSK
Catalog species: Both
Safety (openFDA)
Top reactions: Dog 92 Cat 26 View
Case summaries: 35 (showing 8) View
openFDA reports are unverified and do not prove causation.

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

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) Eosinopenia (1) Elevated serum alkaline phosphatase (1) Elevated haematocrit (1) Elevated alanine aminotransferase (1) Dysphoria (1) Dilated pupils (1) Decreased appetite (1)

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 100 Clinical 2 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Clinical, 2026-04-11)
  • administration: Administer orally with food on the labeled interval and dose by the dog's body weight; owners should follow the veterinarian's prescription and label direction… (Official, 2026-04-22)
  • approval_reference: NADA 141-459 (Official, 2026-04-22)
  • brand_names: Bravecto (Official, 2026-04-22)
  • contraindications: The official Bravecto Chews label lists no known contraindications. (Official, 2026-04-22)
  • dosage_forms: Chewable tablet (Official, 2026-04-22)
  • drug_profile_type: branded (Official, 2026-04-22)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-04-22)
  • prescription_required: Rx (Official, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-07-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-07-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-07-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-07-20)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-07-19)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-07-16)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-07-16)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-07-13)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-07-12)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-07-11)
Recent Revisions
  • contraindications updated 2026-08-06 19:58 by curated_loader • Contraindication section from the Bravecto Chews label.
  • prescription_required updated 2026-08-06 19:58 by curated_loader • Federal law restricts Bravecto Chews to use by or on the order of a licensed veterinarian.
  • administration updated 2026-08-06 19:58 by curated_loader • Official dosage and administration directions from the Bravecto Chews label.
  • dosage_forms updated 2026-08-06 19:58 by curated_loader • Official label describes Bravecto as flavored chews.
  • species updated 2026-08-06 19:58 by curated_loader • Official label states Bravecto Chews are flavored chews for dogs.
  • usage updated 2026-08-06 19:58 by curated_loader • Official indication summary from the Bravecto Chews label.
  • drug_profile_type updated 2026-08-06 19:58 by curated_loader • Bravecto Chews are the branded FDA-approved animal drug for fluralaner chews.
  • manufacturer_name updated 2026-08-06 19:58 by curated_loader • FDA SPL listing identifies the Bravecto Chews labeler.
  • brand_names updated 2026-08-06 19:58 by curated_loader • Official label identifies Bravecto as the proprietary product name.
  • approval_reference updated 2026-08-06 19:58 by curated_loader • FDA SPL listing identifies Bravecto Chews under NADA 141-459.
  • contraindications updated 2026-08-05 10:11 by curated_loader • Contraindication section from the Bravecto Chews label.
  • prescription_required updated 2026-08-05 10:11 by curated_loader • Federal law restricts Bravecto Chews to use by or on the order of a licensed veterinarian.
  • administration updated 2026-08-05 10:11 by curated_loader • Official dosage and administration directions from the Bravecto Chews label.
  • dosage_forms updated 2026-08-05 10:11 by curated_loader • Official label describes Bravecto as flavored chews.
  • species updated 2026-08-05 10:11 by curated_loader • Official label states Bravecto Chews are flavored chews for dogs.
  • usage updated 2026-08-05 10:11 by curated_loader • Official indication summary from the Bravecto Chews label.
  • drug_profile_type updated 2026-08-05 10:11 by curated_loader • Bravecto Chews are the branded FDA-approved animal drug for fluralaner chews.
  • manufacturer_name updated 2026-08-05 10:11 by curated_loader • FDA SPL listing identifies the Bravecto Chews labeler.
  • brand_names updated 2026-08-05 10:11 by curated_loader • Official label identifies Bravecto as the proprietary product name.
  • approval_reference updated 2026-08-05 10:11 by curated_loader • FDA SPL listing identifies Bravecto Chews under NADA 141-459.

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

Showing top 5 for Digestive.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

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

Showing top 5 for Behavior.

Other
Eosinopenia (1) • Dog Enteritis (1) • Dog Elevated symmetrical dimethylarginine (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated haematocrit (1) • Dog
Show more (19)
Elevated cholesterol (1) • Dog Elevated blood urea nitrogen (1) • Dog Elevated alanine aminotransferase (1) • Dog Dysphoria (1) • Cat Drowsiness - systemic disorder (1) • Dog Discomfort NOS (1) • Dog Dilated pupils (1) • Cat Crust (1) • Cat Cough (1) • Dog Conjunctivitis (1) • Dog Confusion (1) • Dog Collapse of leg (1) • Dog Collapse NOS (1) • Dog Bone and joint disorder NOS (1) • Dog Blood in urine (1) • Dog Blood in faeces (1) • Dog Anaphylaxis (1) • Dog Anaemia NOS (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.

Cat, Domestic Shorthair, Male, 11 month, 5.117 kilogram • Drug: MSK, Unknown • Reactions: Suckling disorder NOS, Licking, Skin scab, Peripheral vascular disorder, Pinnal erythema… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014504
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.00 Month
  • Weight: 5.117 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Suckling disorder NOS Licking Skin scab Peripheral vascular disorder Pinnal erythema Crust Expired drug administered
Outcomes: Outcome Unknown

Dog, ['Beagle', 'Dog (unknown)'], Female, 16 year, 13.6 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Vomiting • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014201
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 16.00 Year
  • Weight: 13.600 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Vomiting
Outcomes: Ongoing

Dog, ['Retriever - Labrador', 'Poodle (unspecified)'], Male, 6 month, 6.985 kilogram • Drug: MSK, Injection, solution, Subcutaneous • Reactions: Vomiting, Generalised itching, Anaphylaxis • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013741
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 6.00 Month
  • Weight: 6.985 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Injection, solution
Reactions Reported:
Vomiting Generalised itching Anaphylaxis
Outcomes: Ongoing

Dog, ['Saint Bernard Dog', 'Dog (unknown)'], Female, 7 month • Drug: MSK, Unknown • Reactions: Lack of efficacy (bacteria) - Borrelia • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-013849
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 7.00 Month
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (bacteria) - Borrelia
Outcomes: Outcome Unknown

Dog, ['Dachshund - Standard Long-haired', 'Terrier - Yorkshire'], Female, 14 year, 6.35 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Seizure NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-013489
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 14.00 Year
  • Weight: 6.350 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Seizure NOS
Outcomes: Outcome Unknown

Dog, Retriever - Labrador, Male, 10 year, 28.576 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Limping, Limb weakness, Cough, Neurological signs NOS, Wobbliness… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013484
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 28.576 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Limping Limb weakness Cough Neurological signs NOS Wobbliness Collapse NOS Fever Joint pain Joint swelling Gait abnormality Tense muscles Elevated alanine aminotransferase Elevated serum alkaline phosphatase Hyperglycaemia Neutrophilia Abnormal radiograph finding Immune-mediated polyarthritis Blood in faeces Medication error NOS
Outcomes: Ongoing

Dog, Retriever - Labrador, Male, 3 year, 28.576 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Increased salivation, Drowsiness - systemic disorder • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-013156
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 28.576 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Increased salivation Drowsiness - systemic disorder
Outcomes: Outcome Unknown

Dog, Crossbred Canine/dog, Male, 8 year, 22.044 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (endoparasite) - hookworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-013522
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 22.044 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (endoparasite) - hookworm
Outcomes: Outcome Unknown

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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