Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
BothReference completeRegulatory linkage incompleteRx requiredChewable tabletMerck Sharp & Dohme Corp.
Official label facts
Owner quick guide first
Showing simplified owner view. Switch to Vet View for full technical detail.
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.
Do not start, stop, or change treatment without your veterinarian.
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
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.
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?
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 contextLimited
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 coverageReported 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 guardrailNot 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 signalLabel / review
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
Source: openFDA case USA-USFDACVM-2026-US-013484
Weaker signalReported 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.
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 patientVet 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 limitationsEvidence review
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
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.
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
Anaemia NOSLeukopenia NOSNeutropeniaLethargy (see also Central nervous system depression in Neurological)AnorexiaDiarrhoeaLymphadenopathyEnteritisAbnormal radiograph findingOther abnormal test result NOSUrinary tract infectionIncreased band neutrophiliaPain NOSWobblinessTiredness
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
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
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
Every non-trivial field is expected to include provenance and update timestamps.
Official 100Clinical 2Manufacturer 0Marketing 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)
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.
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.
Share Your Thoughts
Let others know your experience or advice regarding this medication.
No community reviews yet. Be the first to share your experience.
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.