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Roxee Meds Catalog

Fluralaner 13.64% Chew Tablets

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

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

Storefront facts
Catalog refreshed
May 5, 2026, 10:07 a.m.

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

FDA applications
No FDA application data linked
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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
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:07 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • 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 22, 2026

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

Sources:
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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% storefront ready

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
Dogs
Dosage forms
Chewable tablet
Prescription
Prescription required
Completeness
100%
Validation
Complete
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:

  • Joint swelling (1 reports)
  • Joint pain (1 reports)
  • Isosthenuria (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:

  • Joint swelling
  • Joint pain
  • Isosthenuria

Most reported reactions:

  • Joint swelling (1 reports)
  • Joint pain (1 reports)
  • Isosthenuria (1 reports)

Emergency warning signs:

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

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

Tracked signals
32
Reported cases
32
Serious reports
28
Species represented
2
Grouped by Body System
Digestive (3) · Diarrhea, Decreased appetite, Bloody diarrhoea Skin & allergy (4) · Joint swelling, Injection site swelling, Hives Neurologic (2) · Unsteady walking (ataxia), Grand mal seizure Behavior (2) · Behavioral disorder (unspecified), Anxiety Other (21) · Joint pain, Isosthenuria, Injection site lump
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Skin & allergy 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (22) Cat (10)

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

Documents

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

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

Open original

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

Official Bravecto Chews label.

Bravecto Chews FDA SPL XML

SPL · Structured Product Label

Open original

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.

Source metadata:
Veterinary reference (advanced)

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

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:07 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • 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
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 49 • Cat 15 • View
Case summaries: 19 (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
Joint swelling (1) Joint pain (1) Isosthenuria (1) Injection site lump (1) Injection site complication NOS (1) Injection site bleeding (1) Increased red blood cell count (1) Hyposthenuria (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 22 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, 2026-05-05)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-05-03)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-04-30)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-04-29)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-04-28)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-04-27)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-04-26)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (Official, 2026-04-25)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Lack of efficacy (ectoparasite) - tick NOS, Emesis (multiple), Lethargy (se… (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, 2026-02-12)
Recent Revisions
  • contraindications updated 2026-05-05 10:07 by curated_loader • Contraindication section from the Bravecto Chews label.
  • prescription_required updated 2026-05-05 10:07 by curated_loader • Federal law restricts Bravecto Chews to use by or on the order of a licensed veterinarian.
  • administration updated 2026-05-05 10:07 by curated_loader • Official dosage and administration directions from the Bravecto Chews label.
  • dosage_forms updated 2026-05-05 10:07 by curated_loader • Official label describes Bravecto as flavored chews.
  • species updated 2026-05-05 10:07 by curated_loader • Official label states Bravecto Chews are flavored chews for dogs.
  • usage updated 2026-05-05 10:07 by curated_loader • Official indication summary from the Bravecto Chews label.
  • drug_profile_type updated 2026-05-05 10:07 by curated_loader • Bravecto Chews are the branded FDA-approved animal drug for fluralaner chews.
  • manufacturer_name updated 2026-05-05 10:07 by curated_loader • FDA SPL listing identifies the Bravecto Chews labeler.
  • brand_names updated 2026-05-05 10:07 by curated_loader • Official label identifies Bravecto as the proprietary product name.
  • approval_reference updated 2026-05-05 10:07 by curated_loader • FDA SPL listing identifies Bravecto Chews under NADA 141-459.
  • side_effects updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-03 10:07 by curated_loader • Contraindication section from the Bravecto Chews label.
  • prescription_required updated 2026-05-03 10:07 by curated_loader • Federal law restricts Bravecto Chews to use by or on the order of a licensed veterinarian.
  • administration updated 2026-05-03 10:07 by curated_loader • Official dosage and administration directions from the Bravecto Chews label.
  • dosage_forms updated 2026-05-03 10:07 by curated_loader • Official label describes Bravecto as flavored chews.
  • species updated 2026-05-03 10:07 by curated_loader • Official label states Bravecto Chews are flavored chews for dogs.
  • usage updated 2026-05-03 10:07 by curated_loader • Official indication summary from the Bravecto Chews label.
  • drug_profile_type updated 2026-05-03 10:07 by curated_loader • Bravecto Chews are the branded FDA-approved animal drug for fluralaner chews.
  • manufacturer_name updated 2026-05-03 10:07 by curated_loader • FDA SPL listing identifies the Bravecto Chews labeler.
  • brand_names updated 2026-05-03 10:07 by curated_loader • Official label identifies Bravecto as the proprietary product name.

Top Reported Reactions (openFDA)

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

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

Showing top 5 for Digestive.

Skin & allergy
Joint swelling (1) • Dog Injection site swelling (1) • Dog Hives (1) • Dog Facial swelling (possible allergy) (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Grand mal seizure (1) • Cat

Showing top 5 for Neurologic.

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

Showing top 5 for Behavior.

Other
Joint pain (1) • Dog Isosthenuria (1) • Dog Injection site lump (1) • Cat Injection site complication NOS (1) • Cat Injection site bleeding (1) • Cat
Show more (16)
Increased red blood cell count (1) • Dog Hyposthenuria (1) • Dog Hypersensitivity NOS (1) • Dog Hot spot (1) • Cat Fracture (1) • Dog Fever (1) • Cat Falling (1) • Dog Excessive chewing, licking and/or grooming (1) • Cat Eosinopenia (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated haematocrit (1) • Dog Elevated alanine aminotransferase (1) • Dog Dysphoria (1) • Cat Dilated pupils (1) • Cat Conjunctivitis (1) • Dog Bone and joint disorder NOS (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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