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Roxee Meds Catalog

Fluralaner 5.46% 1-Month Chew

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

Both Source review pending Source coverage pending Owner quick guide first
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Data freshness

Storefront facts
Source review pending
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Roxee is still reviewing source support for this medication profile.

FDA applications
Regulatory match pending
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Roxee has safety or ingredient evidence for this medication, but a regulatory product/application match is still pending.

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, 10:05 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 5.46% 1-Month Chew

Fluralaner 5.46% 1-Month Chew

Drug type: Generic ingredient • Generic profile • Source coverage pending

Both 58% storefront ready

Species: Both

Approval status: Source coverage pending. Roxee has limited supporting content for this record, but no on-page official FDA animal-drug document is linked yet. Treat it as source-limited until the ETL backfill adds official coverage.

Medication Snapshot

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

Fluralaner 5.46% 1-Month Chew

Generic name
Fluralaner 5.46% 1-Month Chew
Species
Both
Completeness
58%
Validation
Incomplete

Side Effects

Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, Lack of efficacy (bacteria) - Borrelia.

FAQ

Both

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:

  • Injection site lump (1 reports)
  • Injection site complication NOS (1 reports)
  • Injection site bleeding (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:

  • Injection site lump
  • Injection site complication NOS
  • Injection site bleeding

Most reported reactions:

  • Injection site lump (1 reports)
  • Injection site complication NOS (1 reports)
  • Injection site bleeding (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: Manufacturer not confirmed

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
26
Species represented
2
Grouped by Body System
Digestive (4) · Vomiting, Diarrhea, Decreased appetite Skin & allergy (5) · Injection site swelling, Hives, Hair loss NOS Neurologic (2) · Unsteady walking (ataxia), Grand mal seizure Behavior (2) · Behavioral disorder (unspecified), Anxiety Other (19) · Injection site lump, Injection site complication NOS, Injection site bleeding
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Skin & allergy 1 Dog 1

Species coverage: Dog (21) Cat (11)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Non-serious - 1
Neurologic Dog Non-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
Skin & allergy Cat 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
Skin & allergy Dog Non-serious - 1
Behavior Dog Non-serious - 1
Behavior Dog Serious - 1
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, 10:05 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
No official FDA brand rows linked yet for this ingredient.
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
Injection site lump (1) Injection site complication NOS (1) Injection site bleeding (1) Increased red blood cell count (1) Hyposthenuria (1) Hypersensitivity NOS (1) Hot spot (1) Hives (1)

Data Sources & Change Log

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

Official 10 Clinical 2 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Clinical, 2026-04-11)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Official, 2026-05-05)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Official, 2026-05-03)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Official, 2026-04-30)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Official, 2026-04-29)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Official, 2026-04-28)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Official, 2026-04-27)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Official, 2026-04-26)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Official, 2026-04-25)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Official, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, L… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-26 10:06 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-25 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • side_effects 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
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

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
Injection site swelling (1) • Dog Hives (1) • Dog Hair loss NOS (1) • Cat Facial swelling (possible allergy) (1) • Dog Biting - pruritus (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
Injection site lump (1) • Cat Injection site complication NOS (1) • Cat Injection site bleeding (1) • Cat Increased red blood cell count (1) • Dog Hyposthenuria (1) • Dog
Show more (14)
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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