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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
Roxee is still reviewing source support for this medication profile.
Roxee has safety or ingredient evidence for this medication, but a regulatory product/application match is still pending.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Generic profile • Source coverage pending
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.
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - flea, Emesis (multiple), Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, Lack of efficacy (bacteria) - Borrelia.
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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:
When to call the vet:
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Fluralaner 5.46% 1-Month Chew; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 26 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
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.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
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.
Injection site lump (1 reports), Injection site complication NOS (1 reports), Injection site bleeding (1 reports), Increased red blood cell count (1 reports), Hyposthenuria (1 reports)
Digestive (4), Skin & allergy (5), Neurologic (2), Behavior (2)
Dog (21 reports), Cat (11 reports)
Dachshund (unspecified) (1), Poodle - Standard (1), Shepherd Dog - German (1), ['Terrier - Bull - American Pit', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Fluralaner 5.46% 1-Month Chew fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
Injection site lump, Injection site complication NOS, Injection site bleeding
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: April 22, 2026, 10:07 AM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2025-12-23 · MSK · MSK
Received 2025-12-23 · MSK · MSK
Received 2025-12-23 · MSK · MSK
Received 2025-12-20 · MSK · MSK
Received 2025-12-18 · MSK · MSK
Received 2025-12-10 · MSK · MSK
Received 2025-12-09 · MSK · MSK
Received 2025-12-02 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Received 2025-11-25 · MSK · MSK
Received 2025-11-25 · MSK · MSK
Received 2025-11-20 · MSK · MSK
Received 2025-11-19 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| 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)
| 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 |
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Diagnosis-code mappings are not available for this medication yet.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Every non-trivial field is expected to include provenance and update timestamps.
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Skin & allergy.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
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
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
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
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
Dog, Shih Tzu, Female, 1 year, 4.445 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Diarrhea, Vomiting, Bloody diarrhoea, Elevated haematocrit, Lymphocytosis • Outcome: Recovered/Normal
Dog, Cattle Dog (unspecified), Female, 3 year • Drug: MSK, Unknown • Reactions: Injection site swelling, Lack of efficacy (endoparasite) - heartworm • Outcome: 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
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
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.