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Roxee Medication Guide

Esafoxolaner

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

Both Source review pending Regulatory linkage incomplete Owner quick guide first
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Veterinary professional?

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Data freshness

Reference 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
No safety reports linked
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openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed May 2, 2026, 10:05 AM UTC
    The reference fact projection used for browse cards and quick facts.
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Esafoxolaner

Esafoxolaner

Drug type: Generic ingredient • Generic profile • Regulatory linkage incomplete

Both 73% 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.

Esafoxolaner

For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens. Species commonly shown: Both.

Generic name
Esafoxolaner
Species
Both
Completeness
73%
Validation
Incomplete

Indications / Uses

For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens.

Side Effects

Top reported reactions (openFDA): Accidental exposure, Vomiting, Behavioural disorder NOS, Incorrect route of drug administration, Anorexia, Ataxia.

FAQ

Both

Related Conditions

Myiasis (fly strike)

Source Transparency

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Pet Owner Quick Guide

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

Used for:

For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens.

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:

  • Death (1 reports)
  • Vomiting (1 reports)
  • Urinary tract infection (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

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
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 Esafoxolaner; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-055900
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 1 serious report; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-055900
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-2025-US-055900
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

Death (1 reports), Vomiting (1 reports), Urinary tract infection (1 reports), Unsteady walking (ataxia) (1 reports), Tremors (1 reports)

Body systems represented Signal grouping

Digestive (4), Skin & allergy (2), Neurologic (4), Effectiveness (2)

Species and breed lens

Species represented in reports Species lens

Cat (18 reports), Dog (14 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Esafoxolaner 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

Death, Vomiting, Urinary tract infection

Call sooner if Escalation

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

Bottom line: Use this Esafoxolaner 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-2025-US-055900 · adverse_reaction · adverse reactions
  2. FOI summary · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: May 2, 2026, 10:05 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Death
  • Vomiting
  • Urinary tract infection

Most reported reactions:

  • Death (1 reports)
  • Vomiting (1 reports)
  • Urinary tract infection (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

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Not linked yet
Indication / use
For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens.
Form / route / dose
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Manufacturer not confirmed
Identifiers:
NADA: 6686 NDC Package: 0010-4120-01 NDC Package: 0010-4120-02 NDC Package: 0010-4120-03 NDC Package: 0010-4121-01 NDC Package: 0010-4121-02 NDC Package: 0010-4121-03 NDC Product: 0010

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
1
Species represented
2
Grouped by Body System
Digestive (4) · Vomiting, Loss of appetite, Diarrhea Skin & allergy (2) · Itching, Application site itching Neurologic (4) · Unsteady walking (ataxia), Tremors, Tiredness (lethargy) Effectiveness (2) · Lack of efficacy (endoparasite) - roundworm NOS, Lack of efficacy (endoparasite) - hookworm Other (20) · Urinary tract infection, Scaly condition NOS, Peeling skin
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Digestive 1 Dog 0
Other 1 Dog 0
Neurologic 1 Dog 0
Neurologic 1 Dog 0
Neurologic 1 Cat 0
Other 1 Cat 0
Other 1 Cat 0

Species coverage: Cat (18) Dog (14)

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

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Only technical FDA review documents are linked right now. Owner handouts, official label / PI, and SPL documents are not linked yet.

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

FOI Summary 006-686 Granted February 18, 2026.pdf FOI · FOI summary

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

0
No SPL links yet.

FOI

1

FOI Summary 006-686 Granted February 18, 2026.pdf

FOI · FOI summary

Open original
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
  • Reference facts: Source Roxee | Refreshed May 2, 2026, 10:05 AM UTC
    The reference fact projection used for browse cards and quick facts.
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Catalog species: Both
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Myiasis (fly strike)
Linked using: Usage_Inferred (0.78)
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
Death (1) Vomiting (1) Urinary tract infection (1) Unsteady walking (ataxia) (1) Tremors (1) Tiredness (lethargy) (1) Scaly condition NOS (1) Peeling skin (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
NADA: 6686 NDC Package: 0010-4120-01 NDC Package: 0010-4120-02 NDC Package: 0010-4120-03 NDC Package: 0010-4121-01 NDC Package: 0010-4121-02 NDC Package: 0010-4121-03 NDC Product: 0010
Package NDC Product NDC Form / Route Status
0010-4120-01 0010 -
0010-4120-02 0010 -
0010-4120-03 0010 -
0010-4121-01 0010 -
0010-4121-02 0010 -
0010-4121-03 0010 -

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 5 Clinical 7 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Accidental exposure, Vomiting, Behavioural disorder NOS, Incorrect route of drug administration, Anorexia, Ataxia. (Clinical, 2026-05-02)
  • side_effects: Top reported reactions (openFDA): Accidental exposure, Vomiting, Behavioural disorder NOS, Incorrect route of drug administration, Anorexia, Ataxia. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Accidental exposure, Vomiting, Behavioural disorder NOS, Incorrect route of drug administration, Anorexia, Ataxia. (Clinical, 2026-04-11)
  • usage: For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens. (Clinical, 2026-05-02)
  • usage: For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens. (Clinical, 2026-04-30)
  • usage: For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens. (Clinical, 2026-04-15)
  • usage: For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens. (Clinical, 2026-04-11)
  • side_effects: Top reported reactions (openFDA): Accidental exposure, Vomiting, Behavioural disorder NOS, Incorrect route of drug administration, Anorexia, Ataxia. (Official, 2026-04-30)
  • side_effects: Top reported reactions (openFDA): Accidental exposure, Vomiting, Behavioural disorder NOS, Incorrect route of drug administration, Anorexia, Ataxia. (Official, 2026-03-03)
  • side_effects: Top reported reactions (openFDA): Accidental exposure, Vomiting, Behavioural disorder NOS, Incorrect route of drug administration, Anorexia, Ataxia. (Official, 2026-02-12)
  • usage: For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens. (Official, 2026-03-03)
Recent Revisions
  • side_effects updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-02 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
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • usage 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
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-03-03 11:08 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-03-03 11:08 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

Usage

For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens.

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) • Cat Diarrhea (1) • Dog Blood in vomit (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Itching (1) • Dog Application site itching (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Tremors (1) • Dog Tiredness (1) • Cat Muscle tremor (1) • Dog

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy (endoparasite) - roundworm NOS (1) • Cat Lack of efficacy (endoparasite) - hookworm (1) • Cat

Showing top 5 for Effectiveness.

Other
Urinary tract infection (1) • Dog Scaly condition NOS (1) • Cat Peeling skin (1) • Cat Pale mucous membrane (1) • Dog Neutrophilia (1) • Dog
Show more (15)
Loose stool (1) • Cat Local erythema (1) • Dog Limb weakness (1) • Dog Leucocytosis NOS (1) • Dog Incorrect route of drug administration (1) • Dog Head bobbing (1) • Cat Foaming at the mouth (1) • Cat Death (1) • Cat Blepharospasm (1) • Cat Application site scab (1) • Cat Application site reddening (1) • Cat Application site pyoderma (1) • Cat Accidental exposure (1) • Dog Abnormal posture NOS (1) • Cat Abnormal movement NOS (1) • Cat

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.

No case-level openFDA reports are linked for this medication yet.

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.

This medication has not been reviewed by a veterinarian yet.