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Esafoxolaner

Detailed information about Esafoxolaner

Official label facts Owner quick guide first Marketing clearly labeled
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Reviewed / Updated / Sources

Reviewed: Not available

Updated: March 3, 2026, 11:08 AM UTC

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

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

What to watch for:

  • Death (1 reports)
  • Vomiting (1 reports)
  • wobbly/unsteady walking (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 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?
Safety & side effects

What to watch:

  • Death
  • Vomiting
  • wobbly/unsteady walking

Most reported reactions:

  • Death (1 reports)
  • Vomiting (1 reports)
  • Unsteady walking (ataxia) (1 reports)

When to call your vet:

  • 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

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:01 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Mar 3, 2026, 11:08 AM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 11, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Mar 3, 2026, 11:00 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 17, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Image coming soon
Esafoxolaner

Esafoxolaner

Drug type: Generic ingredient • Branded profile • FDA branded products available

Species: Both

Manufacturer: Not available (source)

Quick Facts

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

Species: Both
Manufacturer: Not available
Form: Topical Solution
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
Source metadata:

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
21
Reported cases
18
Serious reports
1
Species represented
2
Grouped by Body System
Digestive (3) · Vomiting, Loss of appetite, Diarrhea Skin & allergy (2) · Itching, Application site hair loss Neurologic (3) · Unsteady walking (ataxia), Tremors, Tiredness (lethargy) Effectiveness (2) · Lack of efficacy (endoparasite) - roundworm NOS, Lack of efficacy (endoparasite) - hookworm Other (11) · Pale mucous membrane, Loose stool, Local erythema
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Digestive 1 Dog 0
Neurologic 1 Cat 0
Neurologic 1 Dog 0
Neurologic 1 Dog 0
Other 1 Dog 0
Digestive 1 Dog 0
Other 1 Cat 0

Species coverage: Cat (11) Dog (10)

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

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (0)
  • No official label or package insert links yet.
SPL (1)
  • NexGard® COMBO · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18428/NexGard%C2%AE%20COMBO
FOI (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
  • Medication catalog: Source Roxee | Refreshed Mar 3, 2026, 11:08 AM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 11, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Mar 3, 2026, 11:00 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 17, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: NexGard® COMBO
Case-reported brands (openFDA): MSK
Catalog species: Both
Rx/OTC: RX
Form/route: Topical Solution • Topical
Applications: E 6686
Documents: 1 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 8 • Cat 28 • View
Case summaries: 10 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Myiasis (fly strike)
Linked using: Fda_Label (0.95)
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) Unsteady walking (ataxia) (1) Tremors (1) Tiredness (lethargy) (1) Pale mucous membrane (1) Loss of appetite (1) Loose stool (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 4 Clinical 0 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. (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 2026-03-03 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

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
NexGard® COMBO
RX
Eprinomectin Esafoxolaner Praziquantel
Topical Solution • Topical
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. E 6686 G Mar 2, 2026

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Composition / specifications
Esafoxolaner – 12 mg/mL, Eprinomectin – 4 mg/mL, Praziquantel – 83 mg/mL
Cats
Indication

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

Dosage

NexGard® COMBO is dosed at a minimum of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.65 mg/lb (1.44 mg/kg) esafoxolaner, 0.22 mg/lb (0.48 mg/kg) eprinomectin, and 4.53 mg/lb (9.98 mg/kg) praziquantel.

Limitations

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

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

Source: FDA Animal Drugs @ FDA • Reference

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

Showing top 5 for Digestive.

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

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat Tremors (1) • Dog Tiredness (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
Pale mucous membrane (1) • Dog Loose stool (1) • Cat Local erythema (1) • Dog Incorrect route of drug administration (1) • Dog Head bobbing (1) • Cat
Show more (6)
Death (1) • Cat Accidental exposure (1) • Dog Abnormal posture NOS (1) • Cat Abnormal movement NOS (1) • Cat Application site reddening • Cat Agitation • 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.

Cat, Domestic Shorthair, Male, 3 month, 1.95 kilogram • Drug: MSK, Solution, Topical, Dose: 1 dose per animal • Reactions: Lack of efficacy (endoparasite) - hookworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-056138
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.00 Month
  • Weight: 1.950 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Solution
  • Dose: 1 dose per animal
Reactions Reported:
Lack of efficacy (endoparasite) - hookworm
Outcomes: Outcome Unknown

Cat, Cat (unknown), Unknown • Drug: MSK, Solution, Unknown • Reactions: Lack of efficacy (endoparasite) - roundworm NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-056147
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
Reactions Reported:
Lack of efficacy (endoparasite) - roundworm NOS
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 10 week, 0.757 kilogram • Drug: MSK, Solution, Topical • Reactions: Death • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-056167
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 10.00 Week
  • Weight: 0.757 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Solution
Reactions Reported:
Death
Outcomes: Died

Cat, Domestic Shorthair, Male, 3 month, 1.633 kilogram • Drug: MSK, Solution, Topical, Dose: 1 dose per animal • Reactions: Head bobbing, Unsteady walking (ataxia), Abnormal posture NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-056135
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 3.00 Month
  • Weight: 1.633 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Solution
  • Dose: 1 dose per animal
Reactions Reported:
Head bobbing Unsteady walking (ataxia) Abnormal posture NOS
Outcomes: Outcome Unknown

Cat, Siamese, Female, 12 year, 3.992 kilogram • Drug: MSK, Solution, Topical, Dose: 1 dose per animal • Reactions: Loss of appetite, Unsteady walking (ataxia), Loose stool, Abnormal movement NOS, Abnormal posture NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055900
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 3.992 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Solution
  • Dose: 1 dose per animal
Reactions Reported:
Loss of appetite Unsteady walking (ataxia) Loose stool Abnormal movement NOS Abnormal posture NOS
Outcomes: Ongoing

Dog, Shih Tzu, Female, 10 month, 3.629 kilogram • Drug: MSK, Solution, Oral, Dose: 1 dose per animal • Reactions: Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-046628
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 10.00 Month
  • Weight: 3.629 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 1 dose per animal
Reactions Reported:
Vomiting
Outcomes: Recovered/Normal

Dog, ['Shih Tzu', 'Maltese'], Female, 7 year, 4.536 kilogram • Drug: MSK, Solution, Topical, Dose: 1 dose per animal • Reactions: Itching • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-033763
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.00 Year
  • Weight: 4.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Solution
  • Dose: 1 dose per animal
Reactions Reported:
Itching
Outcomes: Outcome Unknown

Dog, Dog (other), Male, 1 year, 18.144 kilogram • Drug: MSK, Solution, Oral, Frequency: 1 per day • Reactions: Local erythema, Vomiting, Unsteady walking (ataxia), Tremors, Accidental exposure • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2024-US-078274
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 1.00 Year
  • Weight: 18.144 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Frequency: 1 per day
Reactions Reported:
Local erythema Vomiting Unsteady walking (ataxia) Tremors Accidental exposure
Outcomes: Outcome Unknown

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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