Skip to main content
Start triage

Start triage first, then route to emergency care.

Start symptom intake Emergency vets near you

Need urgent help? Start triage first, then route to emergency care.

Start symptom intake Emergency vets near you

Roxee Medication Guide

Afoxolaner 136 Mg Chewable Tablets

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

Both Reference complete FDA data linked Rx required Chewable Tablets Boehringer Ingelheim Animal Health USA, Inc. Official label facts Owner quick guide first
Start Symptom Intake Talk to a Vet / Find a Vet Near You

Veterinary professional?

Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:40 a.m.

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

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:40 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
Jun 21, 2026, 5:14 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:40 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Image coming soon
Afoxolaner 136 Mg Chewable Tablets

Afoxolaner 136 Mg Chewable Tablets

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Chewable Tablets Rx required 100% reference complete

Species: Both

Manufacturer: Boehringer Ingelheim Animal Health USA, Inc.

Medication Snapshot

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

Afoxolaner 136 Mg Chewable Tablets

Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in dogs and puppies. Species commonly shown: Both, Dog.

Generic name
Afoxolaner 136 Mg Chewable Tablets
Brand names
NexGard®
Manufacturer
Boehringer Ingelheim Animal Health USA, Inc.
Species
Both, Dog
Dosage forms
Chewable Tablets
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
NexGard®
Dosage forms
Chewable Tablets

Indications / Uses

Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in dogs and puppies.

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Vomiting, Skin disorders NOS, Lack of efficacy (tick), Diarrhoea, Lack of efficacy (flea), Lethargy (see also Central nervous system depression in 'Neurological').

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Chewable Tablets

Related Conditions

Fleas (Flea Infestation) Myiasis (fly strike)

Source Transparency

Add to My Pet's Medications

Choose a pet, confirm current or past, and optionally add reminder notes.

Sign in to save this medication to your pet profile.

Sign in to continue

Pet Owner Quick Guide

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

Used for:

Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American...

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:

  • Loss of appetite (1 reports)
  • Gall bladder & bile duct disorder NOS (1 reports)
  • Fluid in abdomen NOS (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.

Regulatory restrictions are shown in Vet View.

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 Afoxolaner 136 Mg Chewable Tablets; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-071623
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 23 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-071623
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-071623
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

Loss of appetite (1 reports), Gall bladder & bile duct disorder NOS (1 reports), Fluid in abdomen NOS (1 reports), Falling (1 reports), Eosinopenia (1 reports)

Body systems represented Signal grouping

Digestive (3), Skin & allergy (1), Neurologic (1), Behavior (2)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (29 reports), Cat (3 reports)

Breed metadata in reports Metadata only

Cattle Dog (unspecified) (1), Coonhound (unspecified) (1), ['Coonhound (unspecified)', 'Dog (unknown)'] (1), Beagle (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Afoxolaner 136 Mg Chewable Tablets 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

Loss of appetite, Gall bladder & bile duct disorder NOS, Fluid in abdomen NOS

Call sooner if Escalation

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

Bottom line: Use this Afoxolaner 136 Mg Chewable Tablets 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-071623 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. FOI · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 16, 2026, 10:08 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Loss of appetite
  • Gall bladder & bile duct disorder NOS
  • Fluid in abdomen NOS

Most reported reactions:

  • Loss of appetite (1 reports)
  • Gall bladder & bile duct disorder NOS (1 reports)
  • Fluid in abdomen NOS (1 reports)
Explore reported case details

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
Dog
Indication / use
Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of Ixodes scapularis (black-legge…
Form / route / dose
Form: Chewable Tablets
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Boehringer Ingelheim Animal Health USA, Inc.
Form: Chewable Tablets
Identifiers:
NADA: 141406 NADA: 6685
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
18
Matching reports
2
Active filters
1
Selected filters
Reaction: Death by euthanasia Clear
Reset
Drill into common report signals
Vomiting (4) Lack of efficacy (endoparasite) - roundworm NOS (3) Death by euthanasia (2) Diarrhoea (2) Effectiveness (12) Other (10) Digestive (5) Behavior (1)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-072769

Received 2025-12-08 · MSK · MSK

Serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (6.35 Kilogram)
Age
8+ years (14 Year)
Sex
Female Unknown
Region
USA
Reactions
MalaiseNot himself/herselfConfusionSleepiness - systemic disorderArched backFallingCollapse NOS (see also Cardio-vascular and Neurological disorders)Intervertebral disc diseaseHead downParalysisVocalisationNot defecatingPain NOSHead shake - behavioural disorderRotatory nystagmusDeath by euthanasia
Body systems
OtherNeurologicBehavior
Outcomes
Euthanized

USA-USFDACVM-2025-US-071623

Received 2025-12-01 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Dog (unknown)']
Size / weight
25-49 lb (17.69 Kilogram)
Age
8+ years (12 Year)
Sex
Male Neutered
Region
USA
Reactions
VomitingNot eatingWeight lossIcterusLeucopenia NOSDecreased red blood cell countThrombocytopeniaElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)Elevated total bilirubinHigh pancreatic-specific lipaseUrinary incontinenceInfectious disease NOSOverdoseGall bladder & bile duct disorder NOSLymphopeniaNeutropeniaSplenomegalyLoose stoolPancreas disorderHepatomegalyDeath by euthanasiaHypoalbuminaemiaHypoproteinaemiaFluid in abdomen NOSElevated blood urea nitrogen (BUN)Elevated bile acidsAbnormal ultrasound findingElevated cholesterol (total)Enlarged lymph node (localised)Reduced globulinsMonocytopeniaEosinopeniaLiver nodules
Body systems
DigestiveOther
Outcomes
Euthanized

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

Tracked signals
32
Reported cases
32
Serious reports
23
Species represented
2
Grouped by Body System
Digestive (3) · Vomiting, Loss of appetite, Diarrhea Skin & allergy (1) · Application site hair loss Neurologic (1) · Unsteady walking (ataxia) Behavior (2) · Fly biting behaviour, Anxiety Other (25) · Haemorrhagic gastroenteritis, Gall bladder & bile duct disorder NOS, Fluid in abdomen NOS
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (29) Cat (3)

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

Source Documents

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

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

NexGard® SPL · SPL NexGard® SPL · SPL FOI Summary sN 141-406 Approved June 21, 2023.pdf FOI · FOI

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

2

FOI

7

NexGard®

SPL · SPL

Open original
FDA Structured Product Label

NexGard®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Boehringer Ingelheim Animal Health USA, Inc.
NADA
141-406
Status
RX
Form
Chewable Tablets
Route
Oral
Species
Dog
Composition / specifications
Each chewable contains 11.3 mg, 28.3 mg, 68 mg, or 136 mg afoxolaner.

Dogs (Dogs and Puppies 8 Weeks of Age and Older)

Indication

Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Dosage

NexGard® is given once a month at the minimum dosage of 1.14 mg/lb (2.5 mg/kg).

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

NexGard®

SPL · SPL

Open original
FDA Structured Product Label

NexGard®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Boehringer Ingelheim Animal Health USA, Inc.
E
6685
Status
RX
Form
Chewable Tablets
Route
Oral
Composition / specifications
Each chewable contains 11.3 mg, 28.3 mg, 68 mg, or 136 mg of afoxolaner

Dogs

Indication

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

Dosage

NexGard® is given orally at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). NexGard® should be used in conjunction with the mechanical removal of larvae (live and dead) remaining in the wound after treatment.

FOI Summary sN 141-406 Approved June 21, 2023.pdf

FOI · FOI

Open original

FOI Summary sN 141-406 Approved July 13, 2018.pdf

FOI · FOI

Open original

UCM436418.pdf

FOI · FOI

Open original

UCM409102.pdf

FOI · FOI

Open original

UCM399805.pdf

FOI · FOI

Open original

UCM377867.pdf

FOI · FOI

Open original

FOI Summary 006-685 Granted February 18, 2026.pdf

FOI · FOI

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 Jun 22, 2026, 10:40 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 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 • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Chewable Tablets • Oral
Applications: NADA 141-406 • E 6685
Documents: 7 (FOI: 7) • SPL: 2 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 76 • Cat 4 • View
Case summaries: 18 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: B88.1
Tungiasis and other infestations

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Loss of appetite (1) Gall bladder & bile duct disorder NOS (1) Fluid in abdomen NOS (1) Falling (1) Eosinopenia (1) Enlarged lymph node (1) Elevated total bilirubin (1) Elevated thyroxine (1)

Identifiers & Packages

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

Identifiers
NADA: 141406 NADA: 6685

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 78 Clinical 4 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Clinical, 2026-04-17)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Vomiting, Skin disorders NOS, Lack of efficacy (tick), Diarrhoea, Lack of efficacy (flea), Lethargy (see also Central nervous… (Clinical, 2026-04-11)
  • usage: Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of Ixodes sca… (Clinical, 2026-04-17)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-04-22)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-04-16)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-22)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-22)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-21)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-20)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-13)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-12)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-12)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-11)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-11)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-10)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-09)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-08)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-07)
  • indications: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infe… (Official, 2026-06-06)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-17 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-17 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-17 10:05 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 10:08 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-16 10:08 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

FDA Products & Applications (Animal Drugs @ FDA)

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

Product Sponsor Application Status Published
NexGard®
RX
Afoxolaner
Chewable Tablets • Oral
Label highlights
Official documents
Boehringer Ingelheim Animal Health USA, Inc. NADA 141-406 Approved Apr 1, 2026
NexGard®
RX
Afoxolaner
Chewable Tablets • Oral
Label highlights
Official documents
Boehringer Ingelheim Animal Health USA, Inc. E 6685 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.

Species: Dog
Composition / specifications
Each chewable contains 11.3 mg, 28.3 mg, 68 mg, or 136 mg afoxolaner.
Dogs (Dogs and Puppies 8 Weeks of Age and Older)
Indication

Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Dosage

NexGard® is given once a month at the minimum dosage of 1.14 mg/lb (2.5 mg/kg).

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
Each chewable contains 11.3 mg, 28.3 mg, 68 mg, or 136 mg of afoxolaner
Dogs
Indication

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

Dosage

NexGard® is given orally at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). NexGard® should be used in conjunction with the mechanical removal of larvae (live and dead) remaining in the wound after treatment.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in dogs and puppies.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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) • Cat Loss of appetite (1) • Dog Diarrhea (1) • Dog

Showing top 5 for Digestive.

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

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

Behavior
Fly biting behaviour (1) • Dog Anxiety (1) • Dog

Showing top 5 for Behavior.

Other
Haemorrhagic gastroenteritis (1) • Dog Gall bladder & bile duct disorder NOS (1) • Dog Fluid in abdomen NOS (1) • Dog Falling (1) • Dog Eosinopenia (1) • Dog
Show more (20)
Enlarged lymph node (1) • Dog Elevated total bilirubin (1) • Dog Elevated thyroxine (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated cholesterol (1) • Dog Elevated blood urea nitrogen (1) • Dog Elevated bile acids (1) • Dog Elevated alanine aminotransferase (1) • Dog Ear infection NOS (1) • Dog Drug dose administration interval too short (1) • Dog Dehydration (1) • Dog Decreased red blood cell count (1) • Dog Death by euthanasia (1) • Dog Deafness (1) • Dog Confusion (1) • Dog Complication of diabetes (1) • Dog Collapse NOS (1) • Dog Arched back (1) • Dog Application site skin scaling (1) • Cat Abnormal ultrasound finding (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, Cattle Dog (unspecified), Male, 3 year, 20.412 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (endoparasite) - roundworm NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074808
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 20.412 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (endoparasite) - roundworm NOS
Outcomes: Outcome Unknown

Dog, Coonhound (unspecified), Female, 8.33 year, 42.547 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075224
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.33 Year
  • Weight: 42.547 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm
Outcomes: Outcome Unknown

Dog, ['Coonhound (unspecified)', 'Dog (unknown)'], Female, 5.25 year, 28.44 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075061
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.25 Year
  • Weight: 28.440 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm
Outcomes: Outcome Unknown

Dog, Beagle, Female, 4 year, 9.979 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (endoparasite) - hookworm • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074016
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 9.979 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Lack of efficacy (endoparasite) - hookworm
Outcomes: Ongoing

Dog, Spaniel - King Charles Cavalier, Male, 5 year, 15.422 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (bacteria) - Anaplasma • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-073999
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 15.422 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (bacteria) - Anaplasma
Outcomes: Outcome Unknown

Dog, Schnauzer - Miniature, Male, 5 year, 6.8 kilogram • Drug: MSK, Oral, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - whipworm, Overdose, Drug dose administration interval too short • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075319
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 6.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (endoparasite) - whipworm Overdose Drug dose administration interval too short
Outcomes: Ongoing

Dog, Retriever - Chesapeake Bay, Female, 4 year, 35.743 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Loss of appetite, Loose stool, Neutrophilia, Dehydration… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074217
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 35.743 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Vomiting Loss of appetite Loose stool Neutrophilia Dehydration Low platelet count
Outcomes: Outcome Unknown

Dog, Siberian Husky, Male, 11 year, 30.16 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Polyuria, Polydipsia, Skin discolouration NOS, Poor coat condition, Complication of diabetes… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074352
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 30.160 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Polyuria Polydipsia Skin discolouration NOS Poor coat condition Complication of diabetes Elevated thyroxine Elevated cholesterol Partial lack of efficacy Weight gain
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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.