Meds A-Z
Afoxolaner
Detailed information about Afoxolaner
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ) and roundworm ( Tox...
What it does:
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...
When it's needed:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Call your vet sooner if you notice:
- Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Commonly reported reactions:
- (1 reports)
- (1 reports)
- (1 reports)
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?
Afoxolaner
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141554 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141406 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
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.
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source
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.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 1 | Cat | 1 | |
| 1 | Cat | 0 | |
| 1 | Cat | 0 | |
| 1 | Dog | 0 | |
| 1 | Dog | 0 | |
| 1 | Dog | 0 | |
| 1 | Dog | 0 | |
| 1 | Dog | 0 |
Species coverage: Cat (19) Dog (13)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-050688
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 12 • Secondary summaries: 0
- FOI Summary sN 141-554 Approved January 20, 2026.pdf · FOI
- FOI Summary sN 141-554 Approved April 23 2025_EF.pdf · FOI
- FOI Summary sN 141-554 Approved October 7, 2024.pdf · FOI
- FOI Summary oN 141-554 Approved July 19, 2023.pdf · FOI
- NexGard® PLUS · SPL
- FOI Summary sN 141-406 Approved June 21, 2023.pdf · FOI
- FOI Summary sN 141-406 Approved July 13, 2018.pdf · FOI
- UCM436418.pdf · FOI
- UCM409102.pdf · FOI
- UCM399805.pdf · FOI
- UCM377867.pdf · FOI
- NexGard® · SPL
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17910 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16845 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/15947 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/14288 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/14516/NexGard%C2%AE%20PLUS · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/14165 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/3811 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/914 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/913 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/912 · document · FOI
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:02 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 12, 2026, 10:42 PM UTC
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 0010-2405-01 | 0010 | - | |
| 0010-2405-02 | 0010 | - | |
| 0010-2405-03 | 0010 | - | |
| 0010-2407-01 | 0010 | - | |
| 0010-2407-02 | 0010 | - | |
| 0010-2407-03 | 0010 | - | |
| 0010-2409-01 | 0010 | - | |
| 0010-2409-02 | 0010 | - | |
| 0010-2409-03 | 0010 | - | |
| 0010-2411-01 | 0010 | - | |
| 0010-2411-02 | 0010 | - | |
| 0010-2411-03 | 0010 | - | |
| 0010-4120-01 | 0010 | - | |
| 0010-4120-02 | 0010 | - | |
| 0010-4120-03 | 0010 | - | |
| 0010-4121-01 | 0010 | - | |
| 0010-4121-02 | 0010 | - | |
| 0010-4121-03 | 0010 | - | |
| 0010-4260-01 | 0010 | - | |
| 0010-4260-02 | 0010 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
FOI Summary oN 141-554 Approved July 19, 2023.pdf
• FOI summary • Official
• Feb. 2, 2026
FDA FOI summary for application 141554
-
FOI Summary sN 141-554 Approved October 7, 2024.pdf
• FOI summary • Official
• Feb. 2, 2026
FDA FOI summary for application 141554
-
FOI Summary sN 141-554 Approved April 23 2025_EF.pdf
• FOI summary • Official
• Feb. 2, 2026
FDA FOI summary for application 141554
-
FOI Summary sN 141-554 Approved January 20, 2026.pdf
• FOI summary • Official
• Feb. 2, 2026
FDA FOI summary for application 141554
-
UCM377867.pdf
• FOI summary • Official
• Jan. 14, 2025
FDA FOI summary for application 141406
-
UCM399805.pdf
• FOI summary • Official
• Jan. 14, 2025
FDA FOI summary for application 141406
-
UCM409102.pdf
• FOI summary • Official
• Jan. 14, 2025
FDA FOI summary for application 141406
-
UCM436418.pdf
• FOI summary • Official
• Jan. 14, 2025
FDA FOI summary for application 141406
-
FOI Summary sN 141-406 Approved July 13, 2018.pdf
• FOI summary • Official
• Jan. 14, 2025
FDA FOI summary for application 141406
-
FOI Summary sN 141-406 Approved June 21, 2023.pdf
• FOI summary • Official
• Jan. 14, 2025
FDA FOI summary for application 141406
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-02-12)
- side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - tick NOS, Lethargy (see also Central nervous system depression in 'Neurological')… (Official, 2026-02-12)
- 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… (Official, 2026-02-12)
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage 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® PLUS
RX
Afoxolaner Moxidectin Pyrantel Pamoate
Chewable Tablets
• Oral
|
Boehringer lngelheim Animal Health USA, Inc. | NADA 141-554 | Approved | Feb 2, 2026 |
|
NexGard®
RX
Afoxolaner
Chewable Tablets
• Oral
|
Boehringer lngelheim Animal Health USA, Inc. | NADA 141-406 | Approved | Jan 14, 2025 |
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
For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris leonina) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (blacklegged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (longhorned tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
Administer orally once a month at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel (as pamoate salt). For heartworm disease prevention, give once monthly for at least six months after last exposure to mosquitoes.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
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.
NexGard® is given once a month at the minimum dosage of 1.14 mg/lb (2.5 mg/kg).
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
This supplement provides for the addition of the indication for the treatment and control of Amblyomma maculatum (Gulf Coast tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater.
-
Summary
This supplement provides for the addition of the indication for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
-
Summary
This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater, for one month. This supplement also provides for the addition of label language regarding the results of a second flea field study and improvement of erythema, alopecia, papules, scales, crusts, and excoriation in dogs with flea infestations and signs of Flea Allergy Dermatitis following treatment with afoxolaner alone, as a direct result of eliminating fleas.
-
Summary
For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris leonina) infections. 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), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), and Amblyomma americanum (lone star tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater.
- NexGard® PLUS (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
This supplement provides for a new modified NexGard® formulation.
This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month.
This supplement also provides for the addition of label language regarding the improvement of erythema, alopecia, papules, scales, crusts, and excoriation in dogs with flea infestations and signs of Flea Allergy Dermatitis following treatment with NexGard®, as a direct result of eliminating fleas. -
Summary
This supplement provides for the addition of the indication for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
-
FOI UCM436418.pdf
Summary
The effect of the supplement is to provide for the treatment and control of Brown dog tick ( Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month. -
FOI UCM409102.pdf
Summary
This supplement provides for the treatment and control of Black-legged tick (Ixodes scapularis) and Lone Star tick (Amblyomma americanum) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month. -
FOI UCM399805.pdf
Summary
The effect of the supplement is to add language to the Effectiveness section of the package insert from the flea speed of kill study. -
FOI UCM377867.pdf
Summary
For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month.
- NexGard® (ZIP)
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 prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ) and roundworm ( Toxocara canis and Toxascaris leonina ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (blacklegged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (longhorned tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
Source: FDA Animal Drugs @ FDA • Reference
Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 56 and Cat 20 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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, Retriever - Golden, Unknown, 1 year, 26.76 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (endoparasite) - tapeworm • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-056118
- Serious AE: No
- Treated For AE: Yes
- Sex: Unknown
- Age: 1.00 Year
- Weight: 26.760 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Dog, Retriever - Golden, Unknown, 1 year, 20.86 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (endoparasite) - tapeworm • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-056116
- Serious AE: No
- Treated For AE: Yes
- Sex: Unknown
- Age: 1.00 Year
- Weight: 20.860 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Dog, Crossbred Canine/dog, Female, 12 year, 3.538 kilogram • Drug: MSK, Tablet, chewable, Unknown • Reactions: Hives, Tiredness (lethargy), Decreased appetite • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-055457
- Serious AE: No
- Treated For AE: Yes
- Sex: Female
- Age: 12.00 Year
- Weight: 3.538 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Tablet, chewable
Dog, Crossbred Canine/dog, Male, 8 year, 15.91 kilogram • Drug: MSK, Oral • Reactions: Lack of efficacy (endoparasite) - hookworm, Itching • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055786
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 8.00 Year
- Weight: 15.910 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
Dog, Retriever - Labrador, Male, 7 year, 33.112 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (endoparasite) - tapeworm • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055716
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 7.00 Year
- Weight: 33.112 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet, chewable
- Dose: 1 tablet per animal
Dog, Doberman Pinscher, Male, 5 month, 21.863 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 dose per animal • Reactions: Lack of efficacy (endoparasite) - hookworm, Lack of efficacy (protozoa) - Giardia • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055419
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 5.00 Month
- Weight: 21.863 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet, chewable
- Dose: 1 dose per animal
Cat, Domestic Longhair, Female, 8 year, 6.577 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 0.50 tablet per animal • Reactions: Hiding, Administration error NOS • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-050688
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 8.00 Year
- Weight: 6.577 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet, chewable
- Dose: 0.50 tablet per animal
Cat, Domestic Shorthair, Male, 4 month, 2.404 kilogram • Drug: MSK, Tablet, chewable, Oral • Reactions: Shaking • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-043460
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 4.00 Month
- Weight: 2.404 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet, chewable
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.