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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?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Generic profile • No FDA branded products linked
Species: Both
Manufacturer: Boehringer Ingelheim Animal Health USA, Inc.
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
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. Species commonly shown: Both, Dog.
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.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Top reported reactions (openFDA): Vomiting, Lack of efficacy (ectoparasite) - tick NOS, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Lack of efficacy (ectoparasite) - flea, Seizure NOS.
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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:
When to call the vet:
Regulatory restrictions are shown in Vet View.
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 Afoxolaner; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 24 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.
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)
Digestive (4), Skin & allergy (1), Neurologic (1), Other (26)
Dog (26 reports), Cat (6 reports)
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.
Verify whether Afoxolaner 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.
Loss of appetite, Gall bladder & bile duct disorder NOS, Fluid in abdomen NOS
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 15, 2026, 10:04 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.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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 2025-12-19 · MSK · MSK
Received 2025-12-19 · MSK · MSK
Received 2025-12-19 · MSK · MSK
Received 2025-12-19 · MSK · MSK
Received 2025-12-18 · MSK · MSK
Received 2025-12-17 · MSK · MSK
Received 2025-12-16 · MSK · MSK
Received 2025-12-15 · MSK · MSK
Received 2025-12-11 · MSK · MSK
Received 2025-12-08 · MSK · MSK
Received 2025-12-08 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Received 2025-11-28 · MSK · MSK
Received 2025-11-28 · MSK · MSK
Received 2025-11-26 · MSK · MSK
Received 2025-11-25 · MSK · MSK
Received 2025-10-30 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| 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 (26) Cat (6)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Cat | Non-serious | - | 1 | |
| Neurologic | Cat | Non-serious | - | 1 | |
| Digestive | 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 | 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 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | 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 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 |
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.
Full source previews and metadata remain in the veterinary/professional layer.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
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.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
For the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies.
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 · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
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.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
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 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
NexGard®
RX
Afoxolaner
Chewable Tablets
• Oral
|
Boehringer Ingelheim Animal Health USA, Inc. | NADA 141-406 | Approved | Apr 1, 2026 |
|
NexGard®
RX
Afoxolaner
Chewable Tablets
• Oral
|
Boehringer Ingelheim Animal Health USA, Inc. | E 6685 | G | Mar 2, 2026 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
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
For the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies.
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.
FDA page: Open in Animal Drugs @ FDA
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
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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 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, Cattle Dog (unspecified), Male, 3 year, 20.412 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (endoparasite) - roundworm NOS • Outcome: Outcome Unknown
Dog, Coonhound (unspecified), Female, 8.33 year, 42.547 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: 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
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
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
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
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
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
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.