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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 • Branded profile • FDA branded products available
Species: Both
Manufacturer: Elanco US Inc.
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
To kill fleas and for the prevention and treatment of flea infestations ( Ctenocephalides felis ) for 1 month on dogs and puppies 14 weeks of age and older and 5.0 pounds or body weight or greater. To kill fleas and for the prevention and treatment of flea infestations ( Ctenocephalides felis ) for 1 month on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater. Trifexis™ Chewable Tablets kill fleas and are indicated for the prevention and treatment of flea infestations ( Ctenocephalides felis ), and the treatment and control of adult hookworm ( Ancylostoma caninum ), adult roundworm ( Toxocara canis and Toxascaris leonina ) and adult whipworm ( Trichuris vulpis ) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater. Species commonly shown: Both, Dog, Cat.
To kill fleas and for the prevention and treatment of flea infestations ( Ctenocephalides felis ) for 1 month on dogs and puppies 14 weeks of age and older and 5.0 pounds or body weight or greater. To kill fleas and for the prevention and treatment of flea infestations ( Ctenocephalides felis ) for 1 month on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater. Trifexis™ Chewable Tablets kill fleas and are indicated for the prevention and treatment of flea infestations ( Ctenocephalides felis ), and the treatment and control of adult hookworm ( Ancylostoma caninum ), adult roundworm ( Toxocara canis and Toxascaris leonina ) and adult whipworm ( Trichuris vulpis ) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater.
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Treatment with fewer than 3 monthly doses after the last exposure to mosquitos may not provide complete heartworm prevention. Use with caution in breeding females. The safe use of TRIFEXIS in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy.
Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy (endoparasite) - heartworm, Lack of efficacy (ectoparasite) - flea, Diarrhoea, Lack of efficacy (flea).
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Used for:
To kill fleas and for the prevention and treatment of flea infestations ( Ctenocephalides felis ) for 1 month on dogs and puppies 14 weeks of age and older and 5.0 pounds or body weight or greater.
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 Spinosad; use the official documents and your veterinarian's instructions for product-specific decisions.
30 tracked reaction signals; 28 reported cases; 5 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.
Skin scab (1 reports), Seizure NOS (1 reports), Generalised itching (1 reports), Death (1 reports), Biting - pruritus (1 reports)
Digestive (1), Skin & allergy (5), Neurologic (2), Behavior (1)
Dog (21 reports), Cat (9 reports)
Domestic Shorthair (2), Poodle - Miniature (1), ['Poodle - Miniature', 'Dog (unknown)'] (1), ['Terrier (unspecified)', 'Spaniel (unspecified)'] (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Spinosad 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.
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian, Treatment with fewer than 3 monthly doses after the last exposure to mosquitos may not provide compl, Use with caution in breeding females, The safe use of TRIFEXIS in breeding males has not been evaluated, Use with caution in dogs with pre-existing epilepsy
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: February 12, 2026, 10:44 PM 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. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Treatment with fewer than 3 monthly doses after the last exposure to mosquitos may not provide complete heartworm prevention. Use with caution in breeding females. The safe use of TRIFEXIS in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy.
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 2025-12-08 · MSK · MSK
Received 2025-11-28 · MSK · MSK
Received 2025-11-28 · MSK · MSK
Received 2025-11-11 · MSK · MSK
Received 2025-10-30 · MSK · MSK
Received 2025-10-30 · MSK · MSK
Received 2025-10-30 · MSK · MSK
Received 2025-10-18 · MSK · MSK
Received 2025-10-15 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Other | 1 | Dog | 1 | |
| Neurologic | 1 | Dog | 1 | |
| Skin & allergy | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Skin & allergy | 1 | Dog | 1 | |
| Other | 1 | Cat | 0 | |
| Digestive | 1 | Dog | 0 | |
| Other | 1 | Cat | 0 |
Species coverage: Dog (21) Cat (9)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Other | Cat | Non-serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Neurologic | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Neurologic | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Effectiveness | Dog | Non-serious | - | 1 | |
| Effectiveness | Cat | Non-serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Skin & allergy | Dog | Non-serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Skin & allergy | Dog | Non-serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Unknown | - | - | |
| Other | Dog | Unknown | - | - |
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.
Official label / PI · Labeling
Official label / PI · Official label
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.
To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on dogs and puppies 14 weeks of age and older and 5.0 pounds or body weight or greater.
To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater.
SPL · Structured Product Label
FOI · FOI
FOI · FOI
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 |
|---|---|---|---|
| 58198-0042-1 | 58198 | - | |
| 58198-0042-6 | 58198 | - | |
| 58198-0043-1 | 58198 | - | |
| 58198-0043-6 | 58198 | - | |
| 58198-0044-1 | 58198 | - | |
| 58198-0044-6 | 58198 | - | |
| 58198-0045-1 | 58198 | - | |
| 58198-0045-6 | 58198 | - | |
| 58198-0046-1 | 58198 | - | |
| 58198-0046-6 | 58198 | - | |
| 58198-0071-1 | 58198 | - | |
| 58198-0071-2 | 58198 | - | |
| 58198-0072-1 | 58198 | - | |
| 58198-0072-2 | 58198 | - | |
| 58198-0073-1 | 58198 | - | |
| 58198-0073-2 | 58198 | - | |
| 58198-0074-1 | 58198 | - | |
| 58198-0074-2 | 58198 | - | |
| 58198-0075-1 | 58198 | - | |
| 58198-0075-2 | 58198 | - |
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 |
|---|---|---|---|---|
|
Comfortis®
RX
Spinosad
Tablet (Chewable)
• Oral
|
Elanco US Inc. | NADA 141-277 | Approved | May 17, 2021 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on dogs and puppies 14 weeks of age and older and 5.0 pounds or body weight or greater.
To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater.
FDA page: Open in Animal Drugs @ FDA
To kill fleas and for the prevention and treatment of flea infestations ( Ctenocephalides felis ) for 1 month on dogs and puppies 14 weeks of age and older and 5.0 pounds or body weight or greater. To kill fleas and for the prevention and treatment of flea infestations ( Ctenocephalides felis ) for 1 month on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater. Trifexis™ Chewable Tablets kill fleas and are indicated for the prevention and treatment of flea infestations ( Ctenocephalides felis ), and the treatment and control of adult hookworm ( Ancylostoma caninum ), adult roundworm ( Toxocara canis and Toxascaris leonina ) and adult whipworm ( Trichuris vulpis ) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater.
Source: FDA Animal Drugs @ FDA • Reference
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Treatment with fewer than 3 monthly doses after the last exposure to mosquitos may not provide complete heartworm prevention. Use with caution in breeding females. The safe use of TRIFEXIS in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy.
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 Behavior.
Showing top 5 for Effectiveness.
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, Poodle - Miniature, Male, 17 year, 8.618 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (ectoparasite) - flea • Outcome: Ongoing
Dog, ['Poodle - Miniature', 'Dog (unknown)'], Male, 17 year, 8.618 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Scratching, Lack of efficacy (ectoparasite) - flea • Outcome: Ongoing
Dog, ['Terrier (unspecified)', 'Spaniel (unspecified)'], Female, 17 year, 7.77 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Scratching, Lack of efficacy (ectoparasite) - flea, Itching, Hair loss NOS, Allergy NOS • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Female, 1.49 year, 3.62 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Vomiting, Incorrect dose administered NOS • Outcome: Recovered/Normal
Dog, ['Shepherd Dog - Australian', 'Dog (unknown)'], Unknown, 8 year, 54.4 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Biting - pruritus, Skin scab, Chewing - pruritus, Generalised itching, Lack of efficacy (ectoparasite) - flea • Outcome: Ongoing
Dog, ['Pit Bull', 'Boxer (German Boxer)'], Female, 9 year, 45.5 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Biting - pruritus, Lack of efficacy (ectoparasite) - flea, Generalised itching, Skin scab, Seizure NOS • Outcome: Ongoing
Cat, Domestic Shorthair, Male, 5 year, 6.08 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (ectoparasite) - flea • Outcome: Outcome Unknown
Cat, Domestic Mediumhair, Female, 6 year, 4.082 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Vomiting • Outcome: Recovered/Normal
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.