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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: Zoetis Inc.
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
SIMPARICA® kills adult fleas, and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations [ Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. revolution® PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis, the treatment and control of roundworm ( Toxocara cati ) and intestinal hookworm ( Ancylostoma tubaeforme ) infections, and the treatment and control of ear mite ( Otodectes cynotis ) infestations. revolution® PLUS kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated cat, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), and Ixodes scapularis (black-legged tick) for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater. Simparica TRIO® is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina ) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala ) infections. Simparica TRIO® kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated dog, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. Simparica TR O® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. Species commonly shown: Both, Dog.
SIMPARICA® kills adult fleas, and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations [ Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. revolution® PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis , the treatment and control of roundworm ( Toxocara cati ) and intestinal hookworm ( Ancylostoma tubaeforme ) infections, and the treatment and control of ear mite ( Otodectes cynotis ) infestations. revolution® PLUS kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated cat, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), and Ixodes scapularis (black-legged tick) for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater. Simparica TRIO® is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina ) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala ) infections. Simparica TRIO® kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated dog, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. Simparica TR O® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
Top reported reactions (openFDA): Vomiting, Seizure NOS, Lethargy (see also Central nervous system depression in 'Neurological'), Tremor, Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS.
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Used for:
SIMPARICA® kills adult fleas, and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations [ Amblyomma americanum (lone star tick),...
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:
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 Sarolaner; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 19 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.
Unsteady walking (ataxia) (1 reports), Increased seizure frequency (1 reports), Hyperglycaemia (1 reports), Hyperactivity (1 reports), Heart failure (1 reports)
Digestive (4), Skin & allergy (1), Neurologic (2), Behavior (1)
Cat (17 reports), Dog (15 reports)
Domestic Shorthair (2), Havanese (1), Shepherd Dog - Belgian Malinois (1), Collie - Smooth-haired (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Sarolaner 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.
wobbly/unsteady walking, Increased seizure frequency, Hyperglycaemia
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.
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 2026-03-23 · MSK · MSK
Received 2025-12-23 · MSK · MSK
Received 2025-11-12 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Cat | 1 | |
| Neurologic | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 |
Species coverage: Cat (17) Dog (15)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Dog | Non-serious | - | 1 | |
| Neurologic | Cat | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Neurologic | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Skin & allergy | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-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.
SIMPARICA® kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus
sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
SPL · Structured Product Label
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI summary
FOI · FOI summary
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 |
|---|---|---|---|
| 54771-0411-1 | 54771 | - | |
| 54771-0411-2 | 54771 | - | |
| 54771-0411-3 | 54771 | - | |
| 54771-0412-1 | 54771 | - | |
| 54771-0412-2 | 54771 | - | |
| 54771-0412-3 | 54771 | - | |
| 54771-0416-1 | 54771 | - | |
| 54771-0416-2 | 54771 | - | |
| 54771-0416-3 | 54771 | - | |
| 54771-2015-1 | 54771 | - | |
| 54771-2015-2 | 54771 | - | |
| 54771-2015-3 | 54771 | - | |
| 54771-2016-1 | 54771 | - | |
| 54771-2016-2 | 54771 | - | |
| 54771-2016-3 | 54771 | - | |
| 54771-2017-1 | 54771 | - | |
| 54771-2017-2 | 54771 | - | |
| 54771-2017-3 | 54771 | - | |
| 54771-2018-1 | 54771 | - | |
| 54771-2018-2 | 54771 | - |
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 |
|---|---|---|---|---|
|
SIMPARICA®
RX
Sarolaner
Chewable Tablets
• Oral
|
Zoetis Inc. | NADA 141-452 | Approved | Dec 2, 2024 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
SIMPARICA® kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus
sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
FDA page: Open in Animal Drugs @ FDA
SIMPARICA® kills adult fleas, and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations [ Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. revolution® PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis , the treatment and control of roundworm ( Toxocara cati ) and intestinal hookworm ( Ancylostoma tubaeforme ) infections, and the treatment and control of ear mite ( Otodectes cynotis ) infestations. revolution® PLUS kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated cat, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), and Ixodes scapularis (black-legged tick) for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater. Simparica TRIO® is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina ) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala ) infections. Simparica TRIO® kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated dog, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. Simparica TR O® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
Source: FDA Animal Drugs @ FDA • Reference
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 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, Havanese, Female, 9 year, 5.216 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 20 Milligram per animal, Frequency: 1 per month • Reactions: Seizure NOS • Outcome: Recovered/Normal
Dog, Shepherd Dog - Belgian Malinois, Female, 6 year, 32.205 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 80 Milligram per animal, Frequency: 1 per month • Reactions: Itching, Scratching • Outcome: Ongoing
Dog, Collie - Smooth-haired, Female, 8 year, 27.216 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 80 Milligram per animal, Frequency: 1 per month • Reactions: Seizure NOS • Outcome: Recovered/Normal
Cat, Domestic Shorthair, Female, 12.5 year, 2.268 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 120 Milligram per animal • Reactions: Seizure NOS, Accidental exposure, Labeled drug-species interaction • Outcome: Ongoing
Dog, ['Retriever - Labrador', 'Shepherd (unspecified)'], Male, 9 year, 34.019 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 dose per animal • Reactions: Seizure NOS, Drunken gait, Shaking, Unable to walk, Fear/fearful • Outcome: Ongoing
Dog, ['Retriever - Labrador', 'Poodle - Miniature'], Female, 2 year, 19.68 kilogram • Drug: MSK, Unknown • Reactions: Hiding, Vocalisation, Pacing, Loss of appetite, Generalised itching… • Outcome: Ongoing
Dog, Spaniel (unspecified), Male, 12 year, 11.476 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 40 Milligram per animal • Reactions: Trembling, Unsteady walking (ataxia) • Outcome: Ongoing
Cat, Domestic Shorthair, Female, 11 month, 3.221 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 120 Milligram per animal • Reactions: Accidental exposure, Seizure NOS, Twitching, Labeled drug-species interaction • 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.