Roxee Medication Guide

Sarolaner

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 Zoetis Inc. Official label facts Owner quick guide first

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Data freshness

Reference facts

Reference refreshed

Jun 22, 2026, 10:41 a.m.

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

FDA applications

FDA application data refreshed

Jun 22, 2026, 10:41 a.m.

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

Safety reports

Safety data refreshed

Jun 22, 2026, 10:42 a.m.

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

Source timing details

Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 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 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 Jun 22, 2026, 10:41 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
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

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Sarolaner

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Chewable Tablets Rx required 100% reference complete

Species: Both

Manufacturer: Zoetis Inc.

Medication Snapshot

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

Sarolaner

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.

Generic name

Sarolaner

Brand names

SIMPARICA®, Simparica Chewables

Manufacturer

Zoetis Inc.

Species

Both, Dog

Dosage forms

Chewable Tablets

Prescription

Prescription required

Completeness

100%

Validation

Complete

Brand names

SIMPARICA® Simparica Chewables

Dosage forms

Chewable Tablets

Indications / Uses

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.

Side Effects

Top reported reactions (openFDA): Vomiting, Seizure NOS, Lethargy (see also Central nervous system depression in 'Neurological'), Tremor, Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Chewable Tablets

Related Medications

Related Conditions

Fleas (Flea Infestation) Tick infestation Heartworm Disease

Source Transparency

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://animaldrugsatfda.fda.gov/adafda/views/#/search
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/5847
Last refreshed: Jun 22, 2026, 10:41 a.m.
Last verified: Feb 12, 2026, 10:44 p.m.
Validation status: Complete

Add to My Pet's Medications

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Pet Owner Quick Guide

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

Used for:

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:

wobbly/unsteady walking (1 reports)
very low energy (1 reports)
Medication error 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.

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 Sarolaner; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-051479

Safety signal coverage Reported signals

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.

Source: openFDA case USA-USFDACVM-2025-US-051479

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-051479

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

Unsteady walking (ataxia) (1 reports), Tiredness (lethargy) (1 reports), Medication error NOS (1 reports), Loss of bowel control (1 reports), Intentional misuse (1 reports)

Body systems represented Signal grouping

Digestive (2), Neurologic (3), Behavior (1), Effectiveness (6)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (16 reports), Cat (16 reports)

Breed metadata in reports Metadata only

Crossbred Canine/dog (1), Shepherd Dog - Australian (1), Boxer (German Boxer) (1), Pointing Dog - German Short-haired (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 Sarolaner 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

wobbly/unsteady walking, very low energy, Medication error NOS

Call sooner if Escalation

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

Bottom line: Use this Sarolaner 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

openFDA case USA-USFDACVM-2025-US-051479 · adverse_reaction · adverse reactions
FDA application profile · official_label · quick facts
Medication usage source · fda_animal_drugs · quick facts
FOI · document · documents
FOI · document · documents
FOI · document · documents
FOI · document · documents
SPL · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:

FDA application profile · official_label
Medication usage source · fda_animal_drugs
openFDA case USA-USFDACVM-2025-US-051479 · adverse_reaction
FOI · document
FOI · document

Safety & side effects

Side effects to monitor:

wobbly/unsteady walking
very low energy
Medication error NOS

Most reported reactions:

Unsteady walking (ataxia) (1 reports)
Tiredness (lethargy) (1 reports)
Medication error 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

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 …

Form / route / dose

Form: Chewable Tablets
Route: Oral
Confirm product label and patient-specific plan.

Warnings

No structured warnings linked yet.

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

SIMPARICA® SPL
Simparica Chewables SPL SPL
FOI Summary sN 141-452 Approved November 22, 2024.pdf FOI

Quick Facts

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

Species: Both

Manufacturer: Zoetis Inc.

Form: Chewable Tablets

Identifiers:

NADA: 141452 NADA: 141502 NADA: 141521 NDC Package: 54771-0411-1 NDC Package: 54771-0411-2 NDC Package: 54771-0411-3 NDC Package: 54771-0412-1 NDC Package: 54771-0412-2 NDC Package: 54771-0412-3 NDC Package: 54771-0416-1 NDC Package: 54771-0416-2 NDC Package: 54771-0416-3 NDC Package: 54771-2015-1 NDC Package: 54771-2015-2 NDC Package: 54771-2015-3 NDC Package: 54771-2016-1 NDC Package: 54771-2016-2 NDC Package: 54771-2016-3 NDC Package: 54771-2017-1 NDC Package: 54771-2017-2

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141452 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

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

Matching reports

Active filters

Selected filters

Reaction: Apnoea Clear Body system: Other Clear

Species

Breed

Size / weight

Age

Sex

Seriousness

Outcome

Reaction

Body system

Region

Received after

Received before

Reset

Drill into common report signals

Vomiting (2) Apnoea (1) Ascites (1) Ataxia (1) Other (5) Effectiveness (3) Digestive (2) Neurologic (1)

Showing up to 50 matching reports.

USA-USFDACVM-2025-US-072789

Received 2025-12-11 · MSK · MSK

Serious

Species: Dog
Breed: Dachshund (unspecified)
Size / weight: 10-24 lb (4.536 Kilogram)
Age: 8+ years (12 Year)
Sex: Female Unknown
Region: USA
Reactions: Apnoea
Body systems: Other
Outcomes: Ongoing

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

Tracked signals

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (2) · Vomiting, Decreased appetite Neurologic (3) · Unsteady walking (ataxia), Tiredness (lethargy), Increased seizure frequency Behavior (1) · Behavioral disorder (unspecified) Effectiveness (6) · Lack of efficacy - NOS, Lack of efficacy (endoparasite) - tapeworm, Lack of efficacy (endoparasite) - NOS Other (20) · Medication error NOS, Loss of bowel control, Intentional misuse

Most Reported Reactions

Body system	Cases	Species	Serious cases
Neurologic	1	Dog	1
Neurologic	1	Cat	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Cat	1
Neurologic	1	Cat	1
Other	1	Dog	1
Other	1	Dog	1

Species coverage: Dog (16) Cat (16)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Digestive	Dog	Non-serious	-	1
Neurologic	Dog	Serious	-	1
Neurologic	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Effectiveness	Dog	Non-serious	-	1
Effectiveness	Cat	Non-serious	-	1
Effectiveness	Cat	Non-serious	-	1
Effectiveness	Cat	Non-serious	-	1
Effectiveness	Dog	Non-serious	-	1
Effectiveness	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Neurologic	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Digestive	Dog	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	Serious	-	1

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-051479

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.

SIMPARICA® SPL · SPL Simparica Chewables SPL SPL · Structured Product Label FOI Summary sN 141-452 Approved November 22, 2024.pdf FOI · FOI

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

No owner handouts linked yet.

Official label / PI

No official label or package insert links yet.

SPL

FOI

SIMPARICA®

SPL · SPL

Open original

FDA Structured Product Label

SIMPARICA®

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

Sponsor: Zoetis Inc.
NADA: 141-452
Status: RX
Form: Chewable Tablets
Route: Oral
Species: Dog

Composition / specifications

5 mg, 10 mg, 20 mg, 40 mg, 80 mg, and 120 mg

Dogs

Indication

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.

Dosage

0.91 mg/lb (2 mg/kg body weight), one per month.

Simparica Chewables SPL

SPL · Structured Product Label

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16325 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/10860 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/103 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/940 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2340/SIMPARICA%C2%AE · document · SPL
https://www.accessdata.fda.gov/spl/data/226f4182-e041-4281-b73b-f181e5a16e3f/226f4182-e041-4281-b73b-f181e5a16e3f.xml · document · Structured Product Label
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/8847 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/11809 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16065 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16785 · document · FOI summary

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, 10:41 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 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 Jun 22, 2026, 10:41 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
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 • FDA branded products available

Official FDA brands: Simparica Chewables

Manufacturer mapping: Zoetis Inc.

Case-reported brands (openFDA): MSK

Catalog species: Both • FDA-labeled species: Dog

Rx/OTC: RX

Form/route: Chewable Tablets • Oral

Applications: NADA 141-452

NDC: Packages 54771-2015-1 54771-2015-2 54771-2015-3 54771-2016-1 54771-2016-2 54771-2016-3 • Products 54771

Documents: 4 (FOI: 4) • SPL: 1 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 15 • Cat 6 • View

Case summaries: 8 (showing 8) • View

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Fleas (Flea Infestation) Tick infestation Heartworm Disease

Linked using: Fda_Label (0.95), Fda_Label (0.95), Usage_Inferred (0.78)

Diagnosis Codes

ICD10_CM: B74.8 ICD10_CM: B88.1

Other filariases

Counseling and Monitoring Highlights

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

Top reaction signals

Unsteady walking (ataxia) (1) Tiredness (lethargy) (1) Medication error NOS (1) Loss of bowel control (1) Intentional misuse (1) Increased seizure frequency (1) Hyperactivity (1) Heart failure (1)

Identifiers & Packages

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

Identifiers

Package NDC	Product NDC	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	-

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Simparica Chewables SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
FOI Summary oN 141-521 Approved February 27, 2020.pdf • FOI summary • Official • June 3, 2025
FDA FOI summary for application 141521
FOI Summary sN 141-521 Approved December 23, 2021.sum.pdf • FOI summary • Official • June 3, 2025
FDA FOI summary for application 141521
FOI Summary sN 141-521 Approved November 6, 2024.pdf • FOI summary • Official • June 3, 2025
FDA FOI summary for application 141521
FOI Summary sN 141-521 Approved April 8 2025_ceg_ef.pdf • FOI summary • Official • June 3, 2025
FDA FOI summary for application 141521
UCM488816.pdf • FOI summary • Official • Dec. 2, 2024
FDA FOI summary for application 141452
FOI Summary sN-141452 Approved December 12, 2016.pdf • FOI summary • Official • Dec. 2, 2024
FDA FOI summary for application 141452
FOI Summary sN 141-452 Approved May 18, 2021.pdf • FOI summary • Official • Dec. 2, 2024
FDA FOI summary for application 141452
FOI Summary sN 141-452 Approved November 22, 2024.pdf • FOI summary • Official • Dec. 2, 2024
FDA FOI summary for application 141452
FOI Summary oN 141-502 Approved November 9, 2018.pdf • FOI summary • Official • Dec. 2, 2024
FDA FOI summary for application 141502
FOI Summary sN 141-502 Approved December 14, 2023.pdf • FOI summary • Official • Dec. 2, 2024
FDA FOI summary for application 141502
FOI Summary sN 141-502 Approved November 13, 2024.pdf • FOI summary • Official • Dec. 2, 2024
FDA FOI summary for application 141502

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 131 Clinical 1 Manufacturer 0 Marketing 0

Current Field Facts

side_effects: Top reported reactions (openFDA): Vomiting, Seizure NOS, Lethargy (see also Central nervous system depression in 'Neurological'), Tremor, Diarrhoea, Lack of ef… (Clinical, 2026-04-11)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-22)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-22)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-21)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-20)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-13)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-12)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-12)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-11)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-11)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-10)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-09)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-08)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-07)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-06)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-05)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-04)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-03)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-02)
indications: Simparica™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of t… (Official, 2026-06-01)

Recent Revisions

side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
usage 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
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
SIMPARICA® RX Sarolaner Chewable Tablets • Oral Label highlights Official documents	Zoetis Inc.	NADA 141-452	Approved	Dec 2, 2024

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

5 mg, 10 mg, 20 mg, 40 mg, 80 mg, and 120 mg

Dogs

Indication

Dosage

0.91 mg/lb (2 mg/kg body weight), one per month.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

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

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) • Dog Decreased appetite (1) • Dog

Showing top 5 for Digestive.

Neurologic

Unsteady walking (1) • Dog Tiredness (1) • Cat Increased seizure frequency (1) • Cat

Showing top 5 for Neurologic.

Behavior

Behavioral disorder (1) • Cat

Showing top 5 for Behavior.

Effectiveness

Lack of efficacy - NOS (1) • Dog Lack of efficacy (endoparasite) - tapeworm (1) • Cat Lack of efficacy (endoparasite) - NOS (1) • Cat Lack of efficacy (endoparasite) - hookworm (1) • Cat Lack of efficacy (ectoparasite) - tick NOS (1) • Dog

Show more (1)

Lack of efficacy (bacteria) - Borrelia (1) • Dog

Showing top 5 for Effectiveness.

Other

Medication error NOS (1) • Dog Loss of bowel control (1) • Dog Intentional misuse (1) • Cat Inappropriate urination (1) • Cat Hyperactivity (1) • Dog

Show more (15)

Heart failure (1) • Dog Foam in the mouth (1) • Dog Fluid in thorax (1) • Dog Excessive chewing, licking and/or grooming (1) • Cat Epilepsy (1) • Dog Dysphoria (1) • Cat Disorientation (1) • Dog Dilated pupils (1) • Cat Clumsy (1) • Cat Ascites (1) • Dog Application site scratching (1) • Cat Application site irritation (1) • Cat Apnoea (1) • Dog Agitation (1) • Cat Accidental exposure (1) • Cat

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, Crossbred Canine/dog, Female, 5 year, 21.772 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 80 Milligram per animal • Reactions: Swollen lip, Swollen gum • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-075426
Serious AE: No
Treated For AE: No
Sex: Female
Age: 5.00 Year
Weight: 21.772 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet, chewable
Dose: 80 Milligram per animal

Reactions Reported:

Swollen lip Swollen gum

Outcomes: Outcome Unknown

Dog, Shepherd Dog - Australian, Female, 7 year, 9.525 kilogram • Drug: MSK, Tablet, chewable, Oral • Reactions: Lack of efficacy - NOS • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-075418
Serious AE: No
Treated For AE: No
Sex: Female
Age: 7.00 Year
Weight: 9.525 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet, chewable

Reactions Reported:

Lack of efficacy - NOS

Outcomes: Ongoing

Dog, Boxer (German Boxer), Female, 8 year, 19.867 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 40 Milligram per animal • Reactions: Vomiting • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-075360
Serious AE: No
Treated For AE: No
Sex: Female
Age: 8.00 Year
Weight: 19.867 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet, chewable
Dose: 40 Milligram per animal

Reactions Reported:

Vomiting

Outcomes: Ongoing

Dog, Pointing Dog - German Short-haired, Female, 4 year, 18.144 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 dose per animal • Reactions: Fluid in thorax, Ascites, Heart failure • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-075267
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 4.00 Year
Weight: 18.144 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet, chewable
Dose: 1 dose per animal

Reactions Reported:

Fluid in thorax Ascites Heart failure

Outcomes: Ongoing

Dog, Shepherd Dog - German, Female, 8.5 year, 29.937 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (bacteria) - Borrelia, Lack of efficacy (ectoparasite) - tick NOS • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-075211
Serious AE: No
Treated For AE: No
Sex: Female
Age: 8.50 Year
Weight: 29.937 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) - Borrelia Lack of efficacy (ectoparasite) - tick NOS

Outcomes: Ongoing

Dog, Dachshund (unspecified), Female, 12 year, 4.536 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 10 Milligram per animal • Reactions: Apnoea • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-072789
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 12.00 Year
Weight: 4.536 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet, chewable
Dose: 10 Milligram per animal

Reactions Reported:

Apnoea

Outcomes: Ongoing

Dog, Retriever - Labrador, Female, 11 year, 34.292 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 dose per animal • Reactions: Tiredness (lethargy), Medication error NOS, Unsteady walking (ataxia), Hyperactivity, Tremors • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2025-US-072879
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 11.00 Year
Weight: 34.292 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet, chewable
Dose: 1 dose per animal

Reactions Reported:

Tiredness (lethargy) Medication error NOS Unsteady walking (ataxia) Hyperactivity Tremors

Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Male, 6 year, 7.938 kilogram • Drug: MSK, Unknown • Reactions: Not himself/herself, Inappropriate urination, Vomiting, Lack of efficacy (endoparasite) - tapeworm, Lack of efficacy (endoparasite) - hookworm… • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-068338
Serious AE: No
Treated For AE: No
Sex: Male
Age: 6.00 Year
Weight: 7.938 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown

Reactions Reported:

Not himself/herself Inappropriate urination Vomiting Lack of efficacy (endoparasite) - tapeworm Lack of efficacy (endoparasite) - hookworm Lack of efficacy (endoparasite) - NOS

Outcomes: Outcome Unknown

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.

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Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Sarolaner

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Sarolaner

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Sarolaner

Indications / Uses

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USA-USFDACVM-2025-US-072789

Grouped by Body System

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Source Documents

Owner handouts

Official label / PI

SPL

FOI

SIMPARICA®

SIMPARICA®

Dogs

Simparica Chewables SPL

FOI Summary sN 141-452 Approved November 22, 2024.pdf

FOI Summary sN 141-452 Approved May 18, 2021.pdf

FOI Summary sN-141452 Approved December 12, 2016.pdf

UCM488816.pdf

FOI Summary oN 141-521 Approved February 27, 2020.pdf

FOI Summary sN 141-521 Approved December 23, 2021.sum.pdf

FOI Summary sN 141-521 Approved November 6, 2024.pdf

FOI Summary sN 141-521 Approved April 8 2025_ceg_ef.pdf

FOI Summary oN 141-502 Approved November 9, 2018.pdf

FOI Summary sN 141-502 Approved December 14, 2023.pdf

FOI Summary sN 141-502 Approved November 13, 2024.pdf

At a Glance

Counseling and Monitoring Highlights

Identifiers & Packages

Enriched Documents

Data Sources & Change Log

FDA Products & Applications (Animal Drugs @ FDA)

What It's For (FDA Label Highlights)

SIMPARICA® • Chewable Tablets • Oral

Usage

Top Reported Reactions (openFDA)

Adverse Event Case Summaries (openFDA)

Dec 26, 2025 • Dog • Crossbred Canine/dog • Swollen lip, Swollen gum • Outcome Unknown

Dec 23, 2025 • Dog • Shepherd Dog - Australian • Lack of efficacy - NOS • Ongoing

Dec 23, 2025 • Dog • Boxer (German Boxer) • Vomiting • Ongoing

Dec 23, 2025 • Dog • Pointing Dog - German Short-haired • Fluid in thorax, Ascites • Ongoing

Dec 23, 2025 • Dog • Shepherd Dog - German • Lack of efficacy (bacteria) - Borrelia, Lack of efficacy (ectoparasite) - tick NOS • Ongoing

Dec 11, 2025 • Dog • Dachshund (unspecified) • Apnoea • Ongoing

Dec 10, 2025 • Dog • Retriever - Labrador • Tiredness (lethargy), Medication error NOS • Recovered/Normal

Nov 12, 2025 • Cat • Domestic Shorthair • Not himself/herself, Inappropriate urination • Outcome Unknown

Overdose Information

Storage & Handling

Share Your Thoughts