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Roxee Meds Catalog

Sarolaner

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Chewable Tablets Zoetis Inc. Official label facts Owner quick guide first

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Data freshness

Storefront facts
Catalog refreshed
May 5, 2026, 10:00 a.m.

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

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

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

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

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

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

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

Sources:
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Sarolaner

Sarolaner

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

Both Chewable Tablets Rx required 100% storefront ready

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, No Use Class Stated Or Implied.

Generic name
Sarolaner
Brand names
SIMPARICA®, Simparica Chewables
Manufacturer
Zoetis Inc.
Species
Both, Dog, No Use Class Stated Or Implied
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, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Chewable Tablets

Source Transparency

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Pet Owner Quick Guide

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

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:

  • 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?
Major cautions & emergency warning signs

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)

Emergency warning signs:

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

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:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

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

Tracked signals
32
Reported cases
32
Serious reports
19
Species represented
2
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
Reaction Body system Cases Species Serious cases
Neurologic 1 Cat 1
Neurologic 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Neurologic 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (16) Cat (16)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Non-serious - 1
Neurologic Cat Serious - 1
Neurologic Dog 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 Dog 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 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 Serious - 1
Source metadata:

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

2

FOI

11

SIMPARICA®

SPL · SPL

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, No Use Class Stated Or Implied
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

FDA Structured Product Label XML for Simparica Chewables. Use the source link for the full official labeling record.

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

FOI · FOI

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

FOI · FOI

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

FOI · FOI

UCM488816.pdf

FOI · FOI

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

FOI · FOI summary

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

FOI · FOI summary

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

FOI · FOI summary

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

FOI · FOI summary

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

FOI · FOI summary

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

FOI · FOI summary

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

FOI · 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
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 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
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
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 NDC Package: 54771-2017-3 NDC Package: 54771-2018-1 NDC Package: 54771-2018-2 NDC Package: 54771-2018-3
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 -

Enriched Documents

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

Data Sources & Change Log

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

Official 44 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, 2026-05-05)
  • 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, 2026-05-03)
  • 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, 2026-05-02)
  • 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, 2026-04-29)
  • 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, 2026-04-28)
  • 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, 2026-04-27)
  • 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, 2026-04-26)
  • 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, 2026-04-25)
  • 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, 2026-04-22)
  • manufacturer_name: Zoetis Inc. (Official, 2026-05-05)
  • manufacturer_name: Zoetis Inc. (Official, 2026-05-03)
  • manufacturer_name: Zoetis Inc. (Official, 2026-05-02)
  • manufacturer_name: Zoetis Inc. (Official, 2026-04-29)
  • manufacturer_name: Zoetis Inc. (Official, 2026-04-28)
  • manufacturer_name: Zoetis Inc. (Official, 2026-04-27)
  • manufacturer_name: Zoetis Inc. (Official, 2026-04-26)
  • manufacturer_name: Zoetis Inc. (Official, 2026-04-25)
  • manufacturer_name: Zoetis Inc. (Official, 2026-04-22)
  • prescription_required: Rx required (Official, 2026-05-05)
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
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, No Use Class Stated Or Implied
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.
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) • Cat

Showing top 5 for Digestive.

Neurologic
Unsteady walking (1) • Cat Tiredness (1) • Dog 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) • Dog 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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This medication has not been reviewed by a veterinarian yet.