Sarolaner: adverse event reports in all combinations
Active ingredient, alone and in combinations
Brand names with this ingredient: Simparica, Revolution Plus.
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.
Read this first. FDA says this about the data:
An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on . The data have the reports that FDA received through .
This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.
Contacting a veterinarianHow to report to FDAFDA reports received through . Counts include this ingredient alone and in combinations. Why brand names have no separate count.
From March 2016 to June 2026, FDA received 83,355 adverse event reports that name a drug with sarolaner, alone or in a combination. 4 sets of active ingredients with sarolaner have a drug page.
Of the 83,355 reports, 70,960 (85.1%) are about dogs. 8,529 reports are about cats (10.2%). In January to March 2026, FDA received 2,822 reports that name sarolaner, alone or in a combination. The signs that appear in the largest number of the 83,355 reports are "Vomiting", "Seizure NOS" and "Lack of efficacy (bacteria) - Borrelia". A report is not proof that a drug caused a sign.
Reports that name this ingredient fell by 4.6% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about dogs are 85.1% of the reports that name this ingredient, and 72.6% of all reports.
Reports in the latest closed quarter
| Species | Jan to Mar 2026 | Oct to Dec 2025 | Jan to Mar 2025 |
|---|---|---|---|
| All species | 2,822 | 2,894 | 2,672 |
| Dog | 2,462 | 2,519 | 2,342 |
| Cat | 250 | 268 | 236 |
| Horse | 0 | 0 | 0 |
| Other or not given | 110 | 107 | 94 |
January to March 2026 is the latest closed quarter in the data.
Drug pages with sarolaner
A report names a drug by its set of active ingredients. Each set with sarolaner that has a drug page is in the table, in order of name. The table has 4 sets.
| Active ingredients | Reports, all years | Reports, latest 12 months |
|---|---|---|
| Moxidectin + Pyrantel Pamoate + Sarolaner | 1,191 | 373 |
| Pyrantel Pamoate + Sarolaner | 55,025 | 10,254 |
| Sarolaner | 17,585 | 835 |
| Sarolaner + Selamectin | 9,828 | 1,306 |
A report can name more than one set, so the counts of the sets can add to more than the count of the page.
An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
Signs that the reports list
A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 83,355 reports that list the sign. One report can list more than one sign and more than one drug.
The sign that is in the largest number of the reports comes first.
- Vomiting16.8%13,988 reports
- Seizure NOS[seizure, type not specified]9%7,529 reports
- Lack of efficacy (bacteria) - Borrelia[the product did not have the expected effect: Borrelia (Lyme disease bacteria)]8.6%7,196 reports
- Lethargy[unusually tired or inactive]7.9%6,613 reports
- Lack of efficacy (endoparasite) - heartworm[the product did not have the expected effect: heartworm]7.8%6,464 reports
- Diarrhoea[diarrhea]6.9%5,713 reports
- Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]5.6%4,682 reports
- Lack of efficacy (ectoparasite) - tick NOS[the product did not have the expected effect: ticks]5.4%4,516 reports
- Lack of efficacy (endoparasite) - roundworm NOS[the product did not have the expected effect: roundworms]4.3%3,607 reports
- Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]4.2%3,539 reports
- Lack of efficacy (endoparasite) - tapeworm[the product did not have the expected effect: tapeworms]3.2%2,693 reports
- Tremor3.2%2,637 reports
- Application site hair loss[hair loss where the product was applied]2.9%2,399 reports
- Ataxia[unsteady, uncoordinated movement]2.7%2,273 reports
Show the next 16 signs
- Intentional misuse[use that was knowingly different from the label]2.6%2,194 reports
- Lack of efficacy (bacteria) - Anaplasma[the product did not have the expected effect: Anaplasma bacteria]2.6%2,174 reports
- Medication error NOS[a mistake in giving the product, type not specified]2.5%2,057 reports
- Anorexia[not eating]2.1%1,711 reports
- Not eating2%1,707 reports
- Behavioural disorder NOS[behaviour change, type not specified]1.8%1,527 reports
- Lack of efficacy (bacteria) - Ehrlichia[the product did not have the expected effect: Ehrlichia bacteria]1.8%1,494 reports
- Emesis (multiple)[vomiting more than once]1.6%1,367 reports
- Shaking1.6%1,332 reports
- Decreased appetite1.5%1,263 reports
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]1.4%1,160 reports
- Twitching1.2%1,013 reports
- Lack of efficacy (endoparasite) - whipworm[the product did not have the expected effect: whipworms]1.1%933 reports
- Underfilling, Container[a product quality report, not a sign in an animal]1.1%911 reports
- Lack of efficacy (tick)[the product did not have the expected effect: ticks]1%860 reports
- Death1%857 reports
Reports by species
Reports for each month, Jul 2021 to Jun 2026
No chart: no month has 5 or more reports.
The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
Reports by year
- Dog
- Cat
- Horse
- Other or not given
| Year | Dog | Cat | Horse | Other or not given | All species |
|---|---|---|---|---|---|
| 2026 | 5,462 | 552 | 0 | 224 | 6,238 |
| 2025 | 11,580 | 1,157 | 0 | 501 | 13,238 |
| 2024 | 11,638 | 1,205 | 0 | 578 | 13,421 |
| 2023 | 11,211 | 1,142 | 0 | 681 | 13,034 |
| 2022 | 10,431 | 970 | 0 | 610 | 12,011 |
| 2021 | 8,205 | 1,224 | 0 | 437 | 9,866 |
| 2020 | 4,254 | 1,210 | 0 | 354 | 5,818 |
| 2019 | 2,891 | 993 | 0 | 240 | 4,124 |
| 2018 | 2,850 | 37 | 0 | 129 | 3,016 |
| 2017 | 1,998 | 35 | 0 | 97 | 2,130 |
| 2016 | 440 | 4 | 0 | 15 | 459 |
2026 has the reports that FDA received through Jun 2026. Download the years (CSV)
What the reports record
Outcome at the time of the report
- Recovered/Normal18.6%15,538
- Recovered with Sequela[recovered, with a lasting effect]under 0.1%41
- Ongoing52.3%43,578
- Died1.1%954
- Euthanized0.9%779
- Outcome Unknown22.6%18,805
An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 83,355 reports that name sarolaner.
Kind of report
- Safety issue52.1%43,469
- Lack of expected effectiveness39.7%33,105
- Both safety and lack of expected effectiveness3.3%2,718
- Manufacturing or product defect4.8%3,978
- Other0.1%85
Age of the animal
- Under 1 year12.8%10,679
- 1 to 3 years33.2%27,697
- 4 to 7 years21.3%17,773
- 8 to 11 years13.4%11,186
- 12 years and over6.9%5,745
- Age not given12.3%10,275
Each share of kind and age is of the 83,355 reports that name sarolaner.
Approved animal drugs with this active ingredient (FDA Green Book)
This section is reference data. It has no report count.
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.
Brand names
- Simparica
- Revolution Plus
What the Green Book records give
- Applications with an approval in force
- 3
- Approved species
- Dogs, Cats
- Dose forms
- Chewable Tablets, Topical Solution
- Routes
- Oral, Topical
- Sale
- RX (prescription)
- Earliest approval date in the records
The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.
| Brand name | Active ingredients | Sponsor | Approved species | Application |
|---|---|---|---|---|
| Simparica | Sarolaner | Zoetis Inc. | Dogs | NADA 141-452 |
| Revolution Plus | Sarolaner, Selamectin | Zoetis Inc. | Cats | NADA 141-502 |
| Simparica Trio | Moxidectin, Pyrantel Pamoate, Sarolaner | Zoetis Inc. | Dogs | NADA 141-521 |
FDA pages for this ingredient
- How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
- Green Book record of NADA 141-452The FDA record of the application for Simparica.
- Green Book record of NADA 141-521The FDA record of the application for Simparica Trio.
- Green Book record of NADA 141-502The FDA record of the application for Revolution Plus.
- Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.
The site checked these addresses on . The links open in a new tab.
Cite this page
Pet Drug Reports. Sarolaner, all combinations: adverse event reports that FDA received. https://petdrugreports.com/ingredient/sarolaner/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .
Where the data come from
The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. Ingredient names follow the Green Book, with salts and forms as FDA lists them.
The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.
Questions about these reports
- Which brand are these reports about?
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book section of this page lists brand names with this active ingredient.
- Do the reports show that the ingredient caused the signs?
No. A report can name more than one drug, and a drug can have more than one active ingredient. FDA states this about the data.
When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.
The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
- How many reports did FDA receive in the latest 12 months?
FDA received 12,749 reports in the 12 months to June 2026. It received 13,360 reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
- What kinds of report are in the count?
Of the 83,355 reports received from March 2016 to June 2026, 52.1% are about a safety issue only. 43% are about a lack of expected effectiveness, alone or with a safety issue. 4.8% are about a defect of the product or its package.