Active ingredient · pooled across combinations
Sarolaner: adverse event reports, pooled
5 ingredient sets in reports · 3 FDA-approved applications in the Green Book
79,689 adverse event reports received by FDA list a drug containing sarolaner, alone or in combination, from March 2016 to March 2026. This page pools every ingredient set that includes it; 5 such sets appear in reports.
The Green Book lists 3 FDA-approved applications containing it. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.
13,141 reports arrived in the 12 months to March 2026, close to the 13,203 of the 12 months before. FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. That is about 7,905 reports a year over its reporting history and 5.9% of all reports.
Pooled across every set, the terms listed most often are vomiting (17%), seizure NOS (9.1%) and lack of efficacy (bacteria) - Borrelia (8.5%). Many drugs combine several ingredients, and many reports list several drugs, so a term on this page may relate to any of them or to none.
Of reports that state seriousness, 48.7% were classed as serious (38.6% across the whole database); 2.1% record a death or euthanasia (6.4% overall). Ingredients used in older or sicker animals, or in anaesthesia and cancer care, carry higher shares for that reason alone.
Ingredient sets that include sarolaner
| Active ingredients recorded for the drug | Reports | Share of this page's reports | Latest 12 months |
|---|---|---|---|
| Pyrantel Pamoate + Sarolaner | 52,066 | 65.3% | 10,626 |
| Sarolaner | 17,337 | 21.8% | 871 |
| Sarolaner + Selamectin | 9,466 | 11.9% | 1,333 |
| Moxidectin + Pyrantel Pamoate + Sarolaner | 1,090 | 1.4% | 344 |
| Moxidectin + Sarolaner | 3 | 0% | 1 |
Ordered by report count. FDA states that these data "cannot be used to estimate the risk associated with the product or compare one drug or device product with another"; counts follow sales volume and years on the market. A report can list more than one set, so shares can add to more than 100%.
Signs listed in reports, pooled
share of sarolaner reports listing the termall reports in the database
- Vomiting17%13,515
- Seizure NOS[seizure, type not specified]9.1%7,248
- Lack of efficacy (bacteria) - Borrelia[the product did not have the expected effect: Borrelia (Lyme disease bacteria)]8.5%6,736
- Lethargy[unusually tired or inactive]8%6,364
- Lack of efficacy (endoparasite) - heartworm[the product did not have the expected effect: heartworm]7.8%6,178
- Diarrhoea[diarrhea]6.9%5,497
- Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]5.5%4,379
- Lack of efficacy (ectoparasite) - tick NOS[the product did not have the expected effect: ticks]5.4%4,305
- Lack of efficacy (endoparasite) - roundworm NOS[the product did not have the expected effect: roundworms]4.3%3,464
- Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]4.3%3,404
- Lack of efficacy (endoparasite) - tapeworm[the product did not have the expected effect: tapeworms]3.2%2,572
- Tremor3.2%2,571
- Application site hair loss[hair loss where the product was applied]2.9%2,297
- Ataxia[unsteady, uncoordinated movement]2.8%2,210
- Intentional misuse[use that was knowingly different from the label]2.4%1,888
- Lack of efficacy (bacteria) - Anaplasma[the product did not have the expected effect: Anaplasma bacteria]2.4%1,879
- Medication error NOS[a mistake in giving the product, type not specified]2.1%1,692
- Anorexia[not eating]2.1%1,673
- Not eating2%1,615
- Behavioural disorder NOS[behaviour change, type not specified]1.8%1,463
- Lack of efficacy (bacteria) - Ehrlichia[the product did not have the expected effect: Ehrlichia bacteria]1.8%1,408
- Shaking1.6%1,286
- Emesis (multiple)[vomiting more than once]1.6%1,255
- Decreased appetite1.5%1,207
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]1.5%1,159
- Twitching1.2%984
- Lack of efficacy (endoparasite) - whipworm[the product did not have the expected effect: whipworms]1.1%897
- Underfilling, Container[a product quality report, not a sign in an animal]1.1%883
- Lack of efficacy (tick)[the product did not have the expected effect: ticks]1.1%860
- Itching1%824
Pooled across every ingredient set and every report that names the ingredient. One report can list several terms and several drugs; a term here may relate to any of them or to none.
Monthly reports by species, five years
By month of receipt; each panel has its own scale. The newest months are incomplete because FDA posts reports with a delay of three to six months.
Outcomes, report types and ages
Outcome recorded in the report
What kind of report it was
Age of the animal
Coloured bar: reports naming sarolaner. Grey bar: all 1,357,245 reports. Outcomes are as stated by the reporter; FDA has not necessarily determined whether any product played a part.
In context
| Measure | Sarolaner | All reports |
|---|---|---|
| Reports | 79,689 | 1,357,245 |
| Latest 12 months against the 12 before | 0% | -5% |
| Classed serious, of reports stating it | 48.7% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 20.8 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 42.6% | 23% |
Shares of reports, not of animals treated: how many animals receive the ingredient is not public. Ingredients used in anaesthesia, cancer care or in old animals carry more serious outcomes in their reports for that reason alone.
FDA-approved products containing sarolaner (Green Book)
Reference information, not report statistics. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The list below is the FDA Green Book as of 30 Sep 2026; nothing on this page says which of these products, if any, a report concerned.
| Trade name | Active ingredients | Sponsor | Approved for | 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 |
Species are the major species the Green Book search lists for the application ("—" where it lists another species or none). Approval dates are not part of the Green Book listing files and are not shown. Pioneer applications (NADA) come first, then generics (ANADA).
Questions about sarolaner reports
How many FDA adverse event reports mention sarolaner?
79,689 reports through March 2026, 13,141 of them in the latest 12 months, counting sarolaner alone and in combinations.
Which brands do these reports concern?
That cannot be known from the public data. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The Green Book reference list on this page names approved products containing sarolaner without any counts.
In which combinations is sarolaner reported?
Pyrantel Pamoate + Sarolaner (65.3% of these reports), Sarolaner (21.8% of these reports), Sarolaner + Selamectin (11.9% of these reports), Moxidectin + Pyrantel Pamoate + Sarolaner (1.4% of these reports) and Moxidectin + Sarolaner (0% of these reports).
What reactions are reported for sarolaner?
vomiting (17%), seizure NOS (9.1%), lack of efficacy (bacteria) - Borrelia (8.5%), lethargy (8%) and lack of efficacy (endoparasite) - heartworm (7.8%). Shares are of reports naming the ingredient; one report can list several terms.
Which animals are these reports about?
dog (85%), cat (10.3%) and human exposure (0.2%).
Does a high count mean sarolaner is a problem ingredient?
A count cannot show that. FDA states that "there is no certainty that the reported drug or device caused the adverse event" and that the event "may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources." Widely used ingredients collect more reports because more animals receive them.
How do I report a problem?
Call the drug company using the number on the label, or send Form FDA 1932a to FDA. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 30 Sep 2026. Ingredient names follow the Green Book; salts and forms are kept as FDA lists them. Drug entries are matched by the active ingredients their unmasked ingredient field discloses. No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.