Pet Drug Reports

Pyrantel Pamoate + Sarolaneradverse event reports that FDA received

Combination of 2 active ingredients

The Green Book lists no brand name for exactly these active ingredients.

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 FDA

From April 2020 to June 2026, FDA received 55,025 adverse event reports that name a drug with pyrantel pamoate and sarolaner as its active ingredients. Of the 55,025 reports, 53,361 (97%) are about dogs.

In January to March 2026, FDA received 2,263 reports that name this drug. The signs that appear in the largest number of the 55,025 reports are "Vomiting" and "Lack of efficacy (bacteria) - Borrelia". A report is not proof that a drug caused a sign.

Reports that name this drug fell by 4.3% 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 97% of the reports that name this drug, and 72.6% of all reports.

Since the last update of the FDA data

The site recorded an update of the FDA data on . FDA changed these counts for January to March 2026:

  • All species: from 2,078 to 2,263.
  • Dog: from 2,021 to 2,202.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 2,263 reports that name pyrantel pamoate + sarolaner: 2,202 dog, 0 cat, 0 horse, 61 other or not given.

All updatesFeed of updates (RSS)

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 55,025 reports that list the sign. One report can list more than one sign.

The sign that is in the largest number of the reports comes first.

  1. Vomiting17%9,367 reports
  2. Lack of efficacy (bacteria) - Borrelia[the product did not have the expected effect: Borrelia (Lyme disease bacteria)]11.8%6,472 reports
  3. Lack of efficacy (endoparasite) - heartworm[the product did not have the expected effect: heartworm]10.5%5,803 reports
  4. Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]8.1%4,480 reports
  5. Seizure NOS[seizure, type not specified]7.9%4,373 reports
  6. Diarrhoea[diarrhea]7.3%4,003 reports
  7. Lethargy[unusually tired or inactive]6.6%3,649 reports
  8. Lack of efficacy (endoparasite) - roundworm NOS[the product did not have the expected effect: roundworms]6.2%3,386 reports
  9. Lack of efficacy (ectoparasite) - tick NOS[the product did not have the expected effect: ticks]5.8%3,183 reports
  10. Lack of efficacy (endoparasite) - tapeworm[the product did not have the expected effect: tapeworms]4.1%2,237 reports
  11. Lack of efficacy (bacteria) - Anaplasma[the product did not have the expected effect: Anaplasma bacteria]3.7%2,021 reports
  12. Intentional misuse[use that was knowingly different from the label]3.6%1,955 reports
  13. Medication error NOS[a mistake in giving the product, type not specified]3.4%1,862 reports
  14. Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]3.2%1,753 reports
Show the next 16 signs
  1. Lack of efficacy (bacteria) - Ehrlichia[the product did not have the expected effect: Ehrlichia bacteria]2.4%1,341 reports
  2. Tremor2%1,091 reports
  3. Emesis (multiple)[vomiting more than once]2%1,081 reports
  4. Ataxia[unsteady, uncoordinated movement]1.9%1,023 reports
  5. Not eating1.8%1,000 reports
  6. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]1.8%963 reports
  7. Lack of efficacy (endoparasite) - whipworm[the product did not have the expected effect: whipworms]1.6%901 reports
  8. Anorexia[not eating]1.5%817 reports
  9. Shaking1.4%793 reports
  10. Behavioural disorder NOS[behaviour change, type not specified]1.3%694 reports
  11. Decreased appetite1.2%665 reports
  12. Not himself/herself1%573 reports
  13. Itching0.9%503 reports
  14. Lack of efficacy (endoparasite) - NOS[the product did not have the expected effect: target not specified]0.9%499 reports
  15. Death0.8%462 reports
  16. Underfilling, Container[a product quality report, not a sign in an animal]0.8%459 reports

The list shows 30 of 1,603 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Dog97%53,361
  • Cat0.1%50
  • Human exposureunder 0.1%26
  • Other Canidsunder 0.1%2
  • Marsupialunder 0.1%1

The share is of all 55,025 reports that name pyrantel pamoate + sarolaner. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog48,392 reports. Largest count in one month: 1,109 (Apr 2025)
Cat45 reports. Largest count in one month: 5 (Aug 2024)
Horse0 reports

No chart: no month has 5 or more reports.

Other or not given1,498 reports. Largest count in one month: 47 (May 2023)

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
Reports that name pyrantel pamoate + sarolaner, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20264,896501305,031
202510,4446027910,729
202410,32112030510,638
202310,0247040910,440
20229,1451103029,458
20216,679901406,828
20201,85200491,901

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/Normal18.5%10,170
  • Recovered with Sequela[recovered, with a lasting effect]under 0.1%11
  • Ongoing59%32,462
  • Died0.9%497
  • Euthanized0.8%422
  • Outcome Unknown18%9,897

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 55,025 reports that name pyrantel pamoate + sarolaner.

A report about more than one animal can have more than one outcome.

Kind of report

  • Safety issue43.7%24,037
  • Lack of expected effectiveness50.4%27,721
  • Both safety and lack of expected effectiveness2.8%1,540
  • Manufacturing or product defect3.1%1,690
  • Other0.1%37

53,440 reports say if the event was serious. 56.1% of them have the serious flag. The person who sends the report sets the flag.

Show age, weight, breed and route

Age of the animal

  • Under 1 year15.4%8,449
  • 1 to 3 years37.4%20,560
  • 4 to 7 years21%11,573
  • 8 to 11 years11.5%6,307
  • 12 years and over4.9%2,691
  • Age not given9.9%5,445

Weight of the animal

  • Under 5 kg (11 lb)9%4,969
  • 5 to 9.9 kg (11 to 22 lb)16.7%9,177
  • 10 to 24.9 kg (22 to 55 lb)31.5%17,312
  • 25 to 44.9 kg (55 to 99 lb)28.7%15,778
  • 45 kg and over (99 lb and over)3.4%1,895
  • Weight not given10.7%5,894

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Oral95.3%52,419
  • Subcutaneous0.2%133
  • Topical0.1%39
  • Ophthalmicunder 0.1%20
  • Otherunder 0.1%8
  • Respiratory (Inhalation)under 0.1%3

Each bar is on a scale of 0 to 100%.

Approved animal drugs with these active ingredients (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.

No approved product has exactly this set of active ingredients. The ingredient field of a report can be incomplete. The approved products below have all the ingredients of this page and one or more other ingredients.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand nameActive ingredientsSponsorApproved speciesApplication
Simparica TrioMoxidectin, Pyrantel Pamoate, SarolanerZoetis Inc.DogsNADA 141-521

Other pages with one of these ingredients

A report names a drug by its set of active ingredients. Each set has its own page. The list is in order of name.

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

The site checked these addresses on . The links open in a new tab.

Cite this page

Pet Drug Reports. Pyrantel Pamoate + Sarolaner: adverse event reports that FDA received. https://petdrugreports.com/drug/pyrantel-pamoate-sarolaner/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

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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. The site does not use the application number that a record has.

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 lists no brand name for exactly these active ingredients.

Do the reports show that the drug caused the signs?

No. 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 10,254 reports in the 12 months to June 2026. It received 10,714 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 55,025 reports received from April 2020 to June 2026, 43.7% are about a safety issue only. 53.2% are about a lack of expected effectiveness, alone or with a safety issue. 3.1% are about a defect of the product or its package.