Pet Drug Reports

Amoxicillin + Clavulanate Potassium (Kesium)adverse event reports that FDA received

Combination of 2 active ingredients

The name in brackets is a brand name with 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 May 2002 to June 2026, FDA received 2,378 adverse event reports that name a drug with amoxicillin and clavulanate potassium as its active ingredients. Of the 2,378 reports, 1,266 (53.2%) are about dogs. 507 reports are about cats (21.3%).

In January to March 2026, FDA received 60 reports that name this drug. The signs that appear in the largest number of the 2,378 reports are "Color, Abnormal", "Vomiting" and "Lethargy". A report is not proof that a drug caused a sign.

Reports that name this drug rose by 8.0% 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 53.2% 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 52 to 60.
  • Dog: from 35 to 41.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 60 reports that name amoxicillin + clavulanate potassium: 41 dog, 17 cat, 0 horse, 2 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 2,378 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. Color, Abnormal[a product quality report, not a sign in an animal]19.6%466 reports
  2. Vomiting16.6%395 reports
  3. Lethargy[unusually tired or inactive]15.6%372 reports
  4. Anorexia[not eating]9.6%228 reports
  5. Other abnormal test result NOS[abnormal laboratory result, type not specified]9.2%218 reports
  6. No sign[no clinical sign was reported]9.1%216 reports
  7. Diarrhoea[diarrhea]8.5%201 reports
  8. Death by euthanasia[the animal was euthanized]7.8%185 reports
  9. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]6.6%156 reports
  10. Decreased appetite6%142 reports
  11. Fever5.7%136 reports
  12. Death5.5%131 reports
  13. Uncoded sign[a sign with no matching dictionary term]5.5%130 reports
  14. Not eating5.3%127 reports
Show the next 16 signs
  1. Leucocytosis NOS[high white blood cell count]5.3%125 reports
  2. Lack of efficacy - NOS[the product did not have the expected effect]5.2%124 reports
  3. Weight loss5.1%122 reports
  4. Anaemia NOS[low red blood cell count]5.1%121 reports
  5. Suspension, Abnormal[a product quality report, not a sign in an animal]5%119 reports
  6. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]4.9%117 reports
  7. Behavioural disorder NOS[behaviour change, type not specified]4.5%107 reports
  8. Urinary tract infection4.5%107 reports
  9. Abnormal radiograph finding4.4%104 reports
  10. Seizure NOS[seizure, type not specified]4.2%100 reports
  11. Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]4%95 reports
  12. Ataxia[unsteady, uncoordinated movement]3.8%90 reports
  13. Neutrophilia[high neutrophil count]3.8%90 reports
  14. Abnormal ultrasound finding3.7%88 reports
  15. Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]3.5%84 reports
  16. Elevated total bilirubin[bilirubin above the normal range]2.9%70 reports

The list shows 30 of 1,405 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Dog53.2%1,266
  • Cat21.3%507
  • Human exposure0.2%5
  • Otherunder 0.1%1
  • Other Birdsunder 0.1%1
  • Parrotunder 0.1%1

The share is of all 2,378 reports that name amoxicillin + clavulanate potassium. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog440 reports. Largest count in one month: 20 (May 2025)
Cat212 reports. Largest count in one month: 9 (Sep 2023)
Horse0 reports

No chart: no month has 5 or more reports.

Other or not given50 reports. Largest count in one month: 5 (Jan 2025)

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 amoxicillin + clavulanate potassium, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
2026802903112
202513463020217
202410754011172
20236742013122
202233200356
20213940043
202048100462
201932120650
20182950236
201716434055253
2016160600114334
2015139710151361
2014162660158386
20134628064138
20121140116
201110001
201010001
200801001
200630003
200561007
200342006
200201001

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/Normal13.3%316
  • Recovered with Sequela[recovered, with a lasting effect]0.3%8
  • Ongoing31.2%742
  • Died6%142
  • Euthanized7.7%184
  • Outcome Unknown16.6%394

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 2,378 reports that name amoxicillin + clavulanate potassium.

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

Kind of report

  • Safety issue63.2%1,502
  • Lack of expected effectiveness2.3%55
  • Both safety and lack of expected effectiveness8.3%197
  • Manufacturing or product defect26.2%622
  • Other0.1%2

1,757 reports say if the event was serious. 46.3% 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 year10.3%245
  • 1 to 3 years10%237
  • 4 to 7 years16.6%395
  • 8 to 11 years18.6%443
  • 12 years and over17.2%410
  • Age not given27.2%648

Weight of the animal

  • Under 5 kg (11 lb)22%522
  • 5 to 9.9 kg (11 to 22 lb)20.5%487
  • 10 to 24.9 kg (22 to 55 lb)13.7%326
  • 25 to 44.9 kg (55 to 99 lb)13.3%317
  • 45 kg and over (99 lb and over)1.3%32
  • Weight not given29.2%694

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Oral55.3%1,314
  • Subcutaneous0.1%3
  • Auricular (Otic)0.1%2
  • Ophthalmic0.1%2
  • Topical0.1%2
  • Otherunder 0.1%1

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.

Brand names

  • Kesium

What the Green Book records give

Applications with an approval in force
1
Approved species
Cats, Dogs
Dose forms
Chewable Tablets
Routes
Oral
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.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand nameActive ingredientsSponsorApproved speciesApplication
KesiumAmoxicillin, Clavulanate PotassiumCeva Sante AnimaleDogs, CatsANADA 200-749

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. Amoxicillin + Clavulanate Potassium: adverse event reports that FDA received. https://petdrugreports.com/drug/amoxicillin-clavulanate-potassium/ 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 section of this page lists the brand names with 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 216 reports in the 12 months to June 2026. It received 200 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 2,378 reports received from May 2002 to June 2026, 63.2% are about a safety issue only. 10.6% are about a lack of expected effectiveness, alone or with a safety issue. 26.2% are about a defect of the product or its package.