Amoxicillin Trihydrate + Clavulanate Potassium (Clavamox, Clavacillin): adverse event reports that FDA received
Combination of 2 active ingredients
The names in brackets are brand names 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 FDAFrom June 2011 to June 2026, FDA received 5,559 adverse event reports that name this drug. Its active ingredients are amoxicillin trihydrate and clavulanate potassium. Of the 5,559 reports, 2,055 (37%) are about dogs. 776 reports are about cats (14%).
In January to March 2026, FDA received 79 reports that name this drug. The signs that appear in the largest number of the 5,559 reports are "Color, Abnormal", "Suspension, Abnormal" and "Vomiting". A report is not proof that a drug caused a sign.
Reports that name this drug rose by 1.1% 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 37% 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 67 to 79.
- Dog: from 41 to 50.
January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 79 reports that name amoxicillin trihydrate + clavulanate potassium: 50 dog, 14 cat, 0 horse, 15 other or not given.
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 5,559 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.
- Color, Abnormal[a product quality report, not a sign in an animal]43.3%2,407 reports
- Suspension, Abnormal[a product quality report, not a sign in an animal]14.3%795 reports
- Vomiting10.8%598 reports
- Lethargy[unusually tired or inactive]10.1%564 reports
- Lack of efficacy - NOS[the product did not have the expected effect]8%444 reports
- Closure, Abnormal[a product quality report, not a sign in an animal]5.2%288 reports
- Diarrhoea[diarrhea]4.9%274 reports
- Anorexia[not eating]4.4%242 reports
- Other abnormal test result NOS[abnormal laboratory result, type not specified]4.1%228 reports
- Death by euthanasia[the animal was euthanized]3.6%200 reports
- Emesis[vomiting]3.6%200 reports
- Not eating3.5%197 reports
- Death3.5%193 reports
- Decreased appetite3.3%185 reports
Show the next 16 signs
- Granules/Powder, Abnormal3.2%177 reports
- Weight loss2.9%160 reports
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]2.7%152 reports
- Seal, Abnormal[a product quality report, not a sign in an animal]2.7%150 reports
- Leucocytosis NOS[high white blood cell count]2.6%143 reports
- Fever2.6%142 reports
- Ataxia[unsteady, uncoordinated movement]2.3%129 reports
- Anaemia NOS[low red blood cell count]2.2%124 reports
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]2.2%122 reports
- Neutrophilia[high neutrophil count]2.1%118 reports
- Seizure NOS[seizure, type not specified]2.1%118 reports
- Urinary tract infection2.1%117 reports
- Abnormal radiograph finding2%110 reports
- Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]1.9%106 reports
- Behavioural disorder NOS[behaviour change, type not specified]1.8%101 reports
- Closure, Missing[a product quality report, not a sign in an animal]1.8%100 reports
The list shows 30 of 1,522 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)
Reports by species
The share is of all 5,559 reports that name amoxicillin trihydrate + clavulanate potassium. The other reports give a different species or no 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 | 113 | 30 | 0 | 22 | 165 |
| 2025 | 246 | 99 | 0 | 60 | 405 |
| 2024 | 167 | 100 | 0 | 40 | 307 |
| 2023 | 120 | 52 | 0 | 55 | 227 |
| 2022 | 110 | 41 | 0 | 82 | 233 |
| 2021 | 122 | 42 | 0 | 56 | 220 |
| 2020 | 160 | 54 | 0 | 97 | 311 |
| 2019 | 176 | 62 | 0 | 1,459 | 1,697 |
| 2018 | 209 | 81 | 0 | 502 | 792 |
| 2017 | 67 | 27 | 0 | 6 | 100 |
| 2016 | 77 | 22 | 0 | 0 | 99 |
| 2015 | 86 | 20 | 0 | 0 | 106 |
| 2014 | 74 | 27 | 0 | 0 | 101 |
| 2013 | 137 | 50 | 0 | 146 | 333 |
| 2012 | 184 | 68 | 0 | 200 | 452 |
| 2011 | 7 | 1 | 0 | 3 | 11 |
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/Normal11.1%618
- Recovered with Sequela[recovered, with a lasting effect]0.4%24
- Ongoing20.5%1,139
- Died3.7%208
- Euthanized3.5%195
- Outcome Unknown12.1%672
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 5,559 reports that name amoxicillin trihydrate + clavulanate potassium.
A report about more than one animal can have more than one outcome.
Kind of report
- Safety issue40.9%2,271
- Lack of expected effectiveness3.8%210
- Both safety and lack of expected effectiveness5.8%324
- Manufacturing or product defect49.5%2,754
- Other0%0
2,848 reports say if the event was serious. 47.1% 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 year7.6%423
- 1 to 3 years7.8%436
- 4 to 7 years10.1%564
- 8 to 11 years11.9%661
- 12 years and over10.8%598
- Age not given51.8%2,877
Weight of the animal
- Under 5 kg (11 lb)14.8%822
- 5 to 9.9 kg (11 to 22 lb)13.7%762
- 10 to 24.9 kg (22 to 55 lb)9.7%539
- 25 to 44.9 kg (55 to 99 lb)7.8%435
- 45 kg and over (99 lb and over)0.6%35
- Weight not given53.4%2,966
Breed, where the report gives one breed
- Domestic Shorthair8.3%459
- Labrador Retriever2.2%120
- Chihuahua1.8%100
- Yorkshire Terrier1.5%81
- Shih Tzu1.4%77
- Domestic Longhair1.2%65
- French Bulldog1%56
- Golden Retriever0.8%45
A breed with many animals has many reports.
Route in the report
- Oral43.6%2,425
- Subcutaneous0.1%7
- Other0.1%5
- Topical0.1%5
- Auricular (Otic)under 0.1%2
- Ophthalmicunder 0.1%2
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
- Clavamox
- Clavacillin
What the Green Book records give
- Applications with an approval in force
- 6
- Approved species
- Cats, Dogs
- Dose forms
- Tablet, Suspension, Chewable Tablets, Liquid
- 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.
| Brand name | Active ingredients | Sponsor | Approved species | Application |
|---|---|---|---|---|
| Clavamox Chewable Tablets; Clavamox tablets | Amoxicillin Trihydrate, Clavulanate Potassium | Zoetis Inc. | Dogs, Cats | NADA 055-099 |
| Clavamox Drops | Amoxicillin Trihydrate, Clavulanate Potassium | Zoetis Inc. | Dogs, Cats | NADA 055-101 |
| Clavacillin | Amoxicillin Trihydrate, Clavulanate Potassium | Dechra Veterinary Products LLC | Dogs, Cats | ANADA 200-592 |
| Clavacillin | Amoxicillin Trihydrate, Clavulanate Potassium | Dechra Veterinary Products LLC | Dogs, Cats | ANADA 200-604 |
| Amoxicillin and Clavulanate Potassium Tablets | Amoxicillin Trihydrate, Clavulanate Potassium | Cronus Pharma Specialities India Private Ltd. | Dogs, Cats | ANADA 200-702 |
| Amoxicillin and Clavulanate Potassium for Oral Suspension | Amoxicillin Trihydrate, Clavulanate Potassium | Cronus Pharma Specialities India Private Ltd. | Dogs, Cats | ANADA 200-709 |
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
FDA pages for this drug
- 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 055-099The FDA record of the application for Clavamox Chewable Tablets, Clavamox tablets.
- Green Book record of NADA 055-101The FDA record of the application for Clavamox Drops.
- Green Book record of ANADA 200-592The FDA record of the application for Clavacillin.
- Green Book record of ANADA 200-604The FDA record of the application for Clavacillin.
- Green Book record of ANADA 200-702The FDA record of the application for Amoxicillin and Clavulanate Potassium Tablets.
- Green Book record of ANADA 200-709The FDA record of the application for Amoxicillin and Clavulanate Potassium for Oral Suspension.
- 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. Amoxicillin Trihydrate + Clavulanate Potassium: adverse event reports that FDA received. https://petdrugreports.com/drug/amoxicillin-trihydrate-clavulanate-potassium/ 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. 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 373 reports in the 12 months to June 2026. It received 369 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 5,559 reports received from June 2011 to June 2026, 40.9% are about a safety issue only. 9.6% are about a lack of expected effectiveness, alone or with a safety issue. 49.5% are about a defect of the product or its package.