Drug · single active ingredient
Clavulanate Potassium: adverse event reports
All products with this active ingredient · no approved product with exactly this set
- Mostly dog reports
- Oral route most often
- Brands masked by FDA
Between June 2012 and October 2025 FDA received 30 adverse event reports listing a drug with clavulanate potassium as the recorded active ingredient. No FDA-approved product has exactly this set of ingredients; the ingredient field of a report can be incomplete.
openFDA masks the brand and manufacturer in every report, so these figures describe the ingredient across all products and cannot be attributed to a brand.
In the 12 months to March 2026, 3 reports named it, down 67% from 9 in the 12 months before. Recent months are provisional: fDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. Over its whole reporting history that is about 2 reports a year and 0% of all 1,357,245 reports (0% of all dog reports). How many animals received it is not published, so a count says nothing about how often a problem occurs per dose.
The most frequently coded terms are pruritus (20%), vomiting (20%) and elevated liver enzymes (16.7%). A report can list several signs, so shares add to more than 100%; 151 different terms appear across these reports. Pruritus appears in 20% of these reports, a larger share than in the pooled reports for every drug containing clavulanate potassium (1.5%).
86.7% of reports concern dogs. Not every report describes illness: 16.7% were filed wholly or partly as lack of expected effectiveness. Of reports that state seriousness, 70% were classed as serious, and 13.3% of all reports record a death or euthanasia as an outcome, as reported. FDA has not necessarily determined whether any drug played a part.
Monthly reports by species, five years
Reports by the month FDA received them. Each panel has its own scale; the peak month is printed at the top right. The newest months are incomplete because FDA posts reports with a delay of three to six months.
Reports by year received
2025 covers reports received through March 2026 only.
Signs listed in reports
share of clavulanate potassium reports listing the termall drugs containing clavulanate potassiumall dog reports
- Pruritus[itching]20%6
- Vomiting20%6
- Elevated liver enzymes[liver enzymes above the normal range]16.7%5
- Injection site lesion[lesion where the injection was given]16.7%5
- Injection site scab[scab where the injection was given]16.7%5
- Injection site thickening[thickening where the injection was given]16.7%5
- Ataxia[unsteady, uncoordinated movement]13.3%4
- Lack of efficacy - NOS[the product did not have the expected effect]13.3%4
- Lethargy[unusually tired or inactive]13.3%4
- Neutrophilia[high neutrophil count]13.3%4
- Aggression10%3
- Injection site infection[infection where the injection was given]10%3
- Injection site pain[pain where the injection was given]10%3
- Injection site weeping[weeping where the injection was given]10%3
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]10%3
- Lack of efficacy (fungi) - NOS[the product did not have the expected effect: target not specified]10%3
- Not eating10%3
- Behavioural disorder NOS[behaviour change, type not specified]6.7%2
- Cough6.7%2
- Death by euthanasia[the animal was euthanized]6.7%2
- Diarrhoea[diarrhea]6.7%2
- Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]6.7%2
- Emesis[vomiting]6.7%2
- Fever6.7%2
- Hyperglycaemia[high blood sugar]6.7%2
- Hypoalbuminaemia[low blood albumin]6.7%2
- Lack of efficacy (ectoparasite) - Demodex[the product did not have the expected effect: Demodex]6.7%2
Top 30 of 151 coded terms (VeDDRA, the veterinary reporting dictionary; plain-language gloss in brackets). One report can list several terms. The ticks show how often the same term appears in a wider pool of reports; they describe the reports, and FDA cautions that such figures cannot be used to estimate risk or to compare one product with another. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.
Outcomes and report types
Outcome recorded in the report
What kind of report it was
Coloured bar: reports naming clavulanate potassium. Grey bar: all 1,357,245 reports in the database. Outcomes are the status at the time of the last report, as stated by the reporter; a report covering several animals can carry more than one outcome. FDA has not necessarily determined whether any drug played a part in any outcome.
Species and breeds in the reports
Single-breed animals
Breed shares follow how common each breed is. Crossbred animals and reports with no breed stay in the species figure only.
Age, weight and route
Age of the animal
Weight of the animal
Route of administration stated in reports: oral (24), parenteral (1).
In context
| Measure | Clavulanate Potassium | All drugs containing clavulanate potassium | All dog reports | All reports |
|---|---|---|---|---|
| Reports | 30 | 8,064 | 985,675 | 1,357,245 |
| Share of that pool's reports naming this drug | — | 0.4% | 0% | 0% |
| Classed serious, of reports stating it | 70% | 46.2% | 38.3% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 133.3 | 89 | 55 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 16.7% | — | — | 23% |
| Top term, share of reports | Pruritus 20% | 1.5% | 1.9% | — |
The clavulanate potassium pool is every report naming clavulanate potassium alone or in any combination; this single-ingredient set accounts for 0.4% of it. Shares are of reports, not of animals treated. The number of doses sold is not public, so none of these figures is a rate of occurrence, and differences between columns reflect which animals receive a drug and who reports as much as anything else.
Other ingredient sets sharing an ingredient
| Active ingredients | Reports | Latest 12 months |
|---|---|---|
| Amoxicillin Trihydrate + Clavulanate Potassium | 5,462 | 385 |
| Amoxicillin + Clavulanate Potassium | 2,319 | 211 |
| Amoxicillin + Amoxicillin Trihydrate + Clavulanate Potassium | 256 | 1 |
Listed for navigation, 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": drugs differ in formulation, in the animals they are given to, in sales volume and in years on the market. A report's ingredient field can be incomplete, so reports about one product may sit under more than one set.
FDA-approved products (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 1 Oct 2026; nothing on this page says which of these products, if any, a report concerned.
No approved product has exactly this set of active ingredients. The ingredient field of a report can be incomplete; these approved products contain all of the ingredients named here, together with others.
| Trade name | Active ingredients | Sponsor | Approved for | 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 |
| Kesium | Amoxicillin, Clavulanate Potassium | Ceva Sante Animale | Dogs, Cats | ANADA 200-749 |
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 clavulanate potassium reports
How many adverse event reports has FDA received for clavulanate potassium?
30 reports record a drug with clavulanate potassium as its active ingredient in the openFDA release of 28 Sep 2026, covering reports received through March 2026. 3 of them arrived in the latest 12 months.
Which brand 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.
What signs are reported most often?
pruritus (20%), vomiting (20%), elevated liver enzymes (16.7%), injection site lesion (16.7%) and injection site scab (16.7%). These are the coded terms listed in reports; several can appear in one report, and a term's presence is not a finding that the drug was responsible.
Which species and breeds appear in these reports?
dog (86.7%) and cat (13.3%). Among single-breed animals the most frequent labels are Domestic Shorthair, Shih Tzu, Border Collie and Black Russian Terrier; popular breeds appear often in any drug's reports because there are more of them.
Are reports rising?
3 reports in the 12 months to March 2026, down 67% from 9 in 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. Counts also move with sales, publicity and time on the market.
Do these reports show that clavulanate potassium harms pets?
Report counts 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." FDA also notes that commonly used products may have more reports simply because more animals receive them.
Are these the side effects of clavulanate potassium?
They are signs listed in reports, not an established list of side effects. The adverse reactions observed in studies are printed on each product's FDA-approved label, which a veterinarian can go through with you. This page is a record of what was reported to FDA.
How do I report a problem with an animal drug?
FDA asks owners and veterinarians to call the drug company first (the number is on the label); companies must pass reports to FDA. Reports can also go directly to FDA on Form FDA 1932a. 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 1 Oct 2026. Drug entries are grouped by the active ingredients their unmasked ingredient field discloses; the application number that records also carry is not used. 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.