Amoxicillin/Clavulanate Potassium

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18 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
18
Total Reports
4
Deaths Reported
2220.0%
Death Rate

Active Ingredients

Amoxicillin/Clavulanate Potassium

Administration Routes

OralUnknown

Species Affected

Dog 17
Cat 1

Most Affected Breeds

Bichon Frise 4
Chihuahua 2
Terrier - Yorkshire 1
Dog (unknown) 1
Dachshund (unspecified) 1
American Pit Bull Terrier 1
Shih Tzu 1
Terrier - Boston 1
Pug 1
Greyhound 1

Most Reported Reactions

Vomiting 9
Diarrhoea 7
Ocular discharge 5
Hyperkalaemia 5
Weight loss 5
Anorexia 4
Elevated alanine aminotransferase (ALT) 4
Hyperglycaemia 4
Muscle wasting 4
Corneal ulcer 4
Hyponatremia 3
Urinary tract infection 3

Outcome Breakdown

Ongoing
5 (27.8%)
Outcome Unknown
5 (27.8%)
Recovered/Normal
3 (16.7%)
Euthanized
2 (11.1%)
Died
2 (11.1%)
Recovered with Sequela
1 (5.6%)

Data Summary

Metric Value
Total adverse event reports 18
Reports involving death 4
Case-fatality rate (reported events) 2220.0%
Distinct species in reports 2
Distinct breeds in reports 14
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Amoxicillin/Clavulanate Potassium Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 18 adverse event reports referencing Amoxicillin/Clavulanate Potassium, including 4 reports in which the animal died — a 2220.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Amoxicillin/Clavulanate Potassium. Reported administration routes include Oral, Unknown. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Amoxicillin/Clavulanate Potassium reports are Dog (17 reports), Cat (1 reports), with Dog accounting for the largest share. Within those species, Bichon Frise (4), Chihuahua (2), Terrier - Yorkshire (1) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Amoxicillin/Clavulanate Potassium are Vomiting (9), Diarrhoea (7), Ocular discharge (5), Hyperkalaemia (5). Of the 18 reports with a coded outcome, Ongoing is the leading category at 27.8%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Amoxicillin/Clavulanate Potassium.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial