Amoxicillin + Clavulanic Acid
263 adverse event reports submitted to the FDA
Active Ingredients
Administration Routes
Species Affected
Most Affected Breeds
Most Reported Reactions
Outcome Breakdown
Data Summary
| Metric | Value |
|---|---|
| Total adverse event reports | 263 |
| Reports involving death | 31 |
| Case-fatality rate (reported events) | 1180.0% |
| Distinct species in reports | 4 |
| Distinct breeds in reports | 20 |
| Distinct reactions reported | 20 |
| Active ingredients on file | 3 |
Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.
Amoxicillin + Clavulanic Acid Adverse Event Insights
The FDA Center for Veterinary Medicine database currently holds 263 adverse event reports referencing Amoxicillin + Clavulanic Acid, including 31 reports in which the animal died — a 1180.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Amoxicillin, Amoxicillin + Clavulanic Acid, Clavulanic Acid. Reported administration routes include Unknown, Oral, Auricular (Otic). 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 + Clavulanic Acid reports are Dog (152 reports), Cat (107 reports), Human (3 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (73), Retriever - Labrador (15), Cat (unknown) (10) 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 + Clavulanic Acid are Vomiting (51), Lethargy (see also Central nervous system depression in Neurological) (39), Other abnormal test result NOS (38), Decreased appetite (36). Of the 263 reports with a coded outcome, Ongoing is the leading category at 37.6%. 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 + Clavulanic Acid.
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
Read our methodology — how this data is sourced, computed, and verified.