Application site papule
VeDDRA Code: 2195
45 adverse event reports referencing this reaction
Species Most Affected
Breeds Most Affected
Associated Drugs
Data Summary
| Metric | Value |
|---|---|
| Total reports referencing reaction | 45 |
| Reports with fatal outcome | 0 |
| Case-fatality rate (reported events) | 0.0% |
| Species observed | 3 |
| Breeds observed | 20 |
| Drugs associated with reaction | 20 |
Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER); reaction term coded under VeDDRA 2195.
Application site papule Reaction Insights
The FDA Center for Veterinary Medicine database currently lists 45 adverse event reports that reference Application site papule as a reaction term, including 0 reports with a death outcome — a 0.0% case-fatality figure calculated across only those events where this reaction was coded. The reaction is indexed in the openFDA system under VeDDRA code 2195, the standardized veterinary dictionary used to normalize clinical signs across submitters. Because reports are voluntary and often describe multiple concurrent signs per animal, the volume here reflects reporting intensity rather than true incidence in the broader pet population.
Application site papule appears most frequently in reports for Dog (24 reports), Cat (18 reports), Human (3 reports) — with Dog dominating at 24 entries. Within those species, the breeds most often named alongside this reaction are Domestic Shorthair (14), Crossbred Canine/dog (3), Unknown (3). These distributions are influenced both by underlying breed popularity and by how veterinarians and owners code a given clinical sign, so they should be interpreted as a reporting fingerprint rather than a pure susceptibility ranking.
The drugs most commonly co-reported with Application site papule are Imidacloprid + Moxidectin (10 reports), Fluralaner Spot-On Solution (6 reports), Diphenhydramine (4 reports), Ivermectin + Pyrantel As Pamoate Salt (4 reports), with Imidacloprid + Moxidectin appearing alongside this reaction in 10 submissions. Co-reporting does not establish that any specific product caused the reaction — FDA CVM data captures temporal association only. The value of these aggregates is in flagging which therapeutic classes appear repeatedly alongside a given clinical sign, so owners and veterinarians can ask targeted questions about medications currently in use.
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.