Reaction profile

The FDA adverse-event record for application site papule

45 FDA adverse-event reports reference application site papule (VeDDRA 2195). See the species, breeds, and drugs most associated with it below.

45
reports citing this reaction
0.0%
death-coded share
Dog
most-affected species
Imidacloprid + Moxidectin
most-associated drug
Verify with FDA CVM →
45
Total Reports
0
Deaths
0.0%
Death Rate

Species Most Affected

Dog 24
Cat 18
Human 3

Breeds Most Affected

Domestic Shorthair 14
Crossbred Canine/dog 3
Unknown 3
Shih Tzu 2
Retriever - Labrador 2
Terrier - Yorkshire 2
Bulldog 2
Ridgeback - Rhodesian 1
Retriever - Golden 1
Terrier - Australian 1

Associated Drugs

Imidacloprid + Moxidectin 10
Fluralaner Spot-On Solution 6
Diphenhydramine 4
Ivermectin + Pyrantel As Pamoate Salt 4
Selamectin;Sarolaner 4
Betamethasone + Clotrimazole + Gentamicin 3
Oclacitinib Maleate 3
Fluralaner/Moxidectin Spot-On 3
Trazodone 3
Fipronil 10%/S Methoprene 9% Spot On 2
Fipronil 9.8%/S-Methoprene 8.8%/Cyphenothrin 5.2% Squeeze-On 2
Selamectin 2
Ketoconazole + Phytosphingosine 2
Dexmedetomidine Hydrochloride 2
Atipamezole Hydrochloride 2
Carprofen 2
Prednisone 2
Famotidine 2
Butorphanol 2
Gabapentin 2

Application site papule Reaction Insights

45 reports name Application site papule; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). VeDDRA code: 2195.

By species: Dog (24 reports), Cat (18 reports), Human (3 reports). By breed: Domestic Shorthair (14), Crossbred Canine/dog (3), Unknown (3).

Most co-reported drugs: Imidacloprid + Moxidectin (10 reports), Fluralaner Spot-On Solution (6 reports), Diphenhydramine (4 reports), Ivermectin + Pyrantel As Pamoate Salt (4 reports).

Read these counts as reporting volume, not risk: per our methodology, co-reporting reflects temporal association captured in voluntary submissions, not proof that a drug caused this reaction. A widely-prescribed drug will rack up more raw co-reports at an identical true rate than a rarely-used one, so compare within similar-exposure products.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.