Reaction profile

The FDA adverse-event record for application site ulcer

483 FDA adverse-event reports reference application site ulcer (VeDDRA 35). See the species, breeds, and drugs most associated with it below.

483
reports citing this reaction
1.9%
death-coded share
Cat
most-affected species
Selamectin
most-associated drug
Verify with FDA CVM →
483
Total Reports
9
Deaths
1.9%
Death Rate

Species Most Affected

Cat 372
Dog 85
Horse 26

Breeds Most Affected

Domestic Shorthair 274
Domestic Longhair 29
Domestic Mediumhair 18
Dog (unknown) 10
Crossbred Canine/dog 9
Retriever - Golden 9
Retriever - Labrador 8
Horse (unknown) 8
Siamese 8
Cat (unknown) 7

Associated Drugs

Selamectin 111
Selamectin;Sarolaner 71
Fluralaner Spot-On Solution 70
Imidacloprid + Moxidectin 57
Emodepside + Praziquantel 32
Flumethrin-Imidacloprid 18
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 15
Mirtazapine 14
Genta/Momet/Clotrim Ear Oint 13
Cefovecin 12
Methylprednisolone Acetate 12
Rabies Vaccine 12
Cefovecin Sodium 11
Fluralaner/Moxidectin Spot-On 11
Eprinomectin + Esafoxolaner + Praziquantel 9
Dexamethasone 8
Ivermectin + Praziquantel 8
Prednisolone 7
Enrofloxacin 6
Maropitant Citrate 6

Application site ulcer Reaction Insights

483 reports name Application site ulcer; 9 recorded a death outcome (1.9% of reported events, not a population-level mortality rate). VeDDRA code: 35.

By species: Cat (372 reports), Dog (85 reports), Horse (26 reports). By breed: Domestic Shorthair (274), Domestic Longhair (29), Domestic Mediumhair (18).

Most co-reported drugs: Selamectin (111 reports), Selamectin;Sarolaner (71 reports), Fluralaner Spot-On Solution (70 reports), Imidacloprid + Moxidectin (57 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.