Reaction profile

The FDA adverse-event record for application site granuloma

16 FDA adverse-event reports reference application site granuloma (VeDDRA 7). See the species, breeds, and drugs most associated with it below.

16
reports citing this reaction
6.3%
death-coded share
Cat
most-affected species
Selamectin
most-associated drug
Verify with FDA CVM →
16
Total Reports
1
Deaths
6.3%
Death Rate

Species Most Affected

Cat 10
Dog 5
Cattle 1

Breeds Most Affected

Domestic Shorthair 5
Cat (unknown) 4
Retriever - Golden 1
American Shorthair 1
Dachshund (unspecified) 1
Retriever - Labrador 1
Pit Bull 1
Terrier - Airedale 1
Cattle (other) 1

Associated Drugs

Selamectin 5
Imidacloprid + Moxidectin 2
Tramadol 2
Fentanyl 2
Amoxicillin Trihydrate/Clavulanic Acid 2
Ivermectin/Pyrantel Pamoate Chewable 272Mcg/652Mg 1
Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On 1
Methylprednisolone Acetate 1
Dexamethasone Sodium Phosphate 1
Ketamine 1
Buprenorphine Hcl 1
Silver Sulfadiazine 1
Nitenpyram 1
Amoxicillin As Amoxicillin Trihydrate; Clavulanate Potassium ( K-Clavulanate) 1
Dexmedetomidine Hydrochloride 1
Atipamezole Hydrochloride 1
Emodepside + Praziquantel 1
Prednisone 1
Doxycycline 1
Polysulfated Glycosaminoglycan 1

Application site granuloma Reaction Insights

16 reports name Application site granuloma; 1 recorded a death outcome (6.3% of reported events, not a population-level mortality rate). VeDDRA code: 7.

By species: Cat (10 reports), Dog (5 reports), Cattle (1 reports). By breed: Domestic Shorthair (5), Cat (unknown) (4), Retriever - Golden (1).

Most co-reported drugs: Selamectin (5 reports), Imidacloprid + Moxidectin (2 reports), Tramadol (2 reports), Fentanyl (2 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.