Reaction profile

The FDA adverse-event record for application site lump

137 FDA adverse-event reports reference application site lump (VeDDRA 21). See the species, breeds, and drugs most associated with it below.

137
reports citing this reaction
2.2%
death-coded share
Dog
most-affected species
Selamectin
most-associated drug
Verify with FDA CVM →
137
Total Reports
3
Deaths
2.2%
Death Rate

Species Most Affected

Dog 66
Cat 58
Horse 10
Cattle 3

Breeds Most Affected

Domestic Shorthair 36
Shih Tzu 6
Chihuahua 6
Cat (other) 6
Boxer (German Boxer) 4
Retriever - Golden 4
Domestic Longhair 4
Retriever - Labrador 3
Quarter Horse 3
Terrier - Bull - American Pit 3

Associated Drugs

Selamectin 43
Imidacloprid + Moxidectin 21
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 8
Fluralaner Spot-On Solution 8
Selamectin;Sarolaner 8
Emodepside + Praziquantel 7
Ivermectin + Pyrantel As Pamoate Salt 5
Buprenorphine 5
Ivermectin/Pyrantel Pamoate Chewable 272Mcg/652Mg 4
Fipronil 10%/S Methoprene 9% Spot On 4
Imidacloprid, Moxidectin 3
Imidacloprid And Moxidectin 3
Fluralaner/Moxidectin Spot-On 3
Maropitant Citrate 3
Melarsomine Dihydrochloride 2
Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On 2
Isoflurane 2
Melarsomine Dihydrochloride Injection 2
Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg 2
Fipronil 9.8%/S-Methoprene 8.8%/Cyphenothrin 5.2% Squeeze-On 2

Application site lump Reaction Insights

137 reports name Application site lump; 3 recorded a death outcome (2.2% of reported events, not a population-level mortality rate). VeDDRA code: 21.

By species: Dog (66 reports), Cat (58 reports), Horse (10 reports). By breed: Domestic Shorthair (36), Shih Tzu (6), Chihuahua (6).

Most co-reported drugs: Selamectin (43 reports), Imidacloprid + Moxidectin (21 reports), Ivermectin(1.55%)/Praziquantel(7.75%) Paste (8 reports), Fluralaner Spot-On Solution (8 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.