Reaction profile

The FDA adverse-event record for application site skin change nos

715 FDA adverse-event reports reference application site skin change nos (VeDDRA 2200). See the species, breeds, and drugs most associated with it below.

715
reports citing this reaction
0.0%
death-coded share
Human
most-affected species
Fluralaner Spot-On Solution
most-associated drug
Verify with FDA CVM →
715
Total Reports
0
Deaths
0.0%
Death Rate

Species Most Affected

Human 533
Cat 132
Dog 44
Cattle 3
Horse 2
Unknown 1

Breeds Most Affected

Unknown 536
Domestic Shorthair 88
Domestic Mediumhair 10
Domestic Longhair 8
Retriever - Labrador 5
Chihuahua 5
Siamese 5
Cat (unknown) 4
Pit Bull 3
Crossbred Canine/dog 3

Associated Drugs

Fluralaner Spot-On Solution 521
Selamectin 37
Imidacloprid + Moxidectin 33
Selamectin;Sarolaner 31
Fluralaner/Moxidectin Spot-On 30
Mirtazapine 15
Emodepside + Praziquantel 11
Ivermectin + Pyrantel As Pamoate Salt 5
Fipronil 10%/S Methoprene 9% Spot On 4
Methylprednisolone Acetate 4
Cyclosporin Ointment 4
Flumethrin-Imidacloprid 4
Imidacloprid, Flumethrin 4
Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On 3
Ivermectin/Pyrantel Pamoate Chewable 272Mcg/652Mg 3
Cefovecin Sodium 3
Gabapentin 3
Tresaderm Dermatological Solution 2
Feline Leukemia Vaccine 2
Cyclosporine 2

Application site skin change NOS Reaction Insights

715 reports name Application site skin change NOS; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). VeDDRA code: 2200.

By species: Human (533 reports), Cat (132 reports), Dog (44 reports). By breed: Unknown (536), Domestic Shorthair (88), Domestic Mediumhair (10).

Most co-reported drugs: Fluralaner Spot-On Solution (521 reports), Selamectin (37 reports), Imidacloprid + Moxidectin (33 reports), Selamectin;Sarolaner (31 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.