Application site skin change NOS

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VeDDRA Code: 2200

715 adverse event reports referencing this reaction

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

Data Summary

Metric Value
Total reports referencing reaction 715
Reports with fatal outcome 0
Case-fatality rate (reported events) 0.0%
Species observed 6
Breeds observed 20
Drugs associated with reaction 20

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER); reaction term coded under VeDDRA 2200.

Application site skin change NOS Reaction Insights

The FDA Center for Veterinary Medicine database currently lists 715 adverse event reports that reference Application site skin change NOS as a reaction term, including 0 reports with a death outcome — a 0.0% case-fatality figure calculated across only those events where this reaction was coded. The reaction is indexed in the openFDA system under VeDDRA code 2200, the standardized veterinary dictionary used to normalize clinical signs across submitters. Because reports are voluntary and often describe multiple concurrent signs per animal, the volume here reflects reporting intensity rather than true incidence in the broader pet population.

Application site skin change NOS appears most frequently in reports for Human (533 reports), Cat (132 reports), Dog (44 reports) — with Human dominating at 533 entries. Within those species, the breeds most often named alongside this reaction are Unknown (536), Domestic Shorthair (88), Domestic Mediumhair (10). These distributions are influenced both by underlying breed popularity and by how veterinarians and owners code a given clinical sign, so they should be interpreted as a reporting fingerprint rather than a pure susceptibility ranking.

The drugs most commonly co-reported with Application site skin change NOS are Fluralaner Spot-On Solution (521 reports), Selamectin (37 reports), Imidacloprid + Moxidectin (33 reports), Selamectin;Sarolaner (31 reports), with Fluralaner Spot-On Solution appearing alongside this reaction in 521 submissions. Co-reporting does not establish that any specific product caused the reaction — FDA CVM data captures temporal association only. The value of these aggregates is in flagging which therapeutic classes appear repeatedly alongside a given clinical sign, so owners and veterinarians can ask targeted questions about medications currently in use.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial