Reaction profile

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

720 FDA reports name application site skin change nos, a high-volume reaction in the CVM extract (VeDDRA 2200). Plate stamps and neighbourhood peers follow.

#502 of 2,481
by report volume (all reactions)
720
reports citing this reaction
0.0%
death-coded share
Human
most-affected species

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Application site skin change NOS has 720 reports now versus 718 in that prior snapshot: 2 more (0.3%).

Report change
+2
Death-coded reports
+0
Death-coded share
+0.0 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Application site skin change NOS changes

FDA AER · VeDDRA plate

Code 2200 VOL-MID

VOL-MID · DEATH-RARE · UPPER-Q · PHOTO-FINISH · SPECIES-HUMAN · DRUG-LEAD · DESK-WIDE · BOOK-FULL

  • VOL-MID 720 reports
  • DEATH-RARE 0.0%
  • UPPER-Q #502/2481
  • PHOTO-FINISH Ketonuria
  • SPECIES-HUMAN Human · 533
  • DRUG-LEAD Fluralaner Spot-O… · 521
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Ketonuria (±1 reports)

Upper-third report volume drives the scale stamps on this plate; death-coded share and co-report peers follow. Not a clinical diagnosis.

High-volume neighbourhood around Application site skin change NOS

Upper-third volume poles plus nearest peers, not a full reaction corpus board reprint.

Vomiting · highest174348Solution/Suspension,… · near722Application site skin… · thi…720Ketonuria · near719Underfilling, Vials · near719Localised itching · near718Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Application site skin change NOS

Application site skin change NOS: low death-coded share in the FDA AER plate

Signature read: Application site skin change NOS's 0.0% death-coded share is among the lowest in the openFDA reaction corpus. Report volume is upper-third scale: 720 named reports in the openFDA extract. Death-coded share is lower-third: 0 of 720 reports (0.0% of named reports). Nearest volume peer: Ketonuria (±1 reports). Lead species Human (533). Lead co-reported drug Fluralaner Spot-On Solution (521).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Fluralaner Spot-On Solution appears in filings alongside this reaction; that is association, not causation. Browse the full reactions index or the about page for how PlainBreed frames FDA CVM extracts.

Species Most Affected

Human 533
Cat 137
Dog 44
Cattle 3
Horse 2
Unknown 1

Breeds Most Affected

Unknown 536
Domestic Shorthair 91
Domestic Mediumhair 10
Domestic Longhair 9
Retriever - Labrador 5
Chihuahua 5
Cat (unknown) 5
Siamese 5
Pit Bull 3
Crossbred Canine/dog 3

Associated Drugs

Fluralaner Spot-On Solution 521
Selamectin 39
Imidacloprid + Moxidectin 33
Selamectin;Sarolaner 32
Fluralaner/Moxidectin Spot-On 31
Mirtazapine 16
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

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Application site skin change NOS, both floored at ≥50 reports so the neighborhoods stay in the advertised mass (the volume chart above is the unfloored photo-finish strip).

Similar report volume

Nearest other reactions by FDA report count (720 here).

Similar death-coded share

Nearest other reactions by death-coded share (0.0% here), distinct from the volume row.

What to do with this reaction

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Application site skin change NOS (#502 of 2,481 by report volume); death-coded 0.0%. PlainBreed reaction plate · death-coded share stamp 0.0% · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →