Reaction profile

The FDA adverse-event record for application site skin discolouration

149 FDA adverse-event reports reference application site skin discolouration (VeDDRA 2197). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.

#1190 of 2,481
by report volume (all reactions)
149
reports citing this reaction
1.3%
death-coded share
Cat
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 discolouration has 149 reports now versus 148 in that prior snapshot: 1 more (0.7%).

Report change
+1
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 discolouration changes

FDA AER · VeDDRA plate

Code 2197 VOL-LOW

VOL-LOW · DEATH-LOW · MID-PACK · PHOTO-FINISH · SPECIES-CAT · DRUG-LEAD · DESK-WIDE · BOOK-FULL

  • VOL-LOW 149 reports
  • DEATH-LOW 1.3%
  • MID-PACK #1190/2481
  • PHOTO-FINISH Abnormal ECG
  • SPECIES-CAT Cat · 79
  • DRUG-LEAD Selamectin · 44
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Abnormal ECG (±0 reports)

Instrument codes from this reaction’s FDA CVM adverse-event extract: volume band, death-coded share, corpus rank, photo-finish peer, lead species, lead drug, breed desk, and book completeness. Not a clinical diagnosis.

Report-volume neighbourhood around Application site skin discolouration

Highest and lowest poles plus nearest volume peers, not a full 2,500-reaction corpus board reprint.

Vomiting · highest174348Abnormal ECG · near149Administration device… · near149Application site skin… · thi…149Burning sensation (sk… · near149Physical product labe… · near149Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Application site skin discolouration

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

Signature read: Application site skin discolouration's 1.3% death-coded share is among the lowest in the openFDA reaction corpus. Report volume sits in the middle third of the reaction corpus. Death-coded share is lower-third: 2 of 149 reports (1.3% of named reports). Nearest volume peer: Abnormal ECG (±0 reports). Lead species Cat (79). Lead co-reported drug Selamectin (44).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Selamectin 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

Cat 79
Dog 42
Human 25
Macaw 1
Horse 1
Unknown 1

Breeds Most Affected

Domestic Shorthair 43
Unknown 28
Cat (unknown) 7
Siamese 6
Shih Tzu 5
Maltese 4
Crossbred Canine/dog 4
Domestic Longhair 4
Domestic Mediumhair 4
Dog (unknown) 3

Associated Drugs

Selamectin 44
Fluralaner Spot-On Solution 16
Selamectin;Sarolaner 16
Imidacloprid + Moxidectin 11
Mirtazapine 8
Ivermectin + Pyrantel As Pamoate Salt 6
Fipronil 10%/S Methoprene 9% Spot On 5
Emodepside + Praziquantel 4
Buprenorphine 4
Fluralaner/Moxidectin Spot-On 4
Eprinomectin + Esafoxolaner + Praziquantel 4
Copper Naphthenate 3
Rabies Vaccine 3
Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg 2
Marbofloxacin 2
Methylprednisolone Acetate 2
Enrofloxacin 2
Phytosphingosine 2
Betamethasone + Florfenicol + Terbinafine 2
Toceranib Phosphate 2

Nationwide reactions with similar profiles

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

Similar death-coded share

Nearest other reactions by death-coded share (1.3% 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 discolouration (#1190 of 2,481 by report volume); death-coded 1.3%. PlainBreed reaction plate · death-coded share stamp 1.3% · 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 →