Reaction profile

The FDA adverse-event record for application site ulcer

503 FDA reports name application site ulcer, a high-volume reaction in the CVM extract (VeDDRA 35). Plate stamps and neighbourhood peers follow.

#642 of 2,481
by report volume (all reactions)
503
reports citing this reaction
1.8%
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 ulcer has 503 reports now versus 495 in that prior snapshot: 8 more (1.6%).

Report change
+8
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 ulcer changes

FDA AER · VeDDRA plate

Code 35 VOL-MID

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

  • VOL-MID 503 reports
  • DEATH-LOW 1.8%
  • MID-PACK #642/2481
  • PHOTO-FINISH Device breakage/fract…
  • SPECIES-CAT Cat · 380
  • DRUG-LEAD Selamectin · 111
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Device breakage/fracture (±0 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 ulcer

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

Vomiting · highest174348Application site ulcer · thi…503Device breakage/fract… · near503Application site stic… · near502Pancreas disorder · near501Blepharospasm · near500Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Application site ulcer

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

Signature read: Application site ulcer's 1.8% death-coded share is among the lowest in the openFDA reaction corpus. Report volume is upper-third scale: 503 named reports in the openFDA extract. Death-coded share is lower-third: 9 of 503 reports (1.8% of named reports). Nearest volume peer: Device breakage/fracture (±0 reports). Lead species Cat (380). Lead co-reported drug Selamectin (111).

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 380
Dog 96
Horse 26
Human 1

Breeds Most Affected

Domestic Shorthair 279
Domestic Longhair 30
Domestic Mediumhair 18
Crossbred Canine/dog 14
Dog (unknown) 11
Retriever - Golden 9
Retriever - Labrador 8
Horse (unknown) 8
Siamese 8
Maine Coon 8

Associated Drugs

Selamectin 111
Selamectin;Sarolaner 74
Fluralaner Spot-On Solution 71
Imidacloprid + Moxidectin 57
Emodepside + Praziquantel 33
Flumethrin-Imidacloprid 18
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 15
Mirtazapine 14
Genta/Momet/Clotrim Ear Oint 13
Methylprednisolone Acetate 12
Cefovecin 12
Rabies Vaccine 12
Fluralaner/Moxidectin Spot-On 12
Cefovecin Sodium 11
Eprinomectin + Esafoxolaner + Praziquantel 9
Dexamethasone 8
Ivermectin + Praziquantel 8
Genta/Posacon/Mometa Eardrops 8
Maropitant Citrate 7
Florfenicol + Mometasone Furoate + Terbinafine Hydrochloride 7

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Application site ulcer, 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 (503 here).

Similar death-coded share

Nearest other reactions by death-coded share (1.8% 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 ulcer (#642 of 2,481 by report volume); death-coded 1.8%. PlainBreed reaction plate · death-coded share stamp 1.8% · 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 →