Reaction profile

The FDA adverse-event record for application site lesion

1,693 FDA reports name application site lesion, a high-volume reaction in the CVM extract (VeDDRA 14). Plate stamps and neighbourhood peers follow.

#263 of 2,481
by report volume (all reactions)
1,693
reports citing this reaction
1.5%
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 lesion has 1,693 reports now versus 1,678 in that prior snapshot: 15 more (0.9%).

Report change
+15
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 lesion changes

FDA AER · VeDDRA plate

Code 14 VOL-MID

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

  • VOL-MID 1,693 reports
  • DEATH-LOW 1.5%
  • UPPER-Q #263/2481
  • PHOTO-FINISH Unresponsive to stimu…
  • SPECIES-CAT Cat · 1,361
  • DRUG-LEAD Selamectin · 707
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Unresponsive to stimuli (±3 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 lesion

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

Vomiting · highest174348Loss of hearing · near1707Unresponsive to stimu… · near1696Application site lesi… · thi…1693Renal disorder NOS · near1684Mucous stool · near1681Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Application site lesion

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

Signature read: 1,693 reports place Application site lesion in the upper third of FDA AER volume (#263 of 2,481). Report volume is upper-third scale: 1,693 named reports in the openFDA extract. Death-coded share is lower-third: 25 of 1,693 reports (1.5% of named reports). Nearest volume peer: Unresponsive to stimuli (±3 reports). Lead species Cat (1,361). Lead co-reported drug Selamectin (707).

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 1,361
Dog 269
Horse 52
Cattle 5
Human 3
Unknown 2
Camel 1

Breeds Most Affected

Domestic Shorthair 688
Domestic (unspecified) 307
Domestic Longhair 75
Cat (unknown) 61
Domestic Mediumhair 61
Maine Coon 33
Retriever - Labrador 33
Siamese 32
Crossbred Canine/dog 31
Cat (other) 26

Associated Drugs

Selamectin 707
Imidacloprid + Moxidectin 232
Selamectin;Sarolaner 191
Fluralaner Spot-On Solution 136
Emodepside + Praziquantel 104
Flumethrin-Imidacloprid 55
Imidacloprid, Moxidectin 45
Fluralaner/Moxidectin Spot-On 34
Buprenorphine 30
Ivermectin, Praziquantel 24
Ivermectin + Pyrantel As Pamoate Salt 22
Fipronil 10%/S Methoprene 9% Spot On 18
Eprinomectin + Esafoxolaner + Praziquantel 18
Cefovecin Sodium 17
Cefovecin 16
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 15
Prednisolone 14
Enrofloxacin 14
Emodepside, Praziquantel 13
Ivermectin 12

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Application site lesion, 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 (1,693 here).

Similar death-coded share

Nearest other reactions by death-coded share (1.5% 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 lesion (#263 of 2,481 by report volume); death-coded 1.5%. PlainBreed reaction plate · report volume stamp 1,693 · 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 →