Reaction profile

The FDA adverse-event record for application site rash

367 FDA reports name application site rash, a high-volume reaction in the CVM extract (VeDDRA 1331). Plate stamps and neighbourhood peers follow.

#782 of 2,481
by report volume (all reactions)
367
reports citing this reaction
0.3%
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 rash has 367 reports now versus 359 in that prior snapshot: 8 more (2.2%).

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 rash changes

FDA AER · VeDDRA plate

Code 1331 VOL-LOW

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

  • VOL-LOW 367 reports
  • DEATH-RARE 0.3%
  • MID-PACK #782/2481
  • PHOTO-FINISH Administration device…
  • SPECIES-CAT Cat · 234
  • DRUG-LEAD Selamectin;Sarola… · 83
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Administration device NOS, malfunction (±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 rash

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

Vomiting · highest174348Administration device… · near367Application site rash · this…367Hallucination · near367Nasal bleeding · near367Swollen mouth · near367Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Application site rash

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

Signature read: Application site rash's 0.3% death-coded share is among the lowest in the openFDA reaction corpus. Report volume is upper-third scale: 367 named reports in the openFDA extract. Death-coded share is lower-third: 1 of 367 reports (0.3% of named reports). Nearest volume peer: Administration device NOS, malfunction (±0 reports). Lead species Cat (234). Lead co-reported drug Selamectin;Sarolaner (83).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Selamectin;Sarolaner 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 234
Dog 116
Human 16
Cattle 1

Breeds Most Affected

Domestic Shorthair 149
Cat (other) 21
Unknown 17
Domestic Mediumhair 16
Crossbred Canine/dog 12
Retriever - Labrador 10
Pit Bull 9
Chihuahua 8
Siamese 8
Cat (unknown) 6

Associated Drugs

Selamectin;Sarolaner 83
Selamectin 60
Imidacloprid + Moxidectin 53
Fluralaner Spot-On Solution 49
Fluralaner/Moxidectin Spot-On 18
Emodepside + Praziquantel 16
Flumethrin-Imidacloprid 14
Eprinomectin + Esafoxolaner + Praziquantel 10
Imidacloprid, Flumethrin 8
Ivermectin + Pyrantel As Pamoate Salt 7
Ophytrium 6
Fipronil 10%/S Methoprene 9% Spot On 5
Oclacitinib Maleate 5
Cefpodoxime Proxetil 4
Methylprednisolone Acetate 4
Cefovecin Sodium 4
Cefovecin 4
Mirtazapine 4
Flumethrin,Imidacloprid 4
Ivermectin/Pyrantel Pamoate Chewable 272Mcg/652Mg 3

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Application site rash, 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 (367 here).

Similar death-coded share

Nearest other reactions by death-coded share (0.3% 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 rash (#782 of 2,481 by report volume); death-coded 0.3%. PlainBreed reaction plate · death-coded share stamp 0.3% · 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 →