Reaction profile

The FDA adverse-event record for application site granuloma

Name: Application site granuloma - FDA Animal Adverse Reaction
Creator: PlainBreed
License: https://open.fda.gov/license/

16 FDA reports name application site granuloma, a lower-volume reaction in the CVM extract (VeDDRA 7). Plate stamps and neighbourhood peers follow.

#2259 of 2,481
by report volume (all reactions): 16
reports citing this reaction: 6.3%
death-coded share: Cat
most-affected species

Compiled by PlainBreed

Verify with FDA CVM →

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 granuloma has 16 reports now versus 16 in that prior snapshot: 0 the same number of (0.0%).

Report change: +0
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 granuloma changes

FDA AER · VeDDRA plate

Code 7 VOL-TRACE

VOL-TRACE · DEATH-PAR · BOTTOM-DECILE · PHOTO-FINISH · SPECIES-CAT · DRUG-LEAD · DESK-WIDE · BOOK-FULL

VOL-TRACE 16 reports
DEATH-PAR 6.3%
BOTTOM-DECILE #2259/2481
PHOTO-FINISH Abdominal transudate
SPECIES-CAT Cat · 10
DRUG-LEAD Selamectin · 5
DESK-WIDE 9 breeds
BOOK-FULL 8/8 fields

Nearest volume peer: Abdominal transudate (±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.

Lower-volume neighbourhood around Application site granuloma

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

FDA AER report volume · neighbourhood around Application site granuloma

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

Signature read: 16 reports place Application site granuloma in the lower third of FDA AER volume (#2259 of 2,481). Report volume is lower-third scale: 16 named reports in the openFDA extract. Death-coded share is lower-third: 1 of 16 reports (6.3% of named reports). Nearest volume peer: Abdominal transudate (±0 reports). Lead species Cat (10). Lead co-reported drug Selamectin (5).

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 10

Dog 5

Cattle 1

Breeds Most Affected

Domestic Shorthair 5

Cat (unknown) 4

Retriever - Golden 1

American Shorthair 1

Dachshund (unspecified) 1

Retriever - Labrador 1

Pit Bull 1

Terrier - Airedale 1

Cattle (other) 1

Associated Drugs

Selamectin 5

Imidacloprid + Moxidectin 2

Tramadol 2

Fentanyl 2

Amoxicillin Trihydrate/Clavulanic Acid 2

Ivermectin/Pyrantel Pamoate Chewable 272Mcg/652Mg 1

Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On 1

Ketamine 1

Buprenorphine Hcl 1

Silver Sulfadiazine 1

Nitenpyram 1

Amoxicillin As Amoxicillin Trihydrate; Clavulanate Potassium ( K-Clavulanate) 1

Dexmedetomidine Hydrochloride 1

Atipamezole Hydrochloride 1

Methylprednisolone Acetate 1

Dexamethasone Sodium Phosphate 1

Emodepside + Praziquantel 1

Prednisone 1

Doxycycline 1

Polysulfated Glycosaminoglycan 1

What to do with this reaction

Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
Browse the full reaction directory to compare report counts across reaction types. All reactions

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 granuloma (#2259 of 2,481 by report volume); death-coded 6.3%. PlainBreed reaction plate · report volume stamp 16 · 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 →