Reaction profile

The FDA adverse-event record for application site lump

143 FDA adverse-event reports reference application site lump (VeDDRA 21). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.

#1217 of 2,481
by report volume (all reactions)
143
reports citing this reaction
2.1%
death-coded share
Dog
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 lump has 143 reports now versus 140 in that prior snapshot: 3 more (2.1%).

Report change
+3
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.

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FDA AER · VeDDRA plate

Code 21 VOL-LOW

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

  • VOL-LOW 143 reports
  • DEATH-LOW 2.1%
  • MID-PACK #1217/2481
  • PHOTO-FINISH Laryngeal paralysis
  • SPECIES-DOG Dog · 67
  • DRUG-LEAD Selamectin · 44
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Laryngeal paralysis (±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 lump

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

Vomiting · highest174348Application site lump · this…143Laryngeal paralysis · near143Mouth ulcer · near143Skin textural change · near143Difficulty eating NOS · near142Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Application site lump

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

Signature read: Application site lump's 2.1% 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: 3 of 143 reports (2.1% of named reports). Nearest volume peer: Laryngeal paralysis (±0 reports). Lead species Dog (67). 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

Dog 67
Cat 63
Horse 10
Cattle 3

Breeds Most Affected

Domestic Shorthair 40
Shih Tzu 6
Chihuahua 6
Cat (other) 6
Boxer (German Boxer) 4
Retriever - Golden 4
Domestic Longhair 4
Retriever - Labrador 3
Quarter Horse 3
Domestic Mediumhair 3

Associated Drugs

Selamectin 44
Imidacloprid + Moxidectin 21
Selamectin;Sarolaner 10
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 8
Fluralaner Spot-On Solution 8
Emodepside + Praziquantel 7
Buprenorphine 6
Ivermectin + Pyrantel As Pamoate Salt 5
Ivermectin/Pyrantel Pamoate Chewable 272Mcg/652Mg 4
Fipronil 10%/S Methoprene 9% Spot On 4
Maropitant Citrate 4
Imidacloprid, Moxidectin 3
Imidacloprid And Moxidectin 3
Fluralaner/Moxidectin Spot-On 3
Dexmedetomidine 3
Melarsomine Dihydrochloride 2
Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On 2
Isoflurane 2
Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg 2
Fipronil 9.8%/S-Methoprene 8.8%/Cyphenothrin 5.2% Squeeze-On 2

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Application site lump, 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 (143 here).

Similar death-coded share

Nearest other reactions by death-coded share (2.1% 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 lump (#1217 of 2,481 by report volume); death-coded 2.1%. PlainBreed reaction plate · death-coded share stamp 2.1% · 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 →