Reaction profile

The FDA adverse-event record for injection site lump

2,181 FDA reports name injection site lump, a high-volume reaction in the CVM extract (VeDDRA 92). Plate stamps and neighbourhood peers follow.

#215 of 2,481
by report volume (all reactions)
2,181
reports citing this reaction
1.8%
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. Injection site lump has 2,181 reports now versus 2,127 in that prior snapshot: 54 more (2.5%).

Report change
+54
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 Injection site lump changes

FDA AER · VeDDRA plate

Code 92 VOL-MID

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

  • VOL-MID 2,181 reports
  • DEATH-LOW 1.8%
  • TOP-DECILE #215/2481
  • PHOTO-FINISH Solution, Abnormal
  • SPECIES-DOG Dog · 1,779
  • DRUG-LEAD Melarsomine Dihyd… · 524
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Solution, Abnormal (±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 Injection site lump

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

Vomiting · highest174348Ear infection NOS · near2187Lack of efficacy (ect… · near2183Injection site lump · this r…2181Solution, Abnormal · near2181Inappropriate defecat… · near2169Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Injection site lump

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

Signature read: 2,181 reports place Injection site lump in the upper third of FDA AER volume (#215 of 2,481). Report volume is upper-third scale: 2,181 named reports in the openFDA extract. Death-coded share is lower-third: 39 of 2,181 reports (1.8% of named reports). Nearest volume peer: Solution, Abnormal (±0 reports). Lead species Dog (1,779). Lead co-reported drug Melarsomine Dihydrochloride (524).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Melarsomine Dihydrochloride 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 1,779
Cat 262
Horse 61
Cattle 57
Human 13
Goat 4
Pig 2
Other Birds 1
Alpaca 1
Llama 1

Breeds Most Affected

Retriever - Labrador 235
Domestic Shorthair 169
Crossbred Canine/dog 134
Retriever - Golden 96
Shepherd Dog - German 95
Chihuahua 75
Dog (unknown) 61
Terrier - Bull - American Pit 55
Shepherd Dog - Australian 51
Dog (other) 43

Associated Drugs

Melarsomine Dihydrochloride 524
Moxidectin 299
Melarsomine Dihydrochloride Injection 297
Carprofen 184
Prednisone 124
Cefovecin 98
Ivermectin + Pyrantel As Pamoate Salt 83
Gabapentin 83
Maropitant Citrate 76
Enrofloxacin 56
Methylprednisolone Acetate 54
Lufenuron 53
Polysulfated Glycosaminoglycan 48
Meloxicam 47
Afoxolaner 45
Butorphanol 44
Robenacoxib 43
Praziquantel 39
Buprenorphine 38
Bedinvetmab 38

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Injection 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 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 Injection site lump (#215 of 2,481 by report volume); death-coded 1.8%. PlainBreed reaction plate · report volume stamp 2,181 · 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 →