Reaction profile

The FDA adverse-event record for injection site swelling

5,505 FDA reports name injection site swelling, a high-volume reaction in the CVM extract (VeDDRA 91). Plate stamps and neighbourhood peers follow.

#91 of 2,481
by report volume (all reactions)
5,505
reports citing this reaction
5.4%
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 swelling has 5,505 reports now versus 5,423 in that prior snapshot: 82 more (1.5%).

Report change
+82
Death-coded reports
+6
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 swelling changes

FDA AER · VeDDRA plate

Code 91 VOL-HIGH

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

  • VOL-HIGH 5,505 reports
  • DEATH-PAR 5.4%
  • TOP-DECILE #91/2481
  • PHOTO-FINISH Neutrophilia
  • SPECIES-DOG Dog · 3,734
  • DRUG-LEAD Melarsomine Dihyd… · 878
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Neutrophilia (±68 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 swelling

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

Vomiting · highest174348Anxiety · near5617Neutrophilia · near5573Injection site swelli… · thi…5505Elevated total biliru… · near5424Disorientation · near5405Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Injection site swelling

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

Signature read: 5,505 reports place Injection site swelling in the upper third of FDA AER volume (#91 of 2,481). Report volume is upper-third scale: 5,505 named reports in the openFDA extract. Death-coded share is lower-third: 297 of 5,505 reports (5.4% of named reports). Nearest volume peer: Neutrophilia (±68 reports). Lead species Dog (3,734). Lead co-reported drug Melarsomine Dihydrochloride (878).

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 3,734
Horse 793
Cattle 436
Human 309
Cat 193
Pig 11
Monkey 8
Goat 6
Donkey 3
Other Equids 3

Breeds Most Affected

Retriever - Labrador 509
Unknown 335
Crossbred Canine/dog 268
Quarter Horse 250
Pit Bull 192
Dog (unknown) 182
Boxer (German Boxer) 158
Chihuahua 151
Thoroughbred 144
Shepherd Dog - German 144

Associated Drugs

Melarsomine Dihydrochloride 878
Tigilanol Tiglate 693
Carprofen 529
Melarsomine Dihydrochloride Injection 487
Ceftiofur Crystalline Free Acid 475
Moxidectin 431
Prednisone 280
Maropitant Citrate 231
Gabapentin 222
Diphenhydramine 189
Butorphanol 181
Famotidine 160
Dexmedetomidine 135
Ceftiofur 134
Polysulfated Glycosaminoglycan 121
Ivermectin + Pyrantel As Pamoate Salt 107
Buprenorphine 97
Bedinvetmab 95
Atipamezole 91
Dinoprost Tromethamine 89

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Injection site swelling, 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 (5,505 here).

Similar death-coded share

Nearest other reactions by death-coded share (5.4% 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 swelling (#91 of 2,481 by report volume); death-coded 5.4%. PlainBreed reaction plate · report volume stamp 5,505 · 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 →