Reaction profile

The FDA adverse-event record for injection site oedema

514 FDA reports name injection site oedema, a high-volume reaction in the CVM extract (VeDDRA 90). Plate stamps and neighbourhood peers follow.

#637 of 2,481
by report volume (all reactions)
514
reports citing this reaction
11.5%
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 oedema has 514 reports now versus 510 in that prior snapshot: 4 more (0.8%).

Report change
+4
Death-coded reports
+0
Death-coded share
−0.1 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 oedema changes

FDA AER · VeDDRA plate

Code 90 VOL-MID

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

  • VOL-MID 514 reports
  • DEATH-ELEV 11.5%
  • MID-PACK #637/2481
  • PHOTO-FINISH Muscle atrophy (see a…
  • SPECIES-DOG Dog · 276
  • DRUG-LEAD Tigilanol Tiglate · 92
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Muscle atrophy (see also Muscle wasting) (±2 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 oedema

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

Vomiting · highest174348Bumping into walls · near518Muscle atrophy (see a… · near516Injection site oedema · this…514Paresis · near511Swollen lip (see also… · near511Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Injection site oedema

What the FDA AER plate says about Injection site oedema

Signature read: 514 reports place Injection site oedema in the upper third of FDA AER volume (#637 of 2,481). Report volume is upper-third scale: 514 named reports in the openFDA extract. 59 of 514 reports were death-coded (11.5% of named reports, not a population mortality rate). Nearest volume peer: Muscle atrophy (see also Muscle wasting) (±2 reports). Lead species Dog (276). Lead co-reported drug Tigilanol Tiglate (92).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Tigilanol Tiglate 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 276
Horse 89
Human 65
Cat 45
Cattle 35
Pig 2
Sheep 2

Breeds Most Affected

Unknown 70
Retriever - Labrador 37
Domestic (unspecified) 28
Quarter Horse 27
Pit Bull 24
Boxer (German Boxer) 18
Shepherd Dog - German 16
Thoroughbred 15
Horse (unknown) 15
Crossbred Canine/dog 14

Associated Drugs

Tigilanol Tiglate 92
Ceftiofur Crystalline Free Acid 48
Carprofen 39
Melarsomine Dihydrochloride Injection 30
Maropitant Citrate 27
Robenacoxib 26
Enrofloxacin 23
Melarsomine Dihydrochloride 22
Diphenhydramine 22
Ivermectin + Pyrantel As Pamoate Salt 21
Tulathromycin 19
Polysulfated Glycosaminoglycan 19
Prednisone 17
Famotidine 16
Ceftiofur 15
Meloxicam 15
Moxidectin 14
Dexmedetomidine 13
Buprenorphine 12
Gabapentin 12

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Injection site oedema, 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 (11.5% 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 oedema (#637 of 2,481 by report volume); death-coded 11.5%. PlainBreed reaction plate · report volume stamp 514 · 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 →