Reaction profile

The FDA adverse-event record for injection site irritation

179 FDA adverse-event reports reference injection site irritation (VeDDRA 94). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.

#1092 of 2,481
by report volume (all reactions)
179
reports citing this reaction
2.2%
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 irritation has 179 reports now versus 172 in that prior snapshot: 7 more (4.1%).

Report change
+7
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 irritation changes

FDA AER · VeDDRA plate

Code 94 VOL-LOW

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

  • VOL-LOW 179 reports
  • DEATH-LOW 2.2%
  • MID-PACK #1092/2481
  • PHOTO-FINISH Cognitive impairment
  • SPECIES-DOG Dog · 86
  • DRUG-LEAD Tulathromycin · 15
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Cognitive impairment (±1 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 Injection site irritation

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

Vomiting · highest174348Mastitis NOS · near180Pigmentation disorder · near180Injection site irrita… · thi…179Cognitive impairment · near178Dependent oedema · near178Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Injection site irritation

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

Signature read: Injection site irritation's 2.2% 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: 4 of 179 reports (2.2% of named reports). Nearest volume peer: Cognitive impairment (±1 reports). Lead species Dog (86). Lead co-reported drug Tulathromycin (15).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Tulathromycin 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 86
Human 55
Cat 19
Cattle 6
Rabbit 5
Horse 4
Pig 2
Other marine mammal 1
Ferret 1

Breeds Most Affected

Unknown 58
Retriever - Golden 9
Domestic Shorthair 9
Retriever - Labrador 6
Chihuahua 6
Rabbit (unknown) 5
Dog (unknown) 4
Maltese 4
Pit Bull 4
Boxer (German Boxer) 3

Associated Drugs

Tulathromycin 15
Maropitant Citrate 15
Carprofen 14
Enrofloxacin 13
Moxidectin 13
Cefovecin 11
Tigilanol Tiglate 10
Gabapentin 9
Dexmedetomidine Hydrochloride 7
Bedinvetmab 7
Tilmicosin Phosphate 5
Melarsomine Dihydrochloride 5
Ceftiofur Crystalline Free Acid 4
Atipamezole Hydrochloride 4
Oclacitinib Maleate 4
Anti-Il31 Mab Mcs Lot #1283563 4
Meloxicam 4
Prednisone 4
Famotidine 4
Robenacoxib 4

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Injection site irritation, 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 (179 here).

Similar death-coded share

Nearest other reactions by death-coded share (2.2% 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 irritation (#1092 of 2,481 by report volume); death-coded 2.2%. PlainBreed reaction plate · death-coded share stamp 2.2% · 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 →