Reaction profile

The FDA adverse-event record for application site thickening

71 FDA adverse-event reports reference application site thickening (VeDDRA 2515). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.

#1564 of 2,481
by report volume (all reactions)
71
reports citing this reaction
2.8%
death-coded share
Cat
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 thickening has 71 reports now versus 67 in that prior snapshot: 4 more (6.0%).

Report change
+4
Death-coded reports
+0
Death-coded share
−0.2 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 Application site thickening changes

FDA AER · VeDDRA plate

Code 2515 VOL-LOW

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

  • VOL-LOW 71 reports
  • DEATH-LOW 2.8%
  • MID-PACK #1564/2481
  • PHOTO-FINISH Administration device…
  • SPECIES-CAT Cat · 53
  • DRUG-LEAD Mirtazapine · 12
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Administration device NOS, missing component (±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 thickening

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

Vomiting · highest174348Administration device… · near71Application site thic… · thi…71Blotchy rash · near71Enlarged pupils · near71Eye inflamed · near71Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Application site thickening

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

Signature read: 2 death-coded reports is a thin tail count for Application site thickening in the CVM extract. Report volume sits in the middle third of the reaction corpus. Death-coded share is lower-third: 2 of 71 reports (2.8% of named reports). Nearest volume peer: Administration device NOS, missing component (±0 reports). Lead species Cat (53). Lead co-reported drug Mirtazapine (12).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Mirtazapine 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

Cat 53
Dog 15
Cattle 2
Human 1

Breeds Most Affected

Domestic Shorthair 42
Dog (unknown) 4
Domestic Longhair 4
Boxer (German Boxer) 2
Persian 1
Mixed (Cattle) 1
Unknown 1
Russian 1
Terrier - Irish Soft-coated Wheaten 1
Simmental 1

Associated Drugs

Mirtazapine 12
Selamectin 11
Selamectin;Sarolaner 11
Fluralaner Spot-On Solution 9
Emodepside + Praziquantel 6
Buprenorphine 4
Eprinomectin + Esafoxolaner + Praziquantel 3
Chlorhexidine + Ophytrium 3
Device: Catheter 2
Flunixin Megl Topical Solution 2
Imidacloprid + Moxidectin 2
Dexamethasone 2
Anesthetic (Unknown) 2
Prednisolone 2
Genta/Posacon/Mometa Eardrops 2
Fenbendazol Granules 1
Bupivacaine Lipsome Injectable Suspension 1
Nystatin-Neomycin Sulfate-Thiostrepton-Triamcinolone Acetonide Ointment 1
Fluralaner 1
Dexamethasone Sodium Phosphate 1

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Application site thickening, 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 (71 here).

Similar death-coded share

Nearest other reactions by death-coded share (2.8% 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 Application site thickening (#1564 of 2,481 by report volume); death-coded 2.8%. PlainBreed reaction plate · death-coded report count stamp 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 →