Reaction profile

The FDA adverse-event record for ear canal oedema

30 FDA reports name ear canal oedema, a lower-volume reaction in the CVM extract (VeDDRA 2569). Plate stamps and neighbourhood peers follow.

#1995 of 2,481
by report volume (all reactions)
30
reports citing this reaction
6.7%
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. Ear canal oedema has 30 reports now versus 27 in that prior snapshot: 3 more (11.1%).

Report change
+3
Death-coded reports
+0
Death-coded share
−0.7 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 Ear canal oedema changes

FDA AER · VeDDRA plate

Code 2569 VOL-TRACE

VOL-TRACE · DEATH-PAR · LOWER-Q · PHOTO-FINISH · SPECIES-DOG · DRUG-LEAD · DESK-WIDE · BOOK-FULL

  • VOL-TRACE 30 reports
  • DEATH-PAR 6.7%
  • LOWER-Q #1995/2481
  • PHOTO-FINISH Abnormal spermatozoa…
  • SPECIES-DOG Dog · 26
  • DRUG-LEAD Florfenicol + Mom… · 6
  • DESK-WIDE 19 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Abnormal spermatozoa NOS (±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.

Lower-volume neighbourhood around Ear canal oedema

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

Vomiting · highest174348Abnormal spermatozoa… · near30Atelectasis · near30Bone marrow suppressi… · near30Chronic kidney disease · near30Ear canal oedema · this reac…30Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Ear canal oedema

Ear canal oedema: low death-coded share in the FDA AER plate

Signature read: 2 death-coded reports is a thin tail count for Ear canal oedema in the CVM extract. Report volume is lower-third scale: 30 named reports in the openFDA extract. Death-coded share is lower-third: 2 of 30 reports (6.7% of named reports). Nearest volume peer: Abnormal spermatozoa NOS (±0 reports). Lead species Dog (26). Lead co-reported drug Florfenicol + Mometasone Furoate + Terbinafine Hydrochloride (6).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Florfenicol + Mometasone Furoate + Terbinafine Hydrochloride 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 26
Cat 4

Breeds Most Affected

Retriever - Labrador 5
Crossbred Canine/dog 4
Domestic Shorthair 3
Papillon - Spaniel - Continental Toy (with erect ears or with dropped ears (Phaléne)) 2
Pug 2
Basenji 1
Dog (unknown) 1
Shih Tzu 1
Bulldog - French 1
Terrier - West Highland White 1

Associated Drugs

Florfenicol + Mometasone Furoate + Terbinafine Hydrochloride 6
Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate 3
Carprofen 3
Genta/Posacon/Mometa Eardrops 3
Dexamethasone 2
Genta/Momet/Clotrim Ear Oint 2
Enrofloxacin + Silver Sulfadiazine 2
Amoxicillin Trihydrate/Clavulanic Acid 2
Prednisolone 2
Cefovecin 2
Orbiflox/Momet/Posaco Eardrops 2
Ethylene Diamine Tetra Acetic Acid Tris 2
Gentamicin Sulfate + Hydrocortisone Aceponate + Miconazole Nitrate 2
Ilunocitinib 2
Ear Cleaner 2
Ivermectin + Pyrantel 1
Phenylpropanolamine 1
Saline Flush 1
Marbofloxacin 1
Emodepside + Praziquantel 1

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 Ear canal oedema (#1995 of 2,481 by report volume); death-coded 6.7%. 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 →