Reaction profile

The FDA adverse-event record for otic haematoma

19 FDA reports name otic haematoma, a lower-volume reaction in the CVM extract (VeDDRA 351). Plate stamps and neighbourhood peers follow.

#2191 of 2,481
by report volume (all reactions)
19
reports citing this reaction
0.0%
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. Otic haematoma has 19 reports now versus 19 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
Death-coded reports
+0
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 Otic haematoma changes

FDA AER · VeDDRA plate

Code 351 VOL-TRACE

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

  • VOL-TRACE 19 reports
  • DEATH-RARE 0.0%
  • LOWER-Q #2191/2481
  • PHOTO-FINISH Adaptor, damaged
  • SPECIES-DOG Dog · 17
  • DRUG-LEAD Oclacitinib Malea… · 4
  • DESK-WIDE 14 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Adaptor, damaged (±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 Otic haematoma

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

Vomiting · highest174348Adaptor, damaged · near19Amaurosis (see also P… · near19Anhidrosis · near19Cholelithiasis · near19Otic haematoma · this reacti…19Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Otic haematoma

Otic haematoma: low death-coded share in the FDA AER plate

Signature read: Otic haematoma's 0.0% death-coded share is among the lowest in the openFDA reaction corpus. Report volume is lower-third scale: 19 named reports in the openFDA extract. Death-coded share is lower-third: 0 of 19 reports (0.0% of named reports). Nearest volume peer: Adaptor, damaged (±0 reports). Lead species Dog (17). Lead co-reported drug Oclacitinib Maleate (4).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Oclacitinib Maleate 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 17
Cat 2

Breeds Most Affected

Retriever - Labrador 4
Shepherd Dog - German 2
Pit Bull 2
Schnauzer (unspecified) 1
Retriever - Golden 1
Terrier - Bull - American Pit 1
Dog (unknown) 1
Terrier - Bull 1
Coonhound - Treeing Walker 1
Unknown 1

Associated Drugs

Oclacitinib Maleate 4
Milbemycin Oxime + Praziquantel 4
Milbemycin Oxime + Spinosad 2
Anesthetic 2
Pyrantel Pamoate;Sarolaner 2
Frunevetmab 2
Metronidazole 1
Sucralfate 1
Prednisone 1
Diphenhydramine Hcl 1
Grapiprant 1
Estriol 1
Fluralaner 13.64% 12-Week Chew 1
Polysulfated Glycosaminoglycan 1
Sarolaner,Moxidectin,Pyrantel 1
Glucosamine 1
Orbiflox/Momet/Posaco Eardrops 1
Methylprednisolone Acetate 1
Amlodipine 1
Methimazole 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 Otic haematoma (#2191 of 2,481 by report volume); death-coded 0.0%. PlainBreed reaction plate · death-coded share stamp 0.0% · 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 →