Reaction profile

The FDA adverse-event record for mouth ulcer

143 FDA adverse-event reports reference mouth ulcer (VeDDRA 1624). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.

#1219 of 2,481
by report volume (all reactions)
143
reports citing this reaction
18.2%
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. Mouth ulcer has 143 reports now versus 141 in that prior snapshot: 2 more (1.4%).

Report change
+2
Death-coded reports
+1
Death-coded share
+0.5 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 Mouth ulcer changes

FDA AER · VeDDRA plate

Code 1624 VOL-LOW

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

  • VOL-LOW 143 reports
  • DEATH-ELEV 18.2%
  • MID-PACK #1219/2481
  • PHOTO-FINISH Application site lump
  • SPECIES-DOG Dog · 65
  • DRUG-LEAD Ivermectin(1.55%)… · 15
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Application site lump (±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 Mouth ulcer

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

Vomiting · highest174348Application site lump · near143Laryngeal paralysis · near143Mouth ulcer · this reaction143Skin textural change · near143Difficulty eating NOS · near142Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Mouth ulcer

What the FDA AER plate says about Mouth ulcer

Signature read: 26 death-coded reports is the most distinctive absolute-outcome stamp on Mouth ulcer. Report volume sits in the middle third of the reaction corpus. 26 of 143 reports were death-coded (18.2% of named reports, not a population mortality rate). Nearest volume peer: Application site lump (±0 reports). Lead species Dog (65). Lead co-reported drug Ivermectin(1.55%)/Praziquantel(7.75%) Paste (15).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Ivermectin(1.55%)/Praziquantel(7.75%) Paste 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 65
Cat 45
Horse 31
Human 2

Breeds Most Affected

Domestic Shorthair 25
Domestic Longhair 6
Horse (unknown) 6
Quarter Horse 6
Arab 5
Retriever - Labrador 5
Cat (other) 5
Crossbred Canine/dog 4
Shepherd Dog - German 4
Shih Tzu 4

Associated Drugs

Ivermectin(1.55%)/Praziquantel(7.75%) Paste 15
Carprofen 14
Ivermectin + Praziquantel 11
Maropitant Citrate 10
Robenacoxib 9
Gabapentin 9
Bedinvetmab 7
Meloxicam 6
Oclacitinib Maleate 6
Sucralfate 5
Fluralaner Chew Tablets 5
Cefovecin 4
Selamectin 4
Doxycycline 4
Tramadol 4
Prednisone 4
Polysulfated Glycosaminoglycan 4
Pyrantel Pamoate;Sarolaner 4
Selamectin;Sarolaner 4
Frunevetmab 4

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Mouth ulcer, 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 (143 here).

Similar death-coded share

Nearest other reactions by death-coded share (18.2% 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 Mouth ulcer (#1219 of 2,481 by report volume); death-coded 18.2%. PlainBreed reaction plate · death-coded report count stamp 26 · 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 →