Reaction profile

The FDA adverse-event record for pr-mouth/lip(s), lesion(s)

Name: PR-MOUTH/LIP(S), LESION(S) - FDA Animal Adverse Reaction
Creator: PlainBreed
License: https://open.fda.gov/license/

28 FDA reports name pr-mouth/lip(s), lesion(s), a lower-volume reaction in the CVM extract (VeDDRA 99640). Plate stamps and neighbourhood peers follow.

#2032 of 2,481
by report volume (all reactions): 28
reports citing this reaction: 25.0%
death-coded share: Dog
most-affected species

Compiled by PlainBreed

Verify with FDA CVM →

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. PR-MOUTH/LIP(S), LESION(S) has 28 reports now versus 28 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 PR-MOUTH/LIP(S), LESION(S) changes

FDA AER · VeDDRA plate

Code 99640 VOL-TRACE

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

VOL-TRACE 28 reports
DEATH-HOT 25.0%
LOWER-Q #2032/2481
PHOTO-FINISH Absence seizure
SPECIES-DOG Dog · 22
DRUG-LEAD Cyclosporine · 8
DESK-WIDE 20 breeds
BOOK-FULL 8/8 fields

Nearest volume peer: Absence seizure (±0 reports)

Upper-third death-coded share drives the outcome stamps on this plate; volume band, corpus rank, and co-report peers follow. Not a clinical diagnosis.

Lower-volume neighbourhood around PR-MOUTH/LIP, LESION

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

FDA AER report volume · neighbourhood around PR-MOUTH/LIP(S), LESION(S)

PR-MOUTH/LIP(S), LESION(S): high death-coded share in the FDA AER plate

Signature read: 28 reports place PR-MOUTH/LIP(S), LESION(S) in the lower third of FDA AER volume (#2032 of 2,481). Report volume is lower-third scale: 28 named reports in the openFDA extract. Death-coded share is upper-third: 7 of 28 reports (25.0% of named reports). Nearest volume peer: Absence seizure (±0 reports). Lead species Dog (22). Lead co-reported drug Cyclosporine (8).

Read these counts as reporting volume, not risk: per our methodology, A high death-coded share in FDA filings does not prove causation; co-reporting is voluntary temporal association only. Browse the full reactions index or the about page for how PlainBreed frames FDA CVM extracts.

Species Most Affected

Dog 22

Cat 5

Cattle 1

Breeds Most Affected

Retriever - Labrador 3

Terrier - West Highland White 2

Domestic Shorthair 2

Bulldog 2

Crossbred Canine/dog 1

Collie - Border 1

Retriever - Golden 1

Domestic (unspecified) 1

Siamese 1

Holstein-Friesian also known as Holstein 1

Associated Drugs

Cyclosporine 8

Oclacitinib Maleate 8

Prednisone 3

Carprofen 2

Cefovecin Sodium 2

Cefovecin 2

Afoxolaner 2

Fluralaner Chew Tablets 2

Florfenicol, Flunixin 1

Meloxicam 1

Robenacoxib 1

Tiletamine / Midazolam / Ketamine / Xylazine Sedation 1

Herbs 1

Prescription Diet (Unspecified) 1

Methylprednisolone Acetate 1

Vaccines 1

Amoxicillin Trihydrate; Clavulanate Potassium ( K-Clavulanate) 1

Antibiotic 1

Febantel + Praziquantel + Pyrantel 1

Praziquantel 1

What to do with this reaction

Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
Browse the full reaction directory to compare report counts across reaction types. All reactions

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 PR-MOUTH/LIP(S), LESION(S) (#2032 of 2,481 by report volume); death-coded 25.0%. PlainBreed reaction plate · report volume stamp 28 · 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 →