Reaction profile

The FDA adverse-event record for oral discomfort

42 FDA reports name oral discomfort, a lower-volume reaction in the CVM extract (VeDDRA 1657). Plate stamps and neighbourhood peers follow.

#1832 of 2,481
by report volume (all reactions)
42
reports citing this reaction
11.9%
death-coded share
Human
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. Oral discomfort has 42 reports now versus 42 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 Oral discomfort changes

FDA AER · VeDDRA plate

Code 1657 VOL-TRACE

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

  • VOL-TRACE 42 reports
  • DEATH-ELEV 11.9%
  • MID-PACK #1832/2481
  • PHOTO-FINISH Allergy to food
  • SPECIES-HUMAN Human · 14
  • DRUG-LEAD Selamectin · 4
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Allergy to food (±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 Oral discomfort

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

Vomiting · highest174348Allergy to food · near42Asystole · near42Cholecystitis · near42Cutaneous emphysema · near42Oral discomfort · this react…42Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Oral discomfort

What the FDA AER plate says about Oral discomfort

Signature read: 42 reports place Oral discomfort in the lower third of FDA AER volume (#1832 of 2,481). Report volume is lower-third scale: 42 named reports in the openFDA extract. 5 of 42 reports were death-coded (11.9% of named reports, not a population mortality rate). Nearest volume peer: Allergy to food (±0 reports). Lead species Human (14). Lead co-reported drug Selamectin (4).

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

Human 14
Dog 13
Cat 10
Horse 5

Breeds Most Affected

Unknown 14
Domestic Shorthair 7
Retriever - Labrador 2
Horse (unknown) 2
Terrier - Fox (unspecified) 1
Russian 1
Terrier - Yorkshire 1
Corgi - Welsh Cardigan 1
Quarter Horse 1
Chihuahua 1

Associated Drugs

Selamectin 4
Imidacloprid + Moxidectin 3
Butorphanol 3
Oclacitinib Maleate 3
Meloxicam 3
Buprenorphine 3
Ivermectin + Praziquantel 3
Cyclosporine A 2
Tramadol 2
Milbemycin Oxime + Spinosad 2
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 2
Diazepam 2
Cyclosporine 2
Praziquantel 2
Antibiotic (Unknown) 2
Fluralaner 13.64% 12-Week Chew 2
Mirtazapine 2
Metoclopramide 2
Maropitant Citrate 2
Selamectin;Sarolaner 2

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 Oral discomfort (#1832 of 2,481 by report volume); death-coded 11.9%. PlainBreed reaction plate · report volume stamp 42 · 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 →