Reaction profile

The FDA adverse-event record for oral swelling

129 FDA adverse-event reports reference oral swelling (VeDDRA 2444). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.

#1266 of 2,481
by report volume (all reactions)
129
reports citing this reaction
7.0%
death-coded share
Horse
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 swelling has 129 reports now versus 129 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 swelling changes

FDA AER · VeDDRA plate

Code 2444 VOL-LOW

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

  • VOL-LOW 129 reports
  • DEATH-PAR 7.0%
  • MID-PACK #1266/2481
  • PHOTO-FINISH Elevated SAP
  • SPECIES-HORSE Horse · 100
  • DRUG-LEAD Ivermectin + Praz… · 57
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Elevated SAP (±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 Oral swelling

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

Vomiting · highest174348Elevated SAP · near129Oral swelling · this reaction129Protrusion membrana n… · near129Suspect counterfeit p… · near129Chemosis · near128Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Oral swelling

Oral swelling: low death-coded share in the FDA AER plate

Signature read: Oral swelling's 7.0% death-coded share is among the lowest in the openFDA reaction corpus. Report volume sits in the middle third of the reaction corpus. Death-coded share is lower-third: 9 of 129 reports (7.0% of named reports). Nearest volume peer: Elevated SAP (±0 reports). Lead species Horse (100). Lead co-reported drug Ivermectin + Praziquantel (57).

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

Horse 100
Dog 24
Human 2
Cat 2
Donkey 1

Breeds Most Affected

Quarter Horse 27
Horse (unknown) 12
Thoroughbred 10
Paint 9
Boxer (German Boxer) 7
Appaloosa 5
Unknown 5
Crossbred Equine/horse 5
Tennessee Walking Horse 4
Horse (other) 4

Associated Drugs

Ivermectin + Praziquantel 57
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 43
Bedinvetmab 5
Carprofen 3
Oclacitinib Maleate 3
Maropitant Citrate 3
Anti-Il31 Mab Mcs Lot #1283563 2
Milbemycin Oxime + Spinosad 2
Equine Influenza Virus, Killed Virus + Equine Rhinopneumonitis Virus, Killed Virus 2
Tigilanol Tiglate 2
Marbofloxacin 2
Galliprant 2
Amoxicillin (As Trihydrate); Clavulanate Potassium ( K-Clavulanate) 1
Penicillin 1
Afoxolaner 1
Dexmedetomidine Hydrochloride 1
Atipamezole Hydrochloride 1
Rabies Virus, Kv 1
Bordetella Bronchiseptica, Strain 78-9159, Kb 1
Canine Adenovirus Type 2, Strain Manhattan, 12-13-76; Canine Distemper Virus, St 1

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Oral swelling, 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 (129 here).

Similar death-coded share

Nearest other reactions by death-coded share (7.0% 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 Oral swelling (#1266 of 2,481 by report volume); death-coded 7.0%. PlainBreed reaction plate · death-coded share stamp 7.0% · 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 →