Reaction profile

The FDA adverse-event record for oral swelling

126 FDA adverse-event reports reference oral swelling (VeDDRA 2444). See the species, breeds, and drugs most associated with it below.

126
reports citing this reaction
7.1%
death-coded share
Horse
most-affected species
Ivermectin + Praziquantel
most-associated drug
Verify with FDA CVM →
126
Total Reports
9
Deaths
7.1%
Death Rate

Species Most Affected

Horse 98
Dog 23
Human 2
Cat 2
Donkey 1

Breeds Most Affected

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

Associated Drugs

Ivermectin + Praziquantel 55
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 43
Bedinvetmab 4
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
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
Afoxolaner 1

Oral swelling Reaction Insights

126 reports name Oral swelling; 9 recorded a death outcome (7.1% of reported events, not a population-level mortality rate). VeDDRA code: 2444.

By species: Horse (98 reports), Dog (23 reports), Human (2 reports). By breed: Quarter Horse (27), Horse (unknown) (12), Thoroughbred (10).

Most co-reported drugs: Ivermectin + Praziquantel (55 reports), Ivermectin(1.55%)/Praziquantel(7.75%) Paste (43 reports), Bedinvetmab (4 reports), Carprofen (3 reports).

Read these counts as reporting volume, not risk: per our methodology, co-reporting reflects temporal association captured in voluntary submissions, not proof that a drug caused this reaction. A widely-prescribed drug will rack up more raw co-reports at an identical true rate than a rarely-used one, so compare within similar-exposure products.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.