Reaction profile

The FDA adverse-event record for mouth irritation

109 FDA adverse-event reports reference mouth irritation (VeDDRA 245). See the species, breeds, and drugs most associated with it below.

109
reports citing this reaction
3.7%
death-coded share
Horse
most-affected species
Ivermectin(1.55%)/Praziquantel(7.75%) Paste
most-associated drug
Verify with FDA CVM →
109
Total Reports
4
Deaths
3.7%
Death Rate

Species Most Affected

Horse 36
Human 29
Dog 26
Cat 17
Donkey 1

Breeds Most Affected

Unknown 30
Quarter Horse 13
Horse (unknown) 9
Domestic Shorthair 5
Retriever - Labrador 3
Thoroughbred 3
Cat (unknown) 3
Siamese 3
Terrier - Jack Russell 2
Crossbred Canine/dog 2

Associated Drugs

Ivermectin(1.55%)/Praziquantel(7.75%) Paste 23
Ivermectin + Praziquantel 12
Imidacloprid + Moxidectin 9
Milbemycin Oxime + Spinosad 5
Maropitant Citrate 5
Robenacoxib 4
Prednisone 4
Selamectin 4
Selamectin;Sarolaner 4
Carprofen 3
Cyclosporine 2
Spinosad 2
Mercaptobenzothiazole 2
Meloxicam 2
Isoflurane 2
Cyclosporine A 2
Oclacitinib Maleate 2
Antibiotic 2
Sarolaner 2
Fluralaner Spot-On Solution 2

Mouth irritation Reaction Insights

109 reports name Mouth irritation; 4 recorded a death outcome (3.7% of reported events, not a population-level mortality rate). VeDDRA code: 245.

By species: Horse (36 reports), Human (29 reports), Dog (26 reports). By breed: Unknown (30), Quarter Horse (13), Horse (unknown) (9).

Most co-reported drugs: Ivermectin(1.55%)/Praziquantel(7.75%) Paste (23 reports), Ivermectin + Praziquantel (12 reports), Imidacloprid + Moxidectin (9 reports), Milbemycin Oxime + Spinosad (5 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.