Reaction profile

The FDA adverse-event record for swollen mouth

363 FDA adverse-event reports reference swollen mouth (VeDDRA 1819). See the species, breeds, and drugs most associated with it below.

363
reports citing this reaction
0.3%
death-coded share
Horse
most-affected species
Ivermectin(1.55%)/Praziquantel(7.75%) Paste
most-associated drug
Verify with FDA CVM →
363
Total Reports
1
Deaths
0.3%
Death Rate

Species Most Affected

Horse 294
Dog 41
Cat 14
Human 7
Donkey 3
Cattle 2
Sheep 1
Unknown 1

Breeds Most Affected

Horse (unknown) 65
Quarter Horse 57
Thoroughbred 56
Unknown 16
Arab 15
Paint 15
Horse (other) 13
Tennessee Walking Horse 9
Domestic Shorthair 7
Warmblood - Dutch 6

Associated Drugs

Ivermectin(1.55%)/Praziquantel(7.75%) Paste 211
Ivermectin + Praziquantel 73
Milbemycin Oxime + Spinosad 11
Ivermectin/Praziquantel Paste 10
Moxidectin 8
Ivermectin + Pyrantel As Pamoate Salt 5
Propofol 4
Buprenorphine 4
Carprofen 4
Firocoxib 227 Mg Chewable 4
Afoxolaner 4
Diphenhydramine Hcl 3
Firocoxib 3
Oclacitinib Maleate 3
Sevoflurane 2
Shampoo 2
Selamectin 2
Firocoxib 57 Mg Chewable 2
Cyclosporine A 2
Betamethasone Valerate + Gentamicin Sulfate 2

Swollen mouth Reaction Insights

363 reports name Swollen mouth; 1 recorded a death outcome (0.3% of reported events, not a population-level mortality rate). VeDDRA code: 1819.

By species: Horse (294 reports), Dog (41 reports), Cat (14 reports). By breed: Horse (unknown) (65), Quarter Horse (57), Thoroughbred (56).

Most co-reported drugs: Ivermectin(1.55%)/Praziquantel(7.75%) Paste (211 reports), Ivermectin + Praziquantel (73 reports), Milbemycin Oxime + Spinosad (11 reports), Ivermectin/Praziquantel Paste (10 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.