Reaction profile

The FDA adverse-event record for cleft palate

37 FDA adverse-event reports reference cleft palate (VeDDRA 2078). See the species, breeds, and drugs most associated with it below.

37
reports citing this reaction
64.9%
death-coded share
Dog
most-affected species
Fluralaner Chew Tablets
most-associated drug
Verify with FDA CVM →
37
Total Reports
24
Deaths
64.9%
Death Rate

Species Most Affected

Dog 34
Pig 2
Cat 1

Breeds Most Affected

Schnauzer - Miniature 5
Retriever - Labrador 3
Dog (unknown) 3
Retriever - Golden 2
Shih Tzu 2
Spaniel - King Charles 2
Bulldog - French 2
Terrier - Silky 1
Pointing Dog - German Short-haired 1
Pinscher - Miniature 1

Associated Drugs

Fluralaner Chew Tablets 9
Fluralaner 13.64% 12-Week Chew 7
Milbemycin Oxime + Spinosad 6
Afoxolaner 3
Moxidectin 2
Milbemycin Oxime + Praziquantel 2
Enrofloxacin 2
Tylosin 2
Porcine Reproductive And Respiratory Syndrome Virus, Sd11-21 Strain 2
Bordetella Bronchiseptica, Field Strain,Erysipelothrix Rhusiopathiae, Se-9 Strain,Pasteurella Multocida, 169 Strain,Pasteurella Multocida, Type D, Atcc 12948 Strain 2
Iron 2
Penicillin 2
Tulathromycin 2
Flunixin Meglumine 2
Dexamethasone 2
Ceftiofur 2
Lincomycin,Spectinomycin 2
Gentamicin 2
Vitamin B12 2
Florfenicol 2

Cleft palate Reaction Insights

37 reports name Cleft palate; 24 recorded a death outcome (64.9% of reported events, not a population-level mortality rate). VeDDRA code: 2078.

By species: Dog (34 reports), Pig (2 reports), Cat (1 reports). By breed: Schnauzer - Miniature (5), Retriever - Labrador (3), Dog (unknown) (3).

Most co-reported drugs: Fluralaner Chew Tablets (9 reports), Fluralaner 13.64% 12-Week Chew (7 reports), Milbemycin Oxime + Spinosad (6 reports), Afoxolaner (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.