Reaction profile

The FDA adverse-event record for malformation nos

23 FDA adverse-event reports reference malformation nos (VeDDRA 1164). See the species, breeds, and drugs most associated with it below.

23
reports citing this reaction
26.1%
death-coded share
Dog
most-affected species
Milbemycin Oxime + Spinosad
most-associated drug
Verify with FDA CVM →
23
Total Reports
6
Deaths
26.1%
Death Rate

Species Most Affected

Dog 20
Horse 2
Cat 1

Breeds Most Affected

Retriever - Labrador 3
Crossbred Canine/dog 2
Collie - Border 2
Dog (unknown) 2
Spaniel - Cocker American 1
Great Pyrenees 1
Chihuahua 1
Terrier - Yorkshire 1
Pinscher - German 1
Shepherd Dog - German 1

Associated Drugs

Milbemycin Oxime + Spinosad 6
Spinosad 2
Nitenpyram 2
Fluralaner Chew Tablets 2
Febantel + Praziquantel + Pyrantel Pamoate 2
Afoxolaner 2
Ivermectin + Pyrantel As Pamoate Salt 1
Fipronil 10%/S Methoprene 9% Spot On 1
Melarsomine Dihydrochloride Injection 1
5-Way Vaccine (Unknown) 1
Milbemycin Oxime + Praziquantel 1
Milbemycin Oxime 1
Afoxolaner 68 Mg Chewable Tablets 1
Milbemycin Oxime, Lufenuron 1
Pyrantel 1
Bordetella 1
Rabies Vaccine 1
Distemper Combination Vaccine 1
Ponzuril 1
Milbemycin Oxime And Praziquantel 1

Malformation NOS Reaction Insights

23 reports name Malformation NOS; 6 recorded a death outcome (26.1% of reported events, not a population-level mortality rate). VeDDRA code: 1164.

By species: Dog (20 reports), Horse (2 reports), Cat (1 reports). By breed: Retriever - Labrador (3), Crossbred Canine/dog (2), Collie - Border (2).

Most co-reported drugs: Milbemycin Oxime + Spinosad (6 reports), Spinosad (2 reports), Nitenpyram (2 reports), Fluralaner Chew Tablets (2 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.