Reaction profile

The FDA adverse-event record for birth defect

123 FDA adverse-event reports reference birth defect (VeDDRA 776). See the species, breeds, and drugs most associated with it below.

123
reports citing this reaction
51.2%
death-coded share
Dog
most-affected species
Fluralaner Chew Tablets
most-associated drug
Verify with FDA CVM →
123
Total Reports
63
Deaths
51.2%
Death Rate

Species Most Affected

Dog 98
Cat 7
Horse 4
Goat 4
Cattle 4
Pig 2
Snake 1
Other Deer 1
Human 1
Sheep 1

Breeds Most Affected

Bulldog - French 8
Dog (unknown) 7
Schnauzer - Miniature 7
Retriever - Labrador 6
Dachshund - Miniature 6
Terrier - Boston 5
Pug 5
Retriever - Golden 5
Dachshund (unspecified) 4
Bulldog 4

Associated Drugs

Fluralaner Chew Tablets 20
Nitenpyram 12
Spinosad 10
Milbemycin Oxime + Spinosad 10
Generic Nitenpyram 6
Ivermectin, Pyrantel Pamoate, Praziquantel 5
Moxidectin 5
Fluralaner 13.64% 12-Week Chew 5
Selamectin 4
Afoxolaner 4
Imidacloprid + Moxidectin 4
Fenbendazole 3
Ponazuril 3
Enrofloxacin 3
Spinosad, Milbemycin 3
Albendazole 3
Imidacloprid, Moxidectin 2
Trilostane 2
Oclacitinib Maleate 2
Sarolaner 2

Birth defect Reaction Insights

123 reports name Birth defect; 63 recorded a death outcome (51.2% of reported events, not a population-level mortality rate). VeDDRA code: 776.

By species: Dog (98 reports), Cat (7 reports), Horse (4 reports). By breed: Bulldog - French (8), Dog (unknown) (7), Schnauzer - Miniature (7).

Most co-reported drugs: Fluralaner Chew Tablets (20 reports), Nitenpyram (12 reports), Spinosad (10 reports), Milbemycin Oxime + Spinosad (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.