Reaction profile

The FDA adverse-event record for premature birth

39 FDA adverse-event reports reference premature birth (VeDDRA 786). See the species, breeds, and drugs most associated with it below.

39
reports citing this reaction
43.6%
death-coded share
Cattle
most-affected species
Fluralaner Chew Tablets
most-associated drug
Verify with FDA CVM →
39
Total Reports
17
Deaths
43.6%
Death Rate

Species Most Affected

Cattle 16
Dog 15
Horse 3
Cat 2
Human 1
Sheep 1
Goat 1

Breeds Most Affected

Cattle (unknown) 6
Holstein-Friesian also known as Holstein 5
Rottweiler 2
Domestic Shorthair 2
Poodle - Toy 2
Retriever - Golden 1
Spitz - German Pomeranian 1
Crossbred Canine/dog 1
Retriever - Labrador 1
Charolais 1

Associated Drugs

Fluralaner Chew Tablets 3
Nitenpyram 3
Fenbendazole 2
Spinosad 2
Monensin Sodium 2
Milbemycin Oxime + Spinosad 2
Flunixin Meglumine Injectable 2
K99/Cor*2/Rota*2/Clos Per C,D 2
Fluralaner 13.64% 12-Week Chew 2
Selenium, Vitamin E 1
Maropitant 1
Monensin 1
Milbemycin, Lufenuron 1
Dinoprost Tromethamine 1
Diclofenac 1
Ivermectin 1
Sometribove Zinc Suspension 1
Florfenicol 1
Sometribove 1
Sevoflurane 1

Premature birth Reaction Insights

39 reports name Premature birth; 17 recorded a death outcome (43.6% of reported events, not a population-level mortality rate). VeDDRA code: 786.

By species: Cattle (16 reports), Dog (15 reports), Horse (3 reports). By breed: Cattle (unknown) (6), Holstein-Friesian also known as Holstein (5), Rottweiler (2).

Most co-reported drugs: Fluralaner Chew Tablets (3 reports), Nitenpyram (3 reports), Fenbendazole (2 reports), Spinosad (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.