Reaction profile

The FDA adverse-event record for premature birth

39 FDA reports name premature birth, a lower-volume reaction in the CVM extract (VeDDRA 786). Plate stamps and neighbourhood peers follow.

#1866 of 2,481
by report volume (all reactions)
39
reports citing this reaction
43.6%
death-coded share
Cattle
most-affected species
Verify with FDA CVM →

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Premature birth has 39 reports now versus 39 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
Death-coded reports
+0
Death-coded share
+0.0 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Premature birth changes

FDA AER · VeDDRA plate

Code 786 VOL-TRACE

VOL-TRACE · DEATH-HOT · LOWER-Q · PHOTO-FINISH · SPECIES-CATTLE · DRUG-LEAD · DESK-WIDE · BOOK-FULL

  • VOL-TRACE 39 reports
  • DEATH-HOT 43.6%
  • LOWER-Q #1866/2481
  • PHOTO-FINISH Adaptor, missing
  • SPECIES-CATTLE Cattle · 16
  • DRUG-LEAD Fluralaner Chew T… · 3
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Adaptor, missing (±0 reports)

Upper-third death-coded share drives the outcome stamps on this plate; volume band, corpus rank, and co-report peers follow. Not a clinical diagnosis.

Lower-volume neighbourhood around Premature birth

Lower-third volume poles plus nearest peers, not a full reaction corpus board reprint.

Vomiting · highest174348Adaptor, missing · near39Adrenal gland tumour · near39Cardiopathy · near39CAT SCAN ABNORMAL · near39Premature birth · this react…39Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Premature birth

Premature birth: high death-coded share in the FDA AER plate

Signature read: Premature birth's 43.6% death-coded share is among the highest in the openFDA reaction corpus. Report volume is lower-third scale: 39 named reports in the openFDA extract. Death-coded share is upper-third: 17 of 39 reports (43.6% of named reports). Nearest volume peer: Adaptor, missing (±0 reports). Lead species Cattle (16). Lead co-reported drug Fluralaner Chew Tablets (3).

Read these counts as reporting volume, not risk: per our methodology, A high death-coded share in FDA filings does not prove causation; co-reporting is voluntary temporal association only. Browse the full reactions index or the about page for how PlainBreed frames FDA CVM extracts.

Species Most Affected

Cattle 16
Dog 15
Horse 3
Cat 2
Human 1
Goat 1
Sheep 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
Florfenicol Inj Sol 30% W Pg 1

What to do with this reaction

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Premature birth (#1866 of 2,481 by report volume); death-coded 43.6%. PlainBreed reaction plate · death-coded share stamp 43.6% · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →