Reaction profile

The FDA adverse-event record for birth defect

123 FDA adverse-event reports reference birth defect (VeDDRA 776). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.

#1290 of 2,481
by report volume (all reactions)
123
reports citing this reaction
51.2%
death-coded share
Dog
most-affected species

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. Birth defect has 123 reports now versus 123 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 Birth defect changes

FDA AER · VeDDRA plate

Code 776 VOL-LOW

VOL-LOW · DEATH-HOT · MID-PACK · PHOTO-FINISH · SPECIES-DOG · DRUG-LEAD · DESK-WIDE · BOOK-FULL

  • VOL-LOW 123 reports
  • DEATH-HOT 51.2%
  • MID-PACK #1290/2481
  • PHOTO-FINISH Hypomagnesaemic condi…
  • SPECIES-DOG Dog · 98
  • DRUG-LEAD Fluralaner Chew T… · 20
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Hypomagnesaemic condition (±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.

Report-volume neighbourhood around Birth defect

Highest and lowest poles plus nearest volume peers, not a full 2,500-reaction corpus board reprint.

Vomiting · highest174348Birth defect · this reaction123Hypomagnesaemic condi… · near123Joint ligament disord… · near123Lens disorder NOS · near123Lung tumour · near123Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Birth defect

Birth defect: high death-coded share in the FDA AER plate

Signature read: Birth defect's 51.2% death-coded share is among the highest in the openFDA reaction corpus. Report volume sits in the middle third of the reaction corpus. Death-coded share is upper-third: 63 of 123 reports (51.2% of named reports). Nearest volume peer: Hypomagnesaemic condition (±0 reports). Lead species Dog (98). Lead co-reported drug Fluralaner Chew Tablets (20).

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

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

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Birth defect, both floored at ≥50 reports so the neighborhoods stay in the advertised mass (the volume chart above is the unfloored photo-finish strip).

Similar report volume

Nearest other reactions by FDA report count (123 here).

Similar death-coded share

Nearest other reactions by death-coded share (51.2% here), distinct from the volume row.

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 Birth defect (#1290 of 2,481 by report volume); death-coded 51.2%. PlainBreed reaction plate · death-coded share stamp 51.2% · 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 →