Reaction profile

The FDA adverse-event record for malformation nos

Name: Malformation NOS - FDA Animal Adverse Reaction
Creator: PlainBreed
License: https://open.fda.gov/license/

24 FDA reports name malformation nos, a lower-volume reaction in the CVM extract (VeDDRA 1164). Plate stamps and neighbourhood peers follow.

#2088 of 2,481
by report volume (all reactions): 24
reports citing this reaction: 29.2%
death-coded share: Dog
most-affected species

Compiled by PlainBreed

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. Malformation NOS has 24 reports now versus 23 in that prior snapshot: 1 more (4.3%).

Report change: +1
Death-coded reports: +1
Death-coded share: +3.1 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 Malformation NOS changes

FDA AER · VeDDRA plate

Code 1164 VOL-TRACE

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

VOL-TRACE 24 reports
DEATH-HOT 29.2%
LOWER-Q #2088/2481
PHOTO-FINISH Acute pancreatitis
SPECIES-DOG Dog · 21
DRUG-LEAD Milbemycin Oxime… · 6
DESK-WIDE 19 breeds
BOOK-FULL 8/8 fields

Nearest volume peer: Acute pancreatitis (±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 Malformation NOS

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

FDA AER report volume · neighbourhood around Malformation NOS

Malformation NOS: high death-coded share in the FDA AER plate

Signature read: 24 reports place Malformation NOS in the lower third of FDA AER volume (#2088 of 2,481). Report volume is lower-third scale: 24 named reports in the openFDA extract. Death-coded share is upper-third: 7 of 24 reports (29.2% of named reports). Nearest volume peer: Acute pancreatitis (±0 reports). Lead species Dog (21). Lead co-reported drug Milbemycin Oxime + Spinosad (6).

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 21

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

Shepherd Dog - German 1

Pinscher - 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

What to do with this reaction

Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
Browse the full reaction directory to compare report counts across reaction types. All reactions

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 Malformation NOS (#2088 of 2,481 by report volume); death-coded 29.2%. PlainBreed reaction plate · report volume stamp 24 · 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 →