Reaction profile

The FDA adverse-event record for labels, abnormal

212 FDA adverse-event reports reference labels, abnormal (VeDDRA 99014). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.

#1002 of 2,481
by report volume (all reactions)
212
reports citing this reaction
0.9%
death-coded share
Unknown
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. Labels, Abnormal has 212 reports now versus 209 in that prior snapshot: 3 more (1.4%).

Report change
+3
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 Labels, Abnormal changes

FDA AER · VeDDRA plate

Code 99014 VOL-LOW

VOL-LOW · DEATH-RARE · MID-PACK · PHOTO-FINISH · SPECIES-UNKNOWN · DRUG-LEAD · DESK-MID · BOOK-FULL

  • VOL-LOW 212 reports
  • DEATH-RARE 0.9%
  • MID-PACK #1002/2481
  • PHOTO-FINISH Aspiration pneumonia
  • SPECIES-UNKNOWN Unknown · 195
  • DRUG-LEAD Fluralaner Spot-O… · 23
  • DESK-MID 7 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Aspiration pneumonia (±0 reports)

Instrument codes from this reaction’s FDA CVM adverse-event extract: volume band, death-coded share, corpus rank, photo-finish peer, lead species, lead drug, breed desk, and book completeness. Not a clinical diagnosis.

Report-volume neighbourhood around Labels, Abnormal

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

Vomiting · highest174348Aspiration pneumonia · near212Blood loss NOS · near212Ear irritation · near212INEFFECTIVE, ANALGESIA · near212Labels, Abnormal · this reac…212Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Labels, Abnormal

Labels, Abnormal: low death-coded share in the FDA AER plate

Signature read: Labels, Abnormal's 0.9% death-coded share is among the lowest in the openFDA reaction corpus. Report volume sits in the middle third of the reaction corpus. Death-coded share is lower-third: 2 of 212 reports (0.9% of named reports). Nearest volume peer: Aspiration pneumonia (±0 reports). Lead species Unknown (195). Lead co-reported drug Fluralaner Spot-On Solution (23).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Fluralaner Spot-On Solution appears in filings alongside this reaction; that is association, not causation. Browse the full reactions index or the about page for how PlainBreed frames FDA CVM extracts.

Species Most Affected

Unknown 195
Dog 6
Human 6
Cat 5

Breeds Most Affected

Unknown 201
Domestic Shorthair 5
Dog (unknown) 2
Portuguese Water Dog 1
Terrier - Airedale 1
Chihuahua 1
Terrier - West Highland White 1

Associated Drugs

Fluralaner Spot-On Solution 23
Nitenpyram 16
Afoxolaner 16
Firocoxib 10
Ivermectin 8
Fluralaner Chew Tablets 8
Praziquantel 7
Phenylpropanolamine Hcl 6
Fenbendazol Granules 6
Milbemycin/Lufenuron Tablets 6
Recombinant Human Insulin 5
Spinosad 5
Dexamethasone Sodium Phosphate 5
Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate 4
Ivermectin + Pyrantel As Pamoate Salt 4
Carprofen 4
Dexamethasone 4
Milbemycin Oxime + Praziquantel 4
Ceftiofur Hydrochloride 3
Ivermectin 0.5% Pour-On Topical Solution 3

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Labels, Abnormal, 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 (212 here).

Similar death-coded share

Nearest other reactions by death-coded share (0.9% 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 Labels, Abnormal (#1002 of 2,481 by report volume); death-coded 0.9%. PlainBreed reaction plate · death-coded share stamp 0.9% · 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 →