Reaction profile

The FDA adverse-event record for product label issues

Name: Product label issues - FDA Animal Adverse Reaction
Creator: PlainBreed
License: https://open.fda.gov/license/

1,916 FDA reports name product label issues, a high-volume reaction in the CVM extract (VeDDRA 99857). Plate stamps and neighbourhood peers follow.

#245 of 2,481
by report volume (all reactions): 1,916
reports citing this reaction: 0.8%
death-coded share: Unknown
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. Product label issues has 1,916 reports now versus 1,853 in that prior snapshot: 63 more (3.4%).

Report change: +63
Death-coded reports: +1
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 Product label issues changes

FDA AER · VeDDRA plate

Code 99857 VOL-MID

VOL-MID · DEATH-RARE · TOP-DECILE · PHOTO-FINISH · SPECIES-UNKNOWN · DRUG-LEAD · DESK-WIDE · BOOK-FULL

VOL-MID 1,916 reports
DEATH-RARE 0.8%
TOP-DECILE #245/2481
PHOTO-FINISH Application site irri…
SPECIES-UNKNOWN Unknown · 1,411
DRUG-LEAD Nitenpyram · 739
DESK-WIDE 20 breeds
BOOK-FULL 8/8 fields

Nearest volume peer: Application site irritation (±2 reports)

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

High-volume neighbourhood around Product label issues

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

FDA AER report volume · neighbourhood around Product label issues

Product label issues: low death-coded share in the FDA AER plate

Signature read: 1,916 reports place Product label issues in the upper third of FDA AER volume (#245 of 2,481). Report volume is upper-third scale: 1,916 named reports in the openFDA extract. Death-coded share is lower-third: 15 of 1,916 reports (0.8% of named reports). Nearest volume peer: Application site irritation (±2 reports). Lead species Unknown (1,411). Lead co-reported drug Nitenpyram (739).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Nitenpyram 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 1,411

Dog 389

Cat 92

Human 13

Horse 3

Cattle 3

Other 3

Hedgehog 1

Marsupial 1

Breeds Most Affected

Unknown 1,428

Chihuahua 77

Dog (unknown) 67

Domestic Shorthair 44

Crossbred Canine/dog 27

Cat (unknown) 22

Terrier - Yorkshire 21

Pit Bull 16

Shih Tzu 14

Retriever - Labrador 13

Associated Drugs

Nitenpyram 739

Praziquantel 329

Febantel + Praziquantel + Pyrantel Pamoate 151

Ivermectin, Pyrantel 67

Imidacloprid 57

Milbemycin Oxime + Spinosad 50

Fluralaner Spot-On Solution 33

Spinosad 29

Afoxolaner 22

Milbemycin Oxime 22

Selamectin 20

Carprofen 19

Omeprazole 19

Milbemycin, Lufenuron 18

Firocoxib 17

Flea And Tick Shampoo 16

Ivermectin 15

Meloxicam 13

Fenbendazol Granules 13

Milbemycin Oxime + Praziquantel 13

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Product label issues, 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 (1,916 here).

Application site irritation 1,918 Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle') 1,919 Facial oedema 1,927 Elevated renal parameters 1,945

Similar death-coded share

Nearest other reactions by death-coded share (0.8% here), distinct from the volume row.

Itching 0.8% Application site inflammation 0.8% Swollen eyelid (see also Eyelid disorders in Eye disorders) 0.8% Application site sore 0.8%

What to do with this reaction

Compare Product label issues's report profile against similar reactions nationwide. See similar reactions
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 Product label issues (#245 of 2,481 by report volume); death-coded 0.8%. PlainBreed reaction plate · report volume stamp 1,916 · 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 →