Reaction profile

The FDA adverse-event record for product problem

10,340 FDA reports name product problem, a high-volume reaction in the CVM extract (VeDDRA 2283). Plate stamps and neighbourhood peers follow.

#44 of 2,481
by report volume (all reactions)
10,340
reports citing this reaction
0.3%
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. Product problem has 10,340 reports now versus 10,340 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 Product problem changes

FDA AER · VeDDRA plate

Code 2283 VOL-HIGH

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

  • VOL-HIGH 10,340 reports
  • DEATH-RARE 0.3%
  • TOP-DECILE #44/2481
  • PHOTO-FINISH Uncoded sign
  • SPECIES-UNKNOWN Unknown · 9,489
  • DRUG-LEAD Milbemycin Oxime… · 2,624
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Uncoded sign (±161 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 problem

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

Vomiting · highest174348Hypersalivation · near10540Product problem · this react…10340Uncoded sign · near10179Elevated blood urea n… · near10167Bloody diarrhoea · near10014Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Product problem

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

Signature read: 10,340 reports place Product problem in the upper third of FDA AER volume (#44 of 2,481). Report volume is upper-third scale: 10,340 named reports in the openFDA extract. Death-coded share is lower-third: 32 of 10,340 reports (0.3% of named reports). Nearest volume peer: Uncoded sign (±161 reports). Lead species Unknown (9,489). Lead co-reported drug Milbemycin Oxime + Spinosad (2,624).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Milbemycin Oxime + Spinosad 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 9,489
Dog 732
Cat 85
Human 20
Cattle 5
Horse 5
Sheep 2
Other 1
Pig 1

Breeds Most Affected

Unknown 9,536
Dog (unknown) 131
Crossbred Canine/dog 104
Retriever - Labrador 42
Chihuahua 38
Domestic Shorthair 35
Shepherd Dog - German 28
Cat (unknown) 27
Shih Tzu 27
Terrier - Yorkshire 18

Associated Drugs

Milbemycin Oxime + Spinosad 2,624
Fluralaner Chew Tablets 1,266
Spinosad 899
Nitenpyram 692
Fluralaner 13.64% 12-Week Chew 491
Cyclosporine 375
Fluralaner Spot-On Solution 283
Cyclosporin Ointment 262
Meloxicam 252
Ivermectin + Pyrantel 184
Lufenuron + Milbemycin Oxime 169
Milbemycin Oxime, Lufenuron 156
Insulin Injectable Vial 149
Milbemycin Oxime 147
Grapiprant 145
Lufenuron + Milbemycin Oxime + Praziquantel 123
Imidacloprid + Moxidectin 119
Deracoxib 116
Genta/Momet/Clotrim Ear Oint 111
Pimobendan 107

Nationwide reactions with similar profiles

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

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 Product problem (#44 of 2,481 by report volume); death-coded 0.3%. PlainBreed reaction plate · report volume stamp 10,340 · 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 →