Reaction profile

The FDA adverse-event record for papule

469 FDA reports name papule, a high-volume reaction in the CVM extract (VeDDRA 953). Plate stamps and neighbourhood peers follow.

#665 of 2,481
by report volume (all reactions)
469
reports citing this reaction
2.1%
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. Papule has 469 reports now versus 465 in that prior snapshot: 4 more (0.9%).

Report change
+4
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 Papule changes

FDA AER · VeDDRA plate

Code 953 VOL-LOW

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

  • VOL-LOW 469 reports
  • DEATH-LOW 2.1%
  • MID-PACK #665/2481
  • PHOTO-FINISH Appetite disorder NOS
  • SPECIES-DOG Dog · 428
  • DRUG-LEAD Afoxolaner · 94
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Appetite disorder NOS (±1 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 Papule

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

Vomiting · highest174348Heart failure · near472Papule · this reaction469Appetite disorder NOS · near468Haemorrhagic gastroen… · near468Missing Labels · near466Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Papule

Papule: low death-coded share in the FDA AER plate

Signature read: Papule's 2.1% death-coded share is among the lowest in the openFDA reaction corpus. Report volume is upper-third scale: 469 named reports in the openFDA extract. Death-coded share is lower-third: 10 of 469 reports (2.1% of named reports). Nearest volume peer: Appetite disorder NOS (±1 reports). Lead species Dog (428). Lead co-reported drug Afoxolaner (94).

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

Dog 428
Cat 33
Horse 4
Human 3
Cattle 1

Breeds Most Affected

Retriever - Labrador 42
Crossbred Canine/dog 28
Boxer (German Boxer) 20
Pit Bull 19
Domestic Shorthair 18
Shepherd Dog - German 17
Shih Tzu 16
Terrier - Yorkshire 16
Retriever - Golden 16
Dachshund (unspecified) 15

Associated Drugs

Afoxolaner 94
Milbemycin Oxime + Spinosad 40
Ivermectin + Pyrantel As Pamoate Salt 37
Oclacitinib Maleate 36
Fluralaner Chew Tablets 32
Spinosad 26
Prednisone 19
Imidacloprid + Moxidectin 16
Selamectin 15
Diphenhydramine 15
Maropitant Citrate 13
Moxidectin 12
Carprofen 12
Milbemycin Oxime + Praziquantel 12
Cefpodoxime Proxetil 11
Trilostane 11
Anti-Il31 Mab Mcs Lot #1283563 11
Cyclosporine A 9
Enrofloxacin 8
Cefovecin 8

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Papule, 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 (469 here).

Similar death-coded share

Nearest other reactions by death-coded share (2.1% 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 Papule (#665 of 2,481 by report volume); death-coded 2.1%. PlainBreed reaction plate · death-coded share stamp 2.1% · 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 →