Reaction profile

The FDA adverse-event record for sleepiness - systemic disorder

1,665 FDA reports name sleepiness - systemic disorder, a high-volume reaction in the CVM extract (VeDDRA 2529). Plate stamps and neighbourhood peers follow.

#267 of 2,481
by report volume (all reactions)
1,665
reports citing this reaction
7.5%
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. Sleepiness - systemic disorder has 1,665 reports now versus 1,620 in that prior snapshot: 45 more (2.8%).

Report change
+45
Death-coded reports
+6
Death-coded share
+0.2 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 Sleepiness - systemic disorder changes

FDA AER · VeDDRA plate

Code 2529 VOL-MID

VOL-MID · DEATH-PAR · UPPER-Q · PHOTO-FINISH · SPECIES-DOG · DRUG-LEAD · DESK-WIDE · BOOK-FULL

  • VOL-MID 1,665 reports
  • DEATH-PAR 7.5%
  • UPPER-Q #267/2481
  • PHOTO-FINISH Nasal discharge
  • SPECIES-DOG Dog · 1,196
  • DRUG-LEAD Milbemycin Oxime… · 119
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Nasal discharge (±3 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 Sleepiness - systemic disorder

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

Vomiting · highest174348Mucous stool · near1681Hypotension · near1676Sleepiness - systemic… · thi…1665Nasal discharge · near1662Increased heart rate · near1651Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Sleepiness - systemic disorder

Sleepiness - systemic disorder: low death-coded share in the FDA AER plate

Signature read: 1,665 reports place Sleepiness - systemic disorder in the upper third of FDA AER volume (#267 of 2,481). Report volume is upper-third scale: 1,665 named reports in the openFDA extract. Death-coded share is lower-third: 125 of 1,665 reports (7.5% of named reports). Nearest volume peer: Nasal discharge (±3 reports). Lead species Dog (1,196). Lead co-reported drug Milbemycin Oxime + Spinosad (119).

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

Dog 1,196
Cat 460
Human 8
Other Equids 1

Breeds Most Affected

Domestic Shorthair 270
Retriever - Labrador 91
Crossbred Canine/dog 86
Chihuahua 79
Dog (unknown) 70
Retriever - Golden 52
Shih Tzu 50
Terrier - Yorkshire 44
Pit Bull 41
Shepherd Dog - German 38

Associated Drugs

Milbemycin Oxime + Spinosad 119
Trilostane 119
Nitenpyram 92
Maropitant Citrate 80
Milbemycin Oxime + Praziquantel 78
Gabapentin 75
Pyrantel Pamoate;Sarolaner 71
Oclacitinib Maleate 70
Afoxolaner 70
Bedinvetmab 70
Fluralaner 13.64% 12-Week Chew 64
Buprenorphine 61
Grapiprant 59
Carprofen 56
Ivermectin + Pyrantel As Pamoate Salt 55
Fluralaner Spot-On Solution 50
Lotilaner 46
Robenacoxib 42
Selamectin;Sarolaner 41
Fluralaner Chew Tablets 37

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Sleepiness - systemic disorder, 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 (1,665 here).

Similar death-coded share

Nearest other reactions by death-coded share (7.5% 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 Sleepiness - systemic disorder (#267 of 2,481 by report volume); death-coded 7.5%. PlainBreed reaction plate · report volume stamp 1,665 · 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 →