Reaction profile

The FDA adverse-event record for sleepiness - neurological disorder

1,112 FDA reports name sleepiness - neurological disorder, a high-volume reaction in the CVM extract (VeDDRA 127). Plate stamps and neighbourhood peers follow.

#362 of 2,481
by report volume (all reactions)
1,112
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 - neurological disorder has 1,112 reports now versus 1,099 in that prior snapshot: 13 more (1.2%).

Report change
+13
Death-coded reports
+2
Death-coded share
+0.1 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 - neurological disorder changes

FDA AER · VeDDRA plate

Code 127 VOL-MID

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

  • VOL-MID 1,112 reports
  • DEATH-PAR 7.5%
  • UPPER-Q #362/2481
  • PHOTO-FINISH Balance problem
  • SPECIES-DOG Dog · 947
  • DRUG-LEAD Milbemycin Oxime… · 426
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Balance problem (±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 Sleepiness - neurological disorder

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

Vomiting · highest174348Lymphocytosis · near1114Sleepiness - neurolog… · thi…1112Balance problem · near1111Application site scra… · near1110Dermal mass · near1109Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Sleepiness - neurological disorder

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

Signature read: 1,112 reports place Sleepiness - neurological disorder in the upper third of FDA AER volume (#362 of 2,481). Report volume is upper-third scale: 1,112 named reports in the openFDA extract. Death-coded share is lower-third: 83 of 1,112 reports (7.5% of named reports). Nearest volume peer: Balance problem (±1 reports). Lead species Dog (947). Lead co-reported drug Milbemycin Oxime + Spinosad (426).

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 947
Cat 136
Human 17
Horse 9
Rabbit 2
Unknown 1

Breeds Most Affected

Domestic Shorthair 81
Retriever - Labrador 67
Crossbred Canine/dog 57
Terrier - Yorkshire 50
Chihuahua 49
Retriever - Golden 48
Shih Tzu 44
Boxer (German Boxer) 44
Maltese 41
Shepherd Dog - German 27

Associated Drugs

Milbemycin Oxime + Spinosad 426
Spinosad 131
Afoxolaner 70
Ivermectin + Pyrantel As Pamoate Salt 52
Oclacitinib Maleate 51
Fluralaner Chew Tablets 29
Selamectin 27
Maropitant Citrate 26
Trilostane 26
Ivermectin 24
Carprofen 23
Cefovecin 22
Imidacloprid + Moxidectin 21
Nitenpyram 21
Rabies Vaccine 20
Dexmedetomidine Hydrochloride 18
Milbemycin Oxime + Praziquantel 18
Pyrantel Pamoate;Sarolaner 17
Buprenorphine 16
Bedinvetmab 16

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Sleepiness - neurological 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 (1,112 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 - neurological disorder (#362 of 2,481 by report volume); death-coded 7.5%. PlainBreed reaction plate · report volume stamp 1,112 · 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 →