Reaction profile

The FDA adverse-event record for restlessness

6,467 FDA reports name restlessness, a high-volume reaction in the CVM extract (VeDDRA 119). Plate stamps and neighbourhood peers follow.

#77 of 2,481
by report volume (all reactions)
6,467
reports citing this reaction
7.9%
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. Restlessness has 6,467 reports now versus 6,349 in that prior snapshot: 118 more (1.9%).

Report change
+118
Death-coded reports
+13
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 Restlessness changes

FDA AER · VeDDRA plate

Code 119 VOL-HIGH

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

  • VOL-HIGH 6,467 reports
  • DEATH-PAR 7.9%
  • TOP-DECILE #77/2481
  • PHOTO-FINISH Pain NOS
  • SPECIES-DOG Dog · 5,695
  • DRUG-LEAD Milbemycin Oxime… · 676
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Pain NOS (±10 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 Restlessness

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

Vomiting · highest174348Pain NOS · near6477Restlessness · this reaction6467Underfilling, Contain… · near6364Anaphylaxis · near6311Weight gain · near6282Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Restlessness

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

Signature read: 6,467 reports place Restlessness in the upper third of FDA AER volume (#77 of 2,481). Report volume is upper-third scale: 6,467 named reports in the openFDA extract. Death-coded share is lower-third: 511 of 6,467 reports (7.9% of named reports). Nearest volume peer: Pain NOS (±10 reports). Lead species Dog (5,695). Lead co-reported drug Milbemycin Oxime + Spinosad (676).

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 5,695
Cat 691
Horse 52
Cattle 20
Pig 2
Other 2
Goat 1
Crustacea 1
Rabbit 1
Fox 1

Breeds Most Affected

Retriever - Labrador 593
Crossbred Canine/dog 494
Domestic Shorthair 329
Retriever - Golden 246
Shih Tzu 227
Terrier - Yorkshire 215
Chihuahua 213
Shepherd Dog - German 182
Maltese 175
Dog (unknown) 157

Associated Drugs

Milbemycin Oxime + Spinosad 676
Afoxolaner 494
Carprofen 335
Spinosad 298
Bedinvetmab 272
Buprenorphine 264
Trilostane 261
Ivermectin + Pyrantel As Pamoate Salt 256
Gabapentin 207
Oclacitinib Maleate 203
Moxidectin 194
Melarsomine Dihydrochloride 190
Pyrantel Pamoate;Sarolaner 174
Maropitant Citrate 169
Selamectin 162
Imidacloprid + Moxidectin 155
Nitenpyram 152
Fluralaner Chew Tablets 151
Melarsomine Dihydrochloride Injection 149
Prednisone 142

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Restlessness, 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 (6,467 here).

Similar death-coded share

Nearest other reactions by death-coded share (7.9% 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 Restlessness (#77 of 2,481 by report volume); death-coded 7.9%. PlainBreed reaction plate · report volume stamp 6,467 · 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 →