Reaction profile

The FDA adverse-event record for malaise

4,165 FDA reports name malaise, a high-volume reaction in the CVM extract (VeDDRA 1027). Plate stamps and neighbourhood peers follow.

#113 of 2,481
by report volume (all reactions)
4,165
reports citing this reaction
18.7%
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. Malaise has 4,165 reports now versus 4,115 in that prior snapshot: 50 more (1.2%).

Report change
+50
Death-coded reports
+11
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 Malaise changes

FDA AER · VeDDRA plate

Code 1027 VOL-MID

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

  • VOL-MID 4,165 reports
  • DEATH-ELEV 18.7%
  • TOP-DECILE #113/2481
  • PHOTO-FINISH Thrombocytopenia
  • SPECIES-DOG Dog · 3,340
  • DRUG-LEAD Milbemycin Oxime… · 879
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Thrombocytopenia (±40 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 Malaise

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

Vomiting · highest174348Thrombocytopenia · near4205Malaise · this reaction4165Reddening of the skin · near4123Reluctant to move · near4123Hypoglycaemia · near4092Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Malaise

What the FDA AER plate says about Malaise

Signature read: 779 death-coded reports is a heavy tail count for Malaise in the CVM extract. Report volume is upper-third scale: 4,165 named reports in the openFDA extract. 779 of 4,165 reports were death-coded (18.7% of named reports, not a population mortality rate). Nearest volume peer: Thrombocytopenia (±40 reports). Lead species Dog (3,340). Lead co-reported drug Milbemycin Oxime + Spinosad (879).

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 3,340
Cat 595
Cattle 99
Human 63
Horse 40
Sheep 6
Goat 5
Pig 4
Turkey 3
Other 2

Breeds Most Affected

Domestic Shorthair 326
Retriever - Labrador 295
Crossbred Canine/dog 221
Dog (unknown) 182
Chihuahua 169
Terrier - Yorkshire 155
Shih Tzu 139
Retriever - Golden 132
Shepherd Dog - German 110
Maltese 89

Associated Drugs

Milbemycin Oxime + Spinosad 879
Trilostane 402
Milbemycin Oxime + Praziquantel 263
Spinosad 213
Carprofen 183
Maropitant Citrate 142
Oclacitinib Maleate 123
Prednisone 119
Moxidectin 114
Fluralaner Chew Tablets 113
Selamectin 110
Afoxolaner 110
Lotilaner 109
Gabapentin 100
Ivermectin + Pyrantel As Pamoate Salt 94
Grapiprant 94
Deracoxib 83
Pyrantel Pamoate;Sarolaner 80
Cefovecin 75
Sarolaner 75

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Malaise, 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 (4,165 here).

Similar death-coded share

Nearest other reactions by death-coded share (18.7% 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 Malaise (#113 of 2,481 by report volume); death-coded 18.7%. PlainBreed reaction plate · death-coded report count stamp 779 · 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 →