Reaction profile

The FDA adverse-event record for hepatomegaly

827 FDA reports name hepatomegaly, a high-volume reaction in the CVM extract (VeDDRA 494). Plate stamps and neighbourhood peers follow.

#450 of 2,481
by report volume (all reactions)
827
reports citing this reaction
40.3%
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. Hepatomegaly has 827 reports now versus 812 in that prior snapshot: 15 more (1.8%).

Report change
+15
Death-coded reports
+5
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 Hepatomegaly changes

FDA AER · VeDDRA plate

Code 494 VOL-MID

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

  • VOL-MID 827 reports
  • DEATH-HOT 40.3%
  • UPPER-Q #450/2481
  • PHOTO-FINISH Squinting
  • SPECIES-DOG Dog · 753
  • DRUG-LEAD Trilostane · 117
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Squinting (±1 reports)

Upper-third death-coded share drives the outcome stamps on this plate; volume band, corpus rank, and co-report peers follow. Not a clinical diagnosis.

High-volume neighbourhood around Hepatomegaly

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

Vomiting · highest174348Hepatomegaly · this reaction827Squinting · near826Abdominal discomfort · near825Increased appetite · near825Decreased bowel movem… · near821Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Hepatomegaly

Hepatomegaly: high death-coded share in the FDA AER plate

Signature read: 333 death-coded reports is a heavy tail count for Hepatomegaly in the CVM extract. Report volume is upper-third scale: 827 named reports in the openFDA extract. Death-coded share is upper-third: 333 of 827 reports (40.3% of named reports). Nearest volume peer: Squinting (±1 reports). Lead species Dog (753). Lead co-reported drug Trilostane (117).

Read these counts as reporting volume, not risk: per our methodology, A high death-coded share in FDA filings does not prove causation; co-reporting is voluntary temporal association only. Browse the full reactions index or the about page for how PlainBreed frames FDA CVM extracts.

Species Most Affected

Dog 753
Cat 63
Cattle 5
Turkey 1
Sheep 1
Human 1
Pig 1
Other Rodents 1
Lynx 1

Breeds Most Affected

Retriever - Labrador 95
Crossbred Canine/dog 69
Chihuahua 41
Retriever - Golden 33
Terrier - Yorkshire 32
Domestic Shorthair 31
Shih Tzu 21
Maltese 18
Schnauzer - Miniature 18
Terrier - West Highland White 17

Associated Drugs

Trilostane 117
Carprofen 109
Maropitant Citrate 90
Milbemycin Oxime + Spinosad 69
Oclacitinib Maleate 68
Bedinvetmab 62
Gabapentin 53
Prednisone 46
Afoxolaner 40
Fluralaner Chew Tablets 37
Moxidectin 31
Metronidazole 31
Cyclosporine 29
Spinosad 29
Doxycycline 27
Tramadol 27
Grapiprant 27
Cefovecin 26
Famotidine 25
Anti-Il31 Mab Mcs Lot #1283563 25

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Hepatomegaly, 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 (827 here).

Similar death-coded share

Nearest other reactions by death-coded share (40.3% 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 Hepatomegaly (#450 of 2,481 by report volume); death-coded 40.3%. PlainBreed reaction plate · death-coded report count stamp 333 · 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 →