Reaction profile

The FDA adverse-event record for urine leakage

668 FDA reports name urine leakage, a high-volume reaction in the CVM extract (VeDDRA 2127). Plate stamps and neighbourhood peers follow.

#533 of 2,481
by report volume (all reactions)
668
reports citing this reaction
10.9%
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. Urine leakage has 668 reports now versus 652 in that prior snapshot: 16 more (2.5%).

Report change
+16
Death-coded reports
+2
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 Urine leakage changes

FDA AER · VeDDRA plate

Code 2127 VOL-MID

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

  • VOL-MID 668 reports
  • DEATH-ELEV 10.9%
  • UPPER-Q #533/2481
  • PHOTO-FINISH Disoriented state
  • SPECIES-DOG Dog · 609
  • DRUG-LEAD Bedinvetmab · 133
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Disoriented state (±2 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 Urine leakage

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

Vomiting · highest174348Lack of efficacy (pro… · near670Sedation prolonged · near670Urine leakage · this reaction668Disoriented state · near666Difficulty to rise · near665Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Urine leakage

What the FDA AER plate says about Urine leakage

Signature read: 668 reports place Urine leakage in the upper third of FDA AER volume (#533 of 2,481). Report volume is upper-third scale: 668 named reports in the openFDA extract. 73 of 668 reports were death-coded (10.9% of named reports, not a population mortality rate). Nearest volume peer: Disoriented state (±2 reports). Lead species Dog (609). Lead co-reported drug Bedinvetmab (133).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Bedinvetmab 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 609
Cat 53
Unknown 3
Horse 2
Cattle 1

Breeds Most Affected

Retriever - Labrador 87
Domestic Shorthair 42
Crossbred Canine/dog 40
Shepherd Dog - German 39
Boxer (German Boxer) 22
Shepherd Dog - Australian 22
Retriever - Golden 21
Siberian Husky 19
Dog (unknown) 17
Chihuahua 16

Associated Drugs

Bedinvetmab 133
Trilostane 82
Gabapentin 61
Carprofen 57
Milbemycin Oxime + Spinosad 52
Oclacitinib Maleate 35
Pyrantel Pamoate;Sarolaner 35
Afoxolaner 31
Prednisone 29
Maropitant Citrate 22
Milbemycin Oxime + Praziquantel 21
Fluralaner Chew Tablets 19
Ivermectin + Pyrantel As Pamoate Salt 18
Grapiprant 18
Fluralaner 13.64% 12-Week Chew 15
Cefovecin 14
Tramadol 14
Desoxycorticosterone Pivalate 14
Anti-Il31 Mab Mcs Lot #1283563 14
Lotilaner 14

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Urine leakage, 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 (668 here).

Similar death-coded share

Nearest other reactions by death-coded share (10.9% 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 Urine leakage (#533 of 2,481 by report volume); death-coded 10.9%. PlainBreed reaction plate · report volume stamp 668 · 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 →