Reaction profile

The FDA adverse-event record for prostate hypertrophy

66 FDA adverse-event reports reference prostate hypertrophy (VeDDRA 2104). See the species, breeds, and drugs most associated with it below.

66
reports citing this reaction
19.7%
death-coded share
Dog
most-affected species
Milbemycin Oxime + Spinosad
most-associated drug
Verify with FDA CVM →
66
Total Reports
13
Deaths
19.7%
Death Rate

Species Most Affected

Dog 66

Breeds Most Affected

Crossbred Canine/dog 8
Retriever - Labrador 7
Shepherd Dog - German 5
Beagle 4
Retriever - Golden 3
Mastiff 2
Poodle (unspecified) 2
Collie (unspecified) 2
Irish Wolfhound 2
Collie - Border 2

Associated Drugs

Milbemycin Oxime + Spinosad 11
Fluralaner Chew Tablets 11
Carprofen 9
Gabapentin 6
Enrofloxacin 6
Grapiprant 6
Famotidine 5
Oclacitinib Maleate 4
Moxidectin 4
Afoxolaner 4
Bedinvetmab 4
Prednisone 3
Cefpodoxime Proxetil 3
Cyclosporine 3
Maropitant Citrate 3
Leptospira Canicola L-15 Strain C-51;Leptospira Grippotyphosa 1550 Lot 10005 Str 3
Trilostane 3
Metronidazole 2
Cyclosporine A 2
Milbemycin Oxime 2

Prostate hypertrophy Reaction Insights

66 reports name Prostate hypertrophy; 13 recorded a death outcome (19.7% of reported events, not a population-level mortality rate). VeDDRA code: 2104.

By species: Dog (66 reports). By breed: Crossbred Canine/dog (8), Retriever - Labrador (7), Shepherd Dog - German (5).

Most co-reported drugs: Milbemycin Oxime + Spinosad (11 reports), Fluralaner Chew Tablets (11 reports), Carprofen (9 reports), Gabapentin (6 reports).

Read these counts as reporting volume, not risk: per our methodology, co-reporting reflects temporal association captured in voluntary submissions, not proof that a drug caused this reaction. A widely-prescribed drug will rack up more raw co-reports at an identical true rate than a rarely-used one, so compare within similar-exposure products.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.