Drug profile

The FDA adverse-event record for Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water

Name: Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water - FDA Animal Adverse Event Reports
Creator: PlainBreed
License: https://creativecommons.org/publicdomain/zero/1.0/

14 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water. See the species affected, top reactions, and outcomes below.

14
adverse-event reports: 14.3%
death-coded share: Dog
most-reported species: 3
Tympanic rupture - top reaction

Compiled by PlainBreed Editorial, Pet Health Editorial Team

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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.

Total Reports

Deaths Reported

14.3%

Death Rate

Active Ingredients

Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water

Administration Routes

Auricular (Otic)

Species Affected

Dog 14

Most Affected Breeds

Maltese 2

Bulldog - French 2

Terrier - West Highland White 1

Retriever - Golden 1

Terrier - Rat 1

Pinscher - Miniature 1

Retriever - Labrador 1

Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 1

Poodle - Miniature 1

Shih Tzu 1

Most Reported Reactions

Tympanic rupture 3

Vomiting 3

Ear discharge 3

Nystagmus 3

Head tilt - ear disorder 3

Application site reddening 2

Application site inflammation 2

Head shake - ear disorder 2

Anorexia 2

Ear pain 2

Dullness 2

Laboured breathing 2

Outcome Breakdown

Outcome Unknown

5 (35.7%)

Recovered/Normal

5 (35.7%)

Euthanized

2 (14.3%)

Recovered with Sequela

1 (7.1%)

Ongoing

1 (7.1%)

Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water Adverse Event Insights

14 reports name Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water; 2 recorded a death outcome (14.3% of reported events, not a population-level mortality rate). Active ingredient: Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water. Administration route: Auricular (Otic).

By species: Dog (14 reports). By breed: Maltese (2), Bulldog - French (2), Terrier - West Highland White (1).

Leading clinical signs: Tympanic rupture (3), Vomiting (3), Ear discharge (3), Nystagmus (3). Outcome, 14 coded reports: Outcome Unknown leads at 35.7%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

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.