Drug profile

The FDA adverse-event record for Tromethamine (Tris) Usp + Edetate Disodium Dihydrate (Edta) Usp

55 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Tromethamine (Tris) Usp + Edetate Disodium Dihydrate (Edta) Usp. See the species affected, top reactions, and outcomes below.

55
adverse-event reports
9.1%
death-coded share
Dog
most-reported species
16
Lack of efficacy - NOS - top reaction
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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.
55
Total Reports
5
Deaths Reported
9.1%
Death Rate

Active Ingredients

Tromethamine (Tris) Usp + Edetate Disodium Dihydrate (Edta) Usp

Administration Routes

Auricular (Otic)Unknown

Species Affected

Dog 44
Cat 11

Most Affected Breeds

Retriever - Labrador 6
Domestic Shorthair 5
Maltese 3
Terrier (unspecified) 3
Pinscher - Miniature 3
Terrier - Yorkshire 2
Hound - Basset 2
Cat (other) 2
Terrier - Boston 2
Spitz - German Pomeranian 2

Most Reported Reactions

Lack of efficacy - NOS 16
Other abnormal test result NOS 11
Ear discharge 9
Not eating 8
Head tilt - ear disorder 7
Vomiting 7
Lethargy (see also Central nervous system depression in Neurological) 7
Horner's syndrome 6
Vestibular disorder NOS 6
Head shake - ear disorder 6
Diarrhoea 5
Other ear disorder NOS 5

Outcome Breakdown

Outcome Unknown
24 (43.6%)
Ongoing
17 (30.9%)
Recovered/Normal
9 (16.4%)
Died
4 (7.3%)
Euthanized
1 (1.8%)

Tromethamine (Tris) Usp + Edetate Disodium Dihydrate (Edta) Usp Adverse Event Insights

55 reports name Tromethamine (Tris) Usp + Edetate Disodium Dihydrate (Edta) Usp; 5 recorded a death outcome (9.1% of reported events, not a population-level mortality rate). Active ingredient: Tromethamine (Tris) Usp + Edetate Disodium Dihydrate (Edta) Usp. Administration routes: Auricular (Otic), Unknown.

By species: Dog (44 reports), Cat (11 reports). By breed: Retriever - Labrador (6), Domestic Shorthair (5), Maltese (3).

Leading clinical signs: Lack of efficacy - NOS (16), Other abnormal test result NOS (11), Ear discharge (9), Not eating (8). Outcome, 55 coded reports: Outcome Unknown leads at 43.6%.

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.