Drug profile

The FDA adverse-event record for Tromethamine + Disodium Edta Dehydrate

19 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Tromethamine + Disodium Edta Dehydrate. See the species affected, top reactions, and outcomes below.

19
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
6
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.
19
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Tromethamine + Disodium Edta Dehydrate

Administration Routes

Auricular (Otic)Unknown

Species Affected

Dog 19

Most Affected Breeds

Bulldog - French 4
Crossbred Canine/dog 2
Terrier - Irish Soft-coated Wheaten 2
Shepherd Dog - German 1
Terrier - West Highland White 1
Chihuahua 1
Retriever - Labrador 1
Retriever - Golden 1
Pug 1
Collie (unspecified) 1

Most Reported Reactions

Lack of efficacy - NOS 6
Corneal ulcer 4
Ocular discharge 4
Neurogenic keratoconjunctivitis sicca (KCS) 4
Seizure NOS 3
Other abnormal test result NOS 3
Head tilt - ear disorder 2
Cloudy eye (for Miosis, Mydriasis, Anisocoria, Nystagmus - see 'Neurological') 2
Third eyelid protrusion 2
Facial paralysis 2
Nasal discharge 2
Stenotic ear canal 2

Outcome Breakdown

Ongoing
12 (63.2%)
Outcome Unknown
6 (31.6%)
Recovered/Normal
1 (5.3%)

Tromethamine + Disodium Edta Dehydrate Adverse Event Insights

19 reports name Tromethamine + Disodium Edta Dehydrate; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredient: Tromethamine + Disodium Edta Dehydrate. Administration routes: Auricular (Otic), Unknown.

By species: Dog (19 reports). By breed: Bulldog - French (4), Crossbred Canine/dog (2), Terrier - Irish Soft-coated Wheaten (2).

Leading clinical signs: Lack of efficacy - NOS (6), Corneal ulcer (4), Ocular discharge (4), Neurogenic keratoconjunctivitis sicca (KCS) (4). Outcome, 19 coded reports: Ongoing leads at 63.2%.

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.