Drug profile

The FDA adverse-event record for Tromethamine Usp, Disodium Edta Dihydrate

13 FDA reports name Tromethamine Usp, Disodium Edta Dihydrate, a lower-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#2286 of 2,679
by report volume (all drugs)
13
adverse-event reports
15.4%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Tromethamine Usp, Disodium Edta Dihydrate ranks #2210 of 2679 by total reports (13). Death-coded-share rank requires at least 50 reports. National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#2210
This drug, reports of 2679

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

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. Tromethamine Usp, Disodium Edta Dihydrate has 13 reports now versus 13 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
Death-coded reports
+0
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 Tromethamine Usp, Disodium Edta Dihydrate changes

Signature read: 13 reports place Tromethamine Usp, Disodium Edta Dihydrate in the lower third of FDA AER volume (#2286 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
13
Total Reports
2
Deaths Reported
15.4%
Death-coded share of reports

Active Ingredients

Tromethamine Usp, Disodium Edta Dihydrate

Administration Routes

UnknownAuricular (Otic)

Species Affected

Dog 9
Cat 4

Most Affected Breeds

Domestic Shorthair 2
Pit Bull 2
Beagle 1
Crossbred Feline/cat 1
Retriever - Labrador 1
Domestic Longhair 1
Collie - Border 1
Poodle - Toy 1
Bulldog 1
Havanese 1

Most Reported Reactions

Ataxia 3
Lack of efficacy - NOS 3
Vestibular disorder NOS 2
Head tilt - ear disorder 2
Circling - neurological disorder (see also 'Behavioural disorders') 2
Anorexia 2
Horner's syndrome 2
Ear discharge 2
Deafness 2
Nystagmus 1
Internal ear disorder 1
Death by euthanasia 1

Outcome Breakdown

Outcome Unknown
8 (61.5%)
Recovered/Normal
3 (23.1%)
Euthanized
1 (7.7%)
Died
1 (7.7%)

Tromethamine Usp, Disodium Edta Dihydrate: lower report volume in the FDA AER row

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.

What to do with this drug

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 Tromethamine Usp, Disodium Edta Dihydrate (#2286 of 2,679 by report volume); death-coded 15.4%. PlainBreed drug row · report volume stamp 13 · 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 →