Drug profile

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

16 FDA reports name Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water, a lower-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#2063 of 2,679
by report volume (all drugs)
16
adverse-event reports
12.5%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water ranks #1995 of 2679 by total reports (16). 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)
#1995
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(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water has 16 reports now versus 16 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(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water changes

Signature read: 16 reports place Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water in the lower third of FDA AER volume (#2063 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.
16
Total Reports
2
Deaths Reported
12.5%
Death-coded share of reports

Active Ingredients

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

Administration Routes

Auricular (Otic)

Species Affected

Dog 16

Most Affected Breeds

Maltese 2
Bulldog - French 2
Terrier - Rat 1
Terrier - West Highland White 1
Retriever - Golden 1
Pinscher - Miniature 1
Retriever - Labrador 1
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 1
Poodle - Miniature 1
Shepherd Dog - German 1

Most Reported Reactions

Deafness 4
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

Outcome Breakdown

Outcome Unknown
7 (43.8%)
Recovered/Normal
5 (31.3%)
Euthanized
2 (12.5%)
Recovered with Sequela
2 (12.5%)

Tromethamine(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water: 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(Tris) Usp, Edetate, Disodium Dihydrate(Edta) Usp, Buffered With Tromethamine Hcl In Ionized Water (#2063 of 2,679 by report volume); death-coded 12.5%. PlainBreed drug row · report volume stamp 16 · 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 →