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

55 adverse event reports submitted to the FDA

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
910.0%
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%)

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.