Tresaderm Dermatological Solution

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543 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.
543
Total Reports
5
Deaths Reported
90.0%
Death Rate

Active Ingredients

Tresaderm Dermatological Solution

Administration Routes

UnknownAuricular (Otic)OphthalmicOtherTopicalOralIntraocular

Species Affected

Unknown 203
Dog 153
Cat 129
Human 58

Most Affected Breeds

Unknown 261
Domestic Shorthair 83
Retriever - Labrador 24
Domestic Longhair 10
Dog (unknown) 10
Chihuahua 10
Domestic Mediumhair 9
Cat (unknown) 8
Shih Tzu 6
Terrier - Yorkshire 6

Most Reported Reactions

Uncoded sign 118
Product dropper missing 78
Accidental exposure 42
Caps, Abnormal 34
Vomiting 33
Containers, Leaking 31
Eye irritation 29
Lethargy (see also Central nervous system depression in 'Neurological') 28
Other abnormal test result NOS 27
Not eating 22
Deafness 19
Ataxia 19

Outcome Breakdown

Outcome Unknown
225 (66.2%)
Recovered/Normal
68 (20.0%)
Ongoing
39 (11.5%)
Euthanized
4 (1.2%)
Recovered with Sequela
3 (0.9%)
Died
1 (0.3%)

Data Summary

Metric Value
Total adverse event reports 543
Reports involving death 5
Case-fatality rate (reported events) 90.0%
Distinct species in reports 4
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Tresaderm Dermatological Solution Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 543 adverse event reports referencing Tresaderm Dermatological Solution, including 5 reports in which the animal died — a 90.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Tresaderm Dermatological Solution. Reported administration routes include Unknown, Auricular (Otic), Ophthalmic, Other. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Tresaderm Dermatological Solution reports are Unknown (203 reports), Dog (153 reports), Cat (129 reports), with Unknown accounting for the largest share. Within those species, Unknown (261), Domestic Shorthair (83), Retriever - Labrador (24) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Tresaderm Dermatological Solution are Uncoded sign (118), Product dropper missing (78), Accidental exposure (42), Caps, Abnormal (34). Of the 340 reports with a coded outcome, Outcome Unknown is the leading category at 66.2%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Tresaderm Dermatological Solution.

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

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial