Dimethyl Sulfoxide;Fluocinolone Acetonide

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53 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.
53
Total Reports
2
Deaths Reported
380.0%
Death Rate

Active Ingredients

Dimethyl Sulfoxide;Fluocinolone Acetonide

Administration Routes

Auricular (Otic)OphthalmicTopicalUnknownIntraocular

Species Affected

Dog 27
Human 12
Unknown 10
Cat 4

Most Affected Breeds

Unknown 22
Retriever - Labrador 4
Retriever - Golden 3
Shih Tzu 2
Domestic Shorthair 2
Dog (unknown) 2
Bulldog - American 1
Weimaraner 1
Griffon - Brussels 1
Spaniel - Springer (unspecified) 1

Most Reported Reactions

Accidental exposure 8
Eye irritation 7
Pruritus 4
Containers, Leaking 3
Underfilling, Container 3
Polydipsia 3
Burning sensation of eye 3
Eye redness 3
Incorrect route of drug administration 3
Lethargy (see also Central nervous system depression in 'Neurological') 2
Injected sclera 2
Deafness 2

Outcome Breakdown

Outcome Unknown
21 (48.8%)
Ongoing
17 (39.5%)
Recovered/Normal
3 (7.0%)
Died
1 (2.3%)
Euthanized
1 (2.3%)

Data Summary

Metric Value
Total adverse event reports 53
Reports involving death 2
Case-fatality rate (reported events) 380.0%
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.

Dimethyl Sulfoxide;Fluocinolone Acetonide Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 53 adverse event reports referencing Dimethyl Sulfoxide;Fluocinolone Acetonide, including 2 reports in which the animal died — a 380.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Dimethyl Sulfoxide;Fluocinolone Acetonide. Reported administration routes include Auricular (Otic), Ophthalmic, Topical, Unknown. 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 Dimethyl Sulfoxide;Fluocinolone Acetonide reports are Dog (27 reports), Human (12 reports), Unknown (10 reports), with Dog accounting for the largest share. Within those species, Unknown (22), Retriever - Labrador (4), Retriever - Golden (3) 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 Dimethyl Sulfoxide;Fluocinolone Acetonide are Accidental exposure (8), Eye irritation (7), Pruritus (4), Containers, Leaking (3). Of the 43 reports with a coded outcome, Outcome Unknown is the leading category at 48.8%. 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 Dimethyl Sulfoxide;Fluocinolone Acetonide.

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