Propylene Glycol, Glycerin, Salicylic Acid

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15 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.
15
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Propylene Glycol, Glycerin, Salicylic Acid

Administration Routes

Auricular (Otic)

Species Affected

Dog 8
Cat 7

Most Affected Breeds

Domestic Shorthair 5
Terrier - Yorkshire 3
Rottweiler 1
Bloodhound 1
Shepherd Dog - German 1
Cat (other) 1
Cat (unknown) 1
Boxer (German Boxer) 1
Poodle - Standard 1

Most Reported Reactions

Deafness 4
Behavioural disorder NOS 3
Vomiting 3
Not eating 3
Weight loss 3
Abnormal radiograph finding 2
Abnormal cytology 2
Ataxia 2
Anisocoria 2
Ear discharge 2
Application site bleeding 2
Decreased appetite 1

Outcome Breakdown

Recovered/Normal
8 (50.0%)
Outcome Unknown
7 (43.8%)
Recovered with Sequela
1 (6.3%)

Data Summary

Metric Value
Total adverse event reports 15
Reports involving death 0
Case-fatality rate (reported events) 0.0%
Distinct species in reports 2
Distinct breeds in reports 9
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.

Propylene Glycol, Glycerin, Salicylic Acid Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 15 adverse event reports referencing Propylene Glycol, Glycerin, Salicylic Acid, including 0 reports in which the animal died — a 0.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Propylene Glycol, Glycerin, Salicylic Acid. Reported administration route is Auricular (Otic). 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 Propylene Glycol, Glycerin, Salicylic Acid reports are Dog (8 reports), Cat (7 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (5), Terrier - Yorkshire (3), Rottweiler (1) 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 Propylene Glycol, Glycerin, Salicylic Acid are Deafness (4), Behavioural disorder NOS (3), Vomiting (3), Not eating (3). Of the 16 reports with a coded outcome, Recovered/Normal is the leading category at 50.0%. 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 Propylene Glycol, Glycerin, Salicylic Acid.

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