Eye Drops (Unknown)

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155 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.
155
Total Reports
5
Deaths Reported
320.0%
Death Rate

Active Ingredients

Eye Drops (Unknown)

Administration Routes

UnknownOphthalmicIntraocularAuricular (Otic)OralTopical

Species Affected

Dog 134
Cat 16
Human 5

Most Affected Breeds

Shih Tzu 21
Bulldog 9
Domestic Shorthair 8
Bichon Frise 6
Maltese 6
Unknown 5
Spaniel - Cocker American 5
Retriever - Labrador 5
Terrier - Yorkshire 5
Poodle (unspecified) 5

Most Reported Reactions

Emesis 51
Lethargy (see also Central nervous system depression in 'Neurological') 26
Vomiting 23
Lack of efficacy (ectoparasite) - flea 19
Behavioural disorder NOS 13
Diarrhoea 12
Lack of efficacy - NOS 12
Not eating 9
Anorexia 8
Weight loss 8
Accidental exposure 7
Lethargy (see also Central nervous system depression in Neurological) 7

Outcome Breakdown

Recovered/Normal
81 (52.3%)
Outcome Unknown
31 (20.0%)
Ongoing
24 (15.5%)
Recovered with Sequela
14 (9.0%)
Died
4 (2.6%)
Euthanized
1 (0.6%)

Data Summary

Metric Value
Total adverse event reports 155
Reports involving death 5
Case-fatality rate (reported events) 320.0%
Distinct species in reports 3
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.

Eye Drops (Unknown) Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 155 adverse event reports referencing Eye Drops (Unknown), including 5 reports in which the animal died — a 320.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Eye Drops (Unknown). Reported administration routes include Unknown, Ophthalmic, Intraocular, 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 Eye Drops (Unknown) reports are Dog (134 reports), Cat (16 reports), Human (5 reports), with Dog accounting for the largest share. Within those species, Shih Tzu (21), Bulldog (9), Domestic Shorthair (8) 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 Eye Drops (Unknown) are Emesis (51), Lethargy (see also Central nervous system depression in 'Neurological') (26), Vomiting (23), Lack of efficacy (ectoparasite) - flea (19). Of the 155 reports with a coded outcome, Recovered/Normal is the leading category at 52.3%. 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 Eye Drops (Unknown).

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