Cyclosporine 2% Drops (Ophthalmic)

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12 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.
12
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Cyclosporine 2% Drops (Ophthalmic)

Administration Routes

Ophthalmic

Species Affected

Dog 12

Most Affected Breeds

Pug 12

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 4
Vomiting 3
Haematuria 2
Urinary tract infection 2
Urine leakage 1
Other abnormal test result NOS 1
Ocular discharge 1
Tachypnoea 1
Decreased appetite 1
Conjunctivitis 1
Pyuria 1
Impaired vision 1

Outcome Breakdown

Recovered/Normal
8 (66.7%)
Outcome Unknown
4 (33.3%)

Data Summary

Metric Value
Total adverse event reports 12
Reports involving death 0
Case-fatality rate (reported events) 0.0%
Distinct species in reports 1
Distinct breeds in reports 1
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.

Cyclosporine 2% Drops (Ophthalmic) Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 12 adverse event reports referencing Cyclosporine 2% Drops (Ophthalmic), 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: Cyclosporine 2% Drops (Ophthalmic). Reported administration route is Ophthalmic. 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 Cyclosporine 2% Drops (Ophthalmic) reports are Dog (12 reports), with Dog accounting for the largest share. Within those species, Pug (12) 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 Cyclosporine 2% Drops (Ophthalmic) are Lethargy (see also Central nervous system depression in 'Neurological') (4), Vomiting (3), Haematuria (2), Urinary tract infection (2). Of the 12 reports with a coded outcome, Recovered/Normal is the leading category at 66.7%. 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 Cyclosporine 2% Drops (Ophthalmic).

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