Drug profile

The FDA adverse-event record for Tacrolimus Ophthalmic

11 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Tacrolimus Ophthalmic. See the species affected, top reactions, and outcomes below.

11
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
4
Seizure NOS - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
11
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Tacrolimus Ophthalmic

Administration Routes

OphthalmicUnknownIntraocular

Species Affected

Dog 11

Most Affected Breeds

Shih Tzu 4
Bulldog - French 2
Bulldog 1
Retriever - Golden 1
Dachshund (unspecified) 1
Schnauzer - Miniature 1
Pug 1

Most Reported Reactions

Seizure NOS 4
Other abnormal test result NOS 3
Keratoconjunctivitis sicca 3
Corneal ulcer 2
Eye disorder NOS (for photophobia see 'neurological') 2
Inappetence 2
Rubbing 2
Corneal disorder NOS 2
Increased seizure frequency 2
Lethargy (see also Central nervous system depression in Neurological) 2
Not eating 2
Abnormal radiograph finding 2

Outcome Breakdown

Ongoing
5 (45.5%)
Outcome Unknown
3 (27.3%)
Recovered with Sequela
2 (18.2%)
Recovered/Normal
1 (9.1%)

Tacrolimus Ophthalmic Adverse Event Insights

11 reports name Tacrolimus Ophthalmic; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredient: Tacrolimus Ophthalmic. Administration routes: Ophthalmic, Unknown, Intraocular.

By species: Dog (11 reports). By breed: Shih Tzu (4), Bulldog - French (2), Bulldog (1).

Leading clinical signs: Seizure NOS (4), Other abnormal test result NOS (3), Keratoconjunctivitis sicca (3), Corneal ulcer (2). Outcome, 11 coded reports: Ongoing leads at 45.5%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.