Drug profile

The FDA adverse-event record for Cyclosporin Ointment

1,493 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Cyclosporin Ointment. See the species affected, top reactions, and outcomes below.

1,493
adverse-event reports
0.7%
death-coded share
Unknown
most-reported species
459
Containers, Leaking - top reaction
Verify with FDA CVM →
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
1,493
Total Reports
11
Deaths Reported
0.7%
Death Rate

Active Ingredients

Cyclosporin Ointment

Administration Routes

UnknownOphthalmicTopicalOralOther

Species Affected

Unknown 1,346
Dog 138
Human 6
Cat 3

Most Affected Breeds

Unknown 1,352
Crossbred Canine/dog 27
Shih Tzu 17
Terrier - Yorkshire 9
Pug 6
Terrier - West Highland White 6
Retriever - Labrador 4
Maltese 4
Pinscher - Miniature 4
Poodle - Miniature 4

Most Reported Reactions

Containers, Leaking 459
Underfilling, Container 424
Tubes, Damaged 385
Tubes, Leaking 373
Underfilling, Tubes 330
Containers, Damaged 303
Product problem 262
Uncoded sign 146
Defect Unknown/Not Specified 126
Appearance, Abnormal 86
Tubes, Abnormal 61
Unclassifiable adverse event 48

Outcome Breakdown

Ongoing
64 (43.5%)
Recovered/Normal
40 (27.2%)
Outcome Unknown
20 (13.6%)
Recovered with Sequela
12 (8.2%)
Euthanized
7 (4.8%)
Died
4 (2.7%)

Cyclosporin Ointment Adverse Event Insights

1,493 reports name Cyclosporin Ointment; 11 recorded a death outcome (0.7% of reported events, not a population-level mortality rate). Active ingredient: Cyclosporin Ointment. Administration routes: Unknown, Ophthalmic, Topical, Oral.

By species: Unknown (1,346 reports), Dog (138 reports), Human (6 reports). By breed: Unknown (1,352), Crossbred Canine/dog (27), Shih Tzu (17).

Leading clinical signs: Containers, Leaking (459), Underfilling, Container (424), Tubes, Damaged (385), Tubes, Leaking (373). Outcome, 147 coded reports: Ongoing leads at 43.5%.

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.