Drug profile

The FDA adverse-event record for Cyclosporine

9,651 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Cyclosporine. See the species affected, top reactions, and outcomes below.

9,651
adverse-event reports
4.1%
death-coded share
Dog
most-reported species
2,185
Vomiting - 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.
9,651
Total Reports
399
Deaths Reported
4.1%
Death Rate

Active Ingredients

Cyclosporine

Administration Routes

OralUnknownOphthalmicTopicalIntraocularCutaneousOtherAuricular (Otic)RectalTransdermal

Species Affected

Dog 5,312
Unknown 2,371
Cat 1,920
Human 47
Other 1

Most Affected Breeds

Unknown 2,424
Domestic Shorthair 954
Crossbred Canine/dog 491
Retriever - Labrador 369
Shih Tzu 331
Cat (unknown) 274
Dog (unknown) 269
Domestic (unspecified) 229
Shepherd Dog - German 223
Terrier - West Highland White 220

Most Reported Reactions

Vomiting 2,185
Diarrhoea 1,067
Lack of efficacy - NOS 537
UNPALATABLE 505
Anorexia 459
Lethargy (see also Central nervous system depression in 'Neurological') 408
Weight loss 400
Product problem 375
Depression 345
Pruritus 344
Other abnormal test result NOS 325
Difficulty of Use 313

Outcome Breakdown

Outcome Unknown
1,549 (33.0%)
Ongoing
1,398 (29.7%)
Recovered/Normal
1,290 (27.4%)
Euthanized
202 (4.3%)
Died
197 (4.2%)
Recovered with Sequela
65 (1.4%)

Cyclosporine Adverse Event Insights

9,651 reports name Cyclosporine; 399 recorded a death outcome (4.1% of reported events, not a population-level mortality rate). Active ingredient: Cyclosporine. Administration routes: Oral, Unknown, Ophthalmic, Topical.

By species: Dog (5,312 reports), Unknown (2,371 reports), Cat (1,920 reports). By breed: Unknown (2,424), Domestic Shorthair (954), Crossbred Canine/dog (491).

Leading clinical signs: Vomiting (2,185), Diarrhoea (1,067), Lack of efficacy - NOS (537), UNPALATABLE (505). Outcome, 4,701 coded reports: Outcome Unknown leads at 33.0%.

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.