Drug profile

The FDA adverse-event record for Sirolimus

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

10
adverse-event reports
60.0%
death-coded share
Cat
most-reported species
3
Death - 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.
10
Total Reports
6
Deaths Reported
60.0%
Death Rate

Active Ingredients

Sirolimus

Administration Routes

OralUnknown

Species Affected

Cat 9
Dog 1

Most Affected Breeds

Domestic Shorthair 4
Shepherd Dog - German 1
American Shorthair 1
Domestic Longhair 1
Cat (unknown) 1
Cat (other) 1
Sphynx 1

Most Reported Reactions

Death 3
Vomiting 2
Hypokalaemia 2
Congestive heart failure 2
Bloody diarrhoea 1
Overdose 1
Lethargy (see also Central nervous system depression in Neurological) 1
Renal disorder NOS 1
Elevated lactate 1
Elevated aspartate aminotransferase (AST) 1
Elevated alanine aminotransferase (ALT) 1
Discomfort NOS 1

Outcome Breakdown

Euthanized
3 (30.0%)
Died
3 (30.0%)
Recovered/Normal
2 (20.0%)
Ongoing
2 (20.0%)

Sirolimus Adverse Event Insights

10 reports name Sirolimus; 6 recorded a death outcome (60.0% of reported events, not a population-level mortality rate). Active ingredient: Sirolimus. Administration routes: Oral, Unknown.

By species: Cat (9 reports), Dog (1 reports). By breed: Domestic Shorthair (4), Shepherd Dog - German (1), American Shorthair (1).

Leading clinical signs: Death (3), Vomiting (2), Hypokalaemia (2), Congestive heart failure (2). Outcome, 10 coded reports: Euthanized leads at 30.0%.

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.