Drug profile

The FDA adverse-event record for Sirolimus

51 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Sirolimus. Species, reactions, and outcomes follow.

#1114 of 2,679
by report volume (all drugs)
51
adverse-event reports
11.8%
death-coded share
Cat
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Sirolimus ranks #1098 of 2679 by total reports (51) and #465 of 1130 by death-coded share (11.8%). National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#1098
This drug, reports of 2679
#465
This drug, death share of 1130

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Sirolimus has 51 reports now versus 35 in that prior snapshot: 16 more (45.7%).

Report change
+16
Death-coded reports
+0
Death-coded share
−5.4 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Sirolimus changes

Signature read: report volume at 51 is the most distinctive stamp on Sirolimus's FDA AER row.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
51
Total Reports
6
Deaths Reported
11.8%
Death-coded share of reports

Active Ingredients

Sirolimus

Administration Routes

OralUnknown

Species Affected

Cat 50
Dog 1

Most Affected Breeds

Domestic Shorthair 25
Sphynx 8
Domestic Longhair 3
Cat (unknown) 3
Ragdoll 2
Norwegian Forest 2
Domestic Mediumhair 2
British cat 2
Shepherd Dog - German 1
American Shorthair 1

Most Reported Reactions

Vomiting 16
Weight loss 11
Elevated alanine aminotransferase (ALT) 8
Administration error NOS 8
Lethargy (see also Central nervous system depression in Neurological) 7
Decreased appetite 6
Congestive heart failure 6
Hypertension 6
Elevated aspartate aminotransferase (AST) 5
Abnormal ultrasound finding 5
Pleural effusion 5
Abnormal radiograph finding 5

Outcome Breakdown

Outcome Unknown
19 (37.3%)
Ongoing
15 (29.4%)
Recovered/Normal
11 (21.6%)
Euthanized
3 (5.9%)
Died
3 (5.9%)

Sirolimus Adverse Event Insights

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.

Nationwide drugs with similar profiles

Two openFDA-derived peer sets for Sirolimus, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar death-coded share

Nearest other drugs by death-coded share (11.8% here), distinct from the volume row.

What to do with this drug

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

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

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Sirolimus (#1114 of 2,679 by report volume); death-coded 11.8%. PlainBreed drug row · report volume stamp 51 · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →