Drug profile

The FDA adverse-event record for Tacrolimus

235 FDA reports name Tacrolimus, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#496 of 2,679
by report volume (all drugs)
235
adverse-event reports
11.5%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Tacrolimus ranks #496 of 2679 by total reports (235) and #479 of 1130 by death-coded share (11.5%). 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)
#496
This drug, reports of 2679
#479
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. Tacrolimus has 235 reports now versus 226 in that prior snapshot: 9 more (4.0%).

Report change
+9
Death-coded reports
+0
Death-coded share
−0.5 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 Tacrolimus changes

Signature read: death-coded report count at 27 is the most distinctive stamp on Tacrolimus'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.
235
Total Reports
27
Deaths Reported
11.5%
Death-coded share of reports

Active Ingredients

Tacrolimus

Administration Routes

UnknownOphthalmicTopicalIntraocularOtherOralAuricular (Otic)

Species Affected

Dog 231
Cat 2
Unknown 1
Human 1

Most Affected Breeds

Shih Tzu 27
Shepherd Dog - German 18
Pug 14
Chihuahua 14
Retriever - Labrador 11
Dog (unknown) 10
Terrier - Yorkshire 9
Lhasa Apso 7
Bulldog - French 7
Maltese 7

Most Reported Reactions

Vomiting 34
Diarrhoea 24
Weight loss 21
Lack of efficacy - NOS 21
Lethargy (see also Central nervous system depression in Neurological) 21
Lethargy (see also Central nervous system depression in 'Neurological') 18
Death by euthanasia 18
Polyuria 16
Behavioural disorder NOS 15
Dry eye 15
Corneal ulcer 14
Other abnormal test result NOS 13

Outcome Breakdown

Ongoing
75 (31.9%)
Outcome Unknown
65 (27.7%)
Recovered/Normal
62 (26.4%)
Euthanized
19 (8.1%)
Died
8 (3.4%)
Recovered with Sequela
6 (2.6%)

Tacrolimus: high report volume in the FDA AER row

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.

High-volume nationwide drug peers

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

Similar death-coded share

Nearest other drugs by death-coded share (11.5% 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 Tacrolimus (#496 of 2,679 by report volume); death-coded 11.5%. PlainBreed drug row · death-coded report count stamp 27 · 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 →