Drug profile

The FDA adverse-event record for Optimmune

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

#1294 of 2,679
by report volume (all drugs)
38
adverse-event reports
21.1%
death-coded share
Dog
most-reported species
Verify with FDA CVM →

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Optimmune ranks #1283 of 2679 by total reports (38). Death-coded-share rank requires at least 50 reports. 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)
#1283
This drug, reports of 2679

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. Optimmune has 38 reports now versus 35 in that prior snapshot: 3 more (8.6%).

Report change
+3
Death-coded reports
+3
Death-coded share
+6.8 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 Optimmune changes

Signature read: Optimmune's 21.1% death-coded share is among the highest in the openFDA drug corpus.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
38
Total Reports
8
Deaths Reported
21.1%
Death-coded share of reports

Active Ingredients

Optimmune

Administration Routes

UnknownOphthalmicTopical

Species Affected

Dog 38

Most Affected Breeds

Shih Tzu 7
Terrier - Yorkshire 5
Shepherd Dog - German 4
Schnauzer - Miniature 3
Terrier - Bull 3
Maltese 2
Dachshund (unspecified) 2
Terrier - West Highland White 2
Chow Chow 2
Terrier (unspecified) 2

Most Reported Reactions

Vomiting 12
Death by euthanasia 8
Seizure NOS 6
Diarrhoea 5
Bloody diarrhoea 5
Lethargy (see also Central nervous system depression in Neurological) 5
Weakness 4
Inappropriate urination 4
Anxiety 4
Ataxia 3
Vocalisation 3
Not eating 3

Outcome Breakdown

Ongoing
16 (42.1%)
Euthanized
8 (21.1%)
Recovered/Normal
7 (18.4%)
Outcome Unknown
6 (15.8%)
Recovered with Sequela
1 (2.6%)

Optimmune: high death-coded share 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.

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 Optimmune (#1294 of 2,679 by report volume); death-coded 21.1%. PlainBreed drug row · death-coded share stamp 21.1% · 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 →