Drug profile

The FDA adverse-event record for Proheart 12

21 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Proheart 12. Species, reactions, and outcomes follow.

#1767 of 2,679
by report volume (all drugs)
21
adverse-event reports
4.8%
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, Proheart 12 ranks #1727 of 2679 by total reports (21). 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)
#1727
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. Proheart 12 has 21 reports now versus 15 in that prior snapshot: 6 more (40.0%).

Report change
+6
Death-coded reports
+0
Death-coded share
−1.9 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 Proheart 12 changes

Signature read: death-coded report count at 1 is the most distinctive stamp on Proheart 12'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.
21
Total Reports
1
Deaths Reported
4.8%
Death-coded share of reports

Active Ingredients

Proheart 12

Administration Routes

SubcutaneousUnknownParenteral

Species Affected

Dog 21

Most Affected Breeds

Retriever - Labrador 4
Crossbred Canine/dog 4
Bulldog - French 2
Terrier - Yorkshire 2
Siberian Husky 2
Beagle 2
Dachshund (unspecified) 1
Corgi - Welsh Cardigan 1
Samoyed 1
Terrier - Cairn 1

Most Reported Reactions

Vomiting 7
Hypersensitivity reaction 4
Facial swelling (see also Skin) 4
Panting 3
Lethargy (see also Central nervous system depression in Neurological) 3
Lack of efficacy (endoparasite) - heartworm 3
Hives (see also Skin) 3
Neutrophilia 2
Uncomfortable 2
Restlessness 2
Emesis (multiple) 2
Vomiting bile 2

Outcome Breakdown

Ongoing
9 (42.9%)
Recovered/Normal
8 (38.1%)
Outcome Unknown
3 (14.3%)
Euthanized
1 (4.8%)

Proheart 12: low 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 Proheart 12 (#1767 of 2,679 by report volume); death-coded 4.8%. PlainBreed drug row · death-coded report count stamp 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 →