Drug profile

The FDA adverse-event record for Protamine Zinc Recombinant Human Insulin

1,869 FDA reports name Protamine Zinc Recombinant Human Insulin, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#115 of 2,679
by report volume (all drugs)
1,869
adverse-event reports
5.1%
death-coded share
Cat
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Protamine Zinc Recombinant Human Insulin ranks #115 of 2679 by total reports (1,869) and #789 of 1130 by death-coded share (5.1%). 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)
#115
This drug, reports of 2679
#789
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. Protamine Zinc Recombinant Human Insulin has 1,869 reports now versus 1,823 in that prior snapshot: 46 more (2.5%).

Report change
+46
Death-coded reports
+8
Death-coded share
+0.3 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 Protamine Zinc Recombinant Human Insulin changes

Signature read: 1,869 reports place Protamine Zinc Recombinant Human Insulin in the upper third of FDA AER volume (#115 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
1,869
Total Reports
95
Deaths Reported
5.1%
Death-coded share of reports

Active Ingredients

Protamine Zinc Recombinant Human Insulin

Administration Routes

UnknownSubcutaneousParenteralOralIntramuscularSubconjunctivalOtherIntradermal

Species Affected

Cat 850
Unknown 783
Dog 229
Human 7

Most Affected Breeds

Unknown 790
Domestic Shorthair 488
Cat (unknown) 170
Domestic Longhair 69
Domestic Mediumhair 33
Siamese 26
Dog (unknown) 19
Retriever - Labrador 19
Terrier - Yorkshire 17
Maine Coon 15

Most Reported Reactions

Containers, Damaged 398
INEFFECTIVE, GLYCEMIC CONTROL 390
Lack of efficacy - NOS 336
Vials, Damaged 240
Hypoglycaemia 175
Appearance, Abnormal 85
Death by euthanasia 72
Vomiting 70
INEFFECTIVE, LOSS OF EFFECT 68
Product Defect, General 67
Seal, Abnormal 50
Lethargy (see also Central nervous system depression in 'Neurological') 45

Outcome Breakdown

Outcome Unknown
758 (69.7%)
Recovered/Normal
177 (16.3%)
Euthanized
72 (6.6%)
Ongoing
58 (5.3%)
Died
23 (2.1%)

Protamine Zinc Recombinant Human Insulin: 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.

High-volume nationwide drug peers

Two openFDA-derived peer sets for Protamine Zinc Recombinant Human Insulin, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other drugs by FDA report count (1,869 here).

Similar death-coded share

Nearest other drugs by death-coded share (5.1% here), distinct from the volume row.

What to do with this drug

  • Compare Protamine Zinc Recombinant Human Insulin's report volume and death-coded share against similar drugs nationwide. See similar drugs
  • Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
  • Browse the full drug directory to compare report counts across products. All drugs

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 Protamine Zinc Recombinant Human Insulin (#115 of 2,679 by report volume); death-coded 5.1%. PlainBreed drug row · report volume stamp 1,869 · 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 →