Drug profile

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

1,762 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Protamine Zinc Recombinant Human Insulin. See the species affected, top reactions, and outcomes below.

1,762
adverse-event reports
4.6%
death-coded share
Cat
most-reported species
388
Containers, Damaged - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
1,762
Total Reports
81
Deaths Reported
4.6%
Death Rate

Active Ingredients

Protamine Zinc Recombinant Human Insulin

Administration Routes

UnknownSubcutaneousParenteralOralIntramuscularSubconjunctival

Species Affected

Cat 783
Unknown 757
Dog 215
Human 7

Most Affected Breeds

Unknown 764
Domestic Shorthair 448
Cat (unknown) 157
Domestic Longhair 67
Domestic Mediumhair 29
Siamese 22
Dog (unknown) 18
Retriever - Labrador 18
Terrier - Yorkshire 16
Maine Coon 15

Most Reported Reactions

Containers, Damaged 388
INEFFECTIVE, GLYCEMIC CONTROL 377
Lack of efficacy - NOS 296
Vials, Damaged 231
Hypoglycaemia 165
Appearance, Abnormal 79
Vomiting 68
Product Defect, General 67
INEFFECTIVE, LOSS OF EFFECT 66
Death by euthanasia 60
Seal, Abnormal 47
Lethargy (see also Central nervous system depression in 'Neurological') 45

Outcome Breakdown

Outcome Unknown
707 (70.2%)
Recovered/Normal
172 (17.1%)
Euthanized
60 (6.0%)
Ongoing
47 (4.7%)
Died
21 (2.1%)

Protamine Zinc Recombinant Human Insulin Adverse Event Insights

1,762 reports name Protamine Zinc Recombinant Human Insulin; 81 recorded a death outcome (4.6% of reported events, not a population-level mortality rate). Active ingredient: Protamine Zinc Recombinant Human Insulin. Administration routes: Unknown, Subcutaneous, Parenteral, Oral.

By species: Cat (783 reports), Unknown (757 reports), Dog (215 reports). By breed: Unknown (764), Domestic Shorthair (448), Cat (unknown) (157).

Leading clinical signs: Containers, Damaged (388), INEFFECTIVE, GLYCEMIC CONTROL (377), Lack of efficacy - NOS (296), Vials, Damaged (231). Outcome, 1,007 coded reports: Outcome Unknown leads at 70.2%.

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.

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

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.