Drug profile

The FDA adverse-event record for Recombinant Human Insulin

1,671 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Recombinant Human Insulin. See the species affected, top reactions, and outcomes below.

1,671
adverse-event reports
4.5%
death-coded share
Dog
most-reported species
223
Vomiting - 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.
1,671
Total Reports
75
Deaths Reported
4.5%
Death Rate

Active Ingredients

Recombinant Human Insulin

Administration Routes

SubcutaneousUnknownIntradermalCutaneousOphthalmicOral

Species Affected

Dog 1,021
Cat 471
Unknown 172
Human 7

Most Affected Breeds

Crossbred Canine/dog 307
Domestic Shorthair 286
Unknown 181
Retriever - Labrador 136
Cat (unknown) 65
Schnauzer - Miniature 61
Pug 60
Dachshund (unspecified) 52
Domestic Longhair 49
Pinscher - Miniature 40

Most Reported Reactions

Vomiting 223
Lack of efficacy - NOS 182
Lethargy (see also Central nervous system depression in 'Neurological') 176
INEFFECTIVE, GLYCEMIC CONTROL 159
Hypoglycaemia 158
Decreased appetite 98
Uncoded sign 88
Suspension, Abnormal 70
Cataract 69
Diarrhoea 68
Urinary tract infection 66
Product problem 61

Outcome Breakdown

Recovered/Normal
866 (57.5%)
Outcome Unknown
445 (29.6%)
Ongoing
107 (7.1%)
Euthanized
52 (3.5%)
Died
23 (1.5%)
Recovered with Sequela
12 (0.8%)

Recombinant Human Insulin Adverse Event Insights

1,671 reports name Recombinant Human Insulin; 75 recorded a death outcome (4.5% of reported events, not a population-level mortality rate). Active ingredient: Recombinant Human Insulin. Administration routes: Subcutaneous, Unknown, Intradermal, Cutaneous.

By species: Dog (1,021 reports), Cat (471 reports), Unknown (172 reports). By breed: Crossbred Canine/dog (307), Domestic Shorthair (286), Unknown (181).

Leading clinical signs: Vomiting (223), Lack of efficacy - NOS (182), Lethargy (see also Central nervous system depression in 'Neurological') (176), INEFFECTIVE, GLYCEMIC CONTROL (159). Outcome, 1,505 coded reports: Recovered/Normal leads at 57.5%.

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.