Drug profile

The FDA adverse-event record for Velagliflozin Proline Monohydrate

3,392 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Velagliflozin Proline Monohydrate. See the species affected, top reactions, and outcomes below.

3,392
adverse-event reports
7.7%
death-coded share
Cat
most-reported species
1,089
Ketosis - 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.
3,392
Total Reports
260
Deaths Reported
7.7%
Death Rate

Active Ingredients

Velagliflozin Proline Monohydrate

Administration Routes

OralUnknownTopicalSubcutaneousParenteralUnassignedPerineural

Species Affected

Cat 3,136
Unknown 179
Dog 70
Human 6
Lynx 1

Most Affected Breeds

Domestic Shorthair 2,165
Domestic Longhair 275
Cat (unknown) 258
Unknown 199
Domestic Mediumhair 194
Beagle 68
Siamese 65
Maine Coon 44
Ragdoll 18
Russian 14

Most Reported Reactions

Ketosis 1,089
Lack of efficacy - NOS 760
Weight loss 710
Diarrhoea 543
Vomiting 469
Ketonuria 420
Lethargy (see also Central nervous system depression in Neurological) 419
Anorexia 299
Death by euthanasia 206
Elevated blood urea nitrogen (BUN) 170
Hypokalaemia 160
Dehydration 146

Outcome Breakdown

Outcome Unknown
2,278 (70.9%)
Recovered/Normal
377 (11.7%)
Ongoing
298 (9.3%)
Euthanized
206 (6.4%)
Died
54 (1.7%)

Velagliflozin Proline Monohydrate Adverse Event Insights

3,392 reports name Velagliflozin Proline Monohydrate; 260 recorded a death outcome (7.7% of reported events, not a population-level mortality rate). Active ingredient: Velagliflozin Proline Monohydrate. Administration routes: Oral, Unknown, Topical, Subcutaneous.

By species: Cat (3,136 reports), Unknown (179 reports), Dog (70 reports). By breed: Domestic Shorthair (2,165), Domestic Longhair (275), Cat (unknown) (258).

Leading clinical signs: Ketosis (1,089), Lack of efficacy - NOS (760), Weight loss (710), Diarrhoea (543). Outcome, 3,213 coded reports: Outcome Unknown leads at 70.9%.

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.