BexacatTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

BexacatTM

Active ingredient

Bexagliflozin

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

May 14, 2026

Adverse event reports

Source: openFDA VeDDRA

3,835

Reports mentioning this ingredient

March 28, 2023 – March 26, 2026

843

Classified serious

per reporter assessment

566

Lack of expected efficacy

resistance signal

14

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “BEXAGLIFLOZIN”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
Ketosis	1,445
Weight loss	999
Hyperglycaemia	828
Diarrhoea	706
Lack of efficacy - NOS	542
Vomiting	419
Lethargy (see also Central nervous system depression in Neurological)	411
Hypoglycaemia	396
Other abnormal test result NOS	376
Glucosuria	343
Not eating	322
Diabetic ketoacidosis	258
Weight gain	240
Elevated blood urea nitrogen (BUN)	237
Death by euthanasia	236
Polyuria	220
Dehydration	218
Decreased appetite	213
Polydipsia	201
Elevated alanine aminotransferase (ALT)	189

Species affected

Source: openFDA VeDDRA

Cat 3,770 Dog 18 Fallow 1 Other 1

Regulatory context

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient