ExzoltTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

ExzoltTM

Active ingredient

Fluralaner

Application type

NADA

Sponsor

Intervet, Inc.

Applications on record

1

First published

August 3, 2026

Adverse event reports

Source: openFDA VeDDRA

3,711

Reports mentioning this ingredient

May 11, 2012 – March 26, 2026

871

Classified serious

per reporter assessment

1,395

Lack of expected efficacy

resistance signal

13

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 “FLURALANER”. 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
Vomiting	81
Lethargy (see also Central nervous system depression in 'Neurological')	46
Seizure NOS	38
Diarrhoea	33
Anorexia	30
Death	29
Lack of efficacy (ectoparasite) - tick NOS	24
Death by euthanasia	24
Lack of efficacy (ectoparasite) - flea	17
Weight loss	14
Ataxia	14
Behavioural disorder NOS	11
Panting	10
Pruritus	9
Renal failure	7
Decreased appetite	7
Polydipsia	7
Depression	6
Bloody diarrhoea	6
Elevated blood urea nitrogen (BUN)	6

Species affected

Source: openFDA VeDDRA

Dog 3,536 Cat 171 Other Canids 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