VerafloxTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

VerafloxTM

Active ingredient

Pradofloxacin

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

April 1, 2021

Adverse event reports

Source: openFDA VeDDRA

620

Reports mentioning this ingredient

February 18, 2013 – March 13, 2026

353

Classified serious

per reporter assessment

34

Lack of expected efficacy

resistance signal

1

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 “PRADOFLOXACIN”. 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
Behavioural disorder NOS	63
Vomiting	56
Hypersalivation	50
Diarrhoea	47
Lethargy (see also Central nervous system depression in 'Neurological')	42
Anorexia	41
Uncoded sign	35
Death	31
Death by euthanasia	30
Other abnormal test result NOS	28
Blindness	27
UNPALATABLE	27
Weight loss	26
Ataxia	20
Vocalisation	18
Lack of efficacy - NOS	18
Elevated blood urea nitrogen (BUN)	16
Hiding	16
Foaming at the mouth	15
Emesis (multiple)	15

Species affected

Source: openFDA VeDDRA

Cat 506 Dog 13 Human 3 Cattle 2 Fallow 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