ZubrinTM Rapidly-Disintegrating Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

ZubrinTM Rapidly-Disintegrating Tablets

Active ingredient

Tepoxalin

Application type

NADA

Sponsor

Intervet, Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

1,166

Reports mentioning this ingredient

April 4, 2003 – August 14, 2013

0

Classified serious

per reporter assessment

1

Lack of expected efficacy

resistance signal

24

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 “TEPOXALIN”. 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	276
Diarrhoea	174
Anorexia	150
Depression	143
Death by euthanasia	104
Bloody diarrhoea	103
Melaena	101
Death	97
Anaemia NOS	94
Blood in vomit	88
Labelled drug-drug interaction medication error	67
Elevated serum alkaline phosphatase (SAP)	50
Ataxia	44
Elevated blood urea nitrogen (BUN)	40
Elevated alanine aminotransferase (ALT)	39
Haematochezia	36
Tablets, Abnormal	35
Convulsion	34
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	34
Elevated creatinine	30

Species affected

Source: openFDA VeDDRA

Dog 1,089 Cat 15 Human 8 Other 2 Pig 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