Deramaxx® Chewable Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Deramaxx® Chewable Tablets

Active ingredient

Deracoxib

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

April 8, 2020

Adverse event reports

Source: openFDA VeDDRA

11,958

Reports mentioning this ingredient

January 14, 2002 – March 18, 2026

1,693

Classified serious

per reporter assessment

305

Lack of expected efficacy

resistance signal

1,517

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 “DERACOXIB”. 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	3,271
Anorexia	2,362
Depression	1,850
Elevated blood urea nitrogen (BUN)	1,656
Elevated serum alkaline phosphatase (SAP)	1,554
Accidental exposure	1,516
Diarrhoea	1,420
Elevated creatinine	1,404
Elevated alanine aminotransferase (ALT)	1,249
Death by euthanasia	1,199
Death	987
Anaemia NOS	848
Leucocytosis NOS	760
Tablets, Abnormal	725
Abnormal radiograph finding	667
Hypoalbuminaemia	656
Other abnormal test result NOS	648
Polydipsia	631
Abdominal pain	604
Peritonitis	604

Species affected

Source: openFDA VeDDRA

Dog 10,989 Cat 101 Human 18 Other Canids 1 Horse 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