DenagardTM 12.5% — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

DenagardTM 12.5%

Active ingredient

Tiamulin Hydrogen Fumarate

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

April 25, 2024

Adverse event reports

Source: openFDA VeDDRA

106

Reports mentioning this ingredient

February 4, 1988 – October 18, 2024

25

Classified serious

per reporter assessment

50

Lack of expected efficacy

resistance signal

3

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 “TIAMULIN HYDROGEN FUMARATE”. 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
Death	34
Lack of efficacy - NOS	28
Lack of efficacy (bacteria) - NOS	21
Diarrhoea	7
Product Defect, General	7
NT - Abnormal necropsy finding NOS	7
Solution, Abnormal	6
Vials, Leaking	6
Unclassifiable adverse event	5
Digestive tract disorder NOS	4
Death by euthanasia	4
Other abnormal test result NOS	4
Depression	3
Granules/Powder, Abnormal	3
Accidental exposure	3
Cardiac disorder NOS	3
Containers, Leaking	3
Pneumonia	2
Suspected infectious agent transmission	2
Labelled drug-drug interaction medication error	2

Species affected

Source: openFDA VeDDRA

Pig 71 Human 3 Other Birds 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