ALBON® Concentrated Solution 12.5% AGRIBON® Concentrated Solution 12.5%

Overview

Source: Animal Drugs @ FDA

Proprietary name

ALBON® Concentrated Solution 12.5% AGRIBON® Concentrated Solution 12.5%

Active ingredient

Sulfadimethoxine

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

January 3, 2017

Adverse event reports

Source: openFDA VeDDRA

1,677

Reports mentioning this ingredient

March 18, 1991 – March 19, 2026

211

Classified serious

per reporter assessment

408

Lack of expected efficacy

resistance signal

40

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 “SULFADIMETHOXINE”. 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
Lack of efficacy (protozoa) - Coccidia	288
Vomiting	166
Death	124
Diarrhoea	120
Depression	110
Anorexia	74
Vials, Leaking	73
Fever	65
Bolus, Abnormal	60
No sign	58
Anaemia NOS	53
Ataxia	47
Containers, Damaged	43
Lethargy (see also Central nervous system depression in 'Neurological')	42
Death by euthanasia	41
Accidental exposure	39
Convulsion	37
Facial oedema	37
Vials, Damaged	36
Seal, Abnormal	34

Species affected

Source: openFDA VeDDRA

Dog 899 Cat 319 Cattle 64 Human 14 Other 8 Sheep 7 Rabbit 5 Chicken 5 Goat 4 Ferret 2 Pig 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