ActogainTM and Monovet® and TylanTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

ActogainTM and Monovet® and TylanTM

Active ingredient

Monensin Ractopamine Hydrochloride Tylosin

Application type

ANADA

Sponsor

Huvepharma EOOD

Applications on record

1

First published

February 21, 2020

Adverse event reports

Source: openFDA VeDDRA

2,605

Reports mentioning this ingredient

May 15, 2009 – March 23, 2026

1,431

Classified serious

per reporter assessment

522

Lack of expected efficacy

resistance signal

53

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 “MONENSIN SODIUM”. 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	1,091
Diarrhoea	248
Decreased appetite	196
Lack of efficacy (protozoa) - Coccidia	193
Milk production decrease	184
Not eating	176
Lack of efficacy - NOS	155
Anorexia	145
NT - Abnormal necropsy finding NOS	145
Recumbency	131
Loose stool	122
Alteration of milk quality	118
INEFFECTIVE, COCCIDIA	108
Cardiac disorder NOS	97
Lethargy (see also Central nervous system depression in 'Neurological')	85
Other abnormal test result NOS	83
Necropsy performed	82
Death by euthanasia	75
Pneumonia	71
Increased mortality rate	60

Species affected

Source: openFDA VeDDRA

Cattle 1,964 Turkey 193 Horse 117 Chicken 95 Goat 42 Sheep 33 Pig 31 Dog 15 Human 14 Quail 6 Donkey 3 Pheasant 3

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

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