TopmaxTM 9 — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

TopmaxTM 9

Active ingredient

Ractopamine Hydrochloride

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

March 25, 2020

Adverse event reports

Source: openFDA VeDDRA

326

Reports mentioning this ingredient

May 15, 2009 – March 26, 2025

164

Classified serious

per reporter assessment

26

Lack of expected efficacy

resistance signal

9

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 “RACTOPAMINE HYDROCHLORIDE”. 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	99
Lameness	32
Behavioural disorder NOS	22
Distress	18
Ruminal bloat	18
Recumbency	14
Respiratory tract disorder NOS	14
Pneumonia	14
Uncoded sign	12
Digestive tract disorder NOS	12
Residues in meat/offal	12
Lack of efficacy - NOS	11
Other abnormal test result NOS	11
Loss of condition	10
Tachycardia	10
Death by euthanasia	9
Accidental exposure	9
Lethargy (see also Central nervous system depression in 'Neurological')	9
Bloated	9
Trauma NOS	8

Species affected

Source: openFDA VeDDRA

Cattle 180 Pig 104 Dog 10 Horse 7 Human 5 Turkey 4 Cat 1 Goat 1 Chicken 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