PayleanTM and TylanTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

PayleanTM and TylanTM

Active ingredient

Ractopamine Hydrochloride Tylosin Phosphate

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

February 9, 2026

Adverse event reports

Source: openFDA VeDDRA

750

Reports mentioning this ingredient

April 11, 2000 – December 30, 2025

24

Classified serious

per reporter assessment

7

Lack of expected efficacy

resistance signal

57

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”. 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	259
Recumbency	112
Accidental exposure	57
Hyperactivity	55
Lameness	47
Unclassifiable adverse event	39
Anorexia	34
Reluctant to move	33
Behavioural disorder NOS	32
Death by euthanasia	31
Depression	25
INEFFECTIVE, WEIGHT INC	25
Ruminal bloat	25
Muscle stiffness	24
INEFFECTIVE, LEAN CARCASS	21
Restlessness	21
Trembling	20
Tachycardia	19
Infertility NOS	19
Claw / hoof / nail disorder NOS	19

Species affected

Source: openFDA VeDDRA

Pig 509 Cattle 112 Turkey 33 Dog 32 Human 23 Horse 12 Sheep 3 Other 2 Goat 2 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