TylanTM 200 Injection TylanTM 50 Injection — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

TylanTM 200 Injection TylanTM 50 Injection

Active ingredient

Tylosin

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

May 14, 2026

Adverse event reports

Source: openFDA VeDDRA

1,160

Reports mentioning this ingredient

June 16, 1987 – March 8, 2026

115

Classified serious

per reporter assessment

239

Lack of expected efficacy

resistance signal

165

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 “TYLOSIN”. 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
Unclassifiable adverse event	225
Accidental exposure	165
Death	159
Lack of efficacy (bacteria) - NOS	157
Diarrhoea	55
Anorexia	54
Injection site pain	50
Lack of efficacy - NOS	42
Injection site swelling	38
UNPALATABLE	38
Depression	36
Granules/Powder, Abnormal	32
No sign	31
Recumbency	29
DEATH-TREATMENT FAILURE	23
Sensory abnormality NOS	22
Vomiting	21
Dyspnoea	20
Pruritus	20
Rash	19

Species affected

Source: openFDA VeDDRA

Dog 276 Human 202 Pig 198 Cattle 168 Chicken 61 Cat 38 Other Birds 21 Horse 18 Goat 13 Turkey 13 Rabbit 5 Other 4

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