Tylan SolubleTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Tylan SolubleTM

Active ingredient

Tylosin Tartrate

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

December 30, 2019

Adverse event reports

Source: openFDA VeDDRA

524

Reports mentioning this ingredient

August 17, 2011 – March 17, 2026

104

Classified serious

per reporter assessment

115

Lack of expected efficacy

resistance signal

7

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 TARTRATE”. 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 - NOS	48
UNPALATABLE	37
Diarrhoea	31
Vomiting	23
Death	17
Other abnormal test result NOS	17
Emesis	17
Color, Abnormal	17
Product problem	16
Underfilling, Container	15
Not eating	14
INEFFECTIVE, ANTIBIOTIC	14
Lethargy (see also Central nervous system depression in 'Neurological')	13
Bad taste	11
Lack of efficacy (bacteria) - NOS	10
Odor, Abnormal	10
Behavioural disorder NOS	9
Appearance, Abnormal	9
Loose stool	8
Death by euthanasia	8

Species affected

Source: openFDA VeDDRA

Dog 332 Human 25 Chicken 20 Cat 18 Cattle 15 Pig 8 Other Birds 2 Turkey 1 Duck 1 Pheasant 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