STELFONTA® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

STELFONTA®

Active ingredient

Tigilanol tiglate

Application type

NADA

Sponsor

QBiotics Group Ltd.

Applications on record

1

First published

October 26, 2023

Adverse event reports

Source: openFDA VeDDRA

1,998

Reports mentioning this ingredient

February 19, 2021 – March 24, 2026

1,230

Classified serious

per reporter assessment

1,086

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 “TIGILANOL TIGLATE”. 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	850
Injection site swelling	616
Wound	368
Injection site pain	286
Swelling NOS	269
Pain NOS	243
Injection site necrosis	213
Injection site complication NOS	202
Injection site bruising	190
Swollen limb	189
Injection site bleeding	166
Licking at injection site	160
Limb non-weight bearing	155
Diarrhoea	144
Lameness	143
Vomiting	130
Injection site serosanguinous discharge	129
Skin slough	122
Anorexia	121
Malodour	121

Species affected

Source: openFDA VeDDRA

Dog 1,974 Human 9 Horse 5 Cat 2 Other 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