Program® Flavor Tabs® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Program® Flavor Tabs®

Active ingredient

Lufenuron

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

November 26, 2018

Adverse event reports

Source: openFDA VeDDRA

3,554

Reports mentioning this ingredient

January 17, 1995 – March 9, 2026

379

Classified serious

per reporter assessment

863

Lack of expected efficacy

resistance signal

38

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 “LUFENURON”. 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
Vomiting	715
Depression	407
Anorexia	328
Diarrhoea	326
INEFFECTIVE, HOOKS	260
Pruritus	233
Lack of efficacy (endoparasite) - heartworm	218
Fever	121
Lack of efficacy (ectoparasite) - flea	121
Death	120
Injection site mass	111
Lethargy (see also Central nervous system depression in 'Neurological')	94
Injection site swelling	89
Product problem	89
Underfilling, Package	88
Alopecia NOS	82
Convulsion	74
Product syringe issue	73
Injection site abscess	70
Ataxia	69

Species affected

Source: openFDA VeDDRA

Dog 2,106 Cat 1,109 Human 15 Ferret 3 Other 2 Wolf 2 Fish 1 Quail 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