advantusTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

advantusTM

Active ingredient

Imidacloprid

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

May 21, 2021

Adverse event reports

Source: openFDA VeDDRA

19,191

Reports mentioning this ingredient

September 5, 2008 – March 24, 2026

9,937

Classified serious

per reporter assessment

5,169

Lack of expected efficacy

resistance signal

472

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 “IMIDACLOPRID”. 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 (ectoparasite) - flea	3,146
Pruritus	2,175
Lethargy (see also Central nervous system depression in 'Neurological')	2,055
Behavioural disorder NOS	1,587
Vomiting	1,203
Hypersalivation	1,025
Anorexia	887
Application site alopecia	860
Diarrhoea	851
Underfilling, Tubes	677
Ataxia	675
Other abnormal test result NOS	636
Application site pruritus	514
Agitation	498
Lack of efficacy (endoparasite) - heartworm	496
Hyperactivity	472
Accidental exposure	464
Seizure NOS	455
Overdose	434
Application site erythema	428

Species affected

Source: openFDA VeDDRA

Dog 10,700 Cat 6,778 Human 297 Rabbit 37 Ferret 21 Cockatiel 7 Wolf 3 Mouse 2 Leopard 1 Chicken 1 Crow 1 Guinea Pig 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