NexGard® PLUS — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

NexGard® PLUS

Active ingredient

Afoxolaner Moxidectin Pyrantel Pamoate

Application type

NADA

Sponsor

Boehringer lngelheim Animal Health USA, Inc.

Applications on record

1

First published

February 2, 2026

Adverse event reports

Source: openFDA VeDDRA

53,605

Reports mentioning this ingredient

April 29, 2013 – March 24, 2026

19,196

Classified serious

per reporter assessment

16,578

Lack of expected efficacy

resistance signal

150

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 “AFOXOLANER”. 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	11,336
Lethargy (see also Central nervous system depression in 'Neurological')	4,591
Lack of efficacy (ectoparasite) - tick NOS	4,497
Diarrhoea	4,105
Lack of efficacy (ectoparasite) - flea	3,979
Seizure NOS	3,404
Lack of efficacy (bacteria) - Borrelia	2,790
Lack of efficacy (bacteria) - NOS	2,462
Lack of efficacy (tick)	2,056
Pruritus	1,799
Tablets, Abnormal	1,791
Itching	1,620
Skin disorders NOS	1,366
Anorexia	1,366
Not eating	1,278
Panting	1,123
Behavioural disorder NOS	1,070
Shaking	971
Other abnormal test result NOS	919
Ataxia	857

Species affected

Source: openFDA VeDDRA

Dog 49,881 Human 81 Cat 72 Other Canids 3 Other 2 Wolf 1 Spider 1 Goat 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