CAPSTAR® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

CAPSTAR®

Active ingredient

Nitenpyram

Application type

NADA

Sponsor

Sergeant’s Pet Care Products LLC

Applications on record

1

First published

May 17, 2021

Adverse event reports

Source: openFDA VeDDRA

21,316

Reports mentioning this ingredient

February 13, 2001 – March 24, 2026

2,036

Classified serious

per reporter assessment

8,746

Lack of expected efficacy

resistance signal

219

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 “NITENPYRAM”. 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	6,268
Hyperactivity	2,511
Panting	2,068
Lack of efficacy (flea)	1,743
Vocalisation	1,438
Vomiting	1,358
Lethargy (see also Central nervous system depression in 'Neurological')	1,156
Scratching	1,144
Agitation	1,093
Pruritus	982
Lack of efficacy - NOS	787
Itching	742
Product label issues	736
Diarrhoea	731
Product problem	688
Behavioural disorder NOS	685
Anorexia	579
Depression	572
Underfilling, Package	555
Death	468

Species affected

Source: openFDA VeDDRA

Dog 10,643 Cat 8,656 Human 158 Other 63 Ferret 5 Other Canids 2 Rabbit 1 Other Mammals 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