Eprizero® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Eprizero®

Active ingredient

Eprinomectin

Application type

ANADA

Sponsor

Norbrook Laboratories, Ltd.

Applications on record

1

First published

July 2, 2018

Adverse event reports

Source: openFDA VeDDRA

5,251

Reports mentioning this ingredient

June 18, 1997 – March 26, 2026

761

Classified serious

per reporter assessment

1,340

Lack of expected efficacy

resistance signal

352

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 “EPRINOMECTIN”. 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	487
Lethargy (see also Central nervous system depression in Neurological)	471
Hypersalivation	398
Death	357
Accidental exposure	351
Foaming at the mouth	310
Application site hair loss	297
Ataxia	261
Drooling	246
Lack of efficacy (endoparasite) - tapeworm	215
Lack of efficacy (endoparasite) - roundworm NOS	209
Not eating	205
Lack of efficacy (ectoparasite) - flea	188
Diarrhoea	159
Death by euthanasia	152
Anorexia	133
Lack of efficacy (ectoparasite) - lice	129
Behavioural disorder NOS	126
Incorrect route of drug administration	126
Seizure NOS	126

Species affected

Source: openFDA VeDDRA

Cat 3,498 Cattle 1,054 Human 160 Dog 97 Horse 7 Goat 7 Sheep 6 Other Deer 4 Deer 2 Fish 1 Alpaca 1 Pig 1

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

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