Ivermectin Chewable Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Ivermectin Chewable Tablets

Active ingredient

Ivermectin

Application type

ANADA

Sponsor

Cronus Pharma Specialities India Private Ltd.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

119,100

Reports mentioning this ingredient

January 2, 1987 – March 27, 2026

43,067

Classified serious

per reporter assessment

70,863

Lack of expected efficacy

resistance signal

1,189

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 “IVERMECTIN”. 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 (endoparasite) - heartworm	20,312
Lack of efficacy (endoparasite) - hookworm	14,429
Digestive tract disorder NOS	12,826
INEFFECTIVE, HEARTWORM LARVAE	12,510
Vomiting	9,319
INEFFECTIVE, HOOKS	6,797
Cardiac disorder NOS	6,522
Lack of efficacy - NOS	5,397
Tablets, Abnormal	5,160
Lack of efficacy (endoparasite) - roundworm NOS	4,982
Diarrhoea	4,429
INEFFECTIVE, ASCARIDS NOS	4,424
Lethargy (see also Central nervous system depression in 'Neurological')	2,489
Death	2,385
Containers, Damaged	2,185
Ataxia	1,780
Lack of efficacy (protozoa) - Coccidia	1,618
Underdose	1,563
Hard, clumping	1,498
Overdose	1,448

Species affected

Source: openFDA VeDDRA

Dog 103,255 Cattle 1,779 Horse 1,184 Cat 930 Human 498 Sheep 218 Pig 125 Goat 65 Other 39 Rabbit 31 Guinea Pig 24 Donkey 22

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