Purina® Horse & Colt Wormer — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Purina® Horse & Colt Wormer

Active ingredient

Pyrantel Tartrate

Application type

NADA

Sponsor

Bimeda Animal Health Ltd.

Applications on record

1

First published

April 26, 2019

Adverse event reports

Source: openFDA VeDDRA

1,023

Reports mentioning this ingredient

March 23, 1988 – August 5, 2025

18

Classified serious

per reporter assessment

70

Lack of expected efficacy

resistance signal

207

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 “PYRANTEL TARTRATE”. 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
Accidental exposure	207
No sign	150
INEFFECTIVE, STRONGYLES	130
Abdominal pain	106
Containers, Abnormal	100
Seal, Abnormal	89
INEFFECTIVE, WORMS NOS	70
INEFFECTIVE, PARASITE(S) NOS	62
Depression	43
Diarrhoea	43
Death	38
Anorexia	32
INEFFECTIVE, ASCARIDS NOS	29
Weight loss	28
Contamination, Mold	27
Containers, Damaged	22
Digestive tract disorder NOS	22
Vomiting	21
Death by euthanasia	21
Lack of efficacy (endoparasite) - Cyathostominae	19

Species affected

Source: openFDA VeDDRA

Horse 739 Dog 49 Pig 8 Human 8 Goat 6 Donkey 4 Other 2 Sheep 2 Cat 1 Mule 1 Alpaca 1 Rabbit 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