Praziquantel Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Praziquantel Tablets

Active ingredient

Praziquantel

Application type

ANADA

Sponsor

Felix Pharmaceuticals Pvt. Ltd.

Applications on record

2

First published

February 1, 2023

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
200734	ANADA	Approved	—
200834	ANADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

14,779

Reports mentioning this ingredient

February 17, 1987 – March 27, 2026

5,323

Classified serious

per reporter assessment

2,289

Lack of expected efficacy

resistance signal

247

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 “PRAZIQUANTEL”. 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	3,162
Lethargy (see also Central nervous system depression in 'Neurological')	1,224
Lack of efficacy (endoparasite) - tapeworm	1,140
Diarrhoea	1,010
Emesis (multiple)	897
Emesis	876
Application site alopecia	804
Hypersalivation	793
Behavioural disorder NOS	675
Anorexia	664
Ataxia	593
Product label issues	487
Overdose	430
Underdose	396
Death	355
Hyperactivity	321
Vocalisation	302
Tablets, Abnormal	296
Lethargy (see also Central nervous system depression in Neurological)	288
Decreased appetite	284

Species affected

Source: openFDA VeDDRA

Dog 7,265 Cat 5,705 Human 102 Other 4 Cockatiel 4 Snake 1 Crustacea 1 Chinchilla 1 Rabbit 1 Horse 1 Whale 1 Cattle 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