Pharmastatin®-20 Type A Medicated Article — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Pharmastatin®-20 Type A Medicated Article

Active ingredient

Nystatin

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

283

Reports mentioning this ingredient

January 21, 2016 – March 6, 2026

196

Classified serious

per reporter assessment

24

Lack of expected efficacy

resistance signal

18

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 “NYSTATIN”. 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
Deafness	86
Loss of hearing	52
Lack of efficacy - NOS	19
Vomiting	19
Accidental exposure	18
Medication error NOS	16
Lethargy (see also Central nervous system depression in Neurological)	14
Diarrhoea	11
Emesis	9
Temporary deafness	8
Potency, Low	8
Incorrect route of drug administration	8
Product Defect, General	7
Emesis (multiple)	6
Weight loss	6
Ear canal disorder	5
Ataxia	5
Partial deafness	5
Anxiety	5
Behavioural disorder NOS	5

Species affected

Source: openFDA VeDDRA

Dog 223 Cat 41 Human 6 Other 2 Horse 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