Prednis-A-Vet Injection — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Prednis-A-Vet Injection

Active ingredient

Prednisolone Sodium Phosphate

Application type

NADA

Sponsor

Bimeda Animal Health Ltd.

Applications on record

1

First published

October 2, 2018

Adverse event reports

Source: openFDA VeDDRA

2,978

Reports mentioning this ingredient

November 18, 1993 – March 27, 2026

1,693

Classified serious

per reporter assessment

533

Lack of expected efficacy

resistance signal

14

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 “PREDNISOLONE”. 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
Loss of hearing	195
Deafness	144
Lack of efficacy - NOS	86
Impaired hearing	78
Hearing decreased	65
Behavioural disorder NOS	36
Vomiting	32
Partial deafness	30
Ear discharge	30
Deafness NOS	29
Drug administration duration too long	27
Lethargy (see also Central nervous system depression in 'Neurological')	22
Ear infection NOS	20
No sign	17
Other ear disorder NOS	17
Diarrhoea	15
Overdose	15
Other abnormal test result NOS	15
Weight loss	13
Tablets, Abnormal	13

Species affected

Source: openFDA VeDDRA

Dog 1,739 Cat 1,142 Ferret 5 Human 5 Horse 4 Cattle 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