Meticortelone Acetate — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Meticortelone Acetate

Active ingredient

Prednisolone Acetate

Application type

NADA

Sponsor

Intervet, Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

187

Reports mentioning this ingredient

June 4, 2012 – October 21, 2025

118

Classified serious

per reporter assessment

20

Lack of expected efficacy

resistance signal

5

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 ACETATE”. 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	38
Deafness	34
Lack of efficacy - NOS	19
Behavioural disorder NOS	17
Impaired hearing	13
Emesis	11
Hearing decreased	10
Lethargy (see also Central nervous system depression in 'Neurological')	9
Other ear disorder NOS	7
Partial deafness	7
Diarrhoea	6
Inappetence	6
Vocalisation	5
Ear pain	5
Accidental exposure	5
INEFFECTIVE, OTHER DRUG(S)	5
Anxiety	4
Otitis NOS	3
Seizure NOS	3
Ear infection NOS	3

Species affected

Source: openFDA VeDDRA

Dog 175 Cat 10 Human 1 Rat 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