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Depo-Medrol®

Methylprednisolone Acetate

Veterinary NADA Approved 2,267 adverse event reports

Overview

Source: Animal Drugs @ FDA
Proprietary name
Depo-Medrol®
Active ingredient
Methylprednisolone Acetate
Application type
NADA
Sponsor
Zoetis Inc.
Applications on record
1
First published
December 7, 2021

Adverse event reports

Source: openFDA VeDDRA
2,267
Reports mentioning this ingredient
May 29, 1987 – March 22, 2026
711
Classified serious
per reporter assessment
327
Lack of expected efficacy
resistance signal
8
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 “METHYLPREDNISOLONE 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
Vomiting 175
Death 174
Anorexia 169
INEFFECTIVE, ANTIINFLAMMATORY 118
Depression 117
Lack of efficacy - NOS 108
Lethargy (see also Central nervous system depression in 'Neurological') 102
Weight loss 99
Death by euthanasia 97
Hyperglycaemia 94
Dyspnoea 81
Polydipsia 76
Suspension, Abnormal 73
Ataxia 67
Fever 67
Elevated alanine aminotransferase (ALT) 66
Abnormal radiograph finding 64
Polyuria 61
Diarrhoea 58
Anaphylaxis 54

Species affected

Source: openFDA VeDDRA
Cat 1,450 Dog 547 Horse 98 Other 5 Human 2 Pig 1 Sheep 1 Goat 1 Cattle 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