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Dex-A-Vet Injection

Dexamethasone Sodium Phosphate

Veterinary NADA Approved 2 applications 819 adverse event reports

Overview

Source: Animal Drugs @ FDA
Proprietary name
Dex-A-Vet Injection
Active ingredient
Dexamethasone Sodium Phosphate
Application type
NADA
Sponsor
Bimeda Animal Health Ltd.
Applications on record
2
First published
October 2, 2018

Applications

Source: Animal Drugs @ FDA
Every Green Book application recorded for this proprietary name.
Application no. Type Status Withdrawn
99604 NADA Approved —
99605 NADA Approved —

Adverse event reports

Source: openFDA VeDDRA
819
Reports mentioning this ingredient
October 30, 1987 – March 24, 2026
616
Classified serious
per reporter assessment
82
Lack of expected efficacy
resistance signal
0
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 “DEXAMETHASONE SODIUM PHOSPHATE”. 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
Lot # and /or Expiration date missing 15
Death 7
Labels, Abnormal 5
Cardiac arrest 2
Collapse (see also 'Cardio-vascular' and 'Systemic disorders') 2
Depression 2
Ataxia 2
Vomiting 2
Physical label missing 2
Apnoea 1
Neurological signs NOS 1
Shock 1
Injection site pain 1
Convulsion 1
Hypersalivation 1
Spasm 1
Murmur 1
Adipsia 1
Anorexia 1
Hypothermia 1

Species affected

Source: openFDA VeDDRA
Dog 622 Cat 166 Other 2 Ferret 2 Horse 1 Lynx 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