Betasone Aqueous Suspension — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Betasone Aqueous Suspension

Active ingredient

Betamethasone Dipropionate Betamethasone Sodium Phosphate

Application type

NADA

Sponsor

Intervet, Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

1,704

Reports mentioning this ingredient

July 21, 1993 – February 21, 2024

0

Classified serious

per reporter assessment

25

Lack of expected efficacy

resistance signal

63

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 “BETAMETHASONE VALERATE, CLOTRIMAZOLE, GENTAMICIN SULFATE”. 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	931
Partial deafness	193
Missing Cap	121
Applicator, Abnormal	84
Accidental exposure	63
Vomiting	37
Depression	36
Pinnal irritation	32
Ataxia	27
Pinnal erythema	27
Diarrhoea	25
Head tilt - ear disorder	24
Death by euthanasia	24
Tubes, Abnormal	23
Dispenser, Abnormal	23
Anorexia	20
Tubes, Leaking	20
External ear disorder NOS	19
Application site erythema	18
Lack of efficacy - NOS	17

Species affected

Source: openFDA VeDDRA

Dog 1,355 Cat 53 Human 10 Other 3 Guinea Pig 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