Ayradiatm — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Ayradiatm

Active ingredient

Metronidazole

Application type

NADA

Sponsor

Virbac AH, Inc.

Applications on record

1

First published

March 26, 2024

Adverse event reports

Source: openFDA VeDDRA

3,533

Reports mentioning this ingredient

June 27, 1998 – March 25, 2026

1,782

Classified serious

per reporter assessment

530

Lack of expected efficacy

resistance signal

18

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 “METRONIDAZOLE”. 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
Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle')	116
Dispenser, Abnormal	61
Administration device NOS, malfunction	25
Administration device NOS, abnormal	24
Appearance, Abnormal	23
Caps, Abnormal	22
Product defect NOS	21
Stopper, abnormal	21
Product syringe issue	17
Ataxia	14
Vomiting	13
Death	13
Foaming at the mouth	11
Product syringe missing	11
Underdose	10
Convulsion	9
Hypersalivation	9
Weakness	8
Nystagmus	7
Lethargy (see also Central nervous system depression in Neurological)	7

Species affected

Source: openFDA VeDDRA

Dog 2,940 Cat 379 Horse 8 Human 4 Ferret 2 Chinchilla 1 Rabbit 1 Donkey 1 Other Reptiles 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