IsoFloTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

IsoFloTM

Active ingredient

Isoflurane

Application type

ANADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

May 17, 2017

Adverse event reports

Source: openFDA VeDDRA

5,033

Reports mentioning this ingredient

July 6, 1990 – March 24, 2026

2,416

Classified serious

per reporter assessment

448

Lack of expected efficacy

resistance signal

86

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 “ISOFLURANE”. 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
INEFFECTIVE, ANESTHESIA	337
Death	322
Cardiac arrest	202
Apnoea	149
Bradycardia	146
Hypotension	90
Accidental exposure	76
Dyspnoea	73
Vomiting	71
Tachycardia	71
Lethargy (see also Central nervous system depression in Neurological)	69
Lack of efficacy - NOS	63
Recovery prolonged	55
Death by euthanasia	52
Tachypnoea	49
Hyperthermia	49
Hypothermia	43
Unclassifiable adverse event	41
Fever	37
Diarrhoea	37

Species affected

Source: openFDA VeDDRA

Dog 2,655 Cat 1,953 Human 89 Other 72 Horse 46 Rabbit 43 Mouse 19 Rat 17 Other Birds 14 Guinea Pig 11 Pig 8 Monkey 7

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

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