SevoFlo® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

SevoFlo®

Active ingredient

Sevoflurane

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

1,296

Reports mentioning this ingredient

November 8, 2000 – March 16, 2026

402

Classified serious

per reporter assessment

61

Lack of expected efficacy

resistance signal

13

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 “SEVOFLURANE”. 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
Death	267
Cardiac arrest	185
Apnoea	166
Bradycardia	96
INEFFECTIVE, ANESTHESIA	87
Cyanosis	36
Tachycardia	36
Recovery prolonged	30
Tachypnoea	29
Hypotension	25
Fever	24
Vomiting	23
Anorexia	23
Pale mucous membrane	23
Hyperexcitation	20
Convulsion	20
Blood and lymphatic system disorder NOS	19
Depression	18
Hypersalivation	18
Bradypnoea	17

Species affected

Source: openFDA VeDDRA

Dog 808 Cat 374 Human 19 Horse 14 Other 13 Rabbit 9 Other Birds 7 Ferret 7 Guinea Pig 5 Goat 3 Sheep 3 Duck 2

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