Aservo® EquiHaler® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Aservo® EquiHaler®

Active ingredient

Ciclesonide

Application type

NADA

Sponsor

Boehringer lngelheim Animal Health USA, Inc.

Applications on record

1

First published

January 8, 2024

Adverse event reports

Source: openFDA VeDDRA

301

Reports mentioning this ingredient

October 17, 2016 – October 23, 2025

11

Classified serious

per reporter assessment

43

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 “CICLESONIDE”. 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
Dispenser, Abnormal	89
Difficulty of Use	80
Lack of efficacy - NOS	41
Inhaler, malfunction	28
Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle')	26
Behavioural disorder NOS	20
Product problem	20
Underfilling, Container	13
Circumstance or info capable of leading to medication error	12
Administration device NOS, priming issue	7
Device breakage/fracture	6
Product Defect, General	6
Death	5
Death by euthanasia	4
Cough	4
Inhaler, damaged	4
Broken components, medical device	4
Administration device NOS, abnormal	3
Lameness	2
Hyperthermia	2

Species affected

Source: openFDA VeDDRA

Horse 94 Human 3

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