MilbemiteTM Otic Solution — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

MilbemiteTM Otic Solution

Active ingredient

Milbemycin Oxime

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

48,055

Reports mentioning this ingredient

May 24, 2002 – March 26, 2026

8,100

Classified serious

per reporter assessment

25,558

Lack of expected efficacy

resistance signal

190

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 “MILBEMYCIN OXIME”. 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
Lack of efficacy (endoparasite) - heartworm	7,905
Vomiting	6,849
INEFFECTIVE, HOOKS	3,435
Diarrhoea	3,124
Lack of efficacy (endoparasite) - hookworm	2,882
Lethargy (see also Central nervous system depression in 'Neurological')	2,580
INEFFECTIVE, HEARTWORM LARVAE	2,369
UNPALATABLE	1,764
Other abnormal test result NOS	1,691
Lack of efficacy (roundworm)	1,472
Lack of efficacy (endoparasite) - roundworm NOS	1,232
Lack of efficacy - NOS	1,112
Seizure NOS	1,053
Emesis	965
Lack of efficacy (endoparasite) - whipworm	857
Not eating	790
Behavioural disorder NOS	756
INEFFECTIVE, WHIPS	687
Death	663
Lack of efficacy (heartworm)	644

Species affected

Source: openFDA VeDDRA

Dog 44,685 Cat 227 Human 56 Other Canids 3 Other 2 Primate 1 Rabbit 1 Cockatiel 1 Ferret 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