EluraTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

EluraTM

Active ingredient

Capromorelin

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

October 16, 2020

Adverse event reports

Source: openFDA VeDDRA

1,115

Reports mentioning this ingredient

October 31, 2017 – March 27, 2026

474

Classified serious

per reporter assessment

161

Lack of expected efficacy

resistance signal

12

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 “CAPROMORELIN”. 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
Vomiting	105
Lack of efficacy - NOS	95
Lethargy (see also Central nervous system depression in 'Neurological')	88
Hypersalivation	85
Lethargy (see also Central nervous system depression in Neurological)	81
UNPALATABLE	79
Death by euthanasia	74
Diarrhoea	66
Bradycardia	64
Not eating	59
Behavioural disorder NOS	56
Death	49
Hypotension	48
Product syringe calibration unreadable	47
Decreased appetite	36
Elevated alanine aminotransferase (ALT)	32
Ataxia	32
Hyperglycaemia	31
Elevated serum alkaline phosphatase (ALP)	31
Anorexia	30

Species affected

Source: openFDA VeDDRA

Dog 657 Cat 305 Human 6 Rabbit 2 Other Birds 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