EncoreTM CompudoseTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

EncoreTM CompudoseTM

Active ingredient

Estradiol

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

November 4, 2025

Adverse event reports

Source: openFDA VeDDRA

174

Reports mentioning this ingredient

January 26, 1987 – December 19, 2025

24

Classified serious

per reporter assessment

19

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 “ESTRADIOL”. 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
Increased sexual interest	29
Death	26
Behavioural disorder NOS	15
Mammary gland oedema	12
Accidental exposure	11
Vaginal swelling	9
INEFFECTIVE, WEIGHT INC	9
Hyperactivity	6
Lack of efficacy - NOS	6
Aggression	6
Implant site bleeding	6
Implant, Abnormal	6
Trauma NOS	5
Alopecia NOS	5
Abnormal oestrus NOS	5
Mammary gland disorder NOS	5
Rectal prolapse	4
Vaginal prolapse	4
Dispenser, Abnormal	4
Blood and lymphatic system disorder NOS	3

Species affected

Source: openFDA VeDDRA

Cattle 104 Dog 34 Human 7 Cat 2 Other 1 Horse 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