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EAZI-BREEDTM CIDR® Cattle Insert

Progesterone

Veterinary NADA Approved 841 adverse event reports

Overview

Source: Animal Drugs @ FDA
Proprietary name
EAZI-BREEDTM CIDR® Cattle Insert
Active ingredient
Progesterone
Application type
NADA
Sponsor
Zoetis Inc.
Applications on record
1
First published
March 2, 2021

Adverse event reports

Source: openFDA VeDDRA
841
Reports mentioning this ingredient
October 12, 2002 – March 11, 2026
75
Classified serious
per reporter assessment
182
Lack of expected efficacy
resistance signal
21
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 “PROGESTERONE”. 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
INEFFECTIVE, ESTRUS SYNCHRONIZ 211
Insert, Damaged 62
Lack of efficacy - NOS 58
Product Defect, General 53
Containers, Damaged 49
Insert, Abnormal 36
Underfilling, Package 35
Implant, Abnormal 34
No sign 32
Rectal prolapse 32
Vaginitis 29
Death 28
Device Defective NOS 27
Uncoded sign 27
Unclassifiable adverse event 24
Tablets, Abnormal 24
Color, Abnormal 22
Accidental exposure 20
INEFFECTIVE, ESTRUS INDUCTION 18
Applicator, Abnormal 17

Species affected

Source: openFDA VeDDRA
Cattle 482 Sheep 28 Human 22 Goat 18 Dog 7 Horse 5 Other Deer 2 White tailed deer 2 Other 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