Prostin F2 Alpha® Sterile Solution — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Prostin F2 Alpha® Sterile Solution

Active ingredient

Dinoprost Tromethamine

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

1,293

Reports mentioning this ingredient

January 20, 1987 – March 17, 2026

256

Classified serious

per reporter assessment

329

Lack of expected efficacy

resistance signal

104

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 “DINOPROST TROMETHAMINE”. 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	271
Death	236
Lack of efficacy - NOS	215
Injection site swelling	187
Unclassifiable adverse event	133
Accidental exposure	103
INEFFECTIVE, ABORTION	63
Myositis	59
Injection site infection	48
Recumbency	41
Death by euthanasia	41
Lameness	40
No sign	39
Injection site gaseous gangrene	38
Injection site pain	36
Injection site abscess	33
Abdominal pain	27
Fever	23
Injection site inflammation	22
Oedema of the extremities (see also other SOCs for most applicable oedema)	20

Species affected

Source: openFDA VeDDRA

Cattle 907 Human 176 Horse 61 Pig 22 Dog 17 Goat 10 Cat 3 Llama 1 Alpaca 1 Sheep 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