Proin Ertm — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Proin Ertm

Active ingredient

Phenylpropanolamine hydrochloride

Application type

NADA

Sponsor

Pegasus Laboratories, Inc.

Applications on record

1

First published

April 1, 2019

Adverse event reports

Source: openFDA VeDDRA

939

Reports mentioning this ingredient

January 28, 2013 – March 17, 2026

298

Classified serious

per reporter assessment

299

Lack of expected efficacy

resistance signal

5

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 “PHENYLPROPANOLAMINE HYDROCHLORIDE”. 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 - NOS	276
Vomiting	143
Panting	101
Diarrhoea	77
Emesis (multiple)	63
Lethargy (see also Central nervous system depression in 'Neurological')	54
Lethargy (see also Central nervous system depression in Neurological)	50
Behavioural disorder NOS	43
Restlessness	41
Agitation	39
Anorexia	39
Underfilling, Package	33
Decreased appetite	28
Tablets, Abnormal	25
Seizure NOS	24
Anxiety	23
Hypertension	23
Weight loss	21
Drooling	21
Underdose	21

Species affected

Source: openFDA VeDDRA

Dog 873 Other 3 Human 2 Dormouse 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