ProHeart® 12 — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

ProHeart® 12

Active ingredient

Moxidectin

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

May 14, 2026

Adverse event reports

Source: openFDA VeDDRA

59,266

Reports mentioning this ingredient

September 15, 1997 – March 27, 2026

28,376

Classified serious

per reporter assessment

21,078

Lack of expected efficacy

resistance signal

540

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 “MOXIDECTIN”. 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	10,341
Lack of efficacy (endoparasite) - heartworm	7,908
Anaphylaxis	4,857
Lack of efficacy (endoparasite) - hookworm	4,194
Lethargy (see also Central nervous system depression in 'Neurological')	3,779
Facial swelling (see also 'Skin')	3,560
Diarrhoea	3,479
Hives (see also 'Skin')	2,570
INEFFECTIVE, HEARTWORM LARVAE	2,387
Depression	2,180
Anorexia	2,154
Pale mucous membrane	1,857
Lack of efficacy (endoparasite) - roundworm NOS	1,827
Urticaria	1,816
Fever	1,796
Death	1,788
Lack of efficacy (endoparasite) - NOS	1,686
Pruritus	1,684
Facial oedema	1,482
Ataxia	1,471

Species affected

Source: openFDA VeDDRA

Dog 51,014 Horse 1,369 Cattle 1,312 Human 348 Goat 94 Cat 61 Sheep 57 Donkey 11 Other 7 Other Deer 4 Fish 3 Llama 3

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